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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,600
Vaccine for intramuscular injection
Placebo comparator
S N Medical College
Agra, India
MGM Medical College and Hospital
Aurangabad, India
Adverse Events
For Phase II study - - Incidence \& severity of adverse events (AEs) after first dose of IMP/Placebo For Phase III study - \- Incidence of related serious adverse events (SAEs) following vaccination during the study
Time frame: For Phase II study - at Day 28; For Phase III study - till day 180 after first dose
Immunogenicity
For Phase II study - \- Seroconversion rate of SARS-CoV-2 glycoprotein-specific antibodies in immunogenicity group
Time frame: For Phase II study - Day 28 after first dose
Immunogenicity
For Phase III study - Geometric mean titre ratio of SARS-CoV-2 glycoprotein-specific antibodies between IMP and placebo in immunogenicity group
Time frame: For Phase III study - Day 42 after first dose
Adverse Events
Incidence and severity of adverse events after injecting the first dose of the IMP/placebo Incidence of SAE following vaccination
Time frame: Baseline to Day 180
Immunogenicity assessment
Seroconversion rate of SARS-CoV-2 glycoprotein-specific antibodies in immunogenicity group Seroconversion rate of SARS-CoV-2 virus-neutralizing antibodies in immunogenicity group
Time frame: Baseline, Day 21, Day 28, Day 42, Day 90, and Day 180
Immunogenicity assessment
Geometric mean virus-neutralizing antibodies titre in immunogenicity group
Time frame: Baseline, Day 21, Day 28, Day 42, Day 90, and Day 180
Immunogenicity assessment
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KLE Prabhakar Kore Hospital
Belagavi, 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
...and 13 more locations
Interferon gamma concentration in T-cells after restimulation with the SARS-CoV-2 glycoprotein in cell mediated immunogenicity group
Time frame: Baseline, Day 28, Day 42, Day 90 and Day 180
Immunogenicity assessment
The number of proliferating cluster of differentiation 4 (CD4) cell and cluster of differentiation 8 (CD8) cells in response to mitogen stimulation in cell mediated immunogenicity group
Time frame: Baseline, Day 28, Day 42, Day 90 and Day 180
Percentage of subjects with mild, moderate, severe coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose of the vaccine/placebo
Comparing percentage of subjects developing COVID-19 disease between Gam-COVID-Vac combined vector vaccine and placebo based on severity course
Time frame: Baseline to Day 180
Incidence of coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose in trial subjects
Comparing incidence of COVID-19 disease between Gam-COVID-Vac combined vector vaccine and placebo
Time frame: Baseline to Day 180