Covid Study to Assess Pfizer, J&J Suitability for HIV Infected
(Bloomberg) -- A South African Covid-19 vaccine trial will assess the safety and impact of varying doses of Johnson & Johnson and Pfizer Inc. shots as boosters for those infected with HIV as well as the wider population.
The study being carried out by the Johannesburg-based Wits Reproductive Health and HIV Institute will recruit about 300 health workers, of which about a third will be HIV positive, said Lee Fairlie, head of child and maternal health at the institute.
With about 8.2 million people in South Africa, or 13% of the population, infected with HIV, the effectiveness, or immunogenicity, of Covid-19 vaccines in generating an immune system response in immuno-compromised individuals has been a key concern. HIV causes AIDS, which weakens the immune system.
“There are a number of concerns about immunogenicity in people with HIV, particularly people with less well-controlled HIV,” Fairlie said. “That is really an area of importance in South Africa. We really need to know: are we doing enough for people with HIV?”
Participants will be randomly allocated a full or half dose of vaccine made by either J&J, or Pfizer and BioNTech SE.
Recruitment has begun and will continue for about four months, with final results from four sites in Johannesburg, Durban and Cape Town expected six months later. Early results on safety will be gleaned from check-ups carried out after two weeks and three months, Fairlie said.
Assessing the effectiveness of the vaccines in preventing Covid-19 is not the primary focus of the trial, Fairlie said.
“We are looking at immunogenicity and safety,” he said.
The study comes after researchers earlier this month started recruiting South African health workers to take part in a vaccine trial comparing the use of J&J and Pfizer shots as boosters. The health workers being targeted for the study were part of an initial trial, known as Sisonke, in which almost half a million people were given an initial dose of J&J’s vaccine.
A booster trial using a second J&J dose has already been run on some Sisonke participants. The government has in recent weeks begun offering both J&J and Pfizer boosters, with the stipulation that those administered with the vaccine receive the same inoculation they got initially.
The new study has been named Booster After Sisonke Study, or BaSiS.
South Africa has been the site of a number of Covid-19 vaccine trials, with studies having been run using shots made by J&J, AstraZeneca Plc, Pfizer, Novavax Inc., ImmunityBio Inc. and Sinovac Biotech Ltd.
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