Ebola Virus DiseasePhase 1/2EBOLAPEDNCT05130398

Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Children Living in Lambaréné, Gabon

A Phase 1/2 study testing rVSVΔG-ZEBOV-GP, V920, Fibre and equilibrate breakfast and lunch and Active detection and treatment of pathogens in people with Ebola Virus Disease, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 1 year to 12 yearsHealthy volunteers can take part
Conditions the study is for: Ebola Virus Disease
What is being tested?: rVSVΔG-ZEBOV-GP, V920, Fibre and equilibrate breakfast and lunch and Active detection and treatment of pathogens
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteGabon
Study dates: 9 Apr 2021to 9 Aug 2022
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

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

Ages 1 year to 12 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy children aged 1 to 12 years (inclusive) at the time of inclusion.
Willingness of parent or legal guardian to provide written informed consent prior to screening procedures.
Willingness of the relatives of the participant to provide written informed consent if they are ≥ 18 years (or an assent when they are 13 to 17 years old).
Available, able, and willing to participate in all study visits and procedures

Who cannot join

History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions, or known allergy to the components of the vaccines.
Ongoing participation in another clinical trial
Participation in previous Ebola vaccine trials
Receipt of a licensed vaccine within 14 days of planned study immunization (30 days for live vaccines)
Presence of any febrile illness (fever >38°C) or any moderate to severe illness within one week prior to vaccination;
Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study.

Trial locations and contacts

1 site in 1 country.

Gabon1 site

Centre de Recherches Médicales de Lambaréné
Lambaréné, Moyen-Ogooué Province, 242

Other trials in Gabon

About this study

Official title: A Phase 1/2, Randomized, Controlled Open-label Trial to Evaluate the Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Healthy Children Aged 1 to 12 Years and in Their Relatives Living in Lambaréné, Gabon

LA rVSVΔG-ZEBOV-GP -02-PED is a Phase 1/2, randomized, controlled open label trial. The LA rVSVΔG-ZEBOV-GP -02-PED trial aims primarily to assess the clinical significance of shedding of the rVSV RNA following vaccination with the rVSVΔG-ZEBOV-GP vaccine in children. The vaccine doses of ≥7.8 x 107 pfu will be evaluated and compared to vaccination with varicella vaccine as a control. In addition, the closest contact persons of the vaccinees will be monitored for possible transmission of the viral vaccine vector.

The study will enroll children of two age groups living in Lambaréné, Gabon. Children will be followed-up for 12 months post vaccination.

The 1-2 closest contact persons of each participant will be involved in the monitoring of rVSV transmission. They will be followed until day 56 post- vaccination of their children/ sibling.

Read the detailed description

LA-rVSVΔG-ZEBOV-GP -02-PED is a Phase 1/2, randomized, controlled, open label, trial and is designed to generate further safety, tolerability and immunogenicity data of the 7.8 x 107 PFU rVSVΔG-ZEBOV-GP vaccine in children aged 1 -12 years living in a sub-Saharan Africa. The study will enroll participants into two age groups. A total of 120 children will be enrolled and followed-up for 12 months post injection. In addition, a maximum of 240 relatives of the study participants will be enrolled to assess the transmission of the rVSVΔG-ZEBOV-GP vaccine.

Group 1: 60 participants aged 6-12 years will be randomized in group 1. 40 participants will receive a single intramuscular dose of 7.8 x 107 pfu rVSVΔG-ZEBOV-GP vaccine. 20 participants will receive a single subcutaneous dose of varicella vaccine The participants will be allocated to each treatment at a ratio of 2:1 respectively Group 2: 60 participants aged 1 -5 years will be randomized into group 2. 40 will receive a single intramuscular dose of 7.8 x 107 pfu of rVSV-ZEBOV vaccine. 20 participants will receive a single subcutaneous dose of varicella vaccine The participants will be allocated to each treatment at a ratio of 2:1 respectively

Vaccinations will start in group 2 after the first 10 participants of group 1 have completed the day 28 post vaccination visit and the SMC has done a review of safety data until that point.

For each vaccinee there will be a 365 -day period of follow-up after vaccination. The contact persons of the vaccinees will be followed-up until day 56 after the vaccination of their relative.

