India 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 sponsored by UK-based pharma giant AstraZeneca, will be the first of its kind, which aims to find possibilities of vaccinating the most vulnerable sets of the population against Covid-19. The company has launched the trial, globally labelled as “VICTORIA – Vaccine for the Prevention of COVID-19 in Immunocompromised Adults.”
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 (CDSCO), is to “demonstrate the safety and characterize the immunogenicity of AZD1222; AstraZeneca’s candidate ChAdOx1 vector vaccine against SARS-CoV-2 (nCoV-19) in previously unvaccinated immunocompromised adults”.
News18.com’s e-mail to AstraZeneca did not elicit a response at the time of publication of this report.
How is the Trial Planned?
While India hasn’t started recruitment under the trials yet as the trial sites are awaiting final confirmation, recruitment has begun in other countries, including Colombia, Egypt, Thailand, Turkey and Ukraine.
The trial aims to recruit around 360 participants with 60 participants each in the six groups — five disease groups and the group of healthy individuals.
These participants will receive two intramuscular doses of AZD1222, the research name of the vaccine developed by Oxford University along with AstraZeneca, separated by four weeks and will be followed for one year after Dose 1. The study is estimated to be completed by August next year.
The objective of the study is to understand the immunogenicity of the vaccine in individuals with chronic disorders apart from checking the safety profile of the vaccine on these 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 (except breast cancer) who have a life expectancy of longer than three months will be recruited.
India Likely to Start Trial by June
According to officials involved in launching the trial in India, all necessary approvals from the drug regulator as well as ethics committees have been acquired and the trial is likely to begin by June.
“The trial is critical but significant in nature. The last lap of approvals is going on and trial sites have been already audited,” said an official, adding that, “India may recruit only 60 participants, in total with 10 participants in each arm.”
“Here, recruitment of participants will be quite challenging and follow-ups hold utmost importance. Hence, the quality of healthcare infrastructure at the sites involved should be of tertiary level.”