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Ebola VaccinePhase 3PREPARENCT05959421

Immunity Induced by VSV-EBOV and Assessment of a Booster Dose in Individuals at Potential Occupational Risk for Exposure

A Phase 3 study testing ERVEBO® (rVSV∆G-ZEBOV-GP) in people with Ebola Vaccine, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is a multi-center, open label, randomized phase 3b trial to assess the durability of Immunity induced by the Ebolavirus Vaccine VSV-EBOV ( with or without booster vaccination) in individuals at potential occupational risk for ebolavirus exposure Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Ebola Vaccine
What is being tested?
ERVEBO® (rVSV∆G-ZEBOV-GP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesGermany
Study dates
Jun 2026to Jun 2028
Phase
Phase 3
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults age ≥18 years.
  • Signed informed consent for the trial.
  • At risk of occupational exposure to Ebola virus through laboratory, clinical contact, or field work, in the judgment of the investigator.
  • Females of child-bearing potential (FOCP) must be willing to use effective methods of con-traception as per the requirements of the protocol (9.3.7) from at least 30 days prior to vac-cination through 2 months following vaccination/booster.
  • Willing to avoid blood and body fluid exposure to high-risk individuals (i.e., immunocompro-mised individuals, individuals receiving immunosuppressive therapy and pregnant or breast-feeding women, children <1 year of age) for at least 6 weeks after vaccination/booster. This includes:
  • Use of effective barrier prophylaxis, such as latex condoms, during any sexual inter-action (regardless of childbearing status or sexual orientation)
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  • Avoiding the sharing of needles, razors, eating utensils, drinking from the same cup, or toothbrushes
  • Avoiding open-mouth kissing
  • Use of universal precautions in the health-care setting The investigator can be counseled and may determine when individuals are classified as "immuno-compromised" and what therapy is defined as immunosuppressive therapy in this context.
  • Willing to forgo blood donation 30 days prior to first vaccination until end of study.
  • Willing to accept randomization (boost versus no boost) at month 6 (time window -1 month) visit.

Who cannot join

  • Any condition that would, in the eyes of the investigator, limit the ability of the participant to meet protocol requirements or would place the participant at unreasonable risk. This includes:
  • Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health, per the investigator. A clinically significant condition or process includes but is not limited to:
  • A process that would adversely affect the systemic immune response
  • A process that would require medication that might adversely affect the systemic immune re-sponse
  • Any contraindication to repeated injections or blood draws
  • A condition that requires active medical intervention or monitoring to avert grave danger to the participant's health or well-being during the study period
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  • A condition or process for which signs or symptoms could be confused with reactions to vaccine
  • Presence of any pre-existing illness or clinical history that, in the opinion of the investigator, would place the participant at an unreasonably increased risk through participation in this study. This in-cludes but is not limited to:
  • Active malignancy
  • History of Guillain-Barré Syndrome
  • History of neurological disorder that may increase risk (history of encephalitis, stroke, or sei-zure)
  • Active autoimmune disorder requiring systemic immunosuppressive treatment
  • Any concomitant medication for which reported side effects or adverse events, in the judg-ment of the investigator, may interfere with assessment of safety.
  • Participants who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of this protocol.
  • Pregnant or breast feeding (must have negative pregnancy test on the day of vaccination, prior to vaccination)
  • Known allergy to the components of the rVSV∆G-ZEBOV-GP vaccine (ERVEBO®) vaccine product (VSV, albumin, tris, rice).
  • History of severe local or systemic reactions to any vaccination.
  • Received killed vaccines 14 days before, or intention to receive within 7 days following vac-cination (Day 0)/booster (Month 6).
  • Received live virus vaccines within 30 days before, or intention to receive live virus vaccines within 30 days following, vaccination (Day 0)/booster (Month 6).
  • Received immunoglobulins and/or any blood products within the 120 days preceding vaccina-tion (Day 0)/booster (Month 6).
  • Received allergy treatment with antigen injections within 30 days before vaccination (Day 0)/booster (Month 6).
  • Clinical evidence (e.g. oral temperature >38.0 degrees Celsius, systemic symptoms) of a sys-temic infection or other acute intercurrent illness at the proposed time of vaccination (Day 0)/booster (Month 6).
  • Prior receipt of a vaccine against EVD or prior EVD in medical history.
  • Participation in a clinical trial or use of an investigational product within 30 days or five times the half-life of the investigational product -whichever is longer- prior to receiving the first dose within this study.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • University Hospital Frankfurt (KGU)

