Ebola Virus DiseasePhase 2EBOVAC3DRCNCT04186000
Study to Evaluate the Immunogenicity and Safety of a Heterologous Vaccine Regimen Against Ebola
A Phase 2 study testing Ad26.ZEBOV vaccine in people with Ebola Virus Disease, run by Universiteit Antwerpen at 1 site in Democratic Republic of the Congo.
Trial summary
This Phase 2 study aims to improve preparedness for future Ebola outbreaks by vaccination of a well-known population at risk, ie, a cohort of health care providers (HCP) (such as primary, emergency, and community health care workers) who may be exposed to Ebola in the event of a future outbreak in the Democratic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ebola Virus Disease
- What is being tested?
- Ad26.ZEBOV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 699 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 18 Dec 2019to 12 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Hôpital Général de Référence de Boende
Boende, Province de La Tshuapa
About this study
Official title: Open-label Phase 2 Study to Evaluate the Immunogenicity and Safety of a Prophylactic Vaccination of Health Care Providers by Administration of a Heterologous Vaccine Regimen Against Ebola in the Democratic Republic of the Congo
This Phase 2 study aims to improve preparedness for future Ebola outbreaks by vaccination of a well-known population at risk, ie, a cohort of health care providers (HCP) (such as primary, emergency, and community health care workers) who may be exposed to Ebola in the event of a future outbreak in the Democratic Republic of the Congo (DRC). This study will enhance the immunogenicity database by investigating the kinetics of the humoral immune response. The study will contribute to the safety database (serious adverse events) for VAC52150 following a heterologous vaccine regimen with Ad26.ZEBOV as first vaccine followed by second dose with MVA-BN-Filo administered 56 days later (Day 57). Additionally, after randomization (1:1), a booster vaccination with Ad26.ZEBOV will be executed at 1 year post first dose or 2 years post first dose.
Read the detailed description
This study is an open-label, monocentric (in Tshuapa province, DRC), phase 2 study to evaluate the immunogenicity and safety of Ad26.ZEBOV (5x1010 viral particles [vp]) as first dose and MVA-BN-Filo (1x108 50% infectious units [Inf U]) as second dose vaccination at a 56-day interval in health care providers (HCP) who may be exposed to Ebola in the event of a future Ebola outbreak in DRC. Additionally, after randomization (1:1) a booster of Ad26.ZEBOV (5x1010 vp) will be offered at respectively 1 year or 2 years after the first dose.
A planned total number of approximately 700 participants will be recruited from the Tshuapa province in DRC. At Day 1, interested participants will be assessed for their understanding of the study, will provide consent, their general health will be evaluated by the investigator, medical history (including vaccination history) will be collected, urine pregnancy testing for women of childbearing potential will be performed. Further during this first visit, vital signs will be measured and a blood sample for baseline immunogenicity assessment will be taken for testing of binding antibody level against EBOV GP using FANG ELISA, presence of pre-existing Human anti-EBOV GP IgG and anti-EBOV NP IgG using ELISA and on the first 100 subjects additionally testing for neutralizing antibody level against Ad26 and MVA vectors using respectively Ad26 VNA and MVA PRNT. Subsequently, a blood sample for baseline safety assessment will be performed to test hemoglobin, hematocrit, blood cell count (red and white), platelet count, urea, creatinine and transaminases. After these primary assessments, they will be vaccinated with first dose Ad26.ZEBOV vaccine. They will be given instructions to contact the study team for any serious adverse event that occurs up until 6 months after each vaccination, or in case of pregnancy of the participant during the study. Lastly on day 1, randomization will be performed (1:1) to determine timing of the booster vaccine at 1 year or 2 years after first dose. Contact information will be verified and an appointment for the second dose on Day 57 will be arranged.
At Day 57, participants will return to the study site for urine pregnancy testing for women of childbearing potential, vital signs measurement, assessment of safety (serious adverse events), for a blood sample for immunogenicity assessment (the binding antibody levels against EBOV GP using FANG ELISA) and afterwards administration of the MVA-BN-Filo vaccination, and they will be reminded to contact the study team for any serious adverse event that occurs, or in case of pregnancy of the participant during the study. Contact information will be verified and an appointment for the 21-day post-dose 2 (Day 78) visit will be arranged.
