Phase I Study to Assess the Safety and Immunology of a COVID-19 Vaccine With GRAd-COV2 Vaccine

Sponsor

ReiThera Srl (Industry)

Overall Status

Completed

CT.gov ID

NCT04528641

Collaborator

Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani (Other)

Enrollment

Locations

Arms

9.3

Actual Duration (Months)

Patients Per Site

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RT-CoV-2 is a Phase I, open-label, dose escalation multicenter clinical trial to assess safety and immunogenicity of the candidate Coronavirus disease (COVID-19) vaccine GRAd-COV2 in Italian healthy volunteers aged 18-55 years and 65-85 years inclusive. GRAd-COV2 is based on a novel replication defective Gorilla Adenovirus and encodes for SARS-COV-2 Spike protein.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Biological: GRAd-COV2	Phase 1

Detailed Description

This study will evaluate a singular intramuscular administration of GRAd-COV2 at 3 dose levels: 5e10, 1e11, 2e11viral particles (vp). There will be 6 study arms for a total of 90 healthy volunteers, divided into 2 cohorts of age, 18-55y and 65-85y, respectively.

Participants will be followed up for 24 weeks after vaccination. Follow up includes safety and immunogenicity assessment. Follow up visits will occur at day2, then 1, 2, 4, 8, 12, 24 weeks after vaccination.

The primary objective is to evaluate the safety and reactogenicity of a single dose vaccination schedule of GRAd-COV2 across 3 dosages in healthy younger and older adults. The secondary objective is to evaluate humoral and cellular immunogenicity.

Study Design

Study Type:

Interventional

Actual Enrollment :

98 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Phase I, open-label, dose escalation, clinical trial to assess the safety and immunogenicity of the candidate GRAd-COV2 vaccine in 90 healthy volunteers aged 18-55 years and elderly volunteers aged 65-85 years. The vaccine will be administered intramuscularly once in time.Phase I, open-label, dose escalation, clinical trial to assess the safety and immunogenicity of the candidate GRAd-COV2 vaccine in 90 healthy volunteers aged 18-55 years and elderly volunteers aged 65-85 years. The vaccine will be administered intramuscularly once in time.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Phase 1, Dosage-Escalation Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine GRAd-COV2 in Healthy Adults and Elderly Subjects

Actual Study Start Date :

Aug 10, 2020

Actual Primary Completion Date :

May 19, 2021

Actual Study Completion Date :

May 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 - Low dose Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15	Biological: GRAd-COV2 Single intramuscular administration.
Experimental: Arm 2 - Intermediate dose Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15	Biological: GRAd-COV2 Single intramuscular administration.
Experimental: Arm 3 - High dose Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15	Biological: GRAd-COV2 Single intramuscular administration.
Experimental: Arm 4 - Low dose Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16	Biological: GRAd-COV2 Single intramuscular administration.
Experimental: Arm 5 - Intermediate dose Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15	Biological: GRAd-COV2 Single intramuscular administration.
Experimental: Arm 6 - High dose Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15	Biological: GRAd-COV2 Single intramuscular administration.

Outcome Measures

Primary Outcome Measures

Occurrence of Solicited Local AE Signs and Symptoms 7 Days Following the Vaccination [7 days following the vaccination]
Participants were monitored for 7 days post-vaccination and the occurrence of solicited local AE signs and symptoms were collected.
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination [7 days following the vaccination]
Participants were monitored for 7 days post-vaccination and the occurrence of solicited systemic AE signs and symptoms were collected.
Occurrence of Unsolicited AE 28 Days Following the Vaccination [28 days following the vaccination]
Occurrence of unsolicited AEs: unsolicited AEs were collected using the patient Diary and reported as "Any AE" occurring 28 days following the vaccination.
Occurrence of Serious AE 24 Weeks Following the Vaccination [24 weeks following the vaccination]
Occurrence of any treatment - emergent serious AE and treatment - emergent SAE related to study drug was monitored during the study period (24 weeks following vaccination)
Change in Leucocytes From Baseline [baseline, Weeks 1,2,4,8,12, and 24]
Change in Basophils From Baseline [Weeks 1,2,4,8,12, and 24]
Change in Eosinophils From Baseline [Weeks 1,2,4,8,12, and 24]
Change in Neutrophils From Baseline [Weeks 1,2,4,8,12, and 24]
Change from baseline was calculated as the value at each week minus the value at the baseline.
Change in Monocytes From Baseline [Weeks 1,2,4,8,12, and 24]
Change in Lymphocytes From Baseline [Weeks 1,2,4,8,12, and 24]
Change in Erythrocytes From Baseline [Weeks 1,2,4,8,12, and 24]
Change in Hematocrit From Baseline [Weeks 1,2,4,8,12, and 24]
Change in Platelets From Baseline [Weeks 1,2,4,8,12, and 24]
Change in Hemoglobin From Baseline [Weeks 1,2,4,8,12, and 24]
Change in Sodium From Baseline [week 1,2,4,8,12, and 24]
Change in Potassium From Baseline [week 1,2,4,8,12, and 24]
Change in Alkaline Phosphatase From Baseline [week 1,2,4,8,12, and 24]
Change in Alanine Aminotransferase From Baseline [week 1,2,4,8,12, and 24]
Change in Aspartate Aminotransferase From Baseline [week 1,2,4,8,12, and 24]
Change in Direct Bilirubin Form Baseline [week 1,2,4,8,12, and 24]
Change in Bilirubin From Baseline [week 1,2,4,8,12, and 24]
Change in Albumin Form Baseline [week 1,2,4,8,12, and 24]
Change in Creatinine Form Baseline [week 1,2,4,8,12, and 24]
Change in Lactate Dehydrogenase From Baseline [week 1,2,4,8,12, and 24]
Change in Urea Nitrogen From Baseline [week 1,2,4,8,12, and 24]

Secondary Outcome Measures

Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody [week 1, 2, 4, 8, 12, and 24]
To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine Immunogenicity Result: Seroconversion for Anti-S Antibody Interpretation: n. of subjects positive, negative or indeterminate at week 1, 2, 4, 8, 12, and 24 after vaccination.
Number of Participants With Positive, Negative Anti-n Antibody [week 1, 2, 4, 8, 12 and 24]
To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated: anti-N Antibody Interpretation: n. of subjects positive, negative at week 1, 2, 4, 8, 12 and 24 compared to baseline
Number of Participants With Positive, Negative for Micro Neutralization Test [week 4 and week 24]
To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated: Micro Neutralization test Interpretation: n. of positive and negative subjects at week 4 and week 24 by evaluating geometric mean titer change from baseline
Immunogenicity - T-cell Response [baseline, week 2, week 4, week 8, week 12, week 24]
To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated. T-cells were evaluated on frozen and fresh (week2) samples Within-cohort comparisons to assess the difference in immune response according to different doses in the same population Across-the-cohort comparison to assess whether elderlies and adults have a different pattern of immune response after vaccination at different endpoints Unit: spot-forming cells [SFC]/1 × 10^6 peripheral blood mononuclear cell [PBMC] Interpretation: values higher than at baseline are indicative of a persistent spike-specific memory T-cell establishment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

