Ebola Virus DiseasePhase 3EBO-BOOSTNCT06126822
Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination with the Zabdeno/Mvabea® or Ervebo® Vaccine Schedules in DRC
A Phase 3 study testing Zabdeno® booster and Ervebo® booster in people with Ebola Virus Disease, run by Institute of Tropical Medicine, Belgium at 2 sites in Democratic Republic of the Congo.
Trial summary
The goal of this randomized controlled trial is to investigate whether individuals in DRC previously vaccinated with Zabdeno/Mvabea® or Ervebo® vaccine schedules against Ebola virus can be safely and adequately boosted with homologous or heterologous vaccine schedules. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola Virus Disease
- What is being tested?
- Zabdeno® booster and Ervebo® booster
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 624 participants
- Where
- 2 sitesDemocratic Republic of the Congo
- Study dates
- 25 Feb 2025to Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who received either the Ervebo® vaccine (MSD), or the full Zabdeno, Mvabea® vaccine regimen (J\&J) more than 4 months prior to recruitment
- Subjects between 18 and 50 years of age at time of randomization
- Subject must be willing and able to provide informed consent
- The subject must be in possession of an identification card (or other identification document)
- Agreement to refrain from blood donation and other vaccinations 30 days after booster vaccination
- Agreement to share and discuss participant's medical history, medical records and concomitant medications when relevant
Who cannot join
- Participants who previously experienced active Ebola Virus Disease (EVD)
- Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment
- Receipt of an additional booster dose of either Ervebo®, Zabdeno®, or any experimental Ebola vaccine
- Incorrect or incomplete primary vaccination scheme with the Zabdeno, Mvabea® (J\&J) vaccine
- Administration of immunoglobulins and/or any blood products within three months prior to recruitment.
- Fever (>38°C) within last 24 hours prior to recruitment.
Show all 19Show fewer
- Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer and HIV); asplenia; recurrent severe infections and use of immunosuppressant medication within the last 6 months, except topical or short-term oral steroids.
- Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed)
- History of anaphylaxis, allergic disease or reactions to any component of the study vaccines
- History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture
- History of any thrombotic disorder, thrombocytopenia, thrombotic thrombocytopenia syndrome (TTP), or heparin-induced thrombocytopenia and thrombosis (HITT)
- Any other significant disease, disorder, planned surgery, or finding which may significantly affect the ability of the volunteer to participate in the study or impair interpretation of the study data
- Suspected or known alcohol or drug dependency
- Subject is not readily available by telephone, email or physical address
- The non-vaccinated control group will also adhere to all the above in- and exclusion criteria, with exemption of:
- Agreement to refrain from blood donation and other vaccinations 30 days after study vaccination
- Subjects who received either the Ervebo® vaccine, or the full Zabdeno, Mvabea® vaccine regimen more than 4 months prior to recruitment
- The latter is rather introduced as an additional exclusion criteria:
- Subjects who received either the Ervebo® vaccine or the full Zabdeno, Mvabea® vaccine regimen
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Selien Oostvogels Oostvogels contact
Democratic Republic of the Congo2 sites, 2 recruiting
- Not yet recruiting
Institut National de Recherche Biomédicale (INRB)
Goma
Kavunga Hugo, Prof
Mukadi Daniel, MD
- Recruiting
Institut National de Recherche Biomédicale (INRB)
Kinshasa
Mulangu Sabue, Prof
About this study
Official title: Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination with the Zabdeno/Mvabea® or Ervebo® Vaccine Schedules in DRC: a Mix-and-match Phase II RCT
The goal of this randomized controlled trial is to investigate whether individuals in DRC previously vaccinated with Zabdeno/Mvabea® or Ervebo® vaccine schedules against Ebola virus can be safely and adequately boosted with homologous or heterologous vaccine schedules.
