GUADALAJARA, Mexico – Describing the value of working with funders, sponsors, industry partners, governments and community members during all stages of tuberculosis vaccine research and development, the Good Participatory Practice Guidelines for TB Vaccine Research released the first day of this conference is the latest step in a movement to ensure those most affected by science inform its discoveries.
Inspired by the Denver Principles rallying cry of “Nothing about us without us,” the first good participatory practice guidelines for biomedical HIV prevention trials were developed in 2007 by UNAIDS and AVAC. Since then, guidelines have been published for HIV and TB drug trials, and for trials related to emerging infections.
The guidelines developed by Aeras, the product development partnership for TB vaccine development, address challenges unique to tuberculosis vaccine research including criteria and conditions for participation. Collaboration with community members in setting standards for vaccine trials will not only ensure that the resulting product will meet the needs and priorities of affected populations, authors said, but will increase research literacy, as well as buy-in for trials and an eventual vaccine, and will aid in product roll-out and research dissemination.
“The goal of a new TB vaccine can only be achieved if the needs and priorities of affected communities are addressed,” Anne Schley, one of the authors of the guidelines, said.
The release of the guidelines comes at an important time, authors noted, with 12 tuberculosis vaccine candidates currently in the pipeline, two of which are in large scale phase III trials in India and China.
The first participatory practice guidelines for HIV treatment and prevention trials followed the closure of PrEP trials in Cambodia and Cameroon after activists protested that affected populations were not involved in the trial design and that in the resulting trial participants were not provided adequate counseling and medical care.