    Frankfurt, 60590

  • Bernhard Nocht Centre for Clinical Trials (BNCCT)

    Hamburg, 20359

Other trials in Germany

About this study

Official title: Durability of Immunity Induced by the Ebolavirus Vaccine VSV-EBOV and As-sessment of a Booster Dose for Pre-Exposure Prophylaxis in Individuals at Potential Occupational Risk for Ebolavirus Exposure

This study is a multi-center, open label, randomized phase 3b trial to assess the durability of Immunity induced by the Ebolavirus Vaccine VSV-EBOV ( with or without booster vaccination) in individuals at potential occupational risk for ebolavirus exposure

Read the detailed description

All participants will receive a single dose of ERVEBO® (≥72 million pfu) on Day 0. The participants will receive a diary to document local and defined systemic adverse events for 14 days after vaccination. We will collect grade 3 and 4 adverse events after vaccination and at Month 1 and Month 7, and seri-ous adverse events (SAE) for the duration of the study, and assess the immune response at Months 1, 3, 6, 7, 12, 18, 24. In a subgroup (Innate Subgroup) we are also going to assess innate immune response at Day 1 and 3 and Month 6 + Day 1 and Month 6 + Day 3.

A single booster immunization with the same dose as the primary dose (≥72 million pfu/mL) will be given to those randomized to the booster arm of the trial six months after primary vaccination.

Conditions
Ebola Vaccine
Being tested
ERVEBO® (rVSV∆G-ZEBOV-GP)
Keywords
Ebola, VSV-EBOV, vaccine, immunity
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.

  • ERVEBO® (rVSV∆G-ZEBOV-GP)Biological

    intramuscular vaccination

  • ERVEBO® (rVSV∆G-ZEBOV-GP)Biological

    intramuscular vaccination

Study groups in NCT05959421
Study groupRoleWhat they receive
BoosterExperimentalParticipants will receive ERVEBO® (rVSV∆G-ZEBOV-GP) ≥72 million pfu/mL primary immunization And a single booster immunization with the same dose of study vaccine as the primary dose (≥72 million pfu/mL) at month 6 following primary vaccination
Receives: Biological: ERVEBO® (rVSV∆G-ZEBOV-GP)
no BoosterExperimentalParticipants will receive ERVEBO® (rVSV∆G-ZEBOV-GP) ≥72 million pfu/mL primary immunization only
Receives: Biological: ERVEBO® (rVSV∆G-ZEBOV-GP)

What is being measured

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

  1. The course of Anti-EBOV immunoglobulin following primary vaccination

    The course of Anti-EBOV immunoglobulin as measured by EBOV ELISA titers during the 24 months following primary vaccination

    Measured: 0-24month

  2. Anti-EBOV immunoglobulin at 12 and 24 months follow-up

    Anti-EBOV immunoglobulin as measured by EBOV ELISA titers at 12 and 24 months follow-up

    Measured: 12 month follow-up

  3. Anti-EBOV immunoglobulin at 12 and 24 months follow-up

    Anti-EBOV immunoglobulin as measured by EBOV ELISA titers at 12 and 24 months follow-up

    Measured: 24 month follow-up

Secondary outcomes (3)

  1. Occurrence of Grade ≥ 3 AE until one month after primary and booster vaccination

    Number of Grade ≥ 3 AE

    Measured: 1 month after primary vaccination

  2. Occurrence of Grade ≥ 3 AE until one month after primary and booster vaccination

    Number of Grade ≥ 3 AE

    Measured: 1 month after boost vaccination

  3. Occurrence of SAE throughout the study

    Number of serious adverse events

    Measured: 0-24 month

Timeline

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

  1. First posted25 Jul 2023
  2. Study startJun 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Why it stopped: Public funding was withdrawn before the start of the clinical trial.

Resources

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
Model description
Randomized non-blinded interventional trial Type of control: Randomized - Booster or no booster at 6 months
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05959421
Sponsor's protocol ID
PREPARE-GERMANY
Acronym
PREPARE
Status last verified
Jun 2026
First submitted
21 May 2023
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ERVEBO® (rVSV∆G-ZEBOV-GP) in people with Ebola Vaccine, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.

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 11 inclusion and 24 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: withdrawn, as of the sponsor's last update on 4 Jun 2026. 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 Germany. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

The course of Anti-EBOV immunoglobulin following primary vaccination (time frame: 0-24month). 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 NCT05959421.

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 4 Jun 2026.

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