Participants will be randomized to receive either a homologous or heterologous vaccine schedule and will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of immunological responses against Ebola virus between both schedules. Safety and tolerability of the vaccines will be evaluated by recording Adverse Events (AE's) and grading physical and vital signs evaluations.
Read the detailed description
The aim of this randomized controlled with four arms is to investigate whether individuals previously vaccinated with Zabdeno/Mvabea® or Ervebo® vaccine schedules against Ebola virus can be safely and adequately boosted with homologous and heterologous vaccine schedules. We hypothesize that heterologous booster vaccine schedules generate a non-inferior boosting in antibodies and cellular responses against Ebola virus as compared to homologous schedules and incite a similar safety profile.
Based on the predefined variables (living place and time since vaccination), the research team will pre-select and re-contact individuals previously included in the Phase III EBOVAC vaccine database, EBOSURV participant database, and the Programme Élargi de Vaccination (PEV) database. Participants will be contacted by phone and, if they agree to participate, they are scheduled on predefined screening/recruitment days taken place at the 2 recruitment sites: INRB Goma and INRB Kinshasa.
A total of 624 participants will be included, 312 will be previously vaccinated with Zabdeno/Mvabea® and 312 participants with Ervebo®. Within those two groups, half of the participants (n=156) will be randomized to a single Ervebo® booster vaccine and the other half (n=156) to a single Zabdeno® booster vaccine. Participants will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of antibody- and cellular response against EBOV between homologous and heterologous schedules. Safety and tolerability of the vaccines will be evaluated by recording Adverse Events (AE's) and grading physical and vital signs evaluations. An additional 50 non-vaccinated participants will be recruited in Kinshasa for assay optimization.
In case of insufficient participants living close to the recruitment centers, a community outreach will be undertaken with a lower amount of visits for logistical reasons.
- Conditions
- Ebola Virus Disease
- Being tested
- Zabdeno® booster, Ervebo® booster
- Keywords
- Ebola vaccines
- 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.
Zabdeno® boosterDrug
A single Zabdeno® booster vaccination
Ervebo® boosterDrug
A single Ervebo® booster vaccination
| Study group | Role | What they receive |
|---|---|---|
| Zabdeno/Mvabea® vaccinated - Zabdeno® booster | Experimental | Participants previously vaccinated with the Zabdeno/Mvabea® vaccination schedule, will receive a single intramuscular Zabdeno® booster vaccine (0,5 ml) = homologous vaccination scheme. Receives: Drug: Zabdeno® booster |
| Zabdeno/Mvabea® vaccinated - Ervebo® booster | Experimental | Participants previously vaccinated with the Zabdeno/Mvabea® vaccination schedule, will receive a single intramuscular Ervebo® booster vaccine (1 ml) = heterologous vaccination scheme. Receives: Drug: Ervebo® booster |
| Ervebo® vaccinated - Ervebo® booster | Experimental | Participants previously vaccinated with Ervebo®, will receive a single intramuscular Ervebo® booster vaccine (1 ml) = homologous vaccination scheme. Receives: Drug: Ervebo® booster |
| Ervebo® vaccinated - Zabdeno® booster | Experimental | Participants previously vaccinated with Ervebo®, will receive a single intramuscular Zabdeno® booster vaccine (0,5 ml) = heterologous vaccination scheme. Receives: Drug: Zabdeno® booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess non-inferiority in EBOV-specific IgG levels elicited by a heterologous to a homologous booster vaccine schedule, by type of primary vaccination, 21 days after administration of the booster.
