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Volunteer in vaccine trial tests COVID-19 positive but may have received a placebo
A candidate in a clinical trial for a potential COVID-19 vaccine tested positive for the disease after travelling out of town.
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Trialing the trial: A health worker injects a would-be vaccine candidate into a volunteer in a simulation for a clinical trial for a COVID-19 vaccine candidate at Padjadjaran University’s School of Medicine in Bandung, West Java, on Aug. 27. The simulation was done to ascertain the readiness of medical workers for carrying out the phase-three clinical trial, which will involve 1,620 volunteers. (JP/Arya Dipa)
T
he team overseeing the clinical trial of a COVID-19 vaccine candidate in Bandung, West Java, announced that a volunteer receiving an injection in the trial had tested positive for the disease.
The clinical research team leader, Kusnadi Rusmil of the Padjadjaran University, said the volunteer was currently in self-isolation. The team would supervise the volunteer’s condition.
“After nine days of observation, [the volunteer’s] condition seems to be good,” said Kusnadi in a statement on Thursday.
He added that the clinical research team had injected the first of three doses of the vaccine candidate – or a placebo – to the volunteer. After receiving the first shot, the volunteer traveled out of town.
Upon returning to Bandung, the volunteer went to get the second injection. Kusnadi said the volunteer was declared healthy following an examination.
A day later, the volunteer tested positive for COVID-19 following a swab test conducted by the Bandung Health Agency. The volunteer was required to take a polymerase chain reaction (PCR) test because of their travel history.
Read also: Govt to set aside Rp 37 trillion for COVID-19 vaccine procurement
Kusnadi said he could not confirm whether the research team had injected a potential vaccine or a placebo. “We conduct the trial under the blind observer principle, so we can’t identify who gets the placebo and who gets the [potential] vaccine.”
The research team is conducting phase III clinical trials for a COVID-19 vaccine candidate developed by Chinese biopharmaceutical company Sinovac Biotech. The trial would involve 1,620 volunteers who would be divided into two groups, with one group receiving the vaccine and the other one the placebo.
Kusnadi went on to say that the team expected volunteers to develop immunity against the SARS-CoV-2 virus two weeks after receiving their second dose.
The research team field manager, Eddy Fadlyana of the Padjadjaran University, said the team had only injected 248 of the 1,620 volunteers so far. Only 110 have received the second dose.
He added that most of the volunteers had yet to report any side effects. (mfp)
