a study of a 2-dose ebola vaccine regimen of ad26.zebov followed by mva-bn-filo in healthy pregnant women

Conditions: Healthy

Summary: the purpose of this study is: a) to assess adverse maternal/fetal outcomes in pregnant women randomized to receive the 2- dose ebola vaccine regimen (ad26.zebov, mva-bn-filo \[group a\]) and in control women (unvaccinated pregnant women \[group b\]); and b) to assess adverse neonatal/infant outcomes in neonates/infants born to women randomized to receive the 2-dose ebola vaccine regimen (ad26.zebov, mva-bn-filo \[group a\]) and in neonates/infants born to control women (unvaccinated during pregnancy \[group b\]).


Eligibility criteria:
inclusion criteria: * healthy on the basis of physical examination, medical history, obstetric history, and vital signs performed at screening * healthy on the basis of clinical laboratory tests performed at screening * confirmed singleton pregnancy by positive urine human chorionic gonadotropin (hcg) and ultrasound at time of screening and informed consent, and reconfirmed pregnancy via ultrasound at randomization/day 1 * residing within catchment area of the study site * evidence of normal progress of gestation prior to randomization (day 1) based on obstetric evaluation (including obstetric history, obstetric examination and fetal ultrasound) exclusion criteria: * history of ebola virus disease (evd) (self-declared or laboratory confirmed) * has received any experimental candidate ad26- or mva-based vaccine in the past * known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines \[for example, polysorbate 80, ethylenediaminetetraacetic acid (edta) or l-histidine for ad26.zebov vaccine; tris (hydroxymethyl)-amino methane (tham) for mva-bn-filo vaccine\]), including known allergy to egg, egg products, chicken proteins and aminoglycosides * participant with acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or body temperature greater than or equal to (\>=)38.0ºc on day 1 will be excluded from enrollment at that time but may be rescheduled for enrollment at a later date * during the 6 weeks prior to screening, have had any of (a) confirmed severe acute respiratory syndrome coronavirus 2 (sars-cov-2) (covid-19) infection (test positive), or (b) suspected sars-cov-2 infection (clinical features without documented test results), or (c) close contact with a person with known or suspected sars-cov-2 infection * obstetric history including: a. \>= 2 consecutive spontaneous abortions, b. history of pre-eclampsia or eclampsia, c. rhesus negative multigravida, d. grand multigravida (greater than \[\>\] 5 previous pregnancies, e. previous late still birth (defined as loss of pregnancy at any time after 28 weeks gestation), f. previous low birth weight baby or premature delivery (defined as a delivery before 37 weeks gestation), g. previous neonatal death (defined as death of an infant within the first 28 days of life), h. previous delivery of an infant with a known or suspected genetic or chromosomal abnormality, i. history of other significant pregnancy-related or neonatal complications judged likely to affect the safety of the mother or infant or to significantly compromise the endpoint data collected