CAPE TOWN - The Sefako Makgatho Health Sciences University, Numolux, and China’s Sinovac have partnered to conduct a paediatric vaccine study on Covid-19 vaccines for children and adolescents, aged between six months and 17 years.
The study will see more than 2 000 children and teenagers take part in research with seven clinical research sites across the country being utilised.
The first child is expected to be vaccinated at the university’s MeCRU Clinical Research Unit on Friday.
The children taking part in the trial will receive two doses of Sinovac’s CoronaVac vaccine or a placebo, 27 days apart.
“Efficacy assessments to include the surveillance for Covid-19 like symptoms, and the laboratory confirmation of Sars-CoV-2 infection by RT-PCR.
“Any confirmed Covid-19 cases will be followed by the investigators until resolution,” said Numolux, the Pretoria-based SA partner to Sinovac.
“Whole viral genome sequencing, to detect mutations or variants of concern, among all the confirmed Covid-19 cases during the trial, will be done.
Interim analysis will be done when 47 Covid-19 cases have been reported. “Safety will be evaluated in terms of solicited local and systemic adverse events, during the seven days following vaccination and of unsolicited adverse events during 28 days post-vaccination.”
Numolux said the study was a multi-centre, randomised, double-blind, placebo-controlled phase 3 clinical trial, which would evaluate the efficacy of the vaccine on children and adolescents.
It would also evaluate the immunogenicity and safety of Sinovac in children and adolescents, between the ages of 6 months and 17 years.
“Efficacy will also be evaluated against hospitalisation and severe Covid-19 cases.
The study, worldwide, will enrol 14 000 children and adolescents, in various paediatric age group cohorts, across five countries – South Africa, Chile, Philippines, Malaysia and Kenya,” said Numolux.
“Numolux has partnered with 7 clinical research sites across South Africa to enroll 2000 participants from 6 months to 17 years.”
Numolux said it would observe those taking part in the trial for 12 months, after they take their second dose.
“Humoral immune response, across a subset of all paediatric age group cohorts, will be evaluated and cell mediated immune response, in a subset of vaccinated participants in Chile, will be investigated.
“In South Africa, the trial has received South African Health Products Regulatory Authority (SAHPRA), Pharma Ethics, and SMUREC, approval and is listed on the South African Clinical Trial Registry,” said Numolux.
“This study has public health importance globally because a vaccine that prevents Covid-19 disease and transmission in paediatrics would be a crucial tool to assist in curbing the pandemic.
“Although children and adolescents have a milder form than adults, they remain susceptible to infection and severe manifestations across all ages.
“Sinovac is committed to the research and development of a safe and effective vaccine.
“It seeks a vaccine that protects people of all ages and comorbidities against Covid-19,” said Numolux.