A subject must meet all of the following criteria to be eligible to participate in this study:

Provides written informed consent prior to initiation of any study procedures.
Be able to understand and agrees to comply with planned study procedures and be available for all study visits.
Agrees to the collection of venous blood per protocol.
Confirms to have not donated blood three months before the study
Agrees to refrain from blood during the study and until the three months after the end of the study.
Body Mass Index 18-29 kg/m2, inclusive, at screening.
Premenopausal women must agree to use one acceptable primary form of contraception.
Premenopausal women must have a negative urine pregnancy test the day of vaccination and are routinely using - and willing to use up to six months from vaccine administration - an effective method of birth control resulting in a low failure rate (i.e., hormonal contraception, condoms in combination with a spermicidal cream, male partner sterilization-vasectomy or total sexual abstinence).
Oral temperature ≤37.0 degrees Celsius the day of the administration of the vaccine
Pulse no greater than 100 beats per minute.
Systolic blood pressure (BP) is 85 to 139 mmHg, inclusive the day of vaccination.
Should not show laboratory values outside the normal range which may have clinical significance even in absence of specific signs or symptoms.

Exclusion Criteria:

A subject who meets any of the following criteria will be excluded from participation in this study:

Positive serology for anti-HIV-Ab
Positive HbBsAg
Positive anti-HCV-Ab
Positive for SARS-CoV-2 (either anti-S-Ab or anti-N-Ab)
Acute illness, as determined by the site PI or appropriate sub-investigator, the day of vaccination.
Breastfeeding women
Autoimmune and hyper-inflammatory condition
History of atopy (or any IgE associated condition) who had required treatment over the last 6 months;
History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines;
Assumption of any immunomodulatory medication over the last 4 months (including, but not limited to, systemic corticosteroids, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs). The use of low dose topical, ophthalmic, inhaled, and intranasal steroid preparations will be permitted.
Presence of self-reported or medically documented significant medical condition
Presence of self-reported or medically documented significant psychiatric condition
Significant cardiovascular disease needing therapy or history of myocarditis or pericarditis or heart surgery. Patients in treatment with Sartans or ACE-Inhibitors and good response to therapy may be included.
Neurological or neurodevelopmental conditions (e.g., history of migraines in the past 5 years, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis).
Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed.
Primary or secondary immunodeficiency of any cause.
Participated in another investigational study involving vaccination of biologic compounds in the last 12 months.
Currently enrolled in or plans to participate in another clinical trial with an investigational agent that will be received during the study-reporting period.
Administration of immunoglobulins and/or any blood or blood products within the 4 months before the first vaccine administration or at any time during the study.
Has any significant disorder of coagulation.
Has any chronic liver disease, including fatty liver.
Has a history of alcohol abuse or other recreational drug use within 6 months before the first vaccine administration.
Has any abnormality or permanent body art (e.g., tattoo) that would interfere with the ability to observe local reactions at the injection site (deltoid region).
Received or plans to receive additional vaccination within 4 weeks before or after each vaccination.
Has been reported as a case (confirmed or probable) of COVID-19 from the regional health system
Has any clinical conditions that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation, this includes any acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	INMI Spallanzani	Rome		Italy	00149
2	Centro Ricerche Cliniche	Verona		Italy	37134

Sponsors and Collaborators

ReiThera Srl
Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani

Investigators

Principal Investigator: Simone Lanini, Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

ReiThera Srl

ClinicalTrials.gov Identifier:

NCT04528641

Other Study ID Numbers:

RT-CoV-2

First Posted:

Aug 27, 2020

Last Update Posted:

Feb 8, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	a total of 180 subjects were screened and 98 subjects were enrolled in the study. seven out of 98 enrolled subjects were not administered vaccine because of withdrawal by subjects (3 subjects) and because the protocol allowed Screening period 21 days passed (4 subjects). a total of 91 subjects were administered vaccine.

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Period Title: Overall Study
STARTED	15	15	15	16	15	15
COMPLETED	15	15	15	15	15	14
NOT COMPLETED	0	0	0	1	0	1

Baseline Characteristics

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose	Total
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Total of all reporting groups
Overall Participants	15	15	15	16	15	15	91
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	15 100%	15 100%	15 100%	0 0%	0 0%	0 0%	45 49.5%
>=65 years	0 0%	0 0%	0 0%	16 100%	15 100%	15 100%	46 50.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.9 (9.1)	37.0 (10.2)	36.2 (11.1)	69.5 (4.6)	70.8 (5.6)	70.0 (3.5)	53.1 (18.9)
Sex: Female, Male (Count of Participants)
Female	7 46.7%	5 33.3%	6 40%	5 31.3%	5 33.3%	5 33.3%	33 36.3%
Male	8 53.3%	10 66.7%	9 60%	11 68.8%	10 66.7%	10 66.7%	58 63.7%
Race/Ethnicity, Customized (participants) [Number]
Hispanic or Latino	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%	1 1.1%
Not Hispanic or Latino	15 100%	14 93.3%	15 100%	16 100%	15 100%	15 100%	90 98.9%
Region of Enrollment (participants) [Number]
Italy	15 100%	15 100%	15 100%	16 100%	15 100%	15 100%	91 100%
Demographic - weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	73.9 (12.172)	69.7 (14.91)	70.9 (13.49)	73.61 (12.874)	70.37 (10.181)	70.9 (10.54)	71.59 (12.224)
Demographic - Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	173.3 (9.82)	171.9 (10.93)	173.8 (10.21)	169.0 (9.01)	168.1 (11.30)	169.7 (9.47)	170.9 (10.12)
Demographic - BMI (Kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg/m^2]	24.514 (2.5747)	23.367 (3.0412)	23.332 (2.7751)	24.767 (3.0552)	24.574 (2.5569)	25.035 (2.2006)	24.514 (2.5747)

Outcome Measures

1. Primary Outcome

Title	Occurrence of Solicited Local AE Signs and Symptoms 7 Days Following the Vaccination
Description	Participants were monitored for 7 days post-vaccination and the occurrence of solicited local AE signs and symptoms were collected.
Time Frame	7 days following the vaccination

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
Injection site pain	10 66.7%	12 80%	10 66.7%	2 12.5%	1 6.7%	4 26.7%
Injection site erythema	1 6.7%	2 13.3%	2 13.3%	0 0%	0 0%	1 6.7%
Injection site swelling	0 0%	0 0%	1 6.7%	0 0%	0 0%	1 6.7%
Injection site Haematoma	0 0%	0 0%	0 0%	0 0%	1 6.7%	0 0%

2. Primary Outcome

Title	Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Description	Participants were monitored for 7 days post-vaccination and the occurrence of solicited systemic AE signs and symptoms were collected.
Time Frame	7 days following the vaccination