At 21 days post-dose 2 (Day 78), all participants will return to the study site for assessment of safety (serious adverse events) and collection of a blood sample for immunogenicity assessment. Contact information will be re-verified. They will be reminded to contact the study team for any serious adverse event that occurs, or in case of pregnancy of participant.
At approximately 6 months post-dose 2 vaccination, participants will be contacted by phone to inquire about any occurrence of serious adverse events, and to confirm contact information for additional follow up at 1 year post-first dose vaccination. At 1 year after first vaccine dose, a blood sample will be collected for immunogenicity assessment of all participants (where applicable, pre-administration of the booster dose).
Depending on randomization performed at Day 1, the booster vaccination with Ad26.ZEBOV (5x1010 vp) will be given at 1 year after the first dose or 2 years post-first dose. Participants will be asked to collect solicited adverse events in a participant diary starting on the day of vaccination and continuing for the subsequent 7 days. At day 8 post booster (PB) the safety data including solicited adverse events will be reviewed and a blood sample for immunogenicity will be taken to document the immunity response. At 6 months PB, the participants will be contacted by phone and questioned about any serious adverse events that have occurred since the last vaccination. For all participants at 2 years after first dose, a sample will be collected for immunogenicity assessment (where applicable, pre-administration of the booster dose).
The total duration of the study is 2 years and 6 months post-first dose.
- Conditions
- Ebola Virus Disease
- Being tested
- Ad26.ZEBOV vaccine
- Keywords
- Ad26.ZEBOV, MVA-BN-Filo, DRC, health care providers
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad26.ZEBOV vaccineBiological
The booster vaccination with Ad26.ZEBOV (5x10^10 vp, same dosage as during the first dose) will be given at 1 year after the first dose or 2 years post-first dose.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Booster vaccine with AD26.ZEBOV after 1 year Receives: Biological: Ad26.ZEBOV vaccine |
| group 2 | Experimental | Booster vaccine with AD26.ZEBOV after 2 years Receives: Biological: Ad26.ZEBOV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binding Antibody Responses Post-dose 2 Vaccination With MVA-BN-Filo
To assess binding antibody levels against the EBOV GP using FANG ELISA
Measured: 21 days post-dose 2 vaccination on Day 78
Secondary outcomes (2)
Safety of a Heterologous Vaccine Regimen Utilizing Ad26.ZEBOV as Dose 1, MVA-BN-Filo as Dose 2 and Ad26.ZEBOV as Booster Dose 3
To assess serious adverse events (SAE) during the entire clinical study (up to 1.5 years for group 1, up to 2.5 years for group 2) and to assess solicited local and systemic adverse events until 7 days post booster/dose 3 vaccination with Ad26.ZEBOV
Measured: Serious Adverse Events: 6 months post-booster (up to 1.5 years for group 1, up to 2.5 years for group 2); All other adverse events: 7 days post 1-year (group 1) or 2-year (group 2) booster
Binding Antibody Responses After Booster Vaccination With Ad26.ZEBOV
To assess binding antibody levels against the EBOV GP using FANG ELISA
Measured: 7 days post-booster vaccination on Day 372 (Group 1) or Day 737 (Group 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start18 Dec 2019
- Primary completion25 Apr 2020
- Study completion12 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Ebola Virus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants receive a heterologous vaccine regimen with Ad26.ZEBOV as first vaccine followed by second dose with MVA-BN-Filo administered 56 days later (Day 57). After randomization (1:1), a booster vaccination with Ad26.ZEBOV will be executed at 1 year post first dose or 2 years post first dose.
- Masking
- None (open label)
- Enrolment
- 699 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson, Ace Africa, Innovative Medicines Initiative, Coalition for Epidemic Preparedness Innovations, University of Kinshasa
- Responsible party
- Principal investigator, Pierre Van Damme, Universiteit Antwerpen
- Investigators
- Hypolite Mavoko Muhindo, Dr., Principal investigator, University of Kinshasa, Tropical Medicine Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186000
- Sponsor's protocol ID
- VAC52150EBL2007
- Other IDs
- EDMS-ERI-176345633
- Acronym
- EBOVAC3DRC
- Status last verified
- Jul 2026
- First submitted
- 1 Dec 2019
- Last updated
- 14 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baize S, Pannetier D, Oestereich L, Rieger T, Koivogui L, Magassouba N, Soropogui B, Sow MS, Keita S, De Clerck H, Tiffany A, Dominguez G, Loua M, Traore A, Kolie M, Malano ER, Heleze E, Bocquin A, Mely S, Raoul H, Caro V, Cadar D, Gabriel M, Pahlmann M, Tappe D, Schmidt-Chanasit J, Impouma B, Diallo AK, Formenty P, Van Herp M, Gunther S. Emergence of Zaire Ebola virus disease in Guinea. N Engl J Med. 2014 Oct 9;371(15):1418-25. doi: 10.1056/NEJMoa1404505. Epub 2014 Apr 16.
