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)
- Conditions
- Ebola virus infection
- Interventions
- Biological: ERVEBO® (rVSV∆G-ZEBOV-GP)
- Registration Number
- 2024-517352-35-00
- Lead Sponsor
- University Medical Center Hamburg-Eppendorf
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 70
Age ≥18 years
Signed informed consent for the trial.
At risk of occupational exposure to Ebola virus through labora-tory, clinical contact, or field work, in the judgment of the in-vestigator.
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.
Willing to avoid blood and body fluid exposure to high-risk individuals for 6 weeks after vaccination/booster.
Willing to forgo blood product donation 30 days prior to first vac-cination until end of study.
Willing to accept randomization (boost versus no boost) at month 6 (time window -1 month) visit.
- 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.
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
Pregnant or breastfeeding (must have negative pregnancy test on the day of vaccination, prior to vaccination)
Known allergy to the components of the rVSV∆G-ZEBOV-GP vac-cine (VSV-EBOV/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, vaccination (Day 0)/booster (Month 6).
Received live virus vaccines within 30 days before, or intention to receive within 30 days following, vaccination (Day 0)/booster (Month 6).
Received immunoglobulins and/or any blood products within the 120 days preceding vaccination (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 systemic infection or other acute in-tercurrent illness at the proposed time of vaccination (Day 0)/booster (Month 6).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description no Booster ERVEBO® (rVSV∆G-ZEBOV-GP) Participants will receive ERVEBO® (rVSV∆G-ZEBOV-GP) ≥72 million pfu/mL primary immunization only Booster ERVEBO® (rVSV∆G-ZEBOV-GP) 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
- Primary Outcome Measures
Name Time Method 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 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. 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 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 Outcome Measures
Name Time Method Occurrence of Grade ≥ 3 AE until one month after primary and booster vaccination Occurrence of Grade ≥ 3 AE until one month after primary and booster vaccination
Occurrence of SAE throughout the study Occurrence of SAE throughout the study
Trial Locations
- Locations (2)
Bernhard-Nocht-Institut Fuer Tropenmedizin
🇩🇪Hamburg, Germany
Goethe University Frankfurt
🇩🇪Frankfurt Am Main, Germany
Bernhard-Nocht-Institut Fuer Tropenmedizin🇩🇪Hamburg, GermanyMarylyn AddoSite contact040741053786m.addo@uke.de