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
Headache	5 33.3%	6 40%	10 66.7%	6 37.5%	3 20%	2 13.3%
Fatigue	8 53.3%	7 46.7%	10 66.7%	7 43.8%	2 13.3%	4 26.7%
Pyrexia	3 20%	4 26.7%	11 73.3%	4 25%	4 26.7%	4 26.7%
Myalgia	1 6.7%	5 33.3%	4 26.7%	5 31.3%	1 6.7%	5 33.3%
Chills	1 6.7%	1 6.7%	6 40%	4 25%	4 26.7%	6 40%
Nausea	2 13.3%	2 13.3%	3 20%	1 6.3%	3 20%	2 13.3%
Neutropeonia	1 6.7%	1 6.7%	2 13.3%	1 6.3%	1 6.7%	2 13.3%
Abdominal Pain	1 6.7%	4 26.7%	0 0%	0 0%	0 0%	0 0%
Diarrhoea	1 6.7%	3 20%	0 0%	0 0%	1 6.7%	0 0%
Arthralgia	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.7%
Back Pain	0 0%	0 0%	0 0%	1 6.3%	0 0%	0 0%
Cough	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.7%
Faeces Soft	0 0%	0 0%	1 6.7%	0 0%	0 0%	0 0%
Hot flush	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%
Hyperkalaemia	0 0%	0 0%	0 0%	0 0%	1 6.7%	0 0%
Muscle injury	0 0%	0 0%	0 0%	0 0%	1 6.7%	0 0%
Muscle strain	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.7%
Tooth fracture	0 0%	0 0%	1 6.7%	0 0%	0 0%	0 0%
Dyspnoea	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.7%
Oropharyngeal pain	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%
Ecchymosis	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%
Tooth abscess	0 0%	0 0%	0 0%	1 6.3%	0 0%	0 0%
Chalazion	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.7%
Lymphadenopathy	1 6.7%	0 0%	0 0%	0 0%	0 0%	0 0%

3. Primary Outcome

Title	Occurrence of Unsolicited AE 28 Days Following the Vaccination
Description	Occurrence of unsolicited AEs: unsolicited AEs were collected using the patient Diary and reported as "Any AE" occurring 28 days following the vaccination.
Time Frame	28 days following the vaccination

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=14 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1 - any AE : Mild	9 60%	9 60%	13 86.7%	9 56.3%	6 40%	7 46.7%
week 1 - any AE : Moderate	3 20%	5 33.3%	6 40%	1 6.3%	2 13.3%	2 13.3%
week 1 - any AE : Severe	0 0%	0 0%	0 0%	1 6.3%	0 0%	1 6.7%
week 2 - any AE: mild	5 33.3%	5 33.3%	0 0%	5 31.3%	1 6.7%	0 0%
week 2 - any AE: moderate	0 0%	1 6.7%	0 0%	0 0%	1 6.7%	0 0%
week 2 - any AE: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
week 3 - Any AE: mild	4 26.7%	3 20%	0 0%	3 18.8%	1 6.7%	0 0%
week 3 - any AE: moderate	0 0%	1 6.7%	2 13.3%	1 6.3%	1 6.7%	0 0%
week 3 - any AE: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
week 4 - any AE: mild	1 6.7%	2 13.3%	0 0%	0 0%	1 6.7%	0 0%
week 4 - any AE: moderate	0 0%	0 0%	1 6.7%	0 0%	0 0%	0 0%
week 4 - any AE: severe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

4. Primary Outcome

Title	Occurrence of Serious AE 24 Weeks Following the Vaccination
Description	Occurrence of any treatment - emergent serious AE and treatment - emergent SAE related to study drug was monitored during the study period (24 weeks following vaccination)
Time Frame	24 weeks following the vaccination

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
Any treatment-emergent SAE related to study drug	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Any treatment-emergent SAE	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

5. Primary Outcome

Title	Change in Leucocytes From Baseline
Description
Time Frame	baseline, Weeks 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	-0.033 (1.285)	-0.199 (1.3799)	-0.265 (0.5758)	-0.159 (0.7563)	-0.019 (0.4475)	0.055 (0.6884)
week 2	0.218 (1.354)	0.091 (1.2248)	-0.099 (0.6808)	0.158 (0.9098)	0.329 (0.7771)	0.190 (0.6531)
week 4	-0.230 (1.2881)	0.472 (1.2324)	-0.286 (0.6787)	-0.261 (1.0477)	0.186 (1.0368)	0.186 (1.1456)
week 8	0.154 (0.8825)	0.094 (1.2006)	-0.029 (1.0882)	-0.013 (0.8416)	0.080 (0.5862)	-0.087 (0.6728)
week 12	-0.045 (1.0228)	0.409 (1.7620)	0.133 (1.1654)	-0.060 (0.9897)	0.357 (0.8966)	-0.175 (0.7302)
week 24	-0.695 (1.199)	-0.125 (1.0887)	-0.263 (0.8854)	-0.310 (1.0615)	0.196 (0.7996)	0.199 (0.8817)

6. Primary Outcome

Title	Change in Basophils From Baseline
Description
Time Frame	Weeks 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	-0.002 (0.0094)	-0.002 (0.0147)	-0.010 (0.0169)	-0.001 (0.0141)	-0.009 (0.0113)	-0.001 (0.0162)
week 2	0.001 (0.0122)	0.007 (0.0129)	-0.002 (0.0142)	0.004 (0.011)	0.003 (0.0272)	0.004 (0.0124)
week 4	-0.004 (0.0118)	0.0 (0.0120)	-0.003 (0.150)	0.001 (0.054)	-0.003 (0.0129)	0.004 (0.0199)
week 8	-0.001 (0.0122)	0.001 (0.0133)	-0.001 (0.0119)	-0.002 (0.0164)	-0.005 (0.0092)	0.003 (0.0116)
week 12	0.002 (0.0142)	0.003 (0.0159)	0.0 (0.0108)	0.0 (0.0121)	0.0 (0.0156)	0.002 (0.0142)
week 24	-0.004 (0.0135)	0.004 (0.0112)	-0.001 (0.0146)	-0.003 (0.0168)	-0.004 (0.0140)	-0.001 (0.0141)

7. Primary Outcome

Title	Change in Eosinophils From Baseline
Description
Time Frame	Weeks 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	0.009 (0.0478)	-0.017 (0.0649)	-0.007 (0.0555)	0.031 (0.0483)	0.009 (0.0674)	0.006 (0.0467)
week 2	0.014 (0.0370)	0.029 (0.0644)	0.024 (0.0697)	0.046 (0.0574)	0.037 (0.0743)	0.021 (0.0439)
week 4	-0.013 (0.0873)	-0.003 (0.0603)	-0.003 (0.0471)	-0.008 (0.0680)	0.001 (0.0442)	0.027 (0.0870)
week 8	-0.023 (0.0716)	-0.002 (0.1202)	-0.033 (0.0979)	0.010 (0.0732)	0.006 (0.0617)	0.021 (0.0935)
week 12	-0.004 (0.0840)	-0.017 (0.077)	-0.013 (0.1085)	-0.001 (0.0804)	0.007 (0.0707)	0.02 (0.0728)
week 24	-0.051 (0.0907)	-0.013 (0.0807)	0.008 (0.1239)	0.012 (0.0914)	0.015 (0.0635)	0.018 (0.0477)

