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Cited by 424SARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research StudiesImmune responses and vaccinations

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Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial

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Ella, Raches, Vadrevu, Krishna Mohan, Jogdand, Harsh, Prasad, Sai, Reddy, Siddharth, Sarangi, Vamshi, Ganneru, Brunda, Sapkal, Gajanan, Yadav, Pragya, Abraham, Priya, Panda, Samiran, Gupta, Nivedita, Reddy, Prabhakar, Verma, Savita, Kumar Rai, Sanjay, Singh, Chandramani, Redkar, Sagar Vivek, Gillurkar, Chandra Sekhar, Kushwaha, Jitendra Singh, Mohapatra, Satyajit, Rao, Venkat, Guleria, Randeep, Ella, Krishna, Bhargava, Balram·2021·The Lancet Infectious Diseases
DOI 10.1016/s1473-3099(20)30942-7PMC PMC7825810

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Abstract

Background To mitigate the effects of COVID-19, a vaccine is urgently needed. BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) or alum (Algel).Methods We did a double-blind, multicentre, randomised, controlled phase 1 trial to assess the safety and immunogenicity of BBV152 at 11 hospitals across India. Healthy adults aged 18-55 years who were deemed healthy by the investigator were eligible. Individuals with positive SARS-CoV-2 nucleic acid and/or serology tests were excluded. Participants were randomly assigned to receive either one of three vaccine formulations (3 μg with Algel-IMDG, 6 μg with Algel-IMDG, or 6 μg with Algel) or an Algel only control vaccine group. Block randomisation was done with a web response platform. Participants and investigators were masked to treatment group allocation. Two intramuscular doses of vaccines were administered on day 0 (the day of randomisation) and day 14. Primary outcomes were solicited local and systemic reactogenicity events at 2 h and 7 days after vaccination and throughout the full study duration, including serious adverse events. Secondary outcome was seroconversion (at least four-fold increase from baseline) based on wild-type virus neutralisation. Cell-mediated responses were evaluated by intracellular staining and ELISpot. The trial is registered at ClinicalTrials.gov (NCT04471519).Findings Between July 13 and 30, 2020, 827 participants were screened, of whom 375 were enrolled. Among the enrolled participants, 100 each were randomly assigned to the three vaccine groups, and 75 were randomly assigned to the control group (Algel only). After both doses, solicited local and systemic adverse reactions were reported by 17 (17%; 95% CI 10·5-26·1) participants in the 3 μg with Algel-IMDG group, 21 (21%; 13·8-30·5) in the 6 μg with Algel-IMDG group, 14 (14%; 8·1-22·7) in the 6 μg with Algel group, and ten (10%; 6·9-23·6) in the Algel-only group. The most common solicited adverse events were injection site pain (17 [5%] of 375 participants), headache (13 [3%]), fatigue (11 [3%]), fever (nine [2%]), and nausea or vomiting (seven [2%]). All solicited adverse events were mild (43 [69%] of 62) or moderate (19 [31%]) and were more frequent after the first dose. One serious adverse event of viral pneumonitis was reported in the 6 μg with Algel group, unrelated to the vaccine. Seroconversion rates (%) were 87·9, 91·9, and 82·8 in the 3 μg with Algel-IMDG, 6 μg with Algel-IMDG, and 6 μg with Algel groups, respectively. CD4+ and CD8+ T-cell responses were detected in a subset of 16 participants from both Algel-IMDG groups.Interpretation BBV152 led to tolerable safety outcomes and enhanced immune responses. Both Algel-IMDG formulations were selected for phase 2 immunogenicity trials. Further efficacy trials are warranted.Funding Bharat Biotech International.

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  1. Mulligan, 2020, Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults, Nature, 586, 589, 10.1038/s41586-020-2639-4 · DOI · Paper page
  2. Walsh, 2020, Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates, N Engl J Med, 10.1056/NEJMoa2027906 · DOI · Paper page

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Metadata

Authors
Ella, R., Vadrevu, K. M., Jogdand, H., Prasad, S., Reddy, S., Sarangi, V., Ganneru, B., Sapkal, G., Yadav, P., Abraham, P., Panda, S., Gupta, N., Reddy, P., Verma, S., Kumar Rai, S., Singh, C., Redkar, S. V., Gillurkar, C. S., Kushwaha, J. S., Mohapatra, S., Rao, V., Guleria, R., Ella, K., & Bhargava, B.
Affiliations
  • Bharat Biotech (India) (IN)
  • ICMR-National Institute of Virology (IN)
  • Indian Council of Medical Research (IN)
  • Nizam's Institute of Medical Sciences (IN)
  • Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (IN)
  • All India Institute of Medical Sciences, Patna (IN)
  • SRM Medical College Hospital and Research Centre (IN)
  • Institute of Medical Sciences and Sum Hospital (IN)
  • All India Institute of Medical Sciences (IN)
Corresponding author
Vadrevu, Krishna Mohan
ORCID
Venue
The Lancet Infectious Diseases
Publisher
Elsevier BV
Published
2021-05
Volume
21
Issue
5
Pages
637-646
ISSN
1473-3099 (ISSN-L)
DOI
10.1016/s1473-3099(20)30942-7
PMC
PMC7825810
OpenAlex
W3121691244
Cited by
424
References
47
Citations by year
2026: 12 · 2025: 14 · 2024: 32 · 2023: 64 · 2022: 135 · 2021: 164
FWCI
31.25
Type
journal article
Language
en
Update notices
Open access
Licence
Locations
  • The Lancet Infectious Diseases (publishedVersion)
  • medRxiv (acceptedVersion, cc-by-nd)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
  • Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
  • Life Sciences › Immunology and Microbiology › Immunology › Immune responses and vaccinations
Keywords
BBV152, inactivated SARS-CoV-2 vaccine, COVID-19 vaccines, vaccine safety, vaccine immunogenicity, alum adjuvant, Toll-like receptor 7/8 agonist, reactogenicity, seroconversion, neutralizing antibodies, cell-mediated immunity, dose comparison, healthy adults, India
MeSH terms
COVID-19, SARS-CoV-2, COVID-19 Vaccines, Adolescent, Adult, Antibodies, Viral, Double-Blind Method, Female, Humans, Immunoglobulin G, Male, Middle Aged, Vaccination, Vaccines, Inactivated, Toll-Like Receptor 7, Toll-Like Receptor 8, Young Adult, Antibodies, Neutralizing

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