Ilona Telefus Goldfarb1, Elana Jaffe2, Kaitlyn James3, Anne Drapkin Lyerly2. 1. Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, MA, United States. Electronic address: igoldfarb@partners.org. 2. Center for Bioethics and Department of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States. 3. Deborah Kelly Center for Outcomes Research, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, MA, United States.
Abstract
INTRODUCTION: As Zika virus infection during pregnancy can cause a range of congenital anomalies, pregnant women may be a target population for vaccination in future outbreaks. Their inclusion in vaccine trials is critical to ensure safe and effective vaccines in pregnancy. Though many vaccine candidates are in development, pregnant women's willingness to participate in Zika virus vaccine research is unknown. This study aims to describe pregnant women's attitudes toward Zika virus vaccine research participation, as well as perceived barriers to and facilitators of enrollment. METHODS: Pregnant and recently postpartum women (n = 128) attending prenatal care at Massachusetts General Hospital completed surveys querying their willingness to participate in four hypothetical Zika virus vaccine trials and their motivations for participation. Demographics, information on prior Zika virus exposure, and vaccine acceptance were collected. RESULTS: Most women (77%) accepted participation in at least one hypothetical Zika virus vaccine trial, and women were significantly more likely to accept prospective enrollment in an inactivated vaccine trial compared to a live-attenuated vaccine trial (p-value <0.0001) or a nucleic acid-based vaccine trial (p-value <0.0444). Important motivators for participation included evidence from research with pregnant and non-pregnant people, a desire to protect the baby from Zika, perceptions of vaccine safety, and provider recommendation. CONCLUSIONS: A majority of women in this cohort were willing to participate in a Zika virus vaccine trial while pregnant, however, differences in acceptance exist between vaccine platforms. The high value placed on evidence by participants highlights the importance of gathering and communicating pregnancy-specific data to potential research participants and their providers. Women's motivations for accepting research participation during pregnancy are important to inform the Zika virus vaccine research agenda, candidate prioritization, and trial design.
INTRODUCTION: As Zika virus infection during pregnancy can cause a range of congenital anomalies, pregnant women may be a target population for vaccination in future outbreaks. Their inclusion in vaccine trials is critical to ensure safe and effective vaccines in pregnancy. Though many vaccine candidates are in development, pregnant women's willingness to participate in Zika virus vaccine research is unknown. This study aims to describe pregnant women's attitudes toward Zika virus vaccine research participation, as well as perceived barriers to and facilitators of enrollment. METHODS: Pregnant and recently postpartum women (n = 128) attending prenatal care at Massachusetts General Hospital completed surveys querying their willingness to participate in four hypothetical Zika virus vaccine trials and their motivations for participation. Demographics, information on prior Zika virus exposure, and vaccine acceptance were collected. RESULTS: Most women (77%) accepted participation in at least one hypothetical Zika virus vaccine trial, and women were significantly more likely to accept prospective enrollment in an inactivated vaccine trial compared to a live-attenuated vaccine trial (p-value <0.0001) or a nucleic acid-based vaccine trial (p-value <0.0444). Important motivators for participation included evidence from research with pregnant and non-pregnant people, a desire to protect the baby from Zika, perceptions of vaccine safety, and provider recommendation. CONCLUSIONS: A majority of women in this cohort were willing to participate in a Zika virus vaccine trial while pregnant, however, differences in acceptance exist between vaccine platforms. The high value placed on evidence by participants highlights the importance of gathering and communicating pregnancy-specific data to potential research participants and their providers. Women's motivations for accepting research participation during pregnancy are important to inform the Zika virus vaccine research agenda, candidate prioritization, and trial design.
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