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Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial.
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.
  • Ella R; Bharat Biotech, Hyderabad, India.
  • Vadrevu KM; Bharat Biotech, Hyderabad, India. Electronic address: kmohan@bharatbiotech.com.
  • Jogdand H; Bharat Biotech, Hyderabad, India.
  • Prasad S; Bharat Biotech, Hyderabad, India.
  • Reddy S; Bharat Biotech, Hyderabad, India.
  • Sarangi V; Bharat Biotech, Hyderabad, India.
  • Ganneru B; Bharat Biotech, Hyderabad, India.
  • Sapkal G; Indian Council of Medical Research-National Institute of Virology, Pune, India.
  • Yadav P; Indian Council of Medical Research-National Institute of Virology, Pune, India.
  • Abraham P; Indian Council of Medical Research-National Institute of Virology, Pune, India.
  • Panda S; Indian Council of Medical Research, New Delhi, India.
  • Gupta N; Indian Council of Medical Research, New Delhi, India.
  • Reddy P; Nizams Institute of Medical Sciences, Hyderabad, India.
  • Verma S; Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, India.
  • Kumar Rai S; All India Institute of Medical Sciences, New Delhi, India.
  • Singh C; All India Institute of Medical Sciences, Patna, India.
  • Redkar SV; Redkar Hospital, Dargalim, India.
  • Gillurkar CS; Gillurkar Hospital, Nagpur, India.
  • Kushwaha JS; Prakhar Hospital, Kanpur, India.
  • Mohapatra S; SRM Hospital and Research Centre, Kattankulathur, India.
  • Rao V; Institute of Medical Sciences and SUM Hospital, Bhubaneswar, India.
  • Guleria R; All India Institute of Medical Sciences, New Delhi, India.
  • Ella K; Bharat Biotech, Hyderabad, India.
  • Bhargava B; Indian Council of Medical Research, New Delhi, India.
Lancet Infect Dis ; 21(5): 637-646, 2021 05.
Article in English | MEDLINE | ID: covidwho-1510469
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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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / SARS-CoV-2 / COVID-19 Type of study: Controlled clinical trial / Observational study / Randomized controlled trials Limits: Adolescent / Adult / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Lancet Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: S1473-3099(20)30942-7

Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / SARS-CoV-2 / COVID-19 Type of study: Controlled clinical trial / Observational study / Randomized controlled trials Limits: Adolescent / Adult / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Lancet Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: S1473-3099(20)30942-7