8. Primary Outcome

Title	Change in Neutrophils From Baseline
Description	Change from baseline was calculated as the value at each week minus the value at the baseline.
Time Frame	Weeks 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	-0.241 (1.1183)	-0.105 (1.3346)	-0.296 (0.5781)	-0.391 (0.7397)	-0.147 (0.3939)	-0.092 (0.5560)
week 2	-0.115 (1.1387)	-0.254 (1.0089)	-0.313 (0.4109)	-0.014 (0.8032)	-0.015 (0.5966)	-0.044 (0.4523)
week 4	-0.273 (1.3001)	-0.417 (1.0814)	-0.273 (0.4670)	-0.208 (1.0731)	0.116 (0.8245)	0.011 (1.0820)
week 8	-0.131 (0.8082)	0.008 (1.1261)	0.097 (0.9320)	0.054 (0.7545)	-0.025 (0.4139)	-0.148 (0.5358)
week 12	-0.159 (0.8592)	0.458 (1.8931)	0.153 (1.0128)	0.027 (0.9118)	0.165 (0.6483)	-0.180 (0.6024)
week 24	-0.376 (1.1492)	-0.141 (0.8632)	-0.151 (0.6475)	-0.378 (0.9802)	0.073 (0.6629)	0.147 (0.7146)

9. Primary Outcome

Title	Change in Monocytes From Baseline
Description
Time Frame	Weeks 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	-0.0040 (0.0733)	-0.0227 (0.11218)	-0.0353 (0.0689)	-0.0525 (0.0668)	0.0100 (0.0860)	-0.0307 (0.0694)
week 2	0.0733 (0.1011)	0.0427 (0.1353)	0.0227 (0.1109)	0.0144 (0.0999)	0.0520 (0.0844)	0.0280 (0.0820)
week 4	-0.0220 (0.0668)	-0.0327 (0.1142)	-0.0287 (0.0666)	-0.0556 (0.0909)	0.0400 (0.1110)	-0.0193 (0.0656)
week 8	0.0073 (0.0612)	0.0113 (0.1336)	-0.0380 (0.0927)	-0.0431 (0.0624)	0.0253 (0.0801)	-0.0227 (0.0849)
week 12	-0.0004 (0.0797)	0.0007 (0.1331)	-0.0240 (0.0662)	-0.0475 (0.0772)	0.0453 (0.0856)	-0.0387 (0.0605)
week 24	-0.0427 (0.0707)	-0.0107 (0.1163)	-0.0233 (0.1271)	-0.0227 (0.0960)	0.0493 (0.1127)	-0.0021 (0.0567)

10. Primary Outcome

Title	Change in Lymphocytes From Baseline
Description
Time Frame	Weeks 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	0.209 (0.5808)	-0.060 (0.4455)	0.077 (0.2050)	0.179 (0.2565)	0.115 (0.2064)	0.179 (0.2516)
week 2	0.247 (0.3868)	0.257 (0.3913)	0.169 (0.4038)	0.109 (0.2490)	0.249 (0.2813)	0.184 (0.3094)
week 4	0.077 (0.4069)	-0.023 (0.3568)	0.013 (0.2528)	0.010 (0.3045)	0.03 (0.2146)	0.103 (0.1823)
week 8	-0.012 (0.3490)	0.063 (0.3991)	-0.058 (0.2627)	-0.039 (0.2856)	0.077 (0.2252)	0.062 (0.2502)
week 12	0.115 (0.4083)	-0.045 (0.3655)	0.015 (0.2884)	-0.046 (0.3200)	0.135 (0.2941)	0.031 (0.2214)
week 24	-0.219 (0.3293)	0.027 (0.5038)	-0.097 (0.2514)	0.072 (0.2427)	0.064 (0.2607)	0.049 (0.3324)

11. Primary Outcome

Title	Change in Erythrocytes From Baseline
Description
Time Frame	Weeks 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	-0.091 (0.1603)	-0.067 (0.2342)	-0.037 (0.1574)	-0.0158 (0.2014)	-0.066 (0.2763)	-0.074 (0.1644)
week 2	0.001 (0.01757)	-0.093 (0.220)	-0.037 (0.2251)	-0.084 (0.1660)	-0.073 (0.2447)	-0.149 (0.0896)
week 4	-0.065 (0.2011)	-0.059 (0.2081)	-0.039 (0.2599)	-0.059 (0.2024)	-0.119 (0.2456)	-0.079 (0.1122)
week 8	0.026 (0.2133)	0.002 (0.2320)	0.047 (0.3186)	-0.024 (0.2767)	-0.061 (0.3035)	-0.034 (0.1874)
week 12	0.054 (0.1722)	-0.036 (0.3260)	0.027 (0.3375)	-0.013 (0.2587)	-0.045 (0.2680)	-0.070 (0.1488)
week 24	0.007 (0.2073)	-0.046 (0.2601)	0.001 (0.2936)	0.018 (0.2453)	-0.058 (0.2505)	-0.062 (0.1691)

12. Primary Outcome

Title	Change in Hematocrit From Baseline
Description
Time Frame	Weeks 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	-1.16 (1.446)	-0.50 (2.429)	-0.35 (1.280)	-1.81 (2.05)	-1.38 (2.155)	-0.59 (1.499)
week 2	-0.19 (1.552)	-0.49 (2.086)	-0.33 (1.991)	-0.52 (2.004)	-0.80 (2.267)	-1.47 (0.647)
week 4	-0.59 (1.492)	-0.41 (2.004)	0.15 (2.091)	-0.41 (2.339)	-1.26 (2.160)	-0.78 (0.986)
week 8	0.26 (1.950)	.047 (2.132)	0.85 (2.857)	-0.04 (2.790)	-0.91 (2.775)	0.05 (2.017)
week 12	0.31 (1.594)	-0.32 (3.175)	0.61 (2.312)	-0.13 (2.819)	-0.49 (2.511)	-0.59 (1.470)
week 24	0.21 (1.758)	-0.29 (2.534)	0.62 (2.020)	0.32 (2.511)	-0.81 (2.255)	-0.79 (1.389)

13. Primary Outcome

Title	Change in Platelets From Baseline
Description
Time Frame	Weeks 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	7.7 (19.56)	-0.1 (24.38)	1.5 (27.38)	-3.2 (16.20)	-8.1 (12.15)	2.3 (21.86)
week 2	17.4 (25.92)	10.5 (33.06)	20.3 (24.62)	4.6 (17.77)	2.7 (16.23)	6.5 (14.79)
week 4	4.3 (22.90)	-0.2 (22.27)	6.1 (24.28)	-0.1 (22.93)	-1.8 (17.76)	6.2 (16.23)
week 8	11.0 (22.90)	8.2 (31.41)	14.2 (23.86)	-3.8 (24.07)	2.0 (14.11)	9.4 (28.11)
week 12	15.9 (31.26)	6.0 (30.25)	13.3 (27.51)	-7.1 (21.05)	-6.3 (16.19)	0.1 (17.94)
week 24	11.3 (30.27)	11.3 (36.34)	5.9 (18.30)	-2.7 (31.25)	1.9 (19.30)	-4.4 (24.42)

