Table 4 Trial objectives and outcomes
Objectives | Outcomes |
|---|---|
Primary | |
Assess adverse maternal/fetal outcomes in pregnant women who were randomized to receive the two-dose Ebola vaccine regimen (group A) and women in the control group (unvaccinated pregnant women—group B) | Outcomes of interest: Frequency of maternal death, spontaneous abortion, stillbirth, pathways to preterm birth (preterm premature rupture of membranes, preterm labor, insufficient cervix and provider-initiated preterm birth), preeclampsia/eclampsia, antenatal bleeding and postpartum hemorrhage from randomization until 6 weeks postcompletion/termination of pregnancy |
Assess adverse neonatal/infant outcomes in neonates/infants born to women who were randomized to receive the two-dose Ebola vaccine regimen (group A) and in neonates/infants born to women in the control group (unvaccinated pregnant women—group B) | Outcomes of interest: Frequency of major congenital malformations, small for gestational age, low birth weight, preterm birth, neonatal death (death within first 28 days) and failure to thrive in infants measured from birth until 14 weeks of age |
Secondary | |
Assess safety in pregnant women who were randomized to receive the two-dose Ebola vaccine regimen (group A) and women in the control group (unvaccinated pregnant women—group B) | Frequency and relatedness of all SAEs in women from randomization until study end |
Assess safety in neonates/infants born to women who were randomized to receive the two-dose Ebola vaccine regimen (group A) and neonates/infants born to women in the control group (unvaccinated pregnant women—group B) | Frequency and relatedness of all SAEs in newborns from birth until study end |
Assess the reactogenicity and unsolicited AEs of the two-dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo) in all vaccinated pregnant women (group A) | Reactogenicity, defined as local and systemic solicited AEs occurring within 7 days after each dose and unsolicited AEs within 28 days after each dose: •Frequency, grade, duration and causality for solicited systemic AEs and unsolicited AEs •Frequency, grade and duration for solicited local AEs |
Describe all pregnancy outcomes | Pregnancy outcome (for example, normal delivery and cesarean section) |
Assess the immunogenicity of the two-dose Ebola vaccine regimen in 150 pregnant women who were anticipated to receive both vaccine doses within the course of their pregnancy (a subset of the 1,000 vaccinated pregnant women from group A), compared to 150 nonpregnant women who were vaccinated after delivery (a subset of group B) | Anti-EBOV GP-specific binding antibody concentrations, in ELISA units per ml from: •Blood samples taken predose 1, 21 days postdose 2, at delivery (group A subset only), and a 1-year postdose 1 Cord blood if feasible from women in the group A subset |
Assess the persistence of maternal antibodies in 75 infants born to women from the group A subset | •Anti-EBOV GP-binding antibody concentrations, in ELISA units per ml (FANG ELISA) from a blood sample taken at 14 weeks of age |
