HARIANHALUAN.COM – A second phase clinical trial for the COVID-19 vaccine is ready to be carried out by the biotechnology company Novavax. This clinical trial will later be carried out on a group of adults in South Africa.
Quoted from the Live Science page, this phase 2 clinical trial will include a group of 2,665 healthy adults in South Africa, as well as 240 adults with HIV. Selection of people with HIV is considered medically stable but their immune responses may differ from those of people without HIV, so that can be used as a reference.
Meanwhile, HIV advocacy groups have encouraged research to include people with HIV in clinical trials for the COVID-19 vaccine. That’s because companies like Moderna and Pfizer initially said they would exclude volunteers with the infection.
Currently, in the previous phase 1 safety trial of the Novavax vaccine, healthy volunteers given two doses of the vaccine showed only minor side effects, such as headache, fatigue, and tenderness or pain at the injection site, according to a report posted Aug.6 to the server. preprint medRxiv.
According to these preliminary data, which have not been peer reviewed, all phase 1 participants also produced neutralizing antibodies, which can prevent the virus from entering cells, after receiving a second dose of vaccine. Novavax will continue to evaluate this immune response in its Phase 2 trials in South Africa, as well as more Phase 2 trials to be held in the US and Australia in the near future.
The South African elections were not without cause. The country is experiencing a spike in COVID-19 in winter.
“So this Phase 2 clinical trial is important and has the potential to provide an early indication of efficacy, along with additional safety and immunogenicity data for [vaksin], “said Dr. Gregory Glenn, as President of research and development at Novavax,
To date, South Africa is the fifth worst-affected country in the world in terms of COVID-19 cases and related deaths, with 583,653 reported cases and 11,677 deaths as of 17 August.
The Novavax trial in South Africa will be funded by The Bill & Melinda Gates Foundation, which provides a US $ 15 million grant, and The Coalition for Epidemic Preparedness Innovations (CEPI), which provides funding to produce the vaccine doses needed for the trial.
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