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From Russia with Love – “Sputnik V” COVID-19 Vaccine Generated an Immune Response

From Russia with Love – “Sputnik V” COVID-19 Vaccine Generated an Immune Response

Between June 18 and Aug 3, 2020, Ministry of Health of the Russian Federation enrolled 76 participants to the two studies (38 in each study). In each study, 9 volunteers received rAd26-S in Phase 1, nine received rAd5-S in phase 1, and 20 received rAd26-S and rAd5-S in Phase 2. Both vaccine formulations were safe and well tolerated.

In both Phase 1 and 2 studies of the Sputnik V vaccine all 76 participants developed antibodies to the virus that causes COVID-19.

The most common adverse events were pain at injection site (44 [58%]), hyperthermia (38 [50%]), headache (32 [42%]), asthenia (21 [28%]), and muscle and joint pain (18 [24%]).

Most adverse events were mild and no serious adverse events were detected.

All participants produced antibodies to SARS-CoV-2 glycoprotein.

Cell-mediated responses were detected in all participants at day 28, with median cell proliferation of 2·5% CD4+ and 1·3% CD8+ with the frozen formulation, and a median cell proliferation of 1·3% CD4+ and 1·1% CD8+ with the lyophilised formulation.

The heterologous rAd26 and rAd5 vector-based COVID-19 vaccine has a good safety profile and induced strong humoral and cellular immune responses in participants.

Further investigation is needed of the effectiveness of this vaccine for prevention of COVID-19.

September 4, 2020

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