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

NCT05959421 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: PREPARE-GERMANY
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Ebola Vaccine

Keywords

Ebola, VSV-EBOV, vaccine, immunity

Outcome Measures

Primary Outcomes (3)

• 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

  0-24month

• 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

  12 month follow-up

• 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

  24 month follow-up

Secondary Outcomes (3)

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

  1 month after primary vaccination

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

  1 month after boost vaccination

• Occurrence of SAE throughout the study

  0-24 month

Study Arms (2)

Booster

EXPERIMENTAL

Participants 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

Biological: ERVEBO® (rVSV∆G-ZEBOV-GP)

no Booster

EXPERIMENTAL

Participants will receive ERVEBO® (rVSV∆G-ZEBOV-GP) ≥72 million pfu/mL primary immunization only

Biological: ERVEBO® (rVSV∆G-ZEBOV-GP)

Interventions

ERVEBO® (rVSV∆G-ZEBOV-GP) BIOLOGICAL

intramuscular vaccination

Booster; no Booster

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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:
• I) 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
• A condition or process for which signs or symptoms could be confused with reactions to vaccine
• II) 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
• III) Any concomitant medication for which reported side effects or adverse events, in the judg-ment of the investigator, may interfere with assessment of safety.
• IV) 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)

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Bernhard Nocht Institute for Tropical Medicine: collaborator
• Goethe University: collaborator
• German Federal Ministry of Education and Research: collaborator
• Monipol Deutschland GmbH: collaborator

Study Sites (2)

University Hospital Frankfurt (KGU)

Frankfurt, 60590, Germany

Location

Bernhard Nocht Centre for Clinical Trials (BNCCT)

Hamburg, 20359, Germany

Location

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Officials

• Marylyn M Addo, Prof

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marylyn M Addo, Prof

CONTACT

+4940741051102; sekretariataddo@uke.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized non-blinded interventional trial Type of control: Randomized - Booster or no booster at 6 months

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: July 25, 2023
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)