14. Primary Outcome

Title	Change in Hemoglobin From Baseline
Description
Time Frame	Weeks 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	-3.6 (5.21)	-2.1 (6.31)	-2.3 (4.89)	-4.5 (5.70)	-1.7 (7.07)	-2.2 (4.44)
week 2	-0.8 (5.54)	-2.6 (6.33)	-2.8 (6.14)	-3.3 (5.51)	-2.1 (7.45)	-3.0 (3.25)
week 4	-2.3 (5.86)	-4.8 (6.05)	-5.8 (6.66)	-1.6 (6.55)	-1.9 (7.52)	1.5 (5.01)
week 8	3.5 (6.15)	-2.9 (6.61)	-0.9 (8.20)	0.3 (7.84)	-1.6 (9.45)	2.4 (4.87)
week 12	-2.0 (4.93)	-2.6 (8.94)	0.1 (8.71)	1.8 (8.07)	0.6 (7.89)	0.3 (5.74)
week 24	-0.8 (6.13)	-3.1 (7.55)	0.1 (8.09)	2.8 (6.97)	-0.2 (7.88)	-0.1 (5.45)

15. Primary Outcome

Title	Change in Sodium From Baseline
Description
Time Frame	week 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	-0.1 (1.33)	0.6 (2.06)	0.3 (2.29)	0.3 (1.65)	0.6 (1.92)	1.8 (1.97)
week 2	0.6 (1.72)	0.4 (2.32)	0.3 (1.79)	0.3 (221)	-0.5 (1.85)	1.5 (1.96)
week 4	0.5 (1.36)	-1.6 (1.96)	0.1 (1.39)	-1.1 (1.18)	0.6 (1.92)	0.8 (2.21)
week 8	0.0 (1.56)	-0.5 (1.81)	-0.1 (2.03)	-0.7 (182)	0.5 (2.07)	0.3 (2.26)
week 12	-0.2 (1.37)	-0.9 (1.25)	1.1 (2.31)	-0.8 (1.84)	-0.2 (2.11)	1.8 (1.47)
week 24	0.8 (1.86)	-0.3 (2.19)	1.8 (2.01)	0.1 (1.85)	0.9 (1.85)	2.1 (2.14)

16. Primary Outcome

Title	Change in Potassium From Baseline
Description
Time Frame	week 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	0.125 (0.3070)	-0.007 (0.3696)	0.189 (0.4025)	0.036 (0.3269)	0.239 (0.5699)	-0.158 (0.3481)
week 2	0.057 (0.2369)	-0.037 (0.2778)	0.064 (0.2900)	-0.049 (0.4433)	-0.137 (0.4979)	-0.089 (0.3626)
week 4	0.036 (0.3004)	-0.195 (0.2952)	0.113 (0.34446)	0.023 (0.4688)	-0.023 (0.4196)	-0.227 (0.3090)
week 8	-0.028 (0.3874)	0.045 (0.3680)	0.241 (0.3395)	-0.008 (0.4328)	0.271 (0.3383)	-0.209 (0.3582)
week 12	0.040 (0.4153)	-0.205 (0.4556)	0.217 (0.2773)	0.072 (0.3896)	0.089 (0.2322)	-0.110 (0.2961)
week 24	0.061 (0.2474)	0.161 (0.2367)	0.324 (0.2924)	0.023 (0.2988)	0.253 (0.410)	-0.190 (0.3313)

17. Primary Outcome

Title	Change in Alkaline Phosphatase From Baseline
Description
Time Frame	week 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	2.1 (7.52)	0.7 (4.92)	-3.7 (6.52)	-4.9 (4.89)	-0.7 (6.76)	0.9 (6.94)
week 2	0.5 (7.06)	2.0 (6.63)	-4.7 (6.43)	-1.8 (5.39)	-4.3 (5.61)	0.3 (7.62)
week 4	1.3 (9.62)	-0.4 (5.74)	3.6 (7.52)	-2.4 (6.31)	-2.7 (6.60)	3.2 (4.21)
week 8	5.0 (6.31)	2.5 (5.36)	1.1 (6.35)	-2.4 (5.94)	3.5 (6.24)	4.1 (5.65)
week 12	2.7 (11.92)	3.2 (5.91)	3.9 (7.81)	-1.1 (5.48)	-2.1 (10.02)	0.1 (6.02)
week 24	1.7 (8.17)	5.3 (9.49)	3.3 (9.50)	-1.7 (7.01)	2.1 (11.48)	2.3 (8.48)

18. Primary Outcome

Title	Change in Alanine Aminotransferase From Baseline
Description
Time Frame	week 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	1.3 (6.69)	2.3 (6.33)	-0.2 (2.91)	-1.8 (2.44)	4.3 (20.30)	0.2 (3.55)
week 2	2.7 (16.39)	2.0 (5.13)	2.5 (5.25)	-1.1 (3.26)	2.6 (3.98)	0.9 (3.68)
week 4	1.1 (10.91)	2.9 (3.81)	0.9 (6.65)	0.9 (3.96)	0.1 (3.84)	0.7 (4.43)
week 8	1.2 (12.13)	4.1 (6.08)	0.1 (5.46)	-1.4 (5.26)	0.8 (7.02)	-0.1 (2.99)
week 12	6.9 (12.59)	4.9 (6.33)	3.9 (9.84)	-0.5 (8.22)	0.4 (3.76)	-1.1 (3.23)
week 24	-0.7 (11.81)	1.2 (4.20)	0.3 (10.26)	10. (3.38)	-0.3 (6.31)	-0.9 (3.83)

19. Primary Outcome

Title	Change in Aspartate Aminotransferase From Baseline
Description
Time Frame	week 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	-1.60 (4.982)	0.40 (4.768)	-0.40 (2.898)	-1.38 (4.530)	3.93 (11.738)	-1.33 (2.380)
week 2	9.07 (32.288)	0.29 (3.106)	2.27 (3.262)	-2.44 (5.151)	0.07 (3.150)	-0.80 (3.649)
week 4	-0.13 (4.518)	2.53 (3.067)	0.87 (4.015)	0.69 (4.191)	1.47 (3.720)	-0.93 (3.240)
week 8	1.07 (4.480)	1.20 (5.735)	1.13 (3.623)	-2.50 (4.487)	1.13 (4.340)	-0.93 (3.411)
week 12	2.73 (6.147)	2.47 (4.533)	2.20 (4.109)	.194 (4.106)	-0.20 (3.986)	0.13 (3.739)
week 24	0.33 (6.091)	0.87 (2.774)	0.07 (5.391)	-1.53 (4.357)	4.27 (18.763)	-0.29 (3.384)

