KIE Director and Senior Research Scholar Maggie Little was asked to present at the National Institute of Allergy and Infectious Diseases (NIAID) last week. The meeting was convened by the National Institutes of Health (NIH) to bring together a working group of leading experts and relevant stakeholders to discuss a clinical development plan for testing a new malaria vaccine in pregnant women.
The new vaccine, known by its acronym “PfSPZ” (Plasmodium falciparum [Pf] and sporozoites [SPZ]) has shown promise in early clinical trials. However, it has in the past been subject to some criticism regarding to large-scale production and delivery in Africa, where need is greatest, since it must be stored in super-cold liquid nitrogen.
The PfSPZ vaccine has demonstrated protective efficacy against malaria infection in both those who’ve been exposed to the disease in the past, and those who have not. The initial planned use for the vaccine or related products in Africa will be for malaria elimination campaigns. This means that safety must be demonstrated in all relevant populations: including pregnant women. At the same time, current ways of treating and preventing malaria are proving inadequate to protect pregnant women in many communities from the disease, and the research community needs to establish a pathway for testing malaria vaccines that might benefit this highly susceptible population.
During the meeting, Dr. Little gave a presentation on the ethics of research with pregnant women, citing her ongoing work with HIV/AIDs and the Zika virus. Following Little’s presentation were several other talks on various aspects of clinical trial design. The meeting ended with discussion of a possible clinical development plan/research protocol for conducting “first in pregnant women” trials for the PfSPZ vaccine.
Little called the event a “fruitful and thought-provoking discussion” of the various evidentiary and regulatory benchmarks required to move into safety (and efficacy) testing in pregnancy, noting that the group emerged from the meeting with a clearer and more actionable clinical development plan that meets scientific, clinical, and regulatory requirements for success.