PubMed 24738640Baden LR, Walsh SR, Seaman MS, Tucker RP, Krause KH, Patel A, Johnson JA, Kleinjan J, Yanosick KE, Perry J, Zablowsky E, Abbink P, Peter L, Iampietro MJ, Cheung A, Pau MG, Weijtens M, Goudsmit J, Swann E, Wolff M, Loblein H, Dolin R, Barouch DH. First-in-human evaluation of the safety and immunogenicity of a recombinant adenovirus serotype 26 HIV-1 Env vaccine (IPCAVD 001). J Infect Dis. 2013 Jan 15;207(2):240-7. doi: 10.1093/infdis/jis670. Epub 2012 Nov 2.
PubMed 23125444Friedrich BM, Trefry JC, Biggins JE, Hensley LE, Honko AN, Smith DR, Olinger GG. Potential vaccines and post-exposure treatments for filovirus infections. Viruses. 2012 Sep;4(9):1619-50. doi: 10.3390/v4091619. Epub 2012 Sep 21.
PubMed 23170176Kohl KS, Walop W, Gidudu J, Ball L, Halperin S, Hammer SJ, Heath P, Varricchio F, Rothstein E, Schuind A, Hennig R; Brighton Collaboration Local Reaction Working Group for Swelling at or near Injection Site. Swelling at or near injection site: case definition and guidelines for collection, analysis and presentation of immunization safety data. Vaccine. 2007 Aug 1;25(31):5858-74. doi: 10.1016/j.vaccine.2007.04.056. Epub 2007 May 11. No abstract available.
PubMed 17548132Kohl KS, Walop W, Gidudu J, Ball L, Halperin S, Hammer SJ, Heath P, Hennig R, Rothstein E, Schuind A, Varricchio F; Brighton Collaboration Local Reactions Working Group for Induration at or near Injection Site. Induration at or near injection site: case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2007 Aug 1;25(31):5839-57. doi: 10.1016/j.vaccine.2007.04.062. Epub 2007 May 8. No abstract available.
PubMed 17553602Marcy SM, Kohl KS, Dagan R, Nalin D, Blum M, Jones MC, Hansen J, Labadie J, Lee L, Martin BL, O'Brien K, Rothstein E, Vermeer P; Brighton Collaboration Fever Working Group. Fever as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation. Vaccine. 2004 Jan 26;22(5-6):551-6. doi: 10.1016/j.vaccine.2003.09.007. No abstract available.
PubMed 14741143Stittelaar KJ, Kuiken T, de Swart RL, van Amerongen G, Vos HW, Niesters HG, van Schalkwijk P, van der Kwast T, Wyatt LS, Moss B, Osterhaus AD. Safety of modified vaccinia virus Ankara (MVA) in immune-suppressed macaques. Vaccine. 2001 Jun 14;19(27):3700-9. doi: 10.1016/s0264-410x(01)00075-5.
PubMed 11395204Verheust C, Goossens M, Pauwels K, Breyer D. Biosafety aspects of modified vaccinia virus Ankara (MVA)-based vectors used for gene therapy or vaccination. Vaccine. 2012 Mar 30;30(16):2623-32. doi: 10.1016/j.vaccine.2012.02.016. Epub 2012 Feb 17.
PubMed 22342706Hoff NA, Mukadi P, Doshi RH, Bramble MS, Lu K, Gadoth A, Sinai C, Spencer D, Nicholson BP, Williams R, Mossoko M, Ilunga-Kebela B, Wasiswa J, Okitolonda-Wemakoy E, Alfonso VH, Steffen I, Muyembe-Tamfum JJ, Simmons G, Rimoin AW. Serologic Markers for Ebolavirus Among Healthcare Workers in the Democratic Republic of the Congo. J Infect Dis. 2019 Jan 29;219(4):517-525. doi: 10.1093/infdis/jiy499.
