Immunity Induced by VSV-EBOV and Assessment of a Booster Dose in Individuals at Potential Occupat… (NCT05959421) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Immunity Induced by VSV-EBOV and Assessment of a Booster Dose in Individuals at Potential Occupational Risk for Exposure
Germany70 participantsStarted 2026-06
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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.
Exclusion criteria
✕. 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:
✕. 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
What they're measuring
1
The course of Anti-EBOV immunoglobulin following primary vaccination
Timeframe: 0-24month
2
Anti-EBOV immunoglobulin at 12 and 24 months follow-up
Timeframe: 12 month follow-up
3
Anti-EBOV immunoglobulin at 12 and 24 months follow-up
. 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