Conditions: Ebola Virus Disease
Being tested: rVSVΔG-ZEBOV-GP, V920, Fibre and equilibrate breakfast and lunch, Active detection and treatment of pathogens, Fibre and equilibrate breakfast and lunch plus Active detection and treatment of pathogens, Chikenpox or Varicella vaccine (VARILRIX)
Keywords: Sub-Saharan Africa Africa ,, Children, rVSV-ZEBOV-GP vaccine, Shedding, Safety, Tolerability
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.

rVSVΔG-ZEBOV-GP, V920Biological
The experimental vaccine is the rVSVΔG-ZEBOV-GP, an Ebola vaccine.
Fibre and equilibrate breakfast and lunchDietary supplement
Participants receive fibres and caloric equilibrate diet during breakfast and lunch every day for 21 consecutive days.
Active detection and treatment of pathogensDiagnostic test
Monthly diagnostic and treatment of childhood infections Active detection and treatment of pathogens.
Fibre and equilibrate breakfast and lunch plus Active detection and treatment of pathogensCombination product
Participants receive fibres and caloric equilibrate diet during breakfast and lunch every day for 21 consecutive days and diagnostic and treatment of childhood infections Active detection and treatment of pathogens every month for 12 months
Chikenpox or Varicella vaccine (VARILRIX)Biological
The active comparator vaccine, a Varicella vaccine (VARILRIX®)
PlaceboOther
About 30 children do not receive diet, nor active pathogen detection

Study groups in NCT05130398
Study group	Role	What they receive
the rVSVΔG-ZEBOV-GP vaccine	Experimental	Participants of the experimental arm will receive a single intramuscular dose of ≥7.8 x 107 pfu of the rVSVΔG-ZEBOV-GP vaccine. In total, 80 participants will receive the experimental vaccine: 40 participants aged 6-12 years and 40 aged 1-5 years. Receives: Biological: rVSVΔG-ZEBOV-GP, V920
The Chikenpox or Varicella (Varilix) vaccine	Active comparator	The control arm consists of the chickenpox vaccine. Forty children will receive a single subcutaneous dose of Varilix, the active comparator vaccine, 20 aged 6-12 years and 20 aged 1-5 years Receives: Biological: Chikenpox or Varicella vaccine (VARILRIX)
Fibre and equilibrate diet	Experimental	Participants were assigned to receive two meals daily ( breakfast and lunch) for 21 days. About 30 children are randomly assigned to fibre and equilibrate diet. Receives: Dietary Supplement: Fibre and equilibrate breakfast and lunch
Active detection and treatment of pathogens according to standard of care	Experimental	The following pathogens: P. falciparum, Ascaris lumbricoides, Trichuris trichiura, Necator americanus, intestinal protozoa, BG+, BG- colonies and pathogens, SARS-CoV2 are actively detected and treated according to the standard of care every month. About 30 children are randomly assigned to this arm. Receives: Diagnostic Test: Active detection and treatment of pathogens
Diet plus Active detection and treatment of pathogens according to standard of care	Experimental	Participants were assigned to receive two meals daily ( breakfast and lunch) for 21 days and concomitantly assigned to active detection of P. falciparum, Ascaris lumbricoides, Trichuris trichiura, Necator americanus, intestinal protozoa, BG+, BG- colonies and pathogens, SARS-CoV2 every month. About 30 children are assigned to receive combined interventions Receives: Combination Product: Fibre and equilibrate breakfast and lunch plus Active detection and treatment of pathogens
No diet and no pathogen detection	Placebo comparator	About 30 children received no diet and no active detection of pathogens Receives: Other: Placebo

What is being measured

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

Concentration of viral vector in blood, saliva and urine in vaccinees
Concentration of rVSVΔG-ZEBOV-GP in blood, urine, or saliva as detected by RT-PCR and expressed as copy number in vaccinees
Measured: at days 0, 1, 2/3, 7, 14 and 28
Prevalence and relative risk of sollicited adverse events in vaccinees
Proportion (percent) of participants experiencing sollicited adverse events in vaccinees groups
Measured: until day 14 post vaccination
Prevalence and relative risk of unsolicited adverse events and serious adverse events in vaccinees
Proportion (percent ) of participant experiencing unsollicited adverse event (AEs) and serious adverse events (SAEs) and relative risk of AEs and SAEs in participant by vaccine groups
Measured: until day 28 after vaccination

Secondary outcomes (11)

