Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects.
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Phase II/III
Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined
Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects.
In phase II trial, 100 subjects of immunogenicity group will be enrolled in 3:1
(Test:Placebo) ratio. These 100 subjects will be assessed for safety and immunogenicity
outcomes till Day 28 post the first dose of investigational medicinal product (IMP)/placebo
administration and will continue with study assessments till Day 180. Safety and
immunogenicity data collected till Day 28 will be submitted to the regulatory authority for
recommendation to proceed with Phase III recruitment.
In Phase III trial, 1500 subjects will be enrolled and randomized in the ratio of 3:1
(Gam-COVID--Vac : Placebo).
Each subject will participate in this adaptive study phase II/III clinical trial for 180±14
days after the first dose of the IMP/placebo and will have one screening visit and seven
on-site visits during the trial period. The IMP/placebo will be administered intramuscularly
during vaccination Visits 1 and 3 (Day 1 and Day 21±2). The observation Visits 2, 4, 5, 6,
and 7 will be made on Day 19±2, Day 28±2, Day 42±2, Day 90±7, and Day 180±14, respectively.
During the observation visits, vital indicators will be assessed in all subjects and changes
in the subjects' condition and well being compared to the previous visit will be recorded.
The schedule of examination procedures is mentioned in the Schedule of Event tables.
Additionally, the subjects will be able to have remote consultations with the study physician
through the weekly telephonic follow-up.
Blood samples will be taken from immunogenicity group of phase II (all 100) and phase III
(284 out of 1500) trials during the following visits to assess the immunogenicity parameters.
Biological: Gam-COVID-Vac
Vaccine for intramuscular injection
Other: Placebo
Placebo comparator
Inclusion Criteria:
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 trial 1
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.
Exclusion Criteria:
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
S N Medical College
Agra, India
MGM Medical College and Hospital
Aurangabad, India
KLE Prabhakar Kore Hospital
Belgaum, India
Apollo Hospital
Delhi, India
Batra Hospital
Delhi, India
HIMSR with CHRD-SAS
Delhi, India
ESIC Medical College & Hospital
Faridabad, India
AIG hospital
Hyderabad, India
Maharaja Agrasen Superspecialty Hospital
Jaipur, India
GSVM Medical College
Kanpur, India
Peerless Hospital
Kolkata, India
Atharva Hospital
Lucknow, India
St. George's Hospital
Mumbai, India
JSS Hospital
Mysore, India
INCLEN trust and Gurunanak Hospital
Palwal, India
PIMS
Puducherry, India
BJ Sassoon Hospital
Pune, India
KEM Hospital
Pune, India
Noble Hospital Private Limited
Pune, India
BAPS hospital
Sūrat, India
Rhythm Heart Institute
Vadodara, India
Sumandeep Vidyapeeth
Vadodara, India
Christian Medical College
Vellore, India