Russia’s Sputnik V Vaccine’s Study Design & Details
Details
Background: The Gamaleya Research Institute in Russia is testing their non-replicating viral vector COVID-19 vaccine candidate, Sputnik V (formerly Gam-COVID-Vac), in two Phase 1/2 trials. The trials recruited about 38 participants each to receive the vaccine candidate (NCT04436471) (NCT04437875).
Outcomes
Results from the two small Phase 1/2 trials published in The Lancet appear to show the vaccine has a good safety profile and "induced strong humoral and cellular immune response" in participants.
Status
The institute plans to test the vaccine candidate on up to 40,000 people at 45 different medical centers across Russia, which would be the equivalent of a Phase 3 trial.
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Study Type : |
Interventional (Clinical Trial) |
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Estimated Enrollment : |
40000 participants |
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Allocation: |
Randomized |
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Intervention Model: |
Parallel Assignment |
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Intervention Model Description: |
Randomized double-blind placebo-controlled |
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Masking: |
Double (Participant, Investigator) |
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Primary Purpose: |
Prevention |
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Official Title: |
Randomized Double-blind Placebo-controlled Multi-center Clinical Trial in Parallel Assignment of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine in SARS-СoV-2 Infection Prophylactic Treatment |
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Estimated Study Start Date : |
August 31, 2020 |
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Estimated Primary Completion Date : |
May 1, 2021 |
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Estimated Study Completion Date : |
May 1, 2021 |
Regulatory Actions
The Health Ministry of the Russian Federation has approved Sputnik V as the first vaccine for COVID-19. However, no trial data has been published to date and a Phase 3 trial of the candidate has not been initiated. The approval has drawn criticism in the medical community due to lack of data on safety and efficacy.
Funding
This candidate is being supported by the Health Ministry of the Russian Federation.
Source:
https://clinicaltrials.gov/ct2/show/NCT04530396
https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker
https://covidvax.org/covid19-vaccine/Gamaleya/Adeno-based-Gamaleya-Research-Institute
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