Prevalence and relative risk of serious adverse events
Proportion (percent) of participants experiencing SAEs and relative risk of SAEs in until study last visit (at 365 days)
Measured: until day 365
Transmission intensity of the viral vector in blood, saliva and urine among the the relatives of the vaccinees
Concentration of rVSVΔG-ZEBOV-GP in blood, urine, or saliva as detected by RT-PCR and expressed as copy number in the close relatives of the vaccinees
Measured: days 0, 1, 3, 14, 28, 56
Titres of ZEBOV-GP-specific binding antibody
Titres of ZEBOV-GP-specific binding antibody by ELISA expressed in geometric mean titres (GMTs)
Measured: days 0, 1, 3, 14, 21, 28, 56, 84, 180, 365
Affinity/Avidity of antibody induced by vaccination
Affinity/avidity of GP-specific serum antibodies as assessed by Surface Plasmon Resonance platform at D28 and D180 expressed as percent of affinity maturation
Measured: days 28 and 180
Concentration of IL-1RN (IL-1Ra), IL-6, TNF-α, IL-10, MCP-1/CCL2, and MIP-1β/CCL4
Cytokines (IL-1RN (IL-1Ra), IL-6, TNF-α, IL-10), chemokines and soluble adhesion molecules (MCP-1/CCL2, and MIP-1β/CCL4) plasma expressed in microgram per milliliter .
Measured: days 0, 1 and 2 or 3
Prevalence of miRNAs
Proportion (percent) of circulating miRNAs using the Human miRNome PCR array v.21 in serum samples
Measured: at days 0, 1, 2/3, 7
Concentration of Lipids, glutamine, Alanine, Aspargine
Proportion (percent ) and concentration ( microgram/ mililiter) of Lipids, glutamine, Alanine, Aspargine in plasma samples
Measured: at day 0, day 1, day 2/3 and day 7
Concentrations Nitric oxides species
Profiling nitric oxides species according to vaccines, diet and pathogens
Measured: days 0, 1, 2/3, 7, 28, 56, 90, 180, 365
Concentration of metabolites of gut bacteria
Measurement of gut metabolites
Measured: days 0, 7, 28, 56, 90
Titres of antibody induced by diphtheria, tetanus, Bordetella, poliomyelitis, hepatitis B, measles, yellow fever ( EPI vaccines)
Concentration of antibody of EPI vaccines
Measured: days 0, 7, 14, 28, 90, 180, 365
Concentration of bystander cytokines
Concentration of cytokines that may induce heterologous vaccine induced immune responses
Measured: days 0, 1, 2/3, 7, 28, 90

Timeline

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

9 Apr 20219 Aug 2022

First posted23 Nov 2021
Study start9 Apr 2021
Primary completion8 Sep 2021
Study completion9 Aug 2022

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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: A Phase 1/2, randomized, controlled, open label clinical trial.
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05130398
Sponsor's protocol ID: LA rVSVΔG-ZEBOV-GP -02-PED
Acronym: EBOLAPED
Status last verified: Apr 2023
First submitted: 25 Aug 2021
Last updated: 20 Apr 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: The Principal investigator or his designee will be the data manager with responsibility for delegating the receiving, entering, cleaning, querying, analysing and storing all data that accrues from the study. All data will be entered in paper case record forms and transcribed by double entry into an electronic database. This includes safety data, laboratory data (both clinical and immunological) and outcome data.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Study to Investigate the Safety and Immunogenicity of mRNA-1469 in African Participants 1 to 65 Years of Age
Ebola-Bundibugyo Virus Disease (Ebola-BDBV)
RecruitingPhase 4
BRAVO is a Phased Outbreak-response Study in the DRC Evaluating ERVEBO® Vaccination in ~20,000 Frontline Workers During the 2026 BDV Outbreak, Step A Assesses Real-world Effectiveness, Safety, and Impact on Severe Disease and Mortality, While Generating Evidence for Future BDV Vaccination Strategies
Ebola, Bundibugyo Virus Disease (BVD)
Not yet recruitingPhase 2/3
Study of Vaccines Against Bundibugyo Virus Disease in Contacts of Cases in the Democratic Republic of the Congo
Ebola Hemorrhagic Fever, Bundibugyo Virus Disease
Active, not recruitingPhase 1
A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants
Ebola-Bundibugyo Virus Disease (Ebola-BDBV)
RecruitingPhase 1
A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health
Sudan Virus Disease

All Ebola Virus Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2, Randomized, Controlled Open-label Trial to Evaluate the Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Healthy Children Aged 1 to 12 Years and in Their Relatives Living in Lambaréné, Gabon
ClinicalTrials.gov ID: NCT05130398
Acronym / sponsor ID: EBOLAPED / LA rVSVΔG-ZEBOV-GP -02-PED
Conditions: Ebola Virus Disease
Keywords: Sub-Saharan Africa Africa ,, Children, rVSV-ZEBOV-GP vaccine, Shedding, Safety, Tolerability
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Centre de Recherche Médicale de LambarénéUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: 9 Apr 2021 (actual)
Primary completion: 8 Sep 2021 (actual)
Study completion: 9 Aug 2022 (actual)
First posted: 23 Nov 2021 (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 study will enroll children of two age groups living in Lambaréné, Gabon. Children will be followed-up for 12 months post vaccination.

