Multi-centre, phase II/III adaptive clinical trial to assess safety and immunogenicity of Gam-COVID-Vac combined vector vaccine
- Registration Number
- CTRI/2020/11/029234
- Lead Sponsor
- Human Vaccine LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Written informed consent of a subject to participate in the trial
2. Males and females aged 18+ years
3. Negative human immunodeficiency virus (HIV 1 & 2) and hepatitis B and C test results
4. Negative immunoglobulin M (IgM) and immunoglobulin G (IgG) SARS-CoV-2 antibodies through enzyme immunoassay test result
5. Negative COVID-2019 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit (72 hours prior to Visit 1 [Day 1])
6. No COVID-2019 in the medical history
7. History of no contact with COVID-2019 persons within at least 14 days before the enrolment (according to subjects)
8. Consent for using effective methods of contraception during the entire trial1
9. Negative urine pregnancy test at the screening visit (for child-bearing age women)
10. No evident vaccine-induced reactions or complications after receiving immunobiological products in the medical history
11. No acute infectious and/or respiratory diseases within at least 14 days before the enrolment.
1. Any vaccination/immunization within 30 days before the enrolment
2. Steroids (except hormonal contraceptives) and immunoglobulins or other blood products therapy not finished 30 days before the enrolment
3. Immunosuppressors therapy finished within 3 months before the enrolment
4. Pregnancy or breast-feeding
5. Acute coronary syndrome or stroke suffered less than one year before the enrolment
6. Tuberculosis, chronic systemic infections
7. Drug allergy (anaphylactic shock, Quincke edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study product components, acute exacerbation of allergic diseases on the enrolment day
8. Subjects who are on drugs that could have potential drug interactions with adenovirus vaccine
9. Medical history of malignancy
10. Donated blood or plasma (450+ mL) within 2 months before the enrolment
11. Splenectomy in the medical history
12. Neutropenia (absolute neutrophil count less than 1,000 mm3), agranulocytosis, significant blood loss, severe anaemia (haemoglobin less than 80 g/L), immunodeficiency including autoimmune disorders in the medical history within 6 months before the enrolment
13. Active form of a disease caused by the HIV and hepatitis B or C
14. Anorexia, protein deficiency of any origin
15. Tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the IMP or placebo administration
16. Alcohol or drug addiction in the medical history.
17. Participation in any other interventional clinical trial within 1 month prior to the Screening
18. Any other medical condition that would limit the participation of the subject as per Investigator discretion
19. Study centre staff or other employees directly involved in the trial and their families
20. Subjects contraindicated for vaccination
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase II-Incidence & severity of AEs,Seroconversion rate of SARS-CoV-2 glycoprotein-specific antibodies <br/ ><br>Phase III-Incidence of SAEs following vaccination during the study, GMT ratio of SARS-CoV-2 glycoprotein-specific antibodies in immunogenicity group <br/ ><br>Timepoint: Phase II-At day 28, Phase III-Entire study duration,At day42
- Secondary Outcome Measures
Name Time Method Incidence of AEs & SAEs, Clinically significant changes. <br/ ><br>GMT & Seroconversion rate of SARS-CoV-2 glycoprotein-specific & SARS-CoV-2 VNA antibodies in immunogenicity. <br/ ><br>Interferon gamma concentration in T-cells after restimulation with the SARS-CoV-2 glycoprotein in CMI, Number of proliferating CD4 and CD8 cells in response to mitogen stimulation & their ratios in CMI, % of subjects with antibodies to SARS-CoV-2 N-protein.Incidence of cases of Covid-19 developedTimepoint: Entire study duration, Baseline (GMT), Day21,28,90,180 <br/ ><br>Baseline,Day28,42,90,180, Day 42 and 180