Planning grant to evaluate the use of pentavalent meningococcal vaccine in pregnant women in sub-Saharan Africa - Project Summary/Abstract Meningococcal disease in sub-Saharan Africa is an annually recurring and devastating public health problem. Building upon what has been observed to be the near elimination of serogroup A disease with the development and implementation of a monovalent meningococcal vaccine, MenAfriVac, a pentavalent meningococcal vaccine was developed. This pentavalent vaccine, MenFive, was recently WHO pre-qualified in 2023 and African country introduction has just begun. However, MenFive has not been evaluated in pregnant women and this lack of data presents an obstacle to implementation of this vaccine to the targeted population. In order to address this gap in knowledge and provide assuring data that can facilitate vaccine uptake, we propose to design a Phase 4 study of MenFive in African pregnant women. A number of activities will be necessary to implement this trial. Aim 1. Develop and finalize clinical protocol for the Phase 4 study. During protocol development, a multidisciplinary team will be assembled to develop a protocol which will establish the trial objectives, sample size, eligibility criteria, recruitment process, schedule of procedures, and assessments for safety and immunogenicity. Aim 2. Generate required supporting documents for the Phase 4 study. Under this aim, we will prepare the necessary supporting documents, systems, and plans for the trial, including: safety oversight, clinical monitoring, quality management plan, statistical analysis plan, manual of procedures, study product management plan, and crisis contingency plan. Aim 3. Build and solidify collaborative partners. The protocol development team will involve members of the Center for Vaccine Development and Global Health, Serum Institute of India (the manufacturer), and PATH (a critical partnering international, non-profit global health organization). A process of assessing qualification of potential candidates and their selection will be performed for the endpoint laboratories, responsible for performing the immunological analysis, and the African field sites, where pregnant women are to be enrolled. These research aims are to be performed within the context of adherence to local legal and regulatory requirements, applicable US federal regulations, ICH guidelines, and Good Clinical Practice (GCP) standards.