The 1-2 closest contact persons of each participant will be involved in the monitoring of rVSV transmission. They will be followed until day 56 post- vaccination of their children/ sibling.

Detailed description

Vaccinations will start in group 2 after the first 10 participants of group 1 have completed the day 28 post vaccination visit and the SMC has done a review of safety data until that point.

For each vaccinee there will be a 365 -day period of follow-up after vaccination. The contact persons of the vaccinees will be followed-up until day 56 after the vaccination of their relative.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6
Model description: A Phase 1/2, randomized, controlled, open label clinical trial.

Arm	Type	Receives
the rVSVΔG-ZEBOV-GP vaccine	Experimental	Biological: rVSVΔG-ZEBOV-GP, V920Participants of the experimental arm will receive a single intramuscular dose of ≥7.8 x 107 pfu of the rVSVΔG-ZEBOV-GP vaccine. In total, 80 participants will receive the experimental vaccine: 40 participants aged 6-12 years and 40 aged 1-5 years.
The Chikenpox or Varicella (Varilix) vaccine	Active comparator	Biological: Chikenpox or Varicella vaccine (VARILRIX)The control arm consists of the chickenpox vaccine. Forty children will receive a single subcutaneous dose of Varilix, the active comparator vaccine, 20 aged 6-12 years and 20 aged 1-5 years
Fibre and equilibrate diet	Experimental	Dietary Supplement: Fibre and equilibrate breakfast and lunchParticipants were assigned to receive two meals daily ( breakfast and lunch) for 21 days. About 30 children are randomly assigned to fibre and equilibrate diet.
Active detection and treatment of pathogens according to standard of care	Experimental	Diagnostic Test: Active detection and treatment of pathogensThe following pathogens: P. falciparum, Ascaris lumbricoides, Trichuris trichiura, Necator americanus, intestinal protozoa, BG+, BG- colonies and pathogens, SARS-CoV2 are actively detected and treated according to the standard of care every month. About 30 children are randomly assigned to this arm.
Diet plus Active detection and treatment of pathogens according to standard of care	Experimental	Combination Product: Fibre and equilibrate breakfast and lunch plus Active detection and treatment of pathogensParticipants were assigned to receive two meals daily ( breakfast and lunch) for 21 days and concomitantly assigned to active detection of P. falciparum, Ascaris lumbricoides, Trichuris trichiura, Necator americanus, intestinal protozoa, BG+, BG- colonies and pathogens, SARS-CoV2 every month. About 30 children are assigned to receive combined interventions
No diet and no pathogen detection	Placebo comparator	Other: PlaceboAbout 30 children received no diet and no active detection of pathogens

Who may qualify

Ages: 1 year to 12 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Healthy children aged 1 to 12 years (inclusive) at the time of inclusion.
Willingness of parent or legal guardian to provide written informed consent prior to screening procedures.
Willingness of the relatives of the participant to provide written informed consent if they are ≥ 18 years (or an assent when they are 13 to 17 years old).
Available, able, and willing to participate in all study visits and procedures

Key exclusion criteria (7 listed)

History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions, or known allergy to the components of the vaccines.
Ongoing participation in another clinical trial
Participation in previous Ebola vaccine trials
Receipt of a licensed vaccine within 14 days of planned study immunization (30 days for live vaccines)
Presence of any febrile illness (fever >38°C) or any moderate to severe illness within one week prior to vaccination;

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
rVSVΔG-ZEBOV-GP, V920The experimental vaccine is the rVSVΔG-ZEBOV-GP, an Ebola vaccine.	Biological	the rVSVΔG-ZEBOV-GP vaccine
Fibre and equilibrate breakfast and lunchParticipants receive fibres and caloric equilibrate diet during breakfast and lunch every day for 21 consecutive days.	Dietary supplement	Fibre and equilibrate diet
Active detection and treatment of pathogensMonthly diagnostic and treatment of childhood infections Active detection and treatment of pathogens.	Diagnostic test	Active detection and treatment of pathogens according to standard of care
Fibre and equilibrate breakfast and lunch plus Active detection and treatment of pathogensParticipants receive fibres and caloric equilibrate diet during breakfast and lunch every day for 21 consecutive days and diagnostic and treatment of childhood infections Active detection and treatment of pathogens every month for 12 months	Combination product	Diet plus Active detection and treatment of pathogens according to standard of care
Chikenpox or Varicella vaccine (VARILRIX)The active comparator vaccine, a Varicella vaccine (VARILRIX®)	Biological	The Chikenpox or Varicella (Varilix) vaccine
PlaceboAbout 30 children do not receive diet, nor active pathogen detection	Other	No diet and no pathogen detection

