RECOMBINANT VESICULAR STOMATITIS VIRUS - ZAIRE EBOLAVIRUS VACCINE (LIVE) for Ebola virus infection

Inclusion criteria

• {"criterion_text":"- Age ≥18 years\n- Signed informed consent for the trial.\n- At risk of occupational exposure to Ebola virus through laboratory, clinical contact, or field work, in the judgment of the investigator.\n- 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.\n- Willing to avoid blood and body fluid exposure to high-risk individuals for 6 weeks after vaccination/booster.\n- Willing to forgo blood product donation 30 days prior to first vaccination until end of study.\n- Willing to accept randomization (boost versus no boost) at month 6 (time window -1 month) visit."}

Exclusion criteria

• {"criterion_text":"- 1. Any condition that would limit the ability of the participant to meet protocol requirements or would place the participant at unreasonable risk. Examples include: 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) 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 monitoring 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 participant at an unreasonably increased risk through participation 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 immunosuppressive treatment III) Any concomitant medication for which reported side effects or adverse events, in the judgment 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.\n- Prior receipt of a vaccine against EVD or prior EVD in medical history\n- 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\n- Pregnant or breastfeeding (must have negative pregnancy test on the day of vaccination, prior to vaccination)\n- Known allergy to the components of the rVSV∆G-ZEBOV-GP vaccine (VSV, albumin, tris, rice).\n- History of severe local or systemic reactions to any vaccination.\n- Received killed vaccines 14 days before, or intention to receive within 7 days following, vaccination (Day 0)/booster (Month 6).\n- Received live virus vaccines within 30 days before, or intention to receive within 30 days following, vaccination (Day 0)/booster (Month 6).\n- Received immunoglobulins and/or any blood products within the 120 days preceding vaccination (Day 0)/booster (Month 6).\n- Received allergy treatment with antigen injections within 30 days before vaccination (Day 0)/booster (Month 6).\n- Clinical evidence (e.g., oral temperature >38.0 degrees Celsius, systemic symptoms) of a systemic infection or other acute intercurrent illness at the proposed time of vaccination (Day 0)/booster (Month 6)."}

Primary endpoints

• {"endpoint_text":"- 1.\tBinding anti-EBOV antibody titers I.\tThe course of anti-EBOV immunoglobulin as measured by EBOV ELISA titers during the 24 months following primary vaccination II.\tAnti-EBOV immunoglobulin as measured by EBOV ELISA titers at 12 and 24 months follow-up","definition_or_measurement_approach":"Binding anti-EBOV immunoglobulin measured by EBOV ELISA titers over 24 months; specific measurements at 12 and 24 months follow-up as stated."}
• {"endpoint_text":"- 2.\tAnti-EBOV neutralizing antibody titers I.\tThe course of anti-EBOV neutralizing antibody titers during the 24 months following primary vaccination II.\tAnti-EBOV neutralizing titers at 12 and 24 months follow-up","definition_or_measurement_approach":"Anti-EBOV neutralizing antibody titers measured over 24 months with assessments at 12 and 24 months follow-up (neutralization assay as implied by 'neutralizing antibody titers')."}

Secondary endpoints

• {"endpoint_text":"- Occurrence of Grade ≥ 3 AE until one month after primary and booster vaccination","definition_or_measurement_approach":"Occurrence and severity of adverse events (Grade ≥3) recorded up to one month after primary and booster vaccinations as reported by investigators and participants."}
• {"endpoint_text":"- Occurrence of SAE throughout the study","definition_or_measurement_approach":"Serious adverse events (SAEs) collected and reported throughout the study period."}

Germany

Earliest CTIS Part Ii Submission Date

17-09-2024

Latest Decision Or Authorization Date

18-10-2024

Processing Time Days

31

Number Of Sites

2

Number Of Participants

70

Primary sponsor

Full Name

University Medical Center Hamburg-Eppendorf

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany