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Sanofi, GSK get nod for first global clinical trial with Indian population

Subject to “subsequent approvals”, enrollment of participants in the country “should soon begin”, said Annapurna Das, Country Head, Sanofi Pasteur India.

Written by Prabha Raghavan | New Delhi |
Updated: July 9, 2021 7:34:29 am
The global trial will include 37,430 volunteers above the age of 18 years across 13 sites in the US, Asia, Africa and Latin America. (Representational Photo)

Sanofi and GlaxoSmithKline have received the drug regulator’s permission to include participants here in late-stage global human trials of their protein-based Covid-19 vaccine candidates. This is the first global clinical trial for a Covid-19 vaccine that will include the Indian population.

The global trial will include 37,430 volunteers above the age of 18 years across 13 sites in the US, Asia, Africa and Latin America, according to Sanofi’s latest submission to the Clinical Trials Registry of India. Of this, India will account for 3,000 participants, according to the submission dated June 25. Three sites have been selected to conduct the Indian arm of the trial — Aartham Multi Super Specialty Hospital in Ahmedabad, Maharaja Agrasen Super Specialty Hospital in Jaipur and Nizam’s Institute of Medical Sciences (NIMS) in Hyderabad.

Subject to “subsequent approvals”, enrollment of participants in the country “should soon begin,” said Annapurna Das, Country Head, Sanofi Pasteur India.

NIMS is still awaiting clearance from its ethics committee, while the other two sites received approvals from non-independent ethics committees between June 21 and 24, according to the latest information available on CTRI. Batches of the vaccines are also expected to undergo testing at the Central Drugs Laboratory in Kasauli before they are administered in the trials, The Indian Express has learnt.

“As Covid-19 vaccination becomes available, study participants are encouraged to receive an approved Covid-19 vaccine during the study, if they wish to do so,” stated Sanofi in a media release about the development on Thursday. “As part of the study design, all participants including the control group will be offered the study vaccine as soon as it is determined to be safe and effective,” it added.

Other countries participating in the trial of the protein-based vaccine candidate include the US, Japan, Sri Lanka, Pakistan, Colombia, Dominican Republic, Honduras, Mexico, Kenya, Nigeria, Ghana and Uganda. It is unclear at this stage how the remaining 34,430 participants will be split across these countries. In a “two-stage” approach, the trial will help assess the ability of the monovalent and bivalent adjuvanted recombinant protein vaccines to prevent symptomatic Covid-19 cases caused by two strains of the SARS-CoV-2 virus — the original D614G and the Beta variant (B.1.351). The trial will further study the safety of the vaccines. It will also compare the neutralising antibody response developed to the two variants in those who do not have existing protection against SARS-CoV-2 because they have not been exposed to the virus (immunologically naïve) and those who have (non-naïve participants).

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