Health Editor’s Note: Results of Russia’s Sputnik V COVID Vaccine Look very good. I would take it….Carol
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
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Denis Y Logunov, DSc *
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Inna V Dolzhikova, PhD *
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Dmitry V Shcheblyakov, PhD
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Amir I Tukhvatulin, PhD
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Olga V Zubkova, PhD
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Alina S Dzharullaeva, MSc
- et al.
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Show all authors
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Background
A heterologous recombinant adenovirus (rAd)-based vaccine, Gam-COVID-Vac (Sputnik V), showed a good safety profile and induced strong humoral and cellular immune responses in participants in phase 1/2 clinical trials. Here, we report preliminary results on the efficacy and safety of Gam-COVID-Vac from the interim analysis of this phase 3 trial.
Methods
We did a randomised, double-blind, placebo-controlled, phase 3 trial at 25 hospitals and polyclinics in Moscow, Russia. We included participants aged at least 18 years, with negative SARS-CoV-2 PCR and IgG and IgM tests, no infectious diseases in the 14 days before enrolment, and no other vaccinations in the 30 days before enrolment. Participants were randomly assigned (3:1) to receive vaccine or placebo, with stratification by age group. Investigators, participants, and all study staff were masked to group assignment. The vaccine was administered (0·5 mL/dose) intramuscularly in a prime-boost regimen: a 21-day interval between the first dose (rAd26) and the second dose (rAd5), both vectors carrying the gene for the full-length SARS-CoV-2 glycoprotein S. The primary outcome was the proportion of participants with PCR-confirmed COVID-19 from day 21 after receiving the first dose. All analyses excluded participants with protocol violations: the primary outcome was assessed in participants who had received two doses of vaccine or placebo, serious adverse events were assessed in all participants who had received at least one dose at the time of database lock, and rare adverse events were assessed in all participants who had received two doses and for whom all available data were verified in the case report form at the time of database lock. The trial is registered at
ClinicalTrials.gov (
NCT04530396).
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Carol graduated from Riverside White Cross School of Nursing in Columbus, Ohio and received her diploma as a registered nurse. She attended Bowling Green State University where she received a Bachelor of Arts Degree in History and Literature. She attended the University of Toledo, College of Nursing, and received a Master’s of Nursing Science Degree as an Educator.
She has traveled extensively, is a photographer, and writes on medical issues. Carol has three children RJ, Katherine, and Stephen – one daughter-in-law; Katie – two granddaughters; Isabella Marianna and Zoe Olivia – and one grandson, Alexander Paul. She also shares her life with her husband Gordon Duff, many cats, and two rescues.
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davor, Lots of countries will be using Sputnik V. Mexico was to import 7.4 million doses of the Russian COVID-19 vaccine Sputnik V from February and April 2021. More vaccines would be delivered in May. Russia was to sell 100 million vaccine doses to India. India was among the countries that agreed with Russia to produce Sputnik V on its territory. Indian company Hetero planned to produce over 100 million doses of the vaccine per year. Sputnik V was registered in Algeria, Argentina, Armenia, Belarus, Bolivia, Guinea, Hungary, Palestine, Paraguay, Russia, Serbia, Tunisia, Turkmenistan, United Arab Emirates, and Venezuela as of February 1, 2021.
Thank you for this info, Carol. Sputnik -V woth it. And it works and becomes popular.
So only Lancet does it for the western-oriented mind. So many other “irrelevant” countries did not wait for Lancet validation.
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