PubMed 30239838Lariviere Y, Matuvanga TZ, Osang'ir BI, Milolo S, Meta R, Kimbulu P, Robinson C, Katwere M, McLean C, Lemey G, Matangila J, Maketa V, Mitashi P, Van Geertruyden JP, Van Damme P, Muhindo-Mavoko H. Ad26.ZEBOV, MVA-BN-Filo Ebola virus disease vaccine regimen plus Ad26.ZEBOV booster at 1 year versus 2 years in health-care and front-line workers in the Democratic Republic of the Congo: secondary and exploratory outcomes of an open-label, randomised, phase 2 trial. Lancet Infect Dis. 2024 Jul;24(7):746-759. doi: 10.1016/S1473-3099(24)00058-6. Epub 2024 Mar 26.
PubMed 38552653Lariviere Y, Matuvanga TZ, Lemey G, Osang'ir BI, Vermeiren PP, Milolo S, Meta R, Kimbulu P, Esanga E, Matangila J, Van Geertruyden JP, Van Damme P, Maketa V, Muhindo-Mavoko H, Mitashi P. Conducting an Ebola vaccine trial in a remote area of the Democratic Republic of the Congo: Challenges, mitigations, and lessons learned. Vaccine. 2023 Dec 12;41(51):7587-7597. doi: 10.1016/j.vaccine.2023.11.030. Epub 2023 Nov 22.
PubMed 37993355Zola Matuvanga T, Lariviere Y, Lemey G, De Bie J, Milolo S, Meta R, Esanga E, Vermeiren PP, Thys S, Van Geertruyden JP, Van Damme P, Maketa V, Matangila J, Mitashi P, Muhindo-Mavoko H. Setting-up an Ebola vaccine trial in a remote area of the Democratic Republic of the Congo: Challenges, mitigations, and lessons learned. Vaccine. 2022 May 31;40(25):3470-3480. doi: 10.1016/j.vaccine.2022.04.094. Epub 2022 May 9.
PubMed 35550847Lariviere Y, Zola T, Stoppie E, Maketa V, Matangila J, Mitashi P, De Bie J, Muhindo-Mavoko H, Van Geertruyden JP, Van Damme P. Open-label, randomised, clinical trial to evaluate the immunogenicity and safety of a prophylactic vaccination of healthcare providers by administration of a heterologous vaccine regimen against Ebola in the Democratic Republic of the Congo: the study protocol. BMJ Open. 2021 Sep 28;11(9):e046835. doi: 10.1136/bmjopen-2020-046835.
PubMed 34588237Zola Matuvanga T, Johnson G, Lariviere Y, Esanga Longomo E, Matangila J, Maketa V, Lapika B, Mitashi P, Mc Kenna P, De Bie J, Van Geertruyden JP, Van Damme P, Muhindo Mavoko H. Use of Iris Scanning for Biometric Recognition of Healthy Adults Participating in an Ebola Vaccine Trial in the Democratic Republic of the Congo: Mixed Methods Study. J Med Internet Res. 2021 Aug 9;23(8):e28573. doi: 10.2196/28573.
PubMed 34378545
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Phase 2 Study to Evaluate the Immunogenicity and Safety of a Prophylactic Vaccination of Health Care Providers by Administration of a Heterologous Vaccine Regimen Against Ebola in the Democratic Republic of the Congo
- ClinicalTrials.gov ID
- NCT04186000
- Acronym / sponsor ID
- EBOVAC3DRC / VAC52150EBL2007
- Conditions
- Ebola Virus Disease
- Keywords
- Ad26.ZEBOV, MVA-BN-Filo, DRC, health care providers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 699 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Johnson & Johnson, Ace Africa, Innovative Medicines Initiative, Coalition for Epidemic Preparedness Innovations, University of Kinshasa
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 25 Apr 2020 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Posted 14 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2 study aims to improve preparedness for future Ebola outbreaks by vaccination of a well-known population at risk, ie, a cohort of health care providers (HCP) (such as primary, emergency, and community health care workers) who may be exposed to Ebola in the event of a future outbreak in the Democratic Republic of the Congo (DRC). This study will enhance the immunogenicity database by investigating the kinetics of the humoral immune response. The study will contribute to the safety database (serious adverse events) for VAC52150 following a heterologous vaccine regimen with Ad26.ZEBOV as first vaccine followed by second dose with MVA-BN-Filo administered 56 days later (Day 57). Additionally, after randomization (1:1), a booster vaccination with Ad26.ZEBOV will be executed at 1 year post first dose or 2 years post first dose.
