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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
70
intramuscular vaccination
intramuscular vaccination
University Hospital Frankfurt (KGU)
Frankfurt, Germany
Bernhard Nocht Centre for Clinical Trials (BNCCT)
Hamburg, Germany
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
Time frame: 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
Time frame: 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
Time frame: 24 month follow-up
Occurrence of Grade ≥ 3 AE until one month after primary and booster vaccination
Number of Grade ≥ 3 AE
Time frame: 1 month after primary vaccination
Occurrence of Grade ≥ 3 AE until one month after primary and booster vaccination
Number of Grade ≥ 3 AE
Time frame: 1 month after boost vaccination
Occurrence of SAE throughout the study
Number of serious adverse events
Time frame: 0-24 month
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