By Fouzia van der Fort
A Worcester toddler is still in good health a year after she became the first patient in the most advanced TB vaccine study in the world so far.
Experts hope the vaccine will help eliminate the disease that affects so many lives - particularly in South Africa.
Sixteen-month-old Janenique Pienaar and her mother, Janie Pienaar, 21, met the designer of the vaccine, Dr Helen McShane, at UCT's SA Tuberculosis Vaccine Initiative (Satvi) trials clinic at Brewelskloof Hospital in Worcester this week.
Based at Oxford University's Centre for Vaccinology and Tropical Medicine in the UK, McShane's visit coincides with the vaccination of 1 392 babies, the half-way mark for the number of infants involved in the trial.
"It is a fantastic collaboration of academic groups who have a mutual respect for each other and have similar backgrounds in working with the disease," said McShane of the trials that were started in July last year.
The Phase 2b study tests the safety and efficacy of the new TB vaccine, MVA85A/AERAS-485, and the response of babies' immune systems to it.
McShane said the next phase would require more than 5 000 participants and the Worcester site would play a "pivotal role" in expanding the programme.
"This is the most developed site in the world and the expertise here will be needed to build up other sites," she said.
Dr Hassan Mahomed, clinical director of the site, said the study had undergone rigorous monitoring which ensured a highly controlled environment.
"We have to ensure that all the documents are in order and that doctors, nurses, medical care and equipment are all available in case of emergency," he said.
The UCT research group, the Aeras Global TB Vaccine Foundation, Oxford University, the Oxford-Emergent Tuberculosis Consortium Ltd and the Wellcome Trust are partners in the study to be conducted at the Satvi site.
The vaccine was first developed in England and is being made in Germany for clinical trials.
Mahomed said 1 400 of the 100 000 residents in the Boland area, including Worcester, Ceres and Robertson, contracted the disease annually, adding that Worcester had one of the highest, if not the highest TB rates in the world.
Janenique was just a few months old when she became involved in the study. She underwent a rigorous screening process which included blood tests, a complete medical history and a check of her liver, kidneys and blood flow to ensure that all were functioning properly.
Since the initiative's inception, half the participants have been injected with the vaccine and the other with a placebo to rule out any possible bias.
Pienaar, a farm worker, who lives with her daughter in a corrugated iron house in Stofland, said: "I am very proud that my child is healthy."
A final report with results of the trial will only be finalised in early 2012 when participants have shown results of possible immunity.