A randomized, observer-blind, placebo-controlled immuno-bridging, and broadening study to demonstrate the equivalence of the immune response between participants enrolled in Phase 3 efficacy trial in India and demographically diverse healthy adult participants in the US which matched in age and vaccine formulation setting to whom those efficacy results are extrapolated; and to assess the broadening of the BBV152 in participants who previously received two shots of messenger ribonucleic acid (mRNA) COVID-19 vaccine at least 6 months earlier or one-shots of viral vector J\&J/Janssen COVID-19 vaccine at least 2 months earlier. Safety and tolerability evaluation is a secondary endpoint.
Participants in stable health will be randomly assigned into one of four groups based on their age to receive either 6 µg of BBV152 or placebo in a 1:1 ratio. Each participant will receive 2 doses of the study vaccine by 0.5 mL intramuscular injection, the first on Day 0 and the second on Day 28. Data will be collected in an observer-blind manner. Safety will be monitored by the Data and Safety Monitoring Board. The Data and Safety Monitoring Board will convene to perform safety reviews at 2 and 6 months and for immediate concerns regarding safety observations as needed. Safety assessment will include monitoring solicited, unsolicited, serious, medically attended adverse events and potentially immune medicated medical conditions. Since this is a bridging study, the maximum sample size of the data from the previous study will be 31 samples from the \<65 years population and 358 with samples from the 18 to \<65 years population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
400
Each participant will receive 2 doses of the investigational product intramuscular injection of either 6 μg of BBV15 vaccine or placebo.
Voyage Medical
Tempe, Arizona, United States
RECRUITINGAngels Clinical Institute
Miami, Florida, United States
RECRUITINGSuncoast Research Group LLC
Miami, Florida, United States
RECRUITINGPalm Springs Community Health Center
Miami Lakes, Florida, United States
RECRUITINGClinical Site Partners
Winter Park, Florida, United States
RECRUITINGIACT Health
Columbus, Georgia, United States
RECRUITINGJay Meyer Meridian Research
Lincoln, Nebraska, United States
RECRUITINGPRX Research
Dallas, Texas, United States
RECRUITINGWellness Clinical Research
McKinney, Texas, United States
RECRUITINGMeridian Research 3235 Academy Ave
Portsmouth, Virginia, United States
RECRUITINGCompare immune response measured by serum neutralizing antibodies against Wild-Type SARS-CoV-2 in US-based participants and age-matched controls participants who participated in the Phase 3 efficacy trial in India.
Serum neutralizing antibodies against Wild-Type SARS-CoV-2 will be measured by Microneutralization Test (MNT) assay.
Time frame: Vaccination days (Day 0 and Day 28), Day 56 and Day 84
Evaluate the change over time in immunogenicity of two doses of BBV152 measured by MNT neutralizing antibodies.
* Geometric Mean Titer (GMT) as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA Immunoglobulin G (IgG) Abs against Spike, Receptor-Binding Domain (RBD), and N protein in BBV152 treatment group, overall, and stratified by age group. * Geometric Mean Fold Rises (GMFR) as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in BBV152 treatment group, overall, and stratified by age group. * Geometric Mean Titer, Geometric Mean Fold Rises, and Seroconversion rate as measured by MNT nAbs against Omicron at Day 0, Wild Type at Day 0 and Day 56 and ELISA IgG Abs against Spike, RBD, and N protein at Day 0, Day 28, Day 56, Day 84 in the placebo treatment group.
Time frame: Day0, Day 28, Day 56 and Day 84
Evaluate the immunogenicity of two doses of BBV152 measured by MNT neutralizing antibodies.
* Geometric Mean Titer (GMT) as measured by MNT Neutralizing Antibodies (nAbs) against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in BBV152 treatment group, overall, and stratified by age group. * Geometric Mean Fold Rises (GMFR) as measured by MNT nAbs against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in each BBV152 treatment group, overall, and stratified by age group. * Geometric Mean Titer, Geometric Mean Fold Rises, and Seroconversion rate as measured by MNT nAbs against Omicron at Day 0, Wild Type at Day 0 and Day 56 and ELISA IgG Abs against Spike, RBD, and N protein at Day 0, Day 28, Day 56, Day 84 in the placebo treatment group.
Time frame: Day 0, Day 28, Day 56 and Day 84
Evaluate the serious adverse events (SAEs)
Total count, duration, frequency of participants, and proportion of participants reporting serious adverse events (SAEs)
Time frame: 1 year
Evaluate response rate of anti-SARS-CoV-2 IgG antibody seroconversion from negative to positive following 28 days of BBV152 administration
* Seroconversion rate, defined as 4-fold rise from day 0, at days 28, 56, and 84 as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in BBV152 treatment group, overall, and stratified by age group. * Seroconversion rate as measured by MNT nAbs against Omicron at Day 0, Wild Type at Day 0 and Day 56 and ELISA IgG Abs against Spike, RBD, and N protein at Day 0, Day 28, Day 56, Day 84 in the placebo treatment group.
Time frame: Day 0, Day 28, Day 56 and Day 84
Evaluate the immunogenicity of the single dose of BBV152.
* Geometric Mean Titer (GMT) as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in BBV152 treatment group, overall, and stratified by age group. * Geometric Mean Fold Rises (GMFR) as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in BBV152 treatment group, overall, and stratified by age group. * Geometric Mean Titer, Geometric Mean Fold Rises, and Seroconversion rate as measured by MNT nAbs against Omicron at Day 0, Wild Type at Day 0 and Day 56 and ELISA IgG Abs against Spike, RBD, and N protein at Day 0, Day 28, Day 56, Day 84 in the placebo treatment group.
Time frame: Day 0, Day 28, Day 56 and Day 84
Evaluate immune-broadening, as measured by MNT neutralizing antibodies, compare the sera taken from previously mRNA or viral vector vaccinated US-based participants with sera taken from previously mRNA or Viral Vector vaccinated placebo controls.
* Geometric Mean Titer (GMT) as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in BBV152 treatment group, overall, and stratified by age group. * Geometric Mean Fold Rises (GMFR) as measured by MNT neutralizing antibodies against Wild-Type and Omicron and ELISA IgG Abs against Spike, RBD, and N protein in BBV152 treatment group, overall, and stratified by age group. * Geometric Mean Titer, Geometric Mean Fold Rises, and Seroconversion rate as measured by MNT nAbs against Omicron at Day 0, Wild Type at Day 0 and Day 56 and ELISA IgG Abs against Spike, RBD, and N protein at Day 0, Day 28, Day 56, Day 84 in the placebo treatment group.
Time frame: Day 0, Day 28, Day 56 and Day 84
Evaluate the medically attended adverse events (MAAEs).
Total count, duration, frequency of participants, and proportion of participants reporting medically attended adverse events (MAAEs)
Time frame: 1 year
Evaluate potential immune-mediated medical conditions (PIMMCs).
Total count, duration, frequency of participants, and proportion of participants reporting potential immune-mediated medical conditions (PIMMCs)
Time frame: 1 year
Evaluate the adverse events of special interest (AESI).
Total count, duration, frequency of participants, and proportion of participants reporting adverse events of special interest (AESI).
Time frame: 1 year
Evaluate the unsolicited adverse events.
Total count, duration, frequency of participants, and proportion of participants reporting unsolicited adverse events.
Time frame: 28 days following the first vaccination and 1 year following the last dose of vaccination
Evaluate the solicited adverse events.
Total count, frequency of participants, and proportion of participants solicited local and systemic adverse events.
Time frame: for 7 days following each dose of vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.