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

January 31, 2025 updated by: Janssen Vaccines & Prevention B.V.

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]).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4031

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Rwanda
      • Cuangugu, Rwanda
        • Gihundwe District Hospital
      • Gysenyi, Rwanda
        • Gisenyi Hospital
      • Kigali, Rwanda, 780
        • Center for Family Health Research/Project San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Biological: 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.
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.
Other: 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.
Biological: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Maternal Deaths
Time Frame: Up to 6 weeks post-completion/termination of pregnancy
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
Time Frame: Up to 6 weeks post-completion/termination of pregnancy
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
Time Frame: Up to 6 weeks post-completion/termination of pregnancy
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
Time Frame: Up to 6 weeks post-completion/termination of pregnancy
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
Time Frame: Up to 6 weeks post-completion/termination of pregnancy
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
Percentage of Participants with Antenatal Bleeding
Time Frame: Up to 6 weeks post-completion/termination of pregnancy
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.
Up to 6 weeks post-completion/termination of pregnancy
Percentage of Participants with Postpartum Hemorrhage
Time Frame: Up to 6 weeks post-completion/termination of pregnancy
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).
Up to 6 weeks post-completion/termination of pregnancy
Percentage of Newborns with Major Congenital Malformations born to Participants
Time Frame: At birth
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).
At birth
Percentage of Newborns Small for Gestational age (SGA) born to Participants
Time Frame: At birth
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).
At birth
Percentage of Newborns with Low Birth Weight born to Participants
Time Frame: At birth
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).
At birth
Percentage of Newborns with Preterm Birth born to Participants
Time Frame: At birth
Percentage of newborns with preterm birth born to participants will be reported. Preterm birth means neonates born at less than 37 weeks' gestation.
At birth
Percentage of Neonatal Deaths in Neonates Born to Participants
Time Frame: Up to 28 days
Percentage of neonatal deaths in neonates born to participants will be reported. Neonatal deaths mean neonate dying in the first 28 days of life.
Up to 28 days
Percentage of Infants (of Participants) who Fail to Thrive
Time Frame: From birth up to 14 weeks of age
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.
From birth up to 14 weeks of age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants (Pregnant Women) with Serious Adverse Events (SAEs) for Group A and B
Time Frame: Up to 6 weeks post-partum or post-pregnancy termination, whichever occurs earlier
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.
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
Time Frame: Up to 365 days or 1 year post dose
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
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
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.
From birth up to 14 weeks of age
Percentage of Participants with Solicited Local and Systemic Adverse Events (AEs)
Time Frame: 7 Days after each vaccination (up to Day 64)
Solicited local AEs: pain/tenderness, erythema, and induration/swelling. Solicited systemic AEs: headache, fatigue, myalgia, arthralgia, chills and fever.
7 Days after each vaccination (up to Day 64)
Percentage of Participants with Unsolicited AEs
Time Frame: 28 Days after each vaccination (up to Day 85)
Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.
28 Days after each vaccination (up to Day 85)
Percentage of Participants with Normal Delivery
Time Frame: Up to 6 weeks post-completion/termination of pregnancy
Percentage of participants with normal delivery will be reported.
Up to 6 weeks post-completion/termination of pregnancy
Percentage of Participants with Caesarian Section
Time Frame: Up to 6 weeks post-completion/termination of pregnancy
Percentage of participants with caesarian section will be reported.
Up to 6 weeks post-completion/termination of pregnancy
Percentage of Participants with Anti-Ebola virus (EBOV) Glycoprotein (GP) Binding Antibodies
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)
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).
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
Time Frame: From birth up to 14 weeks of age
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).
From birth up to 14 weeks of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Vaccines & Prevention B.V.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Emory University
Coalition for Epidemic Preparedness Innovations
Center for Family Health Research (CFHR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial, Janssen Vaccines & Prevention B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108739
  • VAC52150EBL3010 (Other Identifier: Janssen Vaccines & Prevention B.V.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings