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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04556526

CR108739

VAC52150EBL3010 (Other Identifier)

Details and patient eligibility

About

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]).

Enrollment: 4,031 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,031 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Biological: MVA-BN-Filo

Biological: Ad26.ZEBOV

Group B: No vaccination during pregnancy

Other group

Description:

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.

Treatment:

Biological: MVA-BN-Filo

Biological: Ad26.ZEBOV