Pregnancy Outcomes among Women Receiving rVSVΔ-ZEBOV-GP Ebola Vaccine during the Sierra Leone Trial to Introduce a Vaccine against Ebola

Jennifer K Legardy-Williams, Rosalind J Carter, Susan T Goldstein, Olamide D Jarrett, Elena Szefer, Augustin E Fombah, Sarah C Tinker, Mohamed Samai, Barbara E Mahon, Jennifer K Legardy-Williams, Rosalind J Carter, Susan T Goldstein, Olamide D Jarrett, Elena Szefer, Augustin E Fombah, Sarah C Tinker, Mohamed Samai, Barbara E Mahon

Abstract

Little information exists regarding Ebola vaccine rVSVΔG-ZEBOV-GP and pregnancy. The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) randomized participants without blinding to immediate or deferred (18-24 weeks postenrollment) vaccination. Pregnancy was an exclusion criterion, but 84 women were inadvertently vaccinated in early pregnancy or became pregnant <60 days after vaccination or enrollment. Among immediate vaccinated women, 45% (14/31) reported pregnancy loss, compared with 33% (11/33) of unvaccinated women with contemporaneous pregnancies (relative risk 1.35, 95% CI 0.73-2.52). Pregnancy loss was similar among women with higher risk for vaccine viremia (conception before or <14 days after vaccination) (44% [4/9]) and women with lower risk (conception >15 days after vaccination) (45% [10/22]). No congenital anomalies were detected among 44 live-born infants examined. These data highlight the need for Ebola vaccination decisions to balance the possible risk for an adverse pregnancy outcome with the risk for Ebola exposure.

Trial registration: ClinicalTrials.gov NCT02378753.

Keywords: Ebola; Ebola vaccine; Ebola virus; Ebola virus disease; STRIVE; Sierra Leone; Sierra Leone Trial to Introduce a Vaccine against Ebola; West Africa; pregnancy; rVSVΔ-ZEBOV-GP; vaccine safety; vaccine-preventable diseases; viruses.

Figures

Figure 1
Figure 1
Enrollment and vaccination period for 84 participants in Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE). Three participants randomized to the immediate group were unvaccinated. After vaccination, participants in the deferred group were eligible for vaccination at 18–24 weeks postenrollment. Upon vaccination, participants in the deferred group were referred to as the deferred crossover vaccinated group.
Figure 2
Figure 2
Number of pregnancies by estimated date of conception relative to vaccination or enrollment among 81 participants in the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE). A) Immediate vaccination group (n = 31). B) Deferred crossover vaccination group (n = 17). C) Unvaccinated group (n = 33). Because pregnancy outcome for 3 of the 84 women was unknown, these 3 women are not included in the figure. Outcomes include live birth (term and preterm) and pregnancy loss (early and late loss). Gray shaded area denotes the high viremia risk period (i.e., women who were pregnant when vaccinated or became pregnant 0–14 days after vaccination).

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