The Pharma regulator has given Sanofi and GlaxoSmithKline permission to include participants in late-stage worldwide human studies of their protein-based Covid-19 vaccine candidates here. The Indian population will be included in the first worldwide clinical study for a Covid-19 vaccination. According to Sanofi’s recent filing to the Clinical Trials Registry of India, the global trial would comprise 37,430 participants over the age of 18 across 13 sites in the United States, Asia, Africa, and Latin America. According to the proposal dated June 25, India would account for 3,000 participants.
Aartham Multi Super Specialty Hospital in Ahmedabad, Maharaja Agrasen Super Specialty Hospital in Jaipur, and Nizam’s Institute of Medical Sciences (NIMS) in Hyderabad have been chosen to perform the Indian arm of the trial. Enrollment of participants in the country “should soon commence” pending “subsequent clearances,” according to Annapurna Das, Country Head, Sanofi Pasteur India.
According to the most recent information accessible on CTRI, NIMS is currently waiting for approval from its ethics committee, while the other two locations gained approval from non-independent ethics committees between June 21 and 24.The vaccinations are also likely to be tested at the Central Drugs Laboratory in Kasauli before being used in the trials.“As Covid-19 immunisation becomes available, research participants are advised to obtain an approved Covid-19 vaccine during the study if they wish,” Sanofi said in a press release on Thursday.
“All participants, including the control group, will be provided the study vaccination as soon as it is determined to be safe and efficacious as part of the study design,” it continued. The United States, Japan, Sri Lanka, Pakistan, Colombia, Dominican Republic, Honduras, Mexico, Kenya, Nigeria, Ghana, and Uganda are among the countries taking part in the protein-based vaccine candidate trial.
At this time, it’s unknown how the remaining 34,430 participants will be distributed amongst these countries. The experiment will evaluate the effectiveness of monovalent and bivalent adjuvant recombinant protein vaccinations to prevent symptomatic Covid-19 cases caused by two strains of the SARS-CoV-2 virus — the original D614G and the Beta variant — in a “two-stage” strategy (B.1.351).
The vaccines’ safety will be investigated further in the trial. It will also compare the neutralising antibody response developed to the two variants in those who do not have any existing protection against SARS-CoV-2 because they have not been exposed to the virus (immunologically naive participants) and those who have (non-nave participants) who have been exposed to the virus.