20. Primary Outcome

Title	Change in Direct Bilirubin Form Baseline
Description
Time Frame	week 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	0.1026 (0.9712)	-0.3420 (0.9950)	-0.2622 (1.5375)	-0.0214 (1.0992)	0.2280 (0.8878)	0.2280 (0.8419)
week 2	0.4140 (0.8857)	4.5942 (17.8620)	-0.1482 (1.1559)	-0.1603 (0.6767)	-0.0684 (0.05040)	-0.0570 (0.7129)
week 4	0.1140 (0.7907)	0.3762 (0.9053)	-0.1710 (1.6503)	-0.0107 (0.7835)	0.0570 (0.7331)	-0.1254 (0.8802)
week 8	0.6498 (0.8155)	0.2394 (0.9362)	-0.1026 (1.8449)	0.0962 (1.1945)	0.0570 (0.8783)	0.1140 (0.6452)
week 12	0.4789 (1.4059)	0.1938 (0.9209)	-0.3534 (1.3718)	-0.1603 (0.8365)	-0.6270 (0.7720)	-0.0228 (0.8547)
week 24	0.0114 (0.8610)	0.0689 (0.9883)	-0.1482 (2.1081)	0.1254 (0.9531)	-0.0342 (1.2181)	0.1710 (0.6938)

21. Primary Outcome

Title	Change in Bilirubin From Baseline
Description
Time Frame	week 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	0.3534 (3.7254)	-1.1970 (3.7725)	0.1048 (5.4294)	0.0641 (4.2155)	-0.0228 (3.5705)	0.5586 (2.8697)
week 2	1.1286 (3.4315)	-0.1938 (3.5435)	-0.1824 (4.4841)	-0.4275 (2.54871)	-0.7980 (1.7181)	-0.7069 (2.5436)
week 4	-0.7068 (3.0527)	1.0146 (3.526)	-0.2736 (6.4174)	0.1176 (2.9557)	-0.0456 (2.7064)	-0.6954 (2.9706)
week 8	2.1546 (3.7037)	0.2280 (3.2820)	0.2052 (7.1427)	0.0534 (3.9465)	-0.5244 (3.0702)	-0.3192 (1.9269)
week 12	1.9038 (6.9092)	0.3078 (3.7354)	-0.6954 (5.6701)	-1.1222 (2.5108)	-2.6220 (2.8960)	-0.3420 (3.1431)
week 24	-0.7524 (2.8223)	0.05586 (3.9258)	23.9286 (91.7547)	-0.0114 (3.4670)	-0.3078 (4.4235)	-0.1954 (2.9227)

22. Primary Outcome

Title	Change in Albumin Form Baseline
Description
Time Frame	week 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	-2.45 (2.989)	-0.65 (2.370)	-1.70 (2.6376)	-1.67 (2.775)	0.03 (2.343)	-0.64 (2.346)
week 2	-0.01 (2.334)	-0.83 (3.253)	-1.37 (2.943)	-1.03 (1.1885)	-0.73 (2.504)	-1.61 (1.739)
week 4	0.62 (3.150)	-159 (2.035)	-0.08 (2.486)	-1.00 (2.055)	-1.53 (2.707)	-0.87 (2.408)
week 8	-0.23 (2.666)	-2.07 (2.587)	0.71 (2.619)	-1.47 (2.587)	-2.43 (2.880)	-0.45 (2.770)
week 12	-0.86 (2.442)	-1.68 (2.815)	-0.25 (2.167)	-0.64 (2.2143)	-0.93 (1.617)	-0.13 (1.848)
week 24	-0.62 (2.155)	-2.56 (2.201)	-1.59 (2.630)	-1.21 (2.811)	-0.07 (3.501)	1.21 (2.598)

23. Primary Outcome

Title	Change in Creatinine Form Baseline
Description
Time Frame	week 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	-0.6483 (5.2878)	-2.9467 (5.8701)	1.4733 (3.9908)	-4.0333 (8.5827)	1.2963 (9.553)	-0.5304 (7.3491)
week 2	1.5323 (5.3404)	-2.1805 (4.9992)	2.1216 (37176)	0.3315 (7.9125)	0.3536 (5.9657)	-1.3555 (6.7561)
week 4	-2.3575 (4.4284)	-4.2432 (4.7511)	1.6501 (5.2284)	-2.4310 (8.9600)	-1.8959 (6.6394)	-1.7680 (5.9017)
week 8	2.2116 (6.3904)	-0.3536 (5.6088)	2.4163 (3.0889)	-3.228 (8.9278)	-1.5912 (4.6442)	-2.1216 (5.4779)
week 12	0.5893 (6.8610)	-2.8288 (5.5929)	1.1787 (3.2680)	-3.0940 (10.4097)	-4.4789 (6.7279)	-3.2413 (5.6175)
week 24	-4.9504 (5.6088)	-2.0037 (4.6112)	-0.11799 (5.382)	-4.2432 (9.2244)	-3.1824 (5.9751)	-1.6417 (7.1888)

24. Primary Outcome

Title	Change in Lactate Dehydrogenase From Baseline
Description
Time Frame	week 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	-3.5 (12.69)	0.5 (20.00)	6.5 (15.62)	-10.8 (17.09)	-2.6 (19.82)	0.9 (14.11)
week 2	8.4 (35.25)	1.4 (21.89)	7.3 (17.99)	-7.0 (20.64)	-10.9 (13.17)	-5.7 (16.18)
week 4	-3.0 (16.46)	-1.7 (18.67)	5.1 (15.34)	2.1 (12.37)	1.3 (17.54)	-3.9 (19.78)
week 8	-4.3 (10.31)	-2.4 (16.82)	14.2 (24.40)	-11.2 (17.86)	3.7 (37.19)	-4.2 (17.31)
week 12	-9.1 (13.48)	-3.8 (20.23)	1.3 (16.86)	-10.1 (17.55)	-8.9 (15.95)	-3.4 (23.85)
week 24	-9.4 (18.26)	-3.3 (20.58)	-2.1 (12.06)	-10.0 (19.42)	-3.1 (22.96)	2.4 (25.13)

25. Primary Outcome

Title	Change in Urea Nitrogen From Baseline
Description
Time Frame	week 1,2,4,8,12, and 24

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	15	15	15	16	15	15
week 1	0.0571 (1.9802)	0.0524 (1.5732)	-0.5712 (2.7988)	0.1428 (2.0927)	-0.4712 (1.5268)	-0.3237 (2.4570)
week 2	0.2951 (1.9132)	0.5284 (2.2289)	-0.9377 (3.3246)	-0.2365 (2.2977)	0.7854 (1.2804)	-0.6378 (2.4125)
week 4	0.1571 (2.2931)	-0.1856 (1.6149)	-0.1428 (2.3668)	-0.3570 (2.0358)	-0.6474 (1.8290)	-0.5807 (2.3925)
week 8	-0.4522 (2.0612)	-0.0286 (1.5584)	-0.0952 (2.322)	-0.0759 (2.3484)	-1.0900 (2.3572)	0.3237 (2.1001)
week 12	-0.0143 (1.8835)	0.1000 (2.1727)	-0.6045 (2.6703)	0.3525 (2.3561)	-0.4667 (2.1063)	-0.6426 (1.9342)
week 24	-0.0619 (1.7148)	0.2667 (2.8833)	-0.5331 (2.3939)	0.5379 (2.3910)	-0.2999 (1.5902)	-0.1989 (2.9145)

