A Clinical Trial of A COVID-19 Vaccine Named Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Sponsor

CanSino Biologics Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04566770

Collaborator

Beijing Institute of Biotechnology (Other), Jiangsu Province Centers for Disease Control and Prevention (Other)

481

Enrollment

Location

Arms

24.8

Anticipated Duration (Months)

19.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a randomized, double-blind, placebo -controlled IIb clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people 6 years old and above and .

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo	Phase 2

Detailed Description

This is a phase IIb clinical trial to evaluate safety and immuogenicity of Ad5-nCoV developed by Cansino and Beijing Institute of Biotechnology in health people aged 6 years old and above.

The study will be double-blind, placebo-controlled trial with participants randomly allocated 2:1 to placebo and experimental vaccine .

The immunization schedule is two doses intramuscular injections (deltoid).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

481 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A Randomized, Double-blind, Placebo -Controlled Phase IIb Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-nCoV in Person 6 Years of Age and Older and Those Who Have Previously Been Vaccinated With Ad5-EBOV

Actual Study Start Date :

Sep 24, 2020

Anticipated Primary Completion Date :

Aug 21, 2021

Anticipated Study Completion Date :

Oct 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MID A 20 participants(18-49), Ad5-nCoV , two doses, Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Intramuscular other name:Ad5-nCoV
Placebo Comparator: MID B 10 participants(18-49), Ad5-nCoV-placebo , two doses, Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo Intramuscular other name:Ad5-nCoV
Experimental: MIN A 100 participants(6-17), Ad5-nCoV , two doses, Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Intramuscular other name:Ad5-nCoV
Placebo Comparator: MIN B 50 participants(6-17), Ad5-nCoV-placebo , two doses, Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo Intramuscular other name:Ad5-nCoV
Experimental: OLD A 100 participants(56 years of age and above), Ad5-nCoV , two doses(Low dose), Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Intramuscular other name:Ad5-nCoV
Experimental: OLD B 100 participants(56 years of age and above), Ad5-nCoV , two doses(Middle dose), Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Intramuscular other name:Ad5-nCoV
Placebo Comparator: OLD C 50 participants(56 years of age and above), Ad5-nCoV-placebo , two doses, Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo Intramuscular other name:Ad5-nCoV
Experimental: EBOV A 34 participants, Ad5-nCoV , two doses, Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Intramuscular other name:Ad5-nCoV
Placebo Comparator: EBOV B 17 participants, Ad5-nCoV , two doses, Intramuscular administration	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo Intramuscular other name:Ad5-nCoV

Outcome Measures

Primary Outcome Measures

Safety indexes of adverse reactions [within 14 days post each vaccination]
Occurrence of adverse reactions post vaccination
Immunogencity indexes of GMT [Day 28 post the second vaccination]
Evaluate the Geometric mean titer (GMT) of IgG antibody
Immunogencity indexes of neutralizing antibody [Day 28 post the second vaccination]
Evaluate the Geometric mean titer (GMT) of neutralizing antibody

Secondary Outcome Measures

Safety indexes of adverse events [Day 0-7,0-14,0-28 post each vaccination]
Occurrence of adverse reactions post-vaccination
Safety indexes of Hematological examination measures（Hemoglobin, WBC） [pre-vaccination, day 4 post each vaccination]
Occurrence of abnormal changes of Hematological examination indexes(only fit for MID and sentinel group)
Safety indexes of Blood routine measures(ALT, AST) [pre-vaccination, day 4 post each vaccination]
Occurrence of abnormal changes of lBlood routine indexes (only fit for MID and sentinel group)
Safety indexes of SAE [Within 6 months post the second vaccination]
Occurrence of serious adverse events post-vaccination
Immunogencity indexes of GMT [Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination]
Evaluate the Geometric mean titer of IgG antibody
Immunogencity indexes of neutralizing antibody [Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination]
Evaluate the Geometric mean titer (GMT) of neutralizing antibody
Immunogencity indexes of cellular immune [Day 28 post the first vaccination, pre and day 28 post the second vaccination]
Number of cell-mediated immune response against SARS-CoV-2（IL-2）

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Aged 18 to 55 years old in MID group; aged 6-17 years old in MIN group; aged 56 years and above in OLD group; aged in EBO group is not limited.
Able to understand the content of informed consent and willing to sign the informed consent
Able and willing to complete all the secluded study process during the whole 6 months study follow-up period.
Negative in HIV diagnostic test.
Negative in serum antibodies (IgG and IgM) screening of COVID-19.
Axillary temperature ≤37.0°C.
General good health as established by medical history and physical examination.

Exclusion Criteria:

Family history of seizure, epilepsy, brain or mental disease
Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
Woman who is pregnant, breast-feeding or positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months
Any acute fever disease or infections.
History of SARS
Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease.
Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc.
Hereditary angioneurotic edema or acquired angioneurotic edema Urticaria in last one year
No spleen or functional spleen.
Platelet disorder or other bleeding disorder may cause injection contraindication
Faint at the sight of needles.
Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months.
Prior administration of blood products in last 4 months
Prior administration of other research medicines in last 1 month
Prior administration of attenuated vaccine in last 1 month
Prior administration of inactivated vaccine in last 14 days
Current anti-tuberculosis prophylaxis or therapy
According to the judgement of investigator,various medical, psychological, social or other conditions, those could affect the subjects to sign informed consent.