Inclusion of pregnant and lactating women in TB treatment and vaccine trials.

BACKGROUND: Historically, pregnant and lactating women (PLW) have been excluded from clinical trials for TB, thereby denying them access to novel treatment and prevention regimens. We aimed to develop an inventory of TB therapeutic and vaccine trials and determine the barriers and facilitators to the inclusion of PLW in TB clinical trials. METHODS: Using a mixed-methods approach, we conducted: a review of recent, current, and planned trials' inclusion and exclusion practices, and in-depth interviews with trialists and sponsors. RESULTS: Of 40 TB therapeutic trials, 7/40 (18%) included PLW; 3/40 (8%) excluded PLW at enrolment but allowed women to remain on study treatment if they became pregnant. None of 12 vaccine trials included PLW but 6/12 (50%) included PLW in safety and/or immunogenicity assessments during study follow-up. Eighteen participants completed in-depth interviews. We identified four broad themes: shifting the narrative, differentiated risks, perceived concerns of PLW, and strategies for inclusion. CONCLUSIONS: With limited inclusion of PLW in TB therapeutic trials and no inclusion in vaccine trials at the time of enrolment, there was consensus that clear guidance is required for trialists, funders, and sponsors on strategies for inclusion of PLW, thus ensuring equitable access to novel TB prevention and treatment regimens.