Mary Wilson
Well-known member
Published Online November 11, 2021
https://doi.org/10.1016/ S0140-6736(21)02000-6
Raches Ella, Siddarth Reddy, William Blackwelder, Varsha Potdar, Pragya Yadav, Vamshi Sarangi, Vinay K Aileni, Suman Kanungo, Sanjay Rai, Prabhakar Reddy, Savita Verma, Chandramani Singh, Sagar Redkar, Satyajit Mohapatra, Anil Pandey, Pajanivel Ranganadin,
Raghavendra Gumashta, Manish Multani, Shameem Mohammad, Parul Bhatt, Laxmi Kumari, Gajanan Sapkal, Nivedita Gupta, Priya Abraham, Samiran Panda, Sai Prasad, Balram Bhargava, Krishna Ella, Krishna Mohan Vadrevu, on behalf of the COVAXIN Study Group*
Summary
Background We report the clinical e cacy against COVID-19 infection of BBV152, a whole virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) in Indian adults.
Methods
We did a randomised, double-blind, placebo-controlled, multicentre, phase 3 clinical trial in 25 Indian hospitals or medical clinics to evaluate the e cacy, safety, and immunological lot consistency of BBV152. Adults (age ≥18 years) who were healthy or had stable chronic medical conditions (not an immunocompromising condition or requiring treatment with immunosuppressive therapy) were randomised 1:1 with a computer-generated randomisation scheme (strati ed for the presence or absence of chronic conditions) to receive two intramuscular doses of vaccine or placebo administered 4 weeks apart. Participants, investigators, study coordinators, study- related personnel, the sponsor, and nurses who administered the vaccines were masked to treatment group allocation; an unmasked contract research organisation and a masked expert adjudication panel assessed outcomes. The primary outcome was the e cacy of the BBV152 vaccine in preventing a rst occurrence of laboratory- con rmed (RT-PCR-positive) symptomatic COVID-19 (any severity), occurring at least 14 days after the second dose in the per-protocol population. We also assessed safety and reactogenicity throughout the duration of the study in all participants who had received at least one dose of vaccine or placebo. This report contains interim results (data cuto May 17, 2021) regarding immunogenicity and safety outcomes (captured on days 0 to 56) and e cacy results with a median of 99 days for the study population. The trial was registered on the Indian Clinical Trials Registry India, CTRI/2020/11/028976, and ClinicalTrials.gov, NCT04641481 (active, not recruiting).
Findings
Between Nov 16, 2020, and Jan 7, 2021, we recruited 25 798 participants who were randomly assigned to receive BBV152 or placebo; 24419 received two doses of BBV152 (n=12221) or placebo (n=12198). E cacy analysis was dependent on having 130 cases of symptomatic COVID-19, which occurred when 16 973 initially seronegative participants had at least 14 days follow-up after the second dose. 24 (0·3%) cases occurred among 8471 vaccine recipients and 106 (1·2%) among 8502 placebo recipients, giving an overall estimated vaccine e cacy of 77·8% (95% CI 65·2–86·4). In the safety population (n=25 753), 5959 adverse events occurred in 3194 participants. BBV152 was well tolerated; the same proportion of participants reported adverse events in the vaccine group (1597 [12·4%] of 12 879) and placebo group (1597 [12·4%] of 12 874), with no clinically signi cant di erences in the distributions of solicited, unsolicited, or serious adverse events between the groups, and no cases of anaphylaxis or vaccine-related deaths.
Interpretation
BBV152 was highly e cacious against laboratory-con rmed symptomatic COVID-19 disease in adults. Vaccination was well tolerated with no safety concerns raised in this interim analysis.
https://www.thelancet.com/action/showPdf?pii=S0140-6736%2821%2902000-6
https://doi.org/10.1016/ S0140-6736(21)02000-6
Raches Ella, Siddarth Reddy, William Blackwelder, Varsha Potdar, Pragya Yadav, Vamshi Sarangi, Vinay K Aileni, Suman Kanungo, Sanjay Rai, Prabhakar Reddy, Savita Verma, Chandramani Singh, Sagar Redkar, Satyajit Mohapatra, Anil Pandey, Pajanivel Ranganadin,
Raghavendra Gumashta, Manish Multani, Shameem Mohammad, Parul Bhatt, Laxmi Kumari, Gajanan Sapkal, Nivedita Gupta, Priya Abraham, Samiran Panda, Sai Prasad, Balram Bhargava, Krishna Ella, Krishna Mohan Vadrevu, on behalf of the COVAXIN Study Group*
Summary
Background We report the clinical e cacy against COVID-19 infection of BBV152, a whole virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) in Indian adults.
Methods
We did a randomised, double-blind, placebo-controlled, multicentre, phase 3 clinical trial in 25 Indian hospitals or medical clinics to evaluate the e cacy, safety, and immunological lot consistency of BBV152. Adults (age ≥18 years) who were healthy or had stable chronic medical conditions (not an immunocompromising condition or requiring treatment with immunosuppressive therapy) were randomised 1:1 with a computer-generated randomisation scheme (strati ed for the presence or absence of chronic conditions) to receive two intramuscular doses of vaccine or placebo administered 4 weeks apart. Participants, investigators, study coordinators, study- related personnel, the sponsor, and nurses who administered the vaccines were masked to treatment group allocation; an unmasked contract research organisation and a masked expert adjudication panel assessed outcomes. The primary outcome was the e cacy of the BBV152 vaccine in preventing a rst occurrence of laboratory- con rmed (RT-PCR-positive) symptomatic COVID-19 (any severity), occurring at least 14 days after the second dose in the per-protocol population. We also assessed safety and reactogenicity throughout the duration of the study in all participants who had received at least one dose of vaccine or placebo. This report contains interim results (data cuto May 17, 2021) regarding immunogenicity and safety outcomes (captured on days 0 to 56) and e cacy results with a median of 99 days for the study population. The trial was registered on the Indian Clinical Trials Registry India, CTRI/2020/11/028976, and ClinicalTrials.gov, NCT04641481 (active, not recruiting).
Findings
Between Nov 16, 2020, and Jan 7, 2021, we recruited 25 798 participants who were randomly assigned to receive BBV152 or placebo; 24419 received two doses of BBV152 (n=12221) or placebo (n=12198). E cacy analysis was dependent on having 130 cases of symptomatic COVID-19, which occurred when 16 973 initially seronegative participants had at least 14 days follow-up after the second dose. 24 (0·3%) cases occurred among 8471 vaccine recipients and 106 (1·2%) among 8502 placebo recipients, giving an overall estimated vaccine e cacy of 77·8% (95% CI 65·2–86·4). In the safety population (n=25 753), 5959 adverse events occurred in 3194 participants. BBV152 was well tolerated; the same proportion of participants reported adverse events in the vaccine group (1597 [12·4%] of 12 879) and placebo group (1597 [12·4%] of 12 874), with no clinically signi cant di erences in the distributions of solicited, unsolicited, or serious adverse events between the groups, and no cases of anaphylaxis or vaccine-related deaths.
Interpretation
BBV152 was highly e cacious against laboratory-con rmed symptomatic COVID-19 disease in adults. Vaccination was well tolerated with no safety concerns raised in this interim analysis.
https://www.thelancet.com/action/showPdf?pii=S0140-6736%2821%2902000-6