Durability of Immunity induced by the Ebolavirus Vaccine VSV-EBOV and Assessment of a Booster Dose for Pre-Exposure Prophylaxis in Individuals at Potential Occupational Risk for Ebolavirus Exposure: a German Multicenter Study (PREPARE-Germany)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Medical Center Hamburg-Eppendorf

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Decision date (initial)

2024-10-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517352-35-00

EudraCT number

2022-001367-27

ClinicalTrials.gov

NCT05959421

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

To compare the immune response 24 months following primary vac-cination with rVSV∆G-ZEBOV-GP vaccine (VSV-EBOV, brand name ERVEBO®) and a homologous booster immunization at 6 months ver-sus primary vaccination with rVSV∆G-ZEBOV-GP vaccine (VSV-EBOV, brand name ERVEBO®) without a booster at Month 6.

Secondary objectives 1

1. The nature and frequency of severe and serious adverse events asso-ciated with primary vaccination with or without booster vaccination with rVSV∆G-ZEBOV-GP.

Conditions and MedDRA coding

Ebola virus infection

Regulatory references

Scientific advice from competent authorities

Paul-Ehrlich-Institut

EMA paediatric investigation plan (PIP)

EMEA-001786-PIP01-15

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Age ≥18 years
2. Signed informed consent for the trial.
3. At risk of occupational exposure to Ebola virus through labora-tory, clinical contact, or field work, in the judgment of the in-vestigator.
4. Females of childbearing potential must be willing to use effective methods of contraception as per the requirements of the protocol (9.3.7) from at least 30 days prior to vaccination through 2 months following vaccination/booster.
5. Willing to avoid blood and body fluid exposure to high-risk individuals for 6 weeks after vaccination/booster.
6. Willing to forgo blood product donation 30 days prior to first vac-cination until end of study.
7. Willing to accept randomization (boost versus no boost) at month 6 (time window -1 month) visit.

Exclusion criteria 11

1. 1. Any condition that would limit the ability of the participant to meet protocol requirements or would place the participant at un-reasonable risk. Examples include: I) Clinically significant medical condition, physical examina-tion findings, clinically significant abnormal laboratory re-sults, or past medical history with clinically significant im-plications for current health, per the investigator. A clinical-ly significant condition or process includes but is not lim-ited to: a) A process that would adversely affect the systemic immune response b) A process that would require medication that might adversely affect the systemic immune response c) Any contraindication to repeated injections or blood draws d) A condition that requires active medical intervention or moni-toring to avert grave danger to the participant’s health or well-being during the study period e) 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 partici-pant at an unreasonably increased risk through participa-tion in this study. This includes but is not limited to: a) Active malignancy b) History of Guillain-Barré Syndrome c) History of neurological disorder that may increase risk (history of encephalitis, stroke, or seizure) d) Active autoimmune disorder requiring systemic immunosup-pressive treatment III) Any concomitant medication for which reported side ef-fects or adverse events, in the judgment of the investiga-tor, 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.
2. Pregnant or breastfeeding (must have negative pregnancy test on the day of vaccination, prior to vaccination)
3. Known allergy to the components of the rVSV∆G-ZEBOV-GP vac-cine (VSV-EBOV/ERVEBO®) vaccine product (VSV, albumin, tris, rice).
4. History of severe local or systemic reactions to any vaccination.
5. Received killed vaccines 14 days before, or intention to receive within 7 days following, vaccination (Day 0)/booster (Month 6).
6. Received live virus vaccines within 30 days before, or intention to receive within 30 days following, vaccination (Day 0)/booster (Month 6).
7. Received immunoglobulins and/or any blood products within the 120 days preceding vaccination (Day 0)/booster (Month 6).
8. Received allergy treatment with antigen injections within 30 days before vaccination (Day 0)/booster (Month 6).
9. Clinical evidence (e.g., oral temperature >38.0 degrees Celsius, systemic symptoms) of a systemic infection or other acute in-tercurrent illness at the proposed time of vaccination (Day 0)/booster (Month 6).
10. Prior receipt of a vaccine against EVD or prior EVD in medical history
11. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 1. Binding anti-EBOV antibody titers I. The course of anti-EBOV immunoglobulin as measured by EBOV ELISA titers during the 24 months following primary vaccination II. Anti-EBOV immunoglobulin as measured by EBOV ELISA titers at 12 and 24 months follow-up
2. 2. Anti-EBOV neutralizing antibody titers I. The course of anti-EBOV neutralizing antibody titers during the 24 months following primary vaccination II. Anti-EBOV neutralizing titers at 12 and 24 months follow-up

Secondary endpoints 2

1. Occurrence of Grade ≥ 3 AE until one month after primary and booster vaccination
2. Occurrence of SAE throughout the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Medical Center Hamburg-Eppendorf

Sponsor organisation

University Medical Center Hamburg-Eppendorf

Address

Martinistrasse 52, Eppendorf Eppendorf

City

Hamburg

Postcode

20246

Country

Germany

Scientific contact point

Organisation

University Medical Center Hamburg-Eppendorf

Contact name

Svenja Hardtke

Public contact point

Organisation

University Medical Center Hamburg-Eppendorf

Contact name

Svenja Hardtke

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications