אינדקס
Sputnik V (Gam-Covid-Vac)
2 doses, 3 weeks apart
Muscle injection
Freezer storage
Developing an alternative formulation that can be refrigerated
Gamaleya Research Institute (Ministry of Health)
Combination of two adenoviruses called Ad5 and Ad26
August 11th President Putin announced approval
Before phase 3 trials had started
November, Russian government began offering Sputnik V within Russia
Widespread hesitancy
Phase 3, Russia, Belarus, UAE, Venezuela, India
Gamaleya Institute joined forces in December with the AstraZeneca
AstraZeneca / Gamaleya combination started Phase 1 trial on Dec. 24
Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia
https://www.thelancet.com/journals/la...
Background
A heterologous recombinant adenovirus
Phase 2 results,
showed a good safety profile and induced strong humoral and cellular immune responses
Interim analysis of this phase 3 trial
Methods
Randomised, double-blind, placebo-controlled, phase 3 trial
25 hospitals and polyclinics in Moscow
Participants at least 18 years, with negative PCR and IgG and IgM tests
Randomly assigned (3:1) to receive vaccine or placebo
Two shots, 21 days apart
First dose, rAd26
Second dose, rAd5),
Both vectors carrying the gene for the full-length SARS-CoV-2 glycoprotein S
Outcome recorded 21 days after second shot (vaccine or placebo)
Finding
Sept 7 to Nov 24, 2020
N = 21 977
Randomly assigned
Vaccine group, n = 16 501
Placebo group, n = 5476
N = 19 866 received two doses of vaccine or placebo and were included
(2,144 participants older than 60 years, 1,611 in the vaccine group and 533 in the placebo group)
Primary outcome analysis
Included all participants who had received at least two doses at the time of database lock
Vaccine group, n = 14,964
16 (0·1%) confirmed COVID infections
No cases of moderate or severe COVID-19 confirmed at least 21 days after dose 1
Placebo group, n = 4,902
62 (1·3%) confirmed COVID infections
20 cases of moderate or severe COVID-19 confirmed at least 21 days after dose 1
Efficacy
91·6%
Vaccine efficacy was 91·8 in participants older than 60 years
Interim immunogenicity
Vaccine group
RBD-specific IgG detected in 336 (98%) of 342 samples
Seroconversion rate of 98·25%
Higher levels of interferon-gamma
(secreted by activated T helper lymphocytes, T cytotoxic lymphocytes, B lymphocytes and NKs)
Significantly higher levels of IFN-γ secretion upon antigen restimulation
Placebo group
RBD-specific IgG was detected in 17 (15%) of 114 samples
Seroconversion rate of 14·91%
(p less than 0·0001 vs the vaccine group)
Adverse events
Grade 1
7485 [94·0%] of 7966 total events
Serous adverse events
Vaccine group
45 (0·3%) of 16, 427
Placebo group
23 (0·4%) of 5435
None were considered associated with vaccination
Four deaths were reported during the study
Vaccine group
Three (less than 0·1%) of 16 427
Placebo group
One (less than 0·1%) of 5435
None of which were considered related to the vaccine
Interpretation
This interim analysis of the phase 3 trial of Gam-COVID-Vac showed 91·6% efficacy against COVID-19 and was well tolerated in a large cohort
