When surveyed about participation in a hypothetic Zika vaccine clinical trial, pregnant participants placed a high premium on clinical evidence and pregnancy-specific data, according to research results published in Vaccine.
A recent survey study collected data from pregnant and postpartum women in an effort to assess their willingness to participate in a hypothetic Zika virus vaccine trial and their motivations for participating. Information on demographics, prior exposure, and vaccine acceptance was collected. Although there have been previous studies on the willingness of pregnant women to participate in vaccine research, there is significantly less information about pregnant women’s willingness to participate specifically in Zika virus vaccine trials. Congenital Zika syndrome in a baby, caused by infection during the mother’s pregnancy, can result in life-altering anomalies, and the researchers hope that a vaccine can be used against future outbreaks.
The women in the study were given a scenario-based survey to measure their willingness to enroll in a Zika virus vaccine trial. The survey tool presented 4 hypothetic vaccine trials to each survey participant, including a 3-dose trial of an inactivated Zika virus, a 2-dose trial of an inactivated Zika virus, a 1-dose trial of a live-attenuated Zika virus shown to be safe in nonpregnant people, and a 2-dose trial of a nucleic acid-based vaccine shown to be safe in nonpregnant people. Each survey participant was asked to rate the perceived safety of each vaccine as well as their willingness to participate in the trial.
A total of 129 women completed the study. Overall, the participants displayed a high level of willingness to participate in trials of an inactivated virus vaccine (65% and 68% for 2 vaccine scenarios) and the nucleic acid-based vaccine (52%). Only 19% of the women were willing to participate in a live-attenuated virus vaccine trial.
As part of the survey, the women were also asked to choose from a list of factors that influenced their decision to participate or not participate. Among those who were willing, 65% responded that their desire was to protect themselves and 98% cited a desire to protect their babies. Obtaining extra medical care accounted for 25% of the motivation, and contributing to science was a motivating factor for 20% of the participants. Of the women who declined to participate, a majority indicated that they believed the vaccine to be “likely or definitely not safe” for their babies.
The investigators hope the findings of their study may guide researchers, vaccine developers, regulators, and others as Zika virus vaccines are developed. The authors believe that these data may allow future researchers to have a better understanding of when and how best to include pregnant women in Zika virus vaccine trials.
Goldfarb IT, Jaffe E, James K, Lyerly AD. Pregnant women’s attitudes toward Zika virus vaccine trial participation. Vaccine. 2018;36(45):6711-6717.