Covid-19 study to assess Pfizer, J&J suitability for HIV infected
A Covid-19 vaccine trial in SA will assess the safety and impact of varying doses of Johnson & Johnson (J&J) and Pfizer shots as boosters for those infected with HIV and the wider population.
The study 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 Dr Lee Fairlie, head of child and maternal health at the institute.
With about 8.2-million people in SA, or 13% of the population, infected with HIV, the effectiveness, or immunogenicity, of Covid-19 vaccines in generating an immune system response in immunocompromised 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 an area of importance in SA. We need to know if we are 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.
Recruitment has started 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, she said.
“We are looking at immunogenicity and safety.”
The study comes after researchers earlier this month started recruiting SA health workers to take part in a vaccine trial comparing the use of J&J and Pfizer shots as boosters.
The health workers targeted for the study were part of the initial Sisonke trial, 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 get the same inoculation they received initially.
The new study has been named Booster After Sisonke Study, or BaSiS.
SA has been the site of a number of Covid-19 vaccine trials, with studies run using shots made by J&J, AstraZeneca, Pfizer, Novavax, ImmunityBio and Sinovac Biotech.
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