Researchers at Christian Medical College (CMC), Vellore, will carry out the country’s first-ever clinical trials on a booster dose of the Covid-19 vaccine, with the Drugs Controller General of India (DCGI) giving its nod recently.

The team, headed by Dr Winsley Rose, Professor of Paediatrics at CMC, has got the approval to test the efficacy on those who received two doses, a third booster, as well as mixing and matching vaccines for those who received no vaccine shots at all.

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With the Covid-19 pandemic still raging, many countries are looking at the feasibility of giving a booster dose to their citizens, so that they are protected against future waves of the pandemic.

Volunteers for the trials

The CMC scientists, who will carry out trials in and around Vellore, plan to recruit around 1,100 volunteers for the trials, which will last nearly one year, said Dr Rose, who received the DCGI approval on Monday. The trials will be conducted using Covishield and Covaxin.

“There are two parts to the study. One, people who have not received any vaccine will be given either Covaxin or Covishield, and will subsequently be given a shot of the other vaccine. They will then be given the third dose of one of the vaccines,” Dr Rose told BusinessLine.

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In the second part, people who have already received both the shots will be given either Covaxin or Covishield in a random manner. “The other objective of the study would be mix and match the primary doses of the vaccines. So, a person who has received Covaxin as first shot, will be given Covishield as the second, and the booster shot could be either Covaxin or Covishield,” said Dr Rose.

“So, we want to explore all those possibilities. There will be many permutations and combinations,” said Dr Rose, who is also a trained epidemiologist.

The boost-only study will be conducted in 600 people, while 500 volunteers will be drafted in for the prime-and-boost study, he said.

The participants who receive the booster dose will be tested for immunogenicity after 28 days and also at the end of six months, he said. Those who start with their first dose of vaccine, however, will be followed up for nearly one year, said the CMC professor.

Jayaprakash Muliyil, an epidemiologist, who earlier worked with CMC, said both vaccines are seen to be pretty safe.

“This particular study is on exposing people to two Indian vaccines one after another. The body really looks at the protein that you present and it doesn’t look at which company and which State it is produced and all. If they work in a similar (fashion), then we can concretely say that even if we mix them, it doesn’t make any difference,” said Muliyil.

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