A Study of a 2-dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in Healthy Pregnant Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4031 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2023-03-02

Brief Summary

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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 \[Group B\]).

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A: Ad26.ZEBOV, MVA-BN-Filo

Participants will receive intramuscular (IM) injection (0.5 milliliter \[mL\]) of Adenovirus serotype 26 encoding the ebola virus mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5\*10\^10 viral particle(s) \[vp\]) on Day 1, followed by modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1\*10\^8 infectious unit(s) \[Inf U\]) on Day 57.

Group Type EXPERIMENTAL

Ad26.ZEBOV

Intervention Type BIOLOGICAL

Participants in Group A will receive 0.5 mL IM injection of Ad26.ZEBOV vaccine. Participants in Group B will receive Ad26.ZEBOV 6 weeks after delivery/termination of pregnancy.

MVA-BN-Filo

Intervention Type BIOLOGICAL

Participants in Group A will receive 0.5 mL IM injection of MVA-BN-Filo vaccine. Participants in Group B will receive MVA-BN-Filo 6 weeks after delivery/termination of pregnancy.

Group B: No vaccination during pregnancy

Participants (pregnant women) in control Group B will not receive any vaccination during pregnancy. However, women in this group will receive the 2-dose vaccination regimen at the earliest 6 weeks after delivery/termination of pregnancy that is Dose 1 of Ad26.ZEBOV vaccine (0.5 mL) (5\*10\^10 vp) on Day 1 by IM injection followed by 0.5 mL of MVA-BN-Filo (1\*10\^8 Inf U) vaccine by IM injection 56 days after Dose 1.

Group Type OTHER

Ad26.ZEBOV

Intervention Type BIOLOGICAL

Participants in Group A will receive 0.5 mL IM injection of Ad26.ZEBOV vaccine. Participants in Group B will receive Ad26.ZEBOV 6 weeks after delivery/termination of pregnancy.

MVA-BN-Filo

Intervention Type BIOLOGICAL

Participants in Group A will receive 0.5 mL IM injection of MVA-BN-Filo vaccine. Participants in Group B will receive MVA-BN-Filo 6 weeks after delivery/termination of pregnancy.

Interventions

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Ad26.ZEBOV

Participants in Group A will receive 0.5 mL IM injection of Ad26.ZEBOV vaccine. Participants in Group B will receive Ad26.ZEBOV 6 weeks after delivery/termination of pregnancy.

Intervention Type BIOLOGICAL

MVA-BN-Filo

Participants in Group A will receive 0.5 mL IM injection of MVA-BN-Filo vaccine. Participants in Group B will receive MVA-BN-Filo 6 weeks after delivery/termination of pregnancy.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes