India to Participate in Global Trials to Assess Safety of Covishield among Cancer, HIV, Transplant Patients
News 18India will soon kick-start trials to assess the safety and immunity of AstraZeneca’s Covid-19 vaccine, dubbed Covishield in India, among unvaccinated immunocompromised adults, News18.com has learnt. According to the study planned on the global scale, previously unvaccinated immunocompromised adults will be enrolled in five disease cohorts — solid organ transplant, hematopoietic stem cell transplant, solid organ cancer patients receiving cytotoxic chemotherapy, HIV, auto-immune diseases and a group of healthy adults. The trial, which is The purpose of this Phase 4 study, according to the brief shared by the company with the country’s apex drug regulator, Central Drugs Standard Control Organisation, is to “demonstrate the safety and characterize the immunogenicity of AZD1222; AstraZeneca’s candidate ChAdOx1 vector vaccine against SARS-CoV-2 in previously unvaccinated immunocompromised adults”. Under the solid organ transplant category, the trial aims to enroll participants with heart, lung, kidney or liver transplants who are stable on immunosuppressants, whereas under cancer patients category, the participants with solid tumours who have a life expectancy of longer than three months will be recruited.