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

Janssen Vaccines & Prevention B.V.4,031 enrolled

Overview

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 \[Group B\]).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

4,031

Conditions

Healthy

Interventions

Ad26.ZEBOVBIOLOGICAL

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-FiloBIOLOGICAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Gihundwe District Hospital

Cuangugu, Rwanda

Gisenyi Hospital

Gysenyi, Rwanda

Center for Family Health Research/Project San Francisco

Kigali, Rwanda

Outcomes

Primary Outcomes

Percentage of Participants with Maternal Deaths

Percentage of participants with maternal deaths will be reported. Maternal death is the death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes.

Time frame: Up to 6 weeks post-completion/termination of pregnancy

Percentage of Participants with Spontaneous Abortion

Percentage of participants with spontaneous abortion will be reported. Spontaneous abortion is a pregnancy loss that occurs up to 21 weeks 6 days of gestation.

Time frame: Up to 6 weeks post-completion/termination of pregnancy

Percentage of Participants with Stillbirth

Percentage of participants with stillbirth will be reported. Stillbirth is fetal death at or after 21 weeks 6 days of gestation.

Time frame: Up to 6 weeks post-completion/termination of pregnancy

Percentage of Participants on the Pathways to Preterm Birth

Percentage of participants on the pathways to preterm birth will be reported. Pathways to preterm birth is a clinical syndrome characterized by any one or some combination of the following four pathways: 1) Premature preterm rupture of membranes, 2) Preterm labor, 3) Insufficient cervix, 4) Provider- initiated preterm birth.

Time frame: Up to 6 weeks post-completion/termination of pregnancy

Percentage of Participants with Pre-eclampsia/ eclampsia

Percentage of participants with pre-eclampsia/ eclampsia will be reported. Pre-eclampsia is new-onset or worsening of existing hypertension with new-onset proteinuria after 20 weeks gestation.

Time frame: Up to 6 weeks post-completion/termination of pregnancy

Percentage of Participants with Antenatal Bleeding

Data from ClinicalTrials.gov

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Secondary Outcomes

Percentage of Participants (Pregnant Women) with Serious Adverse Events (SAEs) for Group A and B

A SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

Time frame: Up to 6 weeks post-partum or post-pregnancy termination, whichever occurs earlier

Percentage of Participants (Pregnant Women) with SAEs for Subset of Group A and B

A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above

Time frame: Up to 365 days or 1 year post dose

Percentage of Newborns (Born to Participants) with SAEs

Time frame: From birth up to 14 weeks of age

Percentage of Participants with Solicited Local and Systemic Adverse Events (AEs)

Solicited local AEs: pain/tenderness, erythema, and induration/swelling. Solicited systemic AEs: headache, fatigue, myalgia, arthralgia, chills and fever.

Time frame: 7 Days after each vaccination (up to Day 64)

Percentage of Participants with Unsolicited AEs

Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.

Time frame: 28 Days after each vaccination (up to Day 85)

Percentage of Participants with Normal Delivery

Percentage of participants with normal delivery will be reported.

Time frame: Up to 6 weeks post-completion/termination of pregnancy

Percentage of Participants with Caesarian Section

Percentage of participants with caesarian section will be reported.

Time frame: Up to 6 weeks post-completion/termination of pregnancy

Percentage of Participants with Anti-Ebola virus (EBOV) Glycoprotein (GP) Binding Antibodies

Blood samples will be collected for analysis of binding antibodies against EBOV GP using Filovirus Animal Non-Clinical Group (FANG) enzyme-linked immunosorbent assay (ELISA).

Time frame: Day 1 (pre-dose 1), Day 78 (21 days post-dose 2), at delivery (Group A subset only), and 1 year post-dose 1 (Day 365)

Percentage of Infants (Born to Participants) with Anti-Ebola virus (EBOV) Glycoprotein (GP) Binding Antibodies

Blood samples will be collected from infants at 14 weeks of age for analysis of binding antibodies against EBOV GP using Filovirus Animal Non-Clinical Group (FANG) enzyme-linked immunosorbent assay (ELISA).

Time frame: From birth up to 14 weeks of age