FANG ELISA units/mL of anti-EBOV IgG
Measured: Day 21 after booster vaccination = Day 21
Secondary outcomes (14)
To assess the safety of heterologous and homologous booster vaccine schedules, by type of primary vaccine schedule
- The occurrence of solicited local Adverse Events (AEs) [Up to Day 7]
- The occurrence of solicited systemic AEs [Up to Day 7]
- The occurrence of unsolicited AEs [Up to Day 21]
- The occurrence of Serious Adverse Events (SAE's) [Up to Month 6]
Measured: Day 7, Day 21 and Month 6
To compare the EBOV-specific IgG levels at D21 across all vaccine combinations
- FANG ELISA units/mL of anti-EBOV IgG at D21 after vaccination
Measured: Day 21
To compare the fold change between D0 and D21 across all vaccine combinations
- Fold change in FANG ELISA units/mL of anti-EBOV IgG between D0 and D21
Measured: Day 0 and Day 21
To compare the EBOV-specific binding and neutralizing antibodies to the glycoproteins of different EBOV variants across all vaccine combinations and timepoints
- The Mean Fluorescence Intensity (MFI) IgG levels against the GP variants [multiplexed Luminex assay - at D0, D3, D7, D21, M6]
Measured: Day 0, Day 3, Day 7, Day 21, Month 6
To compare the EBOV-specific binding and neutralizing antibodies to the glycoproteins of different EBOV variants across all vaccine combinations and timepoints
- The 50% neutralizing titer (NT50) levels of the GP-specific antibodies [at D0, D21, M6]
Measured: Day 0, Day 21, Month 6
To compare the EBOV-specific effector-memory T cell response across all vaccine combinations and timepoints
- The IFN-y, TNF-α and IL-2 Spot Forming Units (SFU) after T cell stimulation with GP peptide pools [at D0, D7, D21, M6]
Measured: Day 0, Day 7, Day 21 and Month 6
To compare the EBOV-specific effector-memory B cell response across all vaccine combinations and timepoints
- The IgG1, IgG2, IgG3 Spot Forming Units (SFU) after B cell stimulation with recombinant GPs [at D0, D7, D21, M6]
Measured: Day 0, Day 7, Day 21 and Month 6
To characterize the phenotype and polyfunctionality of the vaccine-induced T and B cell response by vaccine combination
Proportions of EBOV GP-specific cell phenotypes and polyfunctional cells
Measured: at Day 0 and Day 21
To assess the impact of the participant age and sex on the vaccine-induced EBOV-specific bAbs
- FANG ELISA units/mL of anti-EBOV IgG at D21 after vaccination
Measured: Day 21
To assess the impact of the participant age and sex on the vaccine-induced EBOV-specific bAbs
- The Mean Fluorescence Intensity (MFI) IgG levels against the GP variants and VP40 [multiplexed Luminex assay - at D0, D3, D7, D21, M6]
Measured: Day 0, Day 3, Day 7, Day 21 and Month 6
To assess the impact of the participant age and sex on the vaccine-induced EBOV-specific nAbs
- The 50% neutralizing titer (NT50) levels of the GP-specific antibodies [at D0, D21, M6]
Measured: Day 0, Day 21 and Month 6
To assess the impact of the participant age and sex on the vaccine-induced EBOV-specific T cells
- The IFN-y, TNF-α and IL-2 Spot Forming Units (SFU) after T cell stimulation with GP peptide pools [at D0, D7, D21, M6]
Measured: Day 0, Day 7, Day 21 and Month 6
To assess the impact of the participant age and sex on the vaccine-induced EBOV-specific B cells
- The IgG1, IgG2, IgG3 Spot Forming Units (SFU) after B cell stimulation with recombinant GPs [at D0, D7, D21, M6]
Measured: Day 0, Day 7, Day 21 and Month 6
To assess the impact of the participant age and sex on the vaccine-induced EBOV-specific T cells
- Proportions of EBOV GP-specific cell phenotypes and polyfunctional cells [at D0, D21]
Measured: Day 0, Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start25 Feb 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 624 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National pour la Recherche Biomedicale (INRB)
- Responsible party
- Sponsor
- Investigators
- Wim Adriaensen, Prof., Principal investigator, Institute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126822
- Sponsor's protocol ID
- 1706/23
- Acronym
- EBO-BOOST
- Status last verified
- Mar 2025
- First submitted
- 5 Oct 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination with the Zabdeno/Mvabea® or Ervebo® Vaccine Schedules in DRC: a Mix-and-match Phase II RCT
- ClinicalTrials.gov ID
- NCT06126822
- Acronym / sponsor ID
- EBO-BOOST / 1706/23
- Conditions
- Ebola Virus Disease
- Keywords
- Ebola vaccines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 624 participants (estimated)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Institut National pour la Recherche Biomedicale (INRB)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled trial is to investigate whether individuals in DRC previously vaccinated with Zabdeno/Mvabea® or Ervebo® vaccine schedules against Ebola virus can be safely and adequately boosted with homologous or heterologous vaccine schedules.
