The vaccine, produced from vector components rAd26 and rAd5, was given to participants at a dose of 10^11 viral particles per dose for both components.  The frozen vaccine (Gam-COVID-Vac) has a volume of 0.5 mL per dose and the lyophilised vaccine (Gam-COVID-Vac-Lyo) must be reconstituted in 1.0 mL of sterile water for injection. Vaccines were all administered intramuscularly into the deltoid muscle.

Procedure: Vaccine dosage and preparation

Two phases (1 and 2) of open non-randomised studies at hospitals were performed in Russia. For each study, 120 healthy adult volunteers (aged 18–60 years) were preselected to be included in the volunteer register. Adult volunteers had a negative PCR and were negative when tested for IgG and IgM antibodies to SARS-CoV-2. Volunteers also had no history of COVID-19 or contact with patients with COVID-19.

Bowdoin College

The methods used in the phase 1/2 studies evaluating the safety and immunogenicity of the rAd26 and rAd5 vector-based COVID-19 vaccine consisted of three main components: the study design and participant selection, clinical procedures, and statistical analysis.

Methods of rAd26 and rAd5 Vector-Based Vaccine Phase 1/2 Studies

Logunov, D., Dolzhikova, I., et. al. "Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia."  The Lancet, vol 396, 4 Sept. 2020, pp. 887-897. https://doi.org/10.1016/S0440-6736(20)31866-3.


Safety and immunogenicity of an rAd26 and rAd5
vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non randomised phase 1/2 studies from Russia

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