Ebola vaccine trial aims to shield frontline workers in congo
NCT ID NCT04186000
First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time
Summary
This study tests a two-dose Ebola vaccine regimen in healthcare workers in the Democratic Republic of the Congo, who are at high risk during outbreaks. Participants receive an initial shot of Ad26.ZEBOV followed by a booster of MVA-BN-Filo 56 days later. Some will also get an additional booster at one or two years. The goal is to measure the immune response and monitor safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a two-dose Ebola vaccine regimen: Ad26.ZEBOV followed by MVA-BN-Filo, with a possible booster of Ad26.ZEBOV at 1 or 2 years
- What this could lead to
- If successful, this vaccine regimen could help protect healthcare workers against Ebola, reducing the risk of outbreaks spreading in high-risk areas.
- What could go wrong
- This is a phase 2 study, so the vaccine's effectiveness and long-term safety are still being evaluated. The immune response may not be strong enough to prevent infection, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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699 people
The number who actually took part.
- Started
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Dec 2019
- Finished
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Oct 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The participant must pass the Test of Understanding (TOU). * Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. In case the participant cannot read or write, the procedures must be explained and informed consent must be witnessed by a trusted literate third party not involved with the conduct of the study. * Participant must be a man or woman aged 18 years or older. * Participant must be a documented health care provider in DRC. * Participant must be healthy in the investigator's clinical judgment and on the basis of vital signs assessed at day 1 screening. * Before vaccination, a woman must be either: Of childbearing potential and practicing (or intending to practice) a highly effective method of birth control consistent with local regulations and/or local culture regarding the use of birth control methods for participants in clinical studies, beginning at least 28 days prior to vaccination and during the study up to at least 3 months after the first (or only) vaccination (Ad26.ZEBOV) and 1 month after the MVA-BN-Filo vaccination (if applicable); and then starting again 14 days before the booster vaccination until 3 months after the booster vaccination. OR Not of childbearing potential: postmenopausal (amenorrhea for at least 12 months without alternative medical cause); permanently sterilized (eg, bilateral tubal occlusion \[which includes tubal ligation procedures as consistent with local regulations\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); OR otherwise be incapable of pregnancy. * Woman of childbearing potential must have a negative urine β-human chorionic gonadotropin (β-hCG) pregnancy test immediately prior to each study vaccine administration. * Participant must be available and willing to participate for the duration of the study. * Participant must be willing and able to comply with the protocol requirements, including the prohibitions and restrictions specified in Section 4.3. * Participant must be willing to provide verifiable identification. * Participant must have a means to be contacted. Exclusion Criteria: * Known history of Ebola virus disease. * Having received any experimental candidate Ebola vaccine less than 3 months prior to the screening at the first visit. * Having received any experimental candidate Ad26-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 \[eg, polysorbate 80, ethylenediaminetetraacetic acid (EDTA) or L-histidine for Ad26.ZEBOV vaccine; and tris (hydroxymethyl)-amino methane (THAM) for MVA BN-Filo vaccine\]), including known allergy to egg, egg products and aminoglycosides. * Presence of acute illness (this does not include minor illnesses such as mild diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC on Day 1. Participants with such symptoms will be excluded from enrollment at that time, but may be rescheduled for enrollment at a later date if feasible. * Pregnant or breastfeeding women, or women planning to become pregnant while enrolled in this study until at least 3 months after the Ad26.ZEBOV vaccination or 1 month after MVA-BN-Filo. * Presence of significant conditions or clinically significant findings at screening or vital signs for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the safety or well-being) or that could prevent, limit, or confound the protocol-specified assessments. * Major surgery (per the investigator's judgment) within the 4 weeks prior to screening, or planned major surgery during the study (from the start of screening onwards). * Post-organ and/or stem cell transplant whether or not with chronic immunosuppressive therapy. * Received an investigational drug or investigational vaccines or used an invasive investigational medical device within 3 months prior to screening, or current or planned participation in another clinical study during the study. * History of chronic urticaria (recurrent hives).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hôpital Général de Référence de Boende
Boende, Province de La Tshuapa, Democratic Republic of the Congo
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Other studies related to the condition(s) this trial covers.
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