A clinical trial that will combine AstraZeneca (AZ)/Oxford University’s COVID-19 vaccine with Russia’s Sputnik V COVID-19 vaccine could begin in February, according to the chairman of Russian pharma R-Pharm.
R-Pharm chairman Alexei Repik told Reuters that human trials of the combined vaccination are expected to start in early February, a month after AZ confirmed that it will explore a combination of its Oxford-partnered vaccine with Sputnik V.
On 11 December 2020, AZ announced “a clinical trial programme to assess the safety and immunogenicity of a combination of AZD1222, developed by AstraZeneca and Oxford University, and Sputnik V, developed by Russian Gamaleya Research institute”.
Repik added that the trials are set to be conducted in Azerbaijan, Argentina, Saudi Arabia, the UAE, Belarus, Russia and other locations.
The clinicaltrials.gov database, which lists information from clinical studies from around the world, gives an estimated study start date of 16 March, with participants set to receive a first dose of the AZ/Oxford vaccine followed by the Russian vaccine on day 29 of the study.
In November 2020, Russia announced that data for Sputnik V showed that the vaccine is 91.4% effective on day 28 after the first dose.
The updated analysis evaluated the vaccine’s efficacy after 39 COVID-19 cases in total were observed in the trial – eight of which occurred in the vaccinated group compared to 31 in the placebo arm.
The efficacy evaluation was conducted among participants 28 days after receiving the first dose, and seven days after the second dose, with the analysis demonstrating a 91.4% efficacy rate.
The vaccine, developed by the Gamaleya Institute, consists of two strains of adenoviruses, which usually cause the common cold and are used as ‘vectors’ to carry the gene for the SARS-CoV-2 spike protein.
Like Sputnik V, the AZ/Oxford vaccine also uses an adenoviral vector and contains genetic material of the SARS-CoV-2 virus spike protein.
Last month, The Lancet published peer-reviewed results from an interim analysis of AZ/Oxford’s phase 3 COVID-19 vaccine programme, confirming the vaccine to be 70.4% effective based on two dosing regimens.
The interim analysis for efficacy of the vaccine, AZD1222, was based on 11,636 participants with 131 symptomatic COVID-19 infections from the phase 3 UK and Brazil trials conducted by Oxford University.
Further analysis of the regimens demonstrated that the vaccine’s efficacy rate was 62.1% for participants receiving two full doses of AZD1222, while participants who received a half dose followed by a full dose showed a 90.0% efficacy rate.