Detailed description
This study is an open-label, monocentric (in Tshuapa province, DRC), phase 2 study to evaluate the immunogenicity and safety of Ad26.ZEBOV (5x1010 viral particles [vp]) as first dose and MVA-BN-Filo (1x108 50% infectious units [Inf U]) as second dose vaccination at a 56-day interval in health care providers (HCP) who may be exposed to Ebola in the event of a future Ebola outbreak in DRC. Additionally, after randomization (1:1) a booster of Ad26.ZEBOV (5x1010 vp) will be offered at respectively 1 year or 2 years after the first dose.
A planned total number of approximately 700 participants will be recruited from the Tshuapa province in DRC. At Day 1, interested participants will be assessed for their understanding of the study, will provide consent, their general health will be evaluated by the investigator, medical history (including vaccination history) will be collected, urine pregnancy testing for women of childbearing potential will be performed. Further during this first visit, vital signs will be measured and a blood sample for baseline immunogenicity assessment will be taken for testing of binding antibody level against EBOV GP using FANG ELISA, presence of pre-existing Human anti-EBOV GP IgG and anti-EBOV NP IgG using ELISA and on the first 100 subjects additionally testing for neutralizing antibody level against Ad26 and MVA vectors using respectively Ad26 VNA and MVA PRNT. Subsequently, a blood sample for baseline safety assessment will be performed to test hemoglobin, hematocrit, blood cell count (red and white), platelet count, urea, creatinine and transaminases. After these primary assessments, they will be vaccinated with first dose Ad26.ZEBOV vaccine. They will be given instructions to contact the study team for any serious adverse event that occurs up until 6 months after each vaccination, or in case of pregnancy of the participant during the study. Lastly on day 1, randomization will be performed (1:1) to determine timing of the booster vaccine at 1 year or 2 years after first dose. Contact information will be verified and an appointment for the second dose on Day 57 will be arranged.
At Day 57, participants will return to the study site for urine pregnancy testing for women of childbearing potential, vital signs measurement, assessment of safety (serious adverse events), for a blood sample for immunogenicity assessment (the binding antibody levels against EBOV GP using FANG ELISA) and afterwards administration of the MVA-BN-Filo vaccination, and they will be reminded to contact the study team for any serious adverse event that occurs, or in case of pregnancy of the participant during the study. Contact information will be verified and an appointment for the 21-day post-dose 2 (Day 78) visit will be arranged.
At 21 days post-dose 2 (Day 78), all participants will return to the study site for assessment of safety (serious adverse events) and collection of a blood sample for immunogenicity assessment. Contact information will be re-verified. They will be reminded to contact the study team for any serious adverse event that occurs, or in case of pregnancy of participant.
At approximately 6 months post-dose 2 vaccination, participants will be contacted by phone to inquire about any occurrence of serious adverse events, and to confirm contact information for additional follow up at 1 year post-first dose vaccination. At 1 year after first vaccine dose, a blood sample will be collected for immunogenicity assessment of all participants (where applicable, pre-administration of the booster dose).
Depending on randomization performed at Day 1, the booster vaccination with Ad26.ZEBOV (5x1010 vp) will be given at 1 year after the first dose or 2 years post-first dose. Participants will be asked to collect solicited adverse events in a participant diary starting on the day of vaccination and continuing for the subsequent 7 days. At day 8 post booster (PB) the safety data including solicited adverse events will be reviewed and a blood sample for immunogenicity will be taken to document the immunity response. At 6 months PB, the participants will be contacted by phone and questioned about any serious adverse events that have occurred since the last vaccination. For all participants at 2 years after first dose, a sample will be collected for immunogenicity assessment (where applicable, pre-administration of the booster dose).
The total duration of the study is 2 years and 6 months post-first dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants receive a heterologous vaccine regimen with Ad26.ZEBOV as first vaccine followed by second dose with MVA-BN-Filo administered 56 days later (Day 57). After randomization (1:1), a booster vaccination with Ad26.ZEBOV will be executed at 1 year post first dose or 2 years post first dose.