Participants will be randomized to receive either a homologous or heterologous vaccine schedule and will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of immunological responses against Ebola virus between both schedules. Safety and tolerability of the vaccines will be evaluated by recording Adverse Events (AE's) and grading physical and vital signs evaluations.
Detailed description
The aim of this randomized controlled with four arms is to investigate whether individuals previously vaccinated with Zabdeno/Mvabea® or Ervebo® vaccine schedules against Ebola virus can be safely and adequately boosted with homologous and heterologous vaccine schedules. We hypothesize that heterologous booster vaccine schedules generate a non-inferior boosting in antibodies and cellular responses against Ebola virus as compared to homologous schedules and incite a similar safety profile.
Based on the predefined variables (living place and time since vaccination), the research team will pre-select and re-contact individuals previously included in the Phase III EBOVAC vaccine database, EBOSURV participant database, and the Programme Élargi de Vaccination (PEV) database. Participants will be contacted by phone and, if they agree to participate, they are scheduled on predefined screening/recruitment days taken place at the 2 recruitment sites: INRB Goma and INRB Kinshasa.
A total of 624 participants will be included, 312 will be previously vaccinated with Zabdeno/Mvabea® and 312 participants with Ervebo®. Within those two groups, half of the participants (n=156) will be randomized to a single Ervebo® booster vaccine and the other half (n=156) to a single Zabdeno® booster vaccine. Participants will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of antibody- and cellular response against EBOV between homologous and heterologous schedules. Safety and tolerability of the vaccines will be evaluated by recording Adverse Events (AE's) and grading physical and vital signs evaluations. An additional 50 non-vaccinated participants will be recruited in Kinshasa for assay optimization.
In case of insufficient participants living close to the recruitment centers, a community outreach will be undertaken with a lower amount of visits for logistical reasons.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Zabdeno/Mvabea® vaccinated - Zabdeno® booster | Experimental | Drug: Zabdeno® boosterParticipants previously vaccinated with the Zabdeno/Mvabea® vaccination schedule, will receive a single intramuscular Zabdeno® booster vaccine (0,5 ml) = homologous vaccination scheme. |
| Zabdeno/Mvabea® vaccinated - Ervebo® booster | Experimental | Drug: Ervebo® boosterParticipants previously vaccinated with the Zabdeno/Mvabea® vaccination schedule, will receive a single intramuscular Ervebo® booster vaccine (1 ml) = heterologous vaccination scheme. |
| Ervebo® vaccinated - Ervebo® booster | Experimental | Drug: Ervebo® boosterParticipants previously vaccinated with Ervebo®, will receive a single intramuscular Ervebo® booster vaccine (1 ml) = homologous vaccination scheme. |
| Ervebo® vaccinated - Zabdeno® booster | Experimental | Drug: Zabdeno® boosterParticipants previously vaccinated with Ervebo®, will receive a single intramuscular Zabdeno® booster vaccine (0,5 ml) = heterologous vaccination scheme. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects who received either the Ervebo® vaccine (MSD), or the full Zabdeno, Mvabea® vaccine regimen (J\&J) more than 4 months prior to recruitment
- Subjects between 18 and 50 years of age at time of randomization
- Subject must be willing and able to provide informed consent
- The subject must be in possession of an identification card (or other identification document)
- Agreement to refrain from blood donation and other vaccinations 30 days after booster vaccination
Key exclusion criteria (19 listed)
- Participants who previously experienced active Ebola Virus Disease (EVD)
- Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment
- Receipt of an additional booster dose of either Ervebo®, Zabdeno®, or any experimental Ebola vaccine
- Incorrect or incomplete primary vaccination scheme with the Zabdeno, Mvabea® (J\&J) vaccine
- Administration of immunoglobulins and/or any blood products within three months prior to recruitment.