26. Secondary Outcome

Title	Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
Description	To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine Immunogenicity Result: Seroconversion for Anti-S Antibody Interpretation: n. of subjects positive, negative or indeterminate at week 1, 2, 4, 8, 12, and 24 after vaccination.
Time Frame	week 1, 2, 4, 8, 12, and 24

Outcome Measure Data

Analysis Population Description

One subject in arm-1 low dose (adult cohort) had an asymptomatic infection around the time of vaccination. This was discovered post hoc, and this subject was excluded from all Immunogenicity Analysis Set(IAS). One subject in Arm-4 low dose (elderly cohort) had a suspicious non-specific reactivity to the tests and was excluded from the IAS. Other specification: % = Calculated as nr. of subjects within category divided by nr. of subjects with non-missing observation at each time point.

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=14 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	14	15	15	15	15	15
positive	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
negative	14 93.3%	15 100%	15 100%	15 93.8%	15 100%	15 100%
indeterminate	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
positive	8 53.3%	7 46.7%	8 53.3%	4 25%	5 33.3%	5 33.3%
negative	6 40%	7 46.7%	6 40%	10 62.5%	7 46.7%	9 60%
indeterminate	0 0%	1 6.7%	1 6.7%	1 6.3%	3 20%	1 6.7%
positive	13 86.7%	14 93.3%	13 86.7%	14 87.5%	14 93.3%	14 93.3%
negative	1 6.7%	0 0%	2 13.3%	1 6.3%	1 6.7%	1 6.7%
indeterminate	0 0%	1 6.7%	0 0%	0 0%	0 0%	0 0%
positive	13 86.7%	14 93.3%	14 93.3%	10 62.5%	12 80%	13 86.7%
negative	1 6.7%	1 6.7%	0 0%	3 18.8%	3 20%	1 6.7%
indeterminate	0 0%	0 0%	0 0%	2 12.5%	0 0%	1 6.7%
positive	13 86.7%	13 86.7%	13 86.7%	10 62.5%	11 73.3%	13 86.7%
negative	1 6.7%	2 13.3%	1 6.7%	4 25%	4 26.7%	2 13.3%
indeterminate	0 0%	0 0%	0 0%	1 6.3%	0 0%	0 0%
positive	10 66.7%	7 46.7%	11 73.3%	6 37.5%	5 33.3%	10 66.7%
negative	4 26.7%	4 26.7%	1 6.7%	6 37.5%	6 40%	3 20%
indeterminate	0 0%	2 13.3%	1 6.7%	0 0%	2 13.3%	0 0%

27. Secondary Outcome

Title	Number of Participants With Positive, Negative Anti-n Antibody
Description	To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated: anti-N Antibody Interpretation: n. of subjects positive, negative at week 1, 2, 4, 8, 12 and 24 compared to baseline
Time Frame	week 1, 2, 4, 8, 12 and 24

Outcome Measure Data

Analysis Population Description

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=14 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	14	15	15	15	15	15
positive	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
negative	14 93.3%	15 100%	15 100%	15 93.8%	15 100%	15 100%
positive	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
negative	14 93.3%	15 100%	15 100%	15 93.8%	15 100%	15 100%
positive	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
negative	14 93.3%	15 100%	15 100%	15 93.8%	15 100%	15 100%
positive	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
negative	14 93.3%	15 100%	15 100%	15 93.8%	15 100%	15 100%
positive	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
negative	14 93.3%	15 100%	14 93.3%	15 93.8%	15 100%	15 100%
positive	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
negative	14 93.3%	13 86.7%	13 86.7%	12 75%	13 86.7%	13 86.7%

28. Secondary Outcome

Title	Number of Participants With Positive, Negative for Micro Neutralization Test
Description	To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated: Micro Neutralization test Interpretation: n. of positive and negative subjects at week 4 and week 24 by evaluating geometric mean titer change from baseline
Time Frame	week 4 and week 24

Outcome Measure Data

Analysis Population Description
number of subjects analyzed is calculated based on number of subjects with non missing observation thus numbers of subjects analyzed may vary between the observation period.

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=14 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	14	15	15	15	15	15
positive week 4	6 40%	10 66.7%	9 60%	12 75%	10 66.7%	11 73.3%
Negative week 4	8 53.3%	5 33.3%	6 40%	3 18.8%	5 33.3%	4 26.7%
Positive week 24	2 13.3%	4 26.7%	5 33.3%	2 12.5%	4 26.7%	6 40%
Negative week 24	12 80%	9 60%	8 53.3%	10 62.5%	9 60%	7 46.7%

29. Secondary Outcome

Title	Immunogenicity - T-cell Response
Description	To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated. T-cells were evaluated on frozen and fresh (week2) samples Within-cohort comparisons to assess the difference in immune response according to different doses in the same population Across-the-cohort comparison to assess whether elderlies and adults have a different pattern of immune response after vaccination at different endpoints Unit: spot-forming cells [SFC]/1 × 10^6 peripheral blood mononuclear cell [PBMC] Interpretation: values higher than at baseline are indicative of a persistent spike-specific memory T-cell establishment.
Time Frame	baseline, week 2, week 4, week 8, week 12, week 24

Outcome Measure Data

Analysis Population Description
number of subjects analyzed is calculated based on number of subjects with non missing observation thus numbers of subjects analyzed may vary between the observation period.

Arm/Group Title	Arm 1 - Low Dose	Arm 2 - Intermediate Dose	Arm 3 - High Dose	Arm 4 - Low Dose	Arm 5 - Intermediate Dose	Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=14 GRAd-COV2: Single intramuscular administration.	Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.	Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
Measure Participants	14	15	15	15	15	15
T-cell response baseline	54	88.0	128.0	320.0	165.0	425.0
T-cell response week 2 (fresh samples)	1161.0	2857.0	2272.0	1917.0	2262.0	3142.0
T-cell response week 2 (frozen samples)	1214.0	1095.0	905.0	1258.0	1363.0	1618.0
T-cell response week 4	788.0	1120.0	1330.0	1153.0	1258.0	1645.0
T-cell response week 8	720.0	948.0	1172.0	898.0	888.0	2133.0
T-cell response week 12	570.0	655.0	856.0	898.0	835.0	1435.0
T-cell response week 24	538.0	500.0	798.0	740.5	643.0	1223.0

Adverse Events

	Arm 1 - Low Dose		Arm 2 - Intermediate Dose		Arm 3 - High Dose		Arm 4 - Low Dose		Arm 5 - Intermediate Dose		Arm 6 - High Dose
Time Frame	Adverse Event occurred during the study period from enrollment to week 24
Adverse Event Reporting Description	Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.