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Biological: Ad26.ZEBOV vaccineBooster vaccine with AD26.ZEBOV after 1 year |
| group 2 | Experimental | Biological: Ad26.ZEBOV vaccineBooster vaccine with AD26.ZEBOV after 2 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ad26.ZEBOV vaccineThe booster vaccination with Ad26.ZEBOV (5x10^10 vp, same dosage as during the first dose) will be given at 1 year after the first dose or 2 years post-first dose. | Biological | group 1, group 2 |
Primary outcome
Binding Antibody Responses Post-dose 2 Vaccination With MVA-BN-Filo
Time frame: 21 days post-dose 2 vaccination on Day 78
To assess binding antibody levels against the EBOV GP using FANG ELISA
2 secondary outcomes
Safety of a Heterologous Vaccine Regimen Utilizing Ad26.ZEBOV as Dose 1, MVA-BN-Filo as Dose 2 and Ad26.ZEBOV as Booster Dose 3
Time frame: Serious Adverse Events: 6 months post-booster (up to 1.5 years for group 1, up to 2.5 years for group 2); All other adverse events: 7 days post 1-year (group 1) or 2-year (group 2) booster
Binding Antibody Responses After Booster Vaccination With Ad26.ZEBOV
Time frame: 7 days post-booster vaccination on Day 372 (Group 1) or Day 737 (Group 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24738640Baize S, Pannetier D, Oestereich L, Rieger T, Koivogui L, Magassouba N, Soropogui B, Sow MS, Keita S, De Clerck H, Tiffany A, Dominguez G, Loua M, Traore A, Kolie M, Malano ER, Heleze E, Bocquin A, Mely S, Raoul H, Caro V, Cadar D, Gabriel M, Pahlmann M, Tappe D, Schmidt-Chanasit J, Impouma B, Diallo AK, Formenty P, Van Herp M, Gunther S. Emergence of Zaire Ebola virus disease in Guinea. N Engl J Med. 2014 Oct 9;371(15):1418-25. doi: 10.1056/NEJMoa1404505. Epub 2014 Apr 16.
- Results publication: PubMed 23125444Baden LR, Walsh SR, Seaman MS, Tucker RP, Krause KH, Patel A, Johnson JA, Kleinjan J, Yanosick KE, Perry J, Zablowsky E, Abbink P, Peter L, Iampietro MJ, Cheung A, Pau MG, Weijtens M, Goudsmit J, Swann E, Wolff M, Loblein H, Dolin R, Barouch DH. First-in-human evaluation of the safety and immunogenicity of a recombinant adenovirus serotype 26 HIV-1 Env vaccine (IPCAVD 001). J Infect Dis. 2013 Jan 15;207(2):240-7. doi: 10.1093/infdis/jis670. Epub 2012 Nov 2.
- Results publication: PubMed 23170176Friedrich BM, Trefry JC, Biggins JE, Hensley LE, Honko AN, Smith DR, Olinger GG. Potential vaccines and post-exposure treatments for filovirus infections. Viruses. 2012 Sep;4(9):1619-50. doi: 10.3390/v4091619. Epub 2012 Sep 21.
- Results publication: PubMed 17548132Kohl KS, Walop W, Gidudu J, Ball L, Halperin S, Hammer SJ, Heath P, Varricchio F, Rothstein E, Schuind A, Hennig R; Brighton Collaboration Local Reaction Working Group for Swelling at or near Injection Site. Swelling at or near injection site: case definition and guidelines for collection, analysis and presentation of immunization safety data. Vaccine. 2007 Aug 1;25(31):5858-74. doi: 10.1016/j.vaccine.2007.04.056. Epub 2007 May 11. No abstract available.
- Results publication: PubMed 17553602Kohl KS, Walop W, Gidudu J, Ball L, Halperin S, Hammer SJ, Heath P, Hennig R, Rothstein E, Schuind A, Varricchio F; Brighton Collaboration Local Reactions Working Group for Induration at or near Injection Site. Induration at or near injection site: case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2007 Aug 1;25(31):5839-57. doi: 10.1016/j.vaccine.2007.04.062. Epub 2007 May 8. No abstract available.
- Results publication: PubMed 14741143Marcy SM, Kohl KS, Dagan R, Nalin D, Blum M, Jones MC, Hansen J, Labadie J, Lee L, Martin BL, O'Brien K, Rothstein E, Vermeer P; Brighton Collaboration Fever Working Group. Fever as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation. Vaccine. 2004 Jan 26;22(5-6):551-6. doi: 10.1016/j.vaccine.2003.09.007. No abstract available.