Primary outcome

Concentration of viral vector in blood, saliva and urine in vaccinees
Time frame: at days 0, 1, 2/3, 7, 14 and 28
Concentration of rVSVΔG-ZEBOV-GP in blood, urine, or saliva as detected by RT-PCR and expressed as copy number in vaccinees
Prevalence and relative risk of sollicited adverse events in vaccinees
Time frame: until day 14 post vaccination
Proportion (percent) of participants experiencing sollicited adverse events in vaccinees groups
Prevalence and relative risk of unsolicited adverse events and serious adverse events in vaccinees
Time frame: until day 28 after vaccination
Proportion (percent ) of participant experiencing unsollicited adverse event (AEs) and serious adverse events (SAEs) and relative risk of AEs and SAEs in participant by vaccine groups

11 secondary outcomes

Prevalence and relative risk of serious adverse events
Time frame: until day 365
Transmission intensity of the viral vector in blood, saliva and urine among the the relatives of the vaccinees
Time frame: days 0, 1, 3, 14, 28, 56
Titres of ZEBOV-GP-specific binding antibody
Time frame: days 0, 1, 3, 14, 21, 28, 56, 84, 180, 365
Affinity/Avidity of antibody induced by vaccination
Time frame: days 28 and 180
Concentration of IL-1RN (IL-1Ra), IL-6, TNF-α, IL-10, MCP-1/CCL2, and MIP-1β/CCL4
Time frame: days 0, 1 and 2 or 3
Prevalence of miRNAs
Time frame: at days 0, 1, 2/3, 7
Concentration of Lipids, glutamine, Alanine, Aspargine
Time frame: at day 0, day 1, day 2/3 and day 7
Concentrations Nitric oxides species
Time frame: days 0, 1, 2/3, 7, 28, 56, 90, 180, 365
Concentration of metabolites of gut bacteria
Time frame: days 0, 7, 28, 56, 90
Titres of antibody induced by diphtheria, tetanus, Bordetella, poliomyelitis, hepatitis B, measles, yellow fever ( EPI vaccines)
Time frame: days 0, 7, 14, 28, 90, 180, 365
Concentration of bystander cytokines
Time frame: days 0, 1, 2/3, 7, 28, 90

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
Individual participant dataSharing planned: Yes. The Principal investigator or his designee will be the data manager with responsibility for delegating the receiving, entering, cleaning, querying, analysing and storing all data that accrues from the study. All data will be entered in paper case record forms and transcribed by double entry into an electronic database. This includes safety data, laboratory data (both clinical and immunological) and outcome data.

Related trials for Ebola Virus Disease

Not yet recruitingPhase 1
A Study to Investigate the Safety and Immunogenicity of mRNA-1469 in African Participants 1 to 65 Years of Age
Ebola-Bundibugyo Virus Disease (Ebola-BDBV)
RecruitingPhase 4
BRAVO is a Phased Outbreak-response Study in the DRC Evaluating ERVEBO® Vaccination in ~20,000 Frontline Workers During the 2026 BDV Outbreak, Step A Assesses Real-world Effectiveness, Safety, and Impact on Severe Disease and Mortality, While Generating Evidence for Future BDV Vaccination Strategies
Ebola, Bundibugyo Virus Disease (BVD)
Not yet recruitingPhase 2/3
Study of Vaccines Against Bundibugyo Virus Disease in Contacts of Cases in the Democratic Republic of the Congo
Ebola Hemorrhagic Fever, Bundibugyo Virus Disease
Active, not recruitingPhase 1
A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants
Ebola-Bundibugyo Virus Disease (Ebola-BDBV)
RecruitingPhase 1
A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health
Sudan Virus Disease

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 7 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 20 Apr 2023. 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 Gabon. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

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

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

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

What does the primary outcome measure?

Concentration of viral vector in blood, saliva and urine in vaccinees (time frame: at days 0, 1, 2/3, 7, 14 and 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05130398.

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 20 Apr 2023.