Arm/Group Title	Arm 1 - Low Dose		Arm 2 - Intermediate Dose		Arm 3 - High Dose		Arm 4 - Low Dose		Arm 5 - Intermediate Dose		Arm 6 - High Dose
Arm/Group Description	Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.		Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.		Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.		Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16 GRAd-COV2: Single intramuscular administration.		Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration.		Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)		0/15 (0%)		0/16 (0%)		0/15 (0%)		0/15 (0%)
Serious Adverse Events
	Arm 1 - Low Dose		Arm 2 - Intermediate Dose		Arm 3 - High Dose		Arm 4 - Low Dose		Arm 5 - Intermediate Dose		Arm 6 - High Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)		0/15 (0%)		0/16 (0%)		0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1 - Low Dose		Arm 2 - Intermediate Dose		Arm 3 - High Dose		Arm 4 - Low Dose		Arm 5 - Intermediate Dose		Arm 6 - High Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/15 (80%)		14/15 (93.3%)		14/15 (93.3%)		13/16 (81.3%)		9/15 (60%)		9/15 (60%)
Blood and lymphatic system disorders
Neutropoenia	1/15 (6.7%)	2	1/15 (6.7%)	1	2/15 (13.3%)	2	1/16 (6.3%)	2	1/15 (6.7%)	1	2/15 (13.3%)	2
Lymphadenopathy	1/15 (6.7%)	1	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Eye disorders
Chalazion	0/15 (0%)	0	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	1/15 (6.7%)	1
Gastrointestinal disorders
Nausea	2/15 (13.3%)	3	4/15 (26.7%)	4	3/15 (20%)	3	1/16 (6.3%)	3	3/15 (20%)	3	2/15 (13.3%)	2
Diarrhoea	2/15 (13.3%)	2	4/15 (26.7%)	4	3/15 (20%)	3	0/16 (0%)	0	2/15 (13.3%)	2	0/15 (0%)	0
Abdominal Pain	1/15 (6.7%)	1	4/15 (26.7%)	5	0/15 (0%)	0	1/16 (6.3%)	1	1/15 (6.7%)	1	0/15 (0%)	0
Faeces Soft	0/15 (0%)	0	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Vomiting	0/15 (0%)	0	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/15 (6.7%)	1	0/15 (0%)	0
General disorders
Fatigue	9/15 (60%)	31	7/15 (46.7%)	35	10/15 (66.7%)	11	7/16 (43.8%)	13	3/15 (20%)	4	4/15 (26.7%)	4
injection site pain	10/15 (66.7%)	11	12/15 (80%)	14	10/15 (66.7%)	10	2/16 (12.5%)	3	1/15 (6.7%)	1	4/15 (26.7%)	4
Pyrexia	3/15 (20%)	5	4/15 (26.7%)	6	11/15 (73.3%)	15	5/16 (31.3%)	6	4/15 (26.7%)	11	4/15 (26.7%)	4
Chills	1/15 (6.7%)	1	2/15 (13.3%)	2	6/15 (40%)	6	4/16 (25%)	7	4/15 (26.7%)	4	6/15 (40%)	7
Injection Site Erithema	1/15 (6.7%)	1	2/15 (13.3%)	2	2/15 (13.3%)	2	0/16 (0%)	0	0/15 (0%)	0	1/15 (6.7%)	1
Injection Site swelling	0/15 (0%)	0	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	1/15 (6.7%)	1
Injection Site hematoma	0/15 (0%)	0	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/15 (6.7%)	1	0/15 (0%)	0
Infections and infestations
Conjunctivitis	1/15 (6.7%)	2	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Oral Herpes	1/15 (6.7%)	1	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Tooth Abscess	0/15 (0%)	0	0/15 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/15 (0%)	0	0/15 (0%)	0
Injury, poisoning and procedural complications
Muscle injury	0/15 (0%)	0	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/15 (6.7%)	1	0/15 (0%)	0
Muscle Strain	0/15 (0%)	0	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	1/15 (6.7%)	1
Tooth Fracture	0/15 (0%)	0	0/15 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Investigations
Aspartate Aminotransferase increased	1/15 (6.7%)	1	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Metabolism and nutrition disorders
Hyperkaliemia	0/15 (0%)	0	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/15 (6.7%)	1	0/15 (0%)	0
Musculoskeletal and connective tissue disorders
Myalgia	1/15 (6.7%)	1	6/15 (40%)	6	4/15 (26.7%)	4	6/16 (37.5%)	12	1/15 (6.7%)	1	5/15 (33.3%)	5
Neck Pain	0/15 (0%)	0	1/15 (6.7%)	1	0/15 (0%)	0	0/16 (0%)	0	1/15 (6.7%)	1	0/15 (0%)	0
Arthralgia	0/15 (0%)	0	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	1/15 (6.7%)	1
Muscle contracture	1/15 (6.7%)	1	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Spinal Pain	1/15 (6.7%)	1	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Back Pain	0/15 (0%)	0	0/15 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/15 (0%)	0	0/15 (0%)	0
Nervous system disorders
Headache	6/15 (40%)	11	8/15 (53.3%)	16	11/15 (73.3%)	15	7/16 (43.8%)	10	3/15 (20%)	4	2/15 (13.3%)	2
Paraesthesia	1/15 (6.7%)	1	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Reproductive system and breast disorders
Dysmenorrhoea	0/15 (0%)	0	1/15 (6.7%)	1	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Premenstrual Syndrome	1/15 (6.7%)	1	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	0/15 (0%)	0	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	2/15 (13.3%)	3
Dyspnoea	0/15 (0%)	0	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	1/15 (6.7%)	1
Oropharyngeal Pain	0/15 (0%)	0	1/15 (6.7%)	1	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Skin and subcutaneous tissue disorders
Pruritus	0/15 (0%)	0	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	2/15 (13.3%)	2	0/15 (0%)	0
Ecchymosis	0/15 (0%)	0	1/15 (6.7%)	1	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Vascular disorders
Hot Flush	1/15 (6.7%)	1	0/15 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/15 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Publication of the results will be agreed between ReiThera SRL and Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani. If one of the parties is interested in proceeding with a scientific publication, it must give written and electronic communication to the other party. Any impediments to publication must be communicated electronically within 30 days. If a party deems it inappropriate to publish, it will try to provide written changes to the text that could allow its publication.

Results Point of Contact

Name/Title	Medical Director
Organization	Reithera
Phone	06 99775 ext 352
Email	roberto.camerini@reithera.com

Responsible Party:

ReiThera Srl

ClinicalTrials.gov Identifier:

NCT04528641

Other Study ID Numbers:

RT-CoV-2

First Posted:

Aug 27, 2020

Last Update Posted:

Feb 8, 2022

Last Verified:

Jan 1, 2022

Phase I Study to Assess the Safety and Immunology of a COVID-19 Vaccine With GRAd-COV2 Vaccine

Study Details

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