Sanofi and GSK received approval for their Phase 3 clinical study in Nepal to assess the safety, efficacy and immunogenicityof their adjuvanted recombinant-protein Covid-19 vaccine candidate. The International Vaccine Institute (IVI) -- an international organisation dedicated to the discovery, development and delivery of safe, effective and affordable vaccines -- will conduct the Phase 3 clinical trial in Nepal, expecting to enroll 4,000 volunteers across 3 study sites in the country.
In addition to generating local data to support the global clinical trial, this Phase 3 study led by IVI will continue to build capacity and infrastructure for vaccine research and development in Nepal. 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. 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.
"Nepal is participating in Sanofi Pasteur’s pivotal Phase 3 study, and we have begun enrollment of study participants in the country," country head of Sanofi Pasteur India and South Asia Annapurna Das said, adding that they have partnered with International Vaccine Institute for the study in Nepal.
"As the virus continues to evolve, we are anticipating what will be needed in the coming months and years, and accordingly, have adapted our vaccine development programme," she said, adding that they believe their Covid-19 adjuvanted, recombinant vaccine can make a significant contribution to the ongoing fight against Covid-19 and are committed toinitiating ourclinical programin Nepal, at the earliest. "Achieving global immunity to end the Covid-19 pandemic requires an innovative generation of new vaccines that have been tested against circulating variants and that will be accessible to low-resource settings."
The company is pleased to partner with Sanofi Pasteur on this pivotal Phase 3 study in Nepal, particularly in light of our recent collaboration agreement with the Nepal Health Research Council earlier this year to strengthen public health in the region,” said deputy director general at IVI Dr Anh Wartel.
The primary endpoint of the study is the prevention of symptomatic Covid-19 in SARS-CoV-2 naïve adults, with secondary endpoints being the prevention of severe Covid-19 disease and prevention of asymptomatic infection.
In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original virus strain (D.614), while a second stage will evaluate a second formulation targeting theBeta variant (B.1.351). Recent scientific evidence shows that antibodies created against the Beta variant may provide broad cross-protection against other more transmissible variants.
The design of the Phase 3 study, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants. Sanofi and GSK will also run clinical studies to assess the ability of the adjuvanted recombinant-protein Covid-19 vaccine candidate to generate a strong booster response regardless of the type of vaccine initially received.
The Phase 3 study initiation follows the global interim Phase 2 results which showed that the adjuvanted recombinant Covid-19 vaccine candidate achieved high rates of neutralising antibody responses in all adult age groups, with 95 per cent to100 per cent seroconversion rates. After a single injection, high neutralizing antibody levels were also generated in participants with evidence of prior SARS.
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