A Study of a 2-dose Ebola Vaccine Regimen of Ad26.ZEBOV F... | NCT04556526

NCT04556526

Protocol Section

Identification Module

Results Section

No data available

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
VAC52150EBL3010	Other Identifier	Janssen Vaccines & Prevention B.V.

Status Module

Name	Class
Center for Family Health Research (CFHR)	UNKNOWN
Coalition for Epidemic Preparedness Innovations	OTHER
Emory University	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A: Ad26.ZEBOV, MVA-BN-Filo	Experimental	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 (510^10 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 (110^8 infectious unit(s) [Inf U]) on Day 57.	Biological: Ad26.ZEBOV Biological: MVA-BN-Filo
Group B: No vaccination during pregnancy	Other	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) (510^10 vp) on Day 1 by IM injection followed by 0.5 mL of MVA-BN-Filo (110^8 Inf U) vaccine by IM injection 56 days after Dose 1.	Biological: Ad26.ZEBOV Biological: MVA-BN-Filo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ad26.ZEBOV	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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.	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.	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.	Up to 6 weeks post-completion/termination of pregnancy

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

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

Name	Affiliation	Role
Janssen Vaccines & Prevention B.V. Clinical Trial	Janssen Vaccines & Prevention B.V.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Gihundwe District Hospital		Cuangugu			Rwanda
Gisenyi Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40921806	Derived	Nyombayire J, Ingabire R, Mazzei A, Sharkey T, Umuhoza C, Mukamuyango J, Allen S, Tichacek A, Parker R, Wall KM, Katwere M, Keshinro B, Gaddah A, Wang Y, Forcheh CA, McLean C, Oriol-Mathieu V, Luhn K, Robinson C, Karita E. Heterologous two-dose Ebola vaccine regimen in pregnant women in Rwanda: a randomized controlled phase 3 trial. Nat Med. 2025 Nov;31(11):3899-3906. doi: 10.1038/s41591-025-03932-z. Epub 2025 Sep 8.
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IPD Sharing Statement Module