- Results publication: PubMed 11395204Stittelaar KJ, Kuiken T, de Swart RL, van Amerongen G, Vos HW, Niesters HG, van Schalkwijk P, van der Kwast T, Wyatt LS, Moss B, Osterhaus AD. Safety of modified vaccinia virus Ankara (MVA) in immune-suppressed macaques. Vaccine. 2001 Jun 14;19(27):3700-9. doi: 10.1016/s0264-410x(01)00075-5.
- Results publication: PubMed 22342706Verheust C, Goossens M, Pauwels K, Breyer D. Biosafety aspects of modified vaccinia virus Ankara (MVA)-based vectors used for gene therapy or vaccination. Vaccine. 2012 Mar 30;30(16):2623-32. doi: 10.1016/j.vaccine.2012.02.016. Epub 2012 Feb 17.
- Results publication: PubMed 30239838Hoff NA, Mukadi P, Doshi RH, Bramble MS, Lu K, Gadoth A, Sinai C, Spencer D, Nicholson BP, Williams R, Mossoko M, Ilunga-Kebela B, Wasiswa J, Okitolonda-Wemakoy E, Alfonso VH, Steffen I, Muyembe-Tamfum JJ, Simmons G, Rimoin AW. Serologic Markers for Ebolavirus Among Healthcare Workers in the Democratic Republic of the Congo. J Infect Dis. 2019 Jan 29;219(4):517-525. doi: 10.1093/infdis/jiy499.
- Derived from this study: PubMed 38552653Lariviere Y, Matuvanga TZ, Osang'ir BI, Milolo S, Meta R, Kimbulu P, Robinson C, Katwere M, McLean C, Lemey G, Matangila J, Maketa V, Mitashi P, Van Geertruyden JP, Van Damme P, Muhindo-Mavoko H. Ad26.ZEBOV, MVA-BN-Filo Ebola virus disease vaccine regimen plus Ad26.ZEBOV booster at 1 year versus 2 years in health-care and front-line workers in the Democratic Republic of the Congo: secondary and exploratory outcomes of an open-label, randomised, phase 2 trial. Lancet Infect Dis. 2024 Jul;24(7):746-759. doi: 10.1016/S1473-3099(24)00058-6. Epub 2024 Mar 26.
- Derived from this study: PubMed 37993355Lariviere Y, Matuvanga TZ, Lemey G, Osang'ir BI, Vermeiren PP, Milolo S, Meta R, Kimbulu P, Esanga E, Matangila J, Van Geertruyden JP, Van Damme P, Maketa V, Muhindo-Mavoko H, Mitashi P. Conducting an Ebola vaccine trial in a remote area of the Democratic Republic of the Congo: Challenges, mitigations, and lessons learned. Vaccine. 2023 Dec 12;41(51):7587-7597. doi: 10.1016/j.vaccine.2023.11.030. Epub 2023 Nov 22.
- Derived from this study: PubMed 35550847Zola Matuvanga T, Lariviere Y, Lemey G, De Bie J, Milolo S, Meta R, Esanga E, Vermeiren PP, Thys S, Van Geertruyden JP, Van Damme P, Maketa V, Matangila J, Mitashi P, Muhindo-Mavoko H. Setting-up an Ebola vaccine trial in a remote area of the Democratic Republic of the Congo: Challenges, mitigations, and lessons learned. Vaccine. 2022 May 31;40(25):3470-3480. doi: 10.1016/j.vaccine.2022.04.094. Epub 2022 May 9.
- IMVANEX suspension for injection. UK Summary of Product Characteristics.Link provided by the sponsor.
- MVA-BN® (Modified Vaccinia Ankara - Bavarian Nordic).Link provided by the sponsor.
- WHO Fact Sheet No103 Ebola Virus Disease 2014Link provided by the sponsor.
- Meeting of the Strategic Advisory Group of Experts on immunization, October 2018Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hypolite Mavoko Muhindo, Dr. principal investigator
University of Kinshasa, Tropical Medicine Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ad26.ZEBOV vaccine in people with Ebola Virus Disease, run by Universiteit Antwerpen at 1 site in Democratic Republic of the Congo.
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 13 inclusion and 10 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 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Binding Antibody Responses Post-dose 2 Vaccination With MVA-BN-Filo (time frame: 21 days post-dose 2 vaccination on Day 78). 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 NCT04186000, which also lists 14 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 14 Jul 2026.