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 |
|---|---|---|
| Zabdeno® boosterA single Zabdeno® booster vaccination | Drug | Ervebo® vaccinated - Zabdeno® booster, Zabdeno/Mvabea® vaccinated - Zabdeno® booster |
| Ervebo® boosterA single Ervebo® booster vaccination | Drug | Ervebo® vaccinated - Ervebo® booster, Zabdeno/Mvabea® vaccinated - Ervebo® booster |
Primary outcome
To assess non-inferiority in EBOV-specific IgG levels elicited by a heterologous to a homologous booster vaccine schedule, by type of primary vaccination, 21 days after administration of the booster.
Time frame: Day 21 after booster vaccination = Day 21
FANG ELISA units/mL of anti-EBOV IgG
14 secondary outcomes
To assess the safety of heterologous and homologous booster vaccine schedules, by type of primary vaccine schedule
Time frame: Day 7, Day 21 and Month 6
To compare the EBOV-specific IgG levels at D21 across all vaccine combinations
Time frame: Day 21
To compare the fold change between D0 and D21 across all vaccine combinations
Time frame: Day 0 and Day 21
To compare the EBOV-specific binding and neutralizing antibodies to the glycoproteins of different EBOV variants across all vaccine combinations and timepoints
Time frame: Day 0, Day 3, Day 7, Day 21, Month 6
To compare the EBOV-specific binding and neutralizing antibodies to the glycoproteins of different EBOV variants across all vaccine combinations and timepoints
Time frame: Day 0, Day 21, Month 6
To compare the EBOV-specific effector-memory T cell response across all vaccine combinations and timepoints
Time frame: Day 0, Day 7, Day 21 and Month 6
To compare the EBOV-specific effector-memory B cell response across all vaccine combinations and timepoints
Time frame: Day 0, Day 7, Day 21 and Month 6
To characterize the phenotype and polyfunctionality of the vaccine-induced T and B cell response by vaccine combination
Time frame: at Day 0 and Day 21
To assess the impact of the participant age and sex on the vaccine-induced EBOV-specific bAbs
Time frame: Day 21
To assess the impact of the participant age and sex on the vaccine-induced EBOV-specific bAbs
Time frame: Day 0, Day 3, Day 7, Day 21 and Month 6
To assess the impact of the participant age and sex on the vaccine-induced EBOV-specific nAbs
Time frame: Day 0, Day 21 and Month 6
To assess the impact of the participant age and sex on the vaccine-induced EBOV-specific T cells
Time frame: Day 0, Day 7, Day 21 and Month 6
To assess the impact of the participant age and sex on the vaccine-induced EBOV-specific B cells
Time frame: Day 0, Day 7, Day 21 and Month 6
To assess the impact of the participant age and sex on the vaccine-induced EBOV-specific T cells
Time frame: Day 0, Day 21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- 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.
Selien Oostvogels Oostvogels contact
Wim Adriaensen, Prof. principal investigator
Institute of Tropical Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zabdeno® booster and Ervebo® booster in people with Ebola Virus Disease, run by Institute of Tropical Medicine, Belgium at 2 sites 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 6 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wim Adriaensen, Prof. (+32(0)33455909, wadriaensen@itg.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess non-inferiority in EBOV-specific IgG levels elicited by a heterologous to a homologous booster vaccine schedule, by type of primary vaccination, 21 days after administration of the booster. (time frame: Day 21 after booster vaccination = Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2025.