Almost a fifth of the 474 South Africans screened for South Africa’s COVID-19 vaccination trial were excluded from participation due to underlying conditions, including untreated hypertension, a lead researcher is quoted in TimesSELECT. Sub-investigator Clare Cutland said of that number, 202 had been enrolled in the trial and vaccinated to date.
And, the report says, she said 35 of the 162 patients enrolled by Monday of last week (21%) tested positive for COVID-19 before receiving the vaccine. “All of them were asymptomatic on the day of their (nasal) sample collection. Global studies are revealing that many people infected with COVID-19 are either asymptomatic or mildly symptomatic. Because of the high numbers of asymptomatic COVID-19 cases enrolled in the trial to date, it means one out of every five participants will have to be excluded from certain planned analyses, which could affect the power of the study.”
She said to avoid this, more participants would need to be enrolled. Cutland, who is also a scientific coordinator at Wits University’s African Leadership in Vaccinology Expertise, said this was not anticipated. “It reflects how extensive the infection rate really is in communities.”
Cutland said because of how many people were infected, but asymptomatic, the trial’s protocol had to be amended. This included restructuring screening protocols. She said trial sites were now testing people during screening for past or current COVID-19 infections.
She said the protocol amendments had been approved by an ethics committee and all those already screened, but not yet vaccinated, would be re-screened, with new nasal and blood samples taken. Participants would be enrolled in the trial for a year, with samples regularly taken from them.
Cutland said they were looking for three different results, which included the trial’s safety results, which were expected within the next couple of months; immune response results to the vaccine, which were expected at the end of the year or early next year; and the efficiency of the vaccine. “The efficiency results are only expected to be known next year.”
The South African Ox1Cov-19 Vaccine VIDA Trial is the first in Africa.
[link url="https://select.timeslive.co.za/news/2020-07-10-sa-vaccine-trial-shock-at-how-many-people-already-had-covid-19/?utm_source=&utm_medium=email&utm_campaign=SA+vaccine+trial+shocked+by+how+many+people+already+had+Covid-19+%7C+Scooter+ambulance+project+crashes+%7C+Tom+Eaton%3A+SA+is+already+primed+for+doom.+We+didn%E2%80%99t+need+Bandile+Masuku&utm_term=https%3A%2F%2Fselect.timeslive.co.za%2Fnews%2F2020-07-10-sa-vaccine-trial-shock-at-how-many-people-already-had-covid-19%2F"]Full TimesSELECT report[/link]