Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine

Sponsor
PT Bio Farma (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05067894
Collaborator
Fakultas Kedokteran Universitas Indonesia (Other), National Institute of Health Research and Development, Ministry of Health Republic of Indonesia (Other)
780
Enrollment
1
Location
6
Arms
5
Anticipated Duration (Months)
157.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is an observer-blind, randomized, controlled prospective intervention study of Phase I/II. The primary objective of Phase I is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose. Whereas, the primary objective of Phase II is to evaluate the immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine
  • Biological: SARS-CoV-2 Inactivated Vaccine
Phase 1/Phase 2

Detailed Description

This trial is observer blinded, comparative, randomized, phase I/II study. For phase I, approximately 90 subjects will be recruited and will seamlessly continue to phase II recruiting 690 subjects, in total 780 subjects (18 years and above).

Two different formulations of vaccine candidate (SARS-CoV-2 protein subunit recombinant vaccine) will be compared to active control. The investigational product is 0.5 ml in three dose-regimen (for all subjects) with 28 days apart between doses. Antibody testing after two doses will be conducted to compare the immunogenicity profile between two and three-dose administration.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
780 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Observer blind: Investigational Product and Active Comparator are masking. Lot number is masking
Primary Purpose:
Treatment
Official Title:
A Phase I/II, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Populations Aged 18 Years and Above in Indonesia
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Adult - Medium dose

25 µg dose, adult group (18-59 years)

Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine
intramuscular injection

Experimental: Adult - High Dose

50 µg dose, adult group (18-59 years)

Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine
intramuscular injection

Active Comparator: Adult - Control

SARS-CoV-2 inactivated vaccine, adult group (18-59 years)

Biological: SARS-CoV-2 Inactivated Vaccine
intramuscular injection

Experimental: Elderly - Medium dose

25 µg dose, elderly group (> 60 years)

Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine
intramuscular injection

Experimental: Elderly - High dose

50 µg dose, elderly group (> 60 years)

Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine
intramuscular injection

Active Comparator: Elderly - Control

SARS-CoV-2 inactivated vaccine, elderly group (> 60 years)

Biological: SARS-CoV-2 Inactivated Vaccine
intramuscular injection

Outcome Measures

Primary Outcome Measures

  1. Phase I Safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose [7 days after each dose]

    percentage of subjects with solicited and unsolicited Adverse Events (AE)

  2. Phase II Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after whole schedule dose [28 days after third dose]

    percentage of subjects with seropositive, seroconversion and Geometric Mean Ration (GMT) of Immunoglobulin (IgG) antibody and Neutralization antibody

Secondary Outcome Measures

  1. safety of the SARS-CoV-2 protein subunit recombinant vaccine within 28 days after each dose [28 days after each dose]

    percentage of subjects with solicited and unsolicited AE

  2. Comparison of AE/ Serious Adverse Events (SAE) between intervention vaccine and active control [28 days after each dose]

    percentage of subjects with AE and SAE between vaccine and active control group

  3. Deviation of laboratory evaluation in Phase I [7 days after whole schedule dose]

    Any deviation from routine laboratory evaluation that probably related to the dosing

  4. Inflammatory factor evaluation in Phase I [7 days after whole-schedule dose]

    The change of interleukin-6 (IL-6) in serum

  5. Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after second dose [28 days after second dose]

    seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody

  6. Comparison of immunogenicity between 2 and 3 doses [28 days after second and third dose]

    seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Clinically healthy subjects within the following age groups: adults (18-59 years) and elderly (60 years and above.

  2. Subjects have been informed properly regarding the study and signed the informed consent form.

  3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:
  1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.

  2. History of vaccination with any investigational product against Covid-19 during or 6 months prior to enrollment.

  3. Subjects who have history of Covid-19 in the last 3 months (based on anamnesis or other examinations).

  4. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).

  5. The result of rapid antigen test is positive.

  6. Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).

  7. Abnormality hematology and biochemical test results (for phase I).

  8. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.

  9. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.

  10. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.

  11. Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)).

  12. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.

  13. Subjects receive any vaccination (other than Covid-19 vaccine) within 1 month before and after Investigational Product (IP) immunization.

  14. Subjects plan to move from the study area before the end of study period.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Fakultas Kedokteran Universitas IndonesiaJakartaGreater JakartaIndonesia

Sponsors and Collaborators

  • PT Bio Farma
  • Fakultas Kedokteran Universitas Indonesia
  • National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Investigators

  • Principal Investigator: Prof. Rini Sekartini, MD, Fakultas Kedokteran Universitas Indonesia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PT Bio Farma
ClinicalTrials.gov Identifier:
NCT05067894
Other Study ID Numbers:
  • CoV2-010221
First Posted:
Oct 5, 2021
Last Update Posted:
Oct 11, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by PT Bio Farma
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2021