April 22, 2024

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Sanofi/GSK adjuvant recombinant COVID-19 vaccine

Sanofi/GSK adjuvant recombinant COVID-19 vaccine

 

Sanofi/GSK adjuvant recombinant COVID-19 vaccine: all adult age groups trigger a strong neutralizing antibody response! 

Recently, Sanofi (SNF) and GlaxoSmithKline (GSK) announced data from a Phase 2 study of adjuvant recombinant COVID-19 vaccine candidates. The study was carried out in 722 healthy adults aged 18 and over, including those with high-risk medical diseases, and evaluated a 2-shot immunization program (21 days apart, 3 antigen dose levels [5, 10, 15μg] ]) safety, reactogenicity and immunogenicity. The results show that in all adult age groups, the neutralizing antibody response rate is high, which is consistent with the neutralizing antibody response rate of COVID-19 recoveries. A key global Phase 3 study is expected to be launched in the next few weeks.

Sanofi/GSK adjuvant recombinant COVID-19 vaccine

 

The mid-term results of the Phase 2 study showed that the seroconversion rate after the second injection of all age groups (18-95 years) and all doses was 95%-100%, which was acceptable tolerable and had no safety issues. In general, the level of strongly neutralizing antibodies produced by the candidate vaccine is comparable to that produced by natural infections, with higher levels observed in younger people (18-59 years old). After a single injection, there is evidence that subjects who have been infected with SARS-CoV-2 have produced high levels of neutralizing antibodies, which shows the development of this vaccine as a booster vaccine (booster vaccine) strong potential.

Based on these positive interim results of the Phase 2 study, Sanofi and GlaxoSmithKline plan to launch a global Phase 3 randomized, double-blind study in the next few weeks to evaluate a 10μg dose of antigen combined with GlaxoSmithKline’s pandemic adjuvant. This phase 3 trial is expected to recruit more than 35,000 adult participants from multiple countries around the world, and will evaluate the efficacy of two vaccine formulations, including variants D614 (Wuhan) and B.1.351 (South Africa).

At the same time, both parties intend to conduct booster studies on various different formulations to evaluate the ability of low-dose vaccines to produce a strong booster response, regardless of the original vaccine platform. If the Phase 3 study achieves positive results and is submitted for regulatory review, the vaccine is expected to be approved in the fourth quarter of 2021.

 

Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur, said: “Our Phase 2 study data confirms the potential of this vaccine to play a role in the current global public health crisis, because we know that multiple vaccines are needed. Especially with the continuous emergence of mutations, the demand for effective and enhanced vaccines that can be stored at room temperature is increasing. With these favorable results, we will conduct a global phase 3 effectiveness study. We look forward to creating more data, And cooperate with partners all over the world to provide our vaccine as soon as possible.”

Roger Connor, President of GlaxoSmithKline Vaccines, said: “These positive data show the potential of this protein-based adjuvant vaccine in the context of the COVID-19 pandemic, including the need to address mutations and provide booster doses. We believe this A vaccine candidate can make a significant contribution to the ongoing fight against COVID-19. We will enter Phase 3 studies as soon as possible to achieve our goal of making the vaccine available by the end of the year.”(

 

(source:internet, reference only)


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