Recommendations have appeared for participants in clinical trials of the Sputnik V vaccine. RIA Novosti reports this with reference to the clinical trial protocol.
The document states that women are not recommended to become pregnant, breastfeed or become an egg donor for three months after vaccination. Those who become pregnant will be immediately excluded from vaccination and will be placed under observation.
Men, in turn, are advised to avoid conceiving a child and not donate sperm for artificial insemination during the tests and for another three months after their completion, RIA Novosti reports.
In addition, trial participants must abstain from alcohol three days before vaccination and drink it in limited quantities during the study. They are also allowed to smoke no more than ten cigarettes per day. The trial itself will last 180 days.
According to the recommendations, all volunteers will be examined before receiving the vaccine. They will take tests for COVID-19, HIV, syphilis, hepatitis B and C, for alcohol and narcotic or psychostimulant substances, and women will undergo a pregnancy test, RIA Novosti reports . The volunteer may not be eligible for the study based on screening results.
On August 11, the world’s first coronavirus vaccine was registered in Russia. The vaccine did not pass the third stage of clinical trials, but back in July it was tested by volunteers at Sechenov University.
On September 9, the first study participants were vaccinated as part of a post-registration study in Moscow.