KATHMANDU: Sanofi and GSK received approval for their Phase 3 clinical study in Nepal to assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate.
The International Vaccine Institute (IVI), an international organization 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.
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 the Beta 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 neutralizing antibody responses in all adult age groups, with 95 to 100% seroconversion rates.
After a single injection, high neutralizing antibody levels were also generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.