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HealthyPhase 3INGABONCT04556526

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

A Phase 3 study testing Ad26.ZEBOV and MVA-BN-Filo in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 3 sites in Rwanda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Ad26.ZEBOV and MVA-BN-Filo
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,031 participants
Where
3 sitesRwanda
Study dates
5 Oct 2020to 2 Mar 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

3 sites in 1 country.

Rwanda3 sites

  • Gihundwe District Hospital

    Cuangugu

  • Gisenyi Hospital

    Gysenyi

  • Center for Family Health Research/Project San Francisco

    Kigali, 780

Other trials in Rwanda

About this study

Official title: A Phase 3 Open-label Randomized Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of a 2-dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in Healthy Pregnant Women

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]).

Conditions
Healthy
Being tested
Ad26.ZEBOV, MVA-BN-Filo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04556526
Study groupRoleWhat they receive
Group A: Ad26.ZEBOV, MVA-BN-FiloExperimentalParticipants 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.
Receives: Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo
Group B: No vaccination during pregnancyOtherParticipants (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.
Receives: Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. Percentage of Participants with Antenatal Bleeding

    Percentage of participants with antenatal bleeding will be reported. Antenatal bleeding is vaginal or suspected intrauterine, intraperitoneal, or retroperitoneal bleeding in the second or third trimester of pregnancy.

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

  7. Percentage of Participants with Postpartum Hemorrhage

    Percentage of participants with postpartum hemorrhage will be reported. Postpartum hemorrhage is genital bleeding after delivery estimated at 1000 ml or more, or leading to hypotension or blood transfusion, or leading to severe maternal outcome (maternal death or maternal near miss) as defined by World Health Organization (WHO).

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

  8. Percentage of Newborns with Major Congenital Malformations born to Participants

    Percentage of newborns with major congenital malformations born to participants will be reported. Major congenital malformations are abnormalities of body structure or function that are present at birth and are of prenatal origin. Major congenital malformations include structural changes that have significant medical, social or cosmetic consequences for the affected individual, and typically require medical intervention (for example, cleft lip and spina bifida).

    Measured: At birth

  9. Percentage of Newborns Small for Gestational age (SGA) born to Participants

    Percentage of newborns small for gestational age (SGA) born to participants will be reported. Small for gestational age (SGA) means newborns that are smaller in size than normal for the gestational age (weight below the tenth percentile for the gestational age using Rwandan standards).

    Measured: At birth

  10. Percentage of Newborns with Low Birth Weight born to Participants

    Percentage of newborns with low birth weight born to participants will be reported. Low birth weight newborns are babies, weighing less than 2500 grams at birth (regardless of child's sex).

    Measured: At birth

  11. Percentage of Newborns with Preterm Birth born to Participants

    Percentage of newborns with preterm birth born to participants will be reported. Preterm birth means neonates born at less than 37 weeks' gestation.

    Measured: At birth

  12. Percentage of Neonatal Deaths in Neonates Born to Participants

    Percentage of neonatal deaths in neonates born to participants will be reported. Neonatal deaths mean neonate dying in the first 28 days of life.

    Measured: Up to 28 days

  13. Percentage of Infants (of Participants) who Fail to Thrive

    Percentage of infants (of participants) who fail to thrive will be reported. Failure to thrive means weight for age deceleration through at least 2 centile spaces on growth chart of infants or as defined according to Rwandan standards.

    Measured: From birth up to 14 weeks of age

Secondary outcomes (9)

  1. 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.

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

  2. 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

    Measured: Up to 365 days or 1 year post dose

  3. Percentage of Newborns (Born to Participants) with SAEs

    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.

    Measured: From birth up to 14 weeks of age

  4. 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.

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

  5. Percentage of Participants with Unsolicited AEs

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

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

  6. Percentage of Participants with Normal Delivery

    Percentage of participants with normal delivery will be reported.

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

  7. Percentage of Participants with Caesarian Section

    Percentage of participants with caesarian section will be reported.

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

  8. 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).

    Measured: 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)

  9. 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).

    Measured: From birth up to 14 weeks of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2020
  2. Study start5 Oct 2020
  3. Primary completion2 Mar 2023
  4. Study completion2 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,031 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04556526
Sponsor's protocol ID
CR108739
Other IDs
VAC52150EBL3010
Acronym
INGABO
Status last verified
Jan 2025
First submitted
16 Sep 2020
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Publications

  • 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.

    PubMed 40921806

  • Karita E, Nyombayire J, Ingabire R, Mazzei A, Sharkey T, Mukamuyango J, Allen S, Tichacek A, Parker R, Priddy F, Sayinzoga F, Nsanzimana S, Robinson C, Katwere M, Anumendem D, Leyssen M, Schaefer M, Wall KM. Safety, reactogenicity, and immunogenicity of a 2-dose Ebola vaccine regimen of Ad26.ZEBOV followed by MVA-BN-Filo in healthy adult pregnant women: study protocol for a phase 3 open-label randomized controlled trial. Trials. 2022 Jun 20;23(1):513. doi: 10.1186/s13063-022-06360-3.

    PubMed 35725488

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ad26.ZEBOV and MVA-BN-Filo in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 3 sites in Rwanda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Maternal Deaths (time frame: Up to 6 weeks post-completion/termination of pregnancy). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04556526, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

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