A COVID-19 candidate inactivated virus vaccine.
Emergency use authorization
COVAXIN™ is a COVID-19 candidate vaccine being developed by Bharat Biotech. It is a whole virion inactivated type of candidate vaccine. It is based on the β-propiolactone-inactivated SARS-CoV-2 NIV-2020-770 strain, which carries the D614G mutation. Alum or IMDG (TLR7 and TLR8 agonist) adsorbed onto alum were the adjuvants tested in a phase I/II clinical trials (Ella et al., 2021). In a Syrian hamster model, the formulation with aluminium hydroxide (Algel)-IMDG administered in the form of two 3 μg doses 14 days apart manifested the best immunogenic properties (Mohandas et al., 2021).
On January 3, 2021, COVAXIN™ was granted emergency use authorization in India.
|Link||Tested on||Impact factor||Notes||Publication date||DB entry date|
Inactivated COVID-19 vaccine BBV152/COVAXIN effectively neutralizes recently emerged B 1.1.7 variant of SARS-CoV-2
In vitro Mixed substance
|Sera of vaccinated individuals; Vero CCL-81 cells; SARS-CoV-2 strains hCoV-19/India/2020770, hCoV19/India/20203522, and hCoV-19/India/2020Q111||7.09||
In vitro, the sera of individuals vaccinated with two doses of the vaccine (collected 4 weeks after the second dose) potently neutralized a SARS-CoV-2 strain carrying the B.1.1.7 hallmark mutations.
Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 trial
Spike protein Phase II clinical trial Phase I clinical trial Randomized controlled double-blind trial Mixed substance
|Healthy adults and adolescents (aged 12–65)||24.45||
In the participants of the phase I study, neutralising antibody response was still present 3 months after the second dose administration. In the phase II study, the individuals vaccinated with 6 μg doses adjuvanted with Algel-IMDG had higher neutralizing antibody titres and seroconversion rates compared to the “3 μg” group. The T cell response in the vaccinated subjects was Th1-biased. The solicited adverse events were mild of moderate, the vaccine was generally well tolerated. Sample size: 184 (“3 μg” group) + 177 (“6 μg” group). Dosage: 2 doses 28 days apart (3 μg each, with Algel-IMDG (phase I and II); 6 μg each, with Algel-IMDG (phase I and II); or 6 μg each, with Algel (phase I) (+ Algel-only control in phase I)). Primary outcomes: Neutralising antibody titres and seroconversion rates at 4 weeks post second dose (phase II).
Immunogenicity and protective efficacy of inactivated SARS-CoV-2 vaccine candidate, BBV152 in rhesus macaques
Animal model Mixed substance
|rhesus macaques; SARS-CoV-2 strain P-3, NIV-2020770||12.12||
The best outcomes were observed in animals vaccinated with 3 μg doses (adjuvanted with Algel 2) (“group III”). SARS-CoV-2-challenged (14 days after the second vaccine dose) rhesus macaques were protected from interstitial pneumonia. By day 7 post viral challenge, viral genomic RNA was detectable in none of the vaccinated animals. No clinical or radiographic abnormalities were observed in animals from the group III. RBD-specific IgGs were detectable in the vaccinated macaques from the third week after the first immunization and were high at 28th day after immunization and 7th day post viral challenge. The presence of neutralizing antibodies positively correlated with the IgGs. Compared to placebo, significantly lower levels of IL-6 and higher levels of IL-8 were observed in group III.
Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial
Phase I clinical trial Randomized controlled double-blind trial Mixed substance
|Healthy adults; SARS-CoV-2 NIV-2020-770 strain (inactivated)||24.45||
No serious (only temporary mild and moderate) adverse events causally associated with the vaccine were noted. The vaccination elicited anti-Spike, RBD, and Nucleocapsid IgG responses which were Th1 biased. After the second dose, seroconversion (MNT50) was observed in 82.8% (6 μg Algel (alum) group) to 91.2% (6 μg Algel-IMDG group). Seroconversion (PRNT50) ranged from 86.4% (6 μg Algel-IMDG group) to 93.4% (3 μg Algel-IMDG group). In some of the Algel-IMDG group patients' blood samples but almost none of the Algel/Algel control group samples there were CD3+, CD4+, and CD8+ T-cell responses (with IFN-γ) observed. Sample size: 99 (3 μg Algel-IMDG group) + 99 (6 μg Algel-IMDG) + 93 (6 μg Algel) + 73 control. Dosage: Two IM doses of 3 μg with Algel-IMDG or 6 μg with Algel-IMDG, or 6 μg with Algel 14 days apart. Endpoints: Safety (primary outcome), seroconversion, and cell-mediated responses.
Immunogenicity and protective efficacy of BBV152, whole virion inactivated SARS- CoV-2 vaccine candidates in the Syrian hamster model
Animal model Mixed substance
The candidate vaccine elicited potent humoral immune response in a Syrian hamster model. In a SARS-CoV-2 challenge, the hamsters were protected from pneumonia and had shortened time to lower respiratory tract viral clearance.
Evaluation of Safety and Immunogenicity of an Adjuvanted, TH-1 Skewed, Whole Virion InactivatedSARS-CoV-2 Vaccine - BBV152
Preprint Animal model
|mice, rats, rabbits||
BBV152 vaccine formulations generated significantly high antigen-binding and neutralizing antibody titers
|Draft landscape of COVID-19 candidate vaccines||healthy adults||Jul/28/2020||Aug/05/2020|
|ID||Title||Status||Phase||Start date||Completion date|
|NCT05258669||Immuno-bridging and Broadening Study of a Whole, Inactivated COVID-19 Vaccine BBV152 in Healthy Adults||Active, not recruiting||Phase 2|Phase 3||Feb/20/2022||Oct/31/2023|
|NCT04834869||COVID-19 Vaccines Safety Tracking (CoVaST)||Recruiting||Apr/01/2021||Jan/31/2022|
|NCT04641481||An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers||Active, not recruiting||Phase 3||Nov/16/2020||Dec/01/2022|
|NCT04471519||Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COVID-19 in Healthy Volunteers||Active, not recruiting||Phase 1|Phase 2||Jul/15/2020||Jun/30/2021|