Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:38 AM
Study NCT ID:
NCT07455318
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Boostability Assessment of Three Rabies Pre-Exposure Regimens in Healthy Volunteers 5 Years Following Priming.
Sponsor:
Institute of Tropical Medicine, Belgium
Organization:
Study Overview
Official Title:
A Multicentre, Open-label Trial in Healthy Volunteers to Assess the Boostability of Three Different Rabies Pre-exposure Prophylaxis Regimens When Administering a Single-dose, Intramuscular Vaccination as Simulated Post-exposure Prophylaxis at Least Five Years Following Priming.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAZOOKA_221
Brief Summary:
A multicentre, open label trial in healthy volunteers to assess the boostability of three different rabies pre-exposure prophylaxis regimens (2 x 1IM regimen, 2 x 2 ID regimen, 1 x 2 ID regimen) when administering a single-dose, intramuscular vaccination as simulated post-exposure prophylaxis at least five years following priming.
Detailed Description:
This multicentre clinical trial will include 561 participants, allocated evenly across 3 groups (187 per group). Participants are assigned to one of three groups according to their prior PrEP regimen, provided their last dose was given at least 5 years prior to enrollment.
• Group 1: 21IM regimen, (N = 187): received PrEP at least 5 years ago through 1 x 1,0 mL IM injection (Day 0 and Day 7), with a 7-day interval between visits (interval of 5 to 56 days is allowed).
• Group 2: 2²ID regimen (N = 187): received PrEP at least 5 years ago through 2 x 0,1 mL ID injections (Day 0 and Day 7) with a 7-day interval between visits (interval of 5 to 56 days is allowed).
• Group 3: 1²ID regimen (N = 187): received PrEP at least 5 years ago through 2 x 0,1 mL ID injections on Day 0
All subjects will receive 1 x 1,0 mL IM injection of purified chick-embryo cell-culture rabies vaccine as sPEP (booster) at least five years after primary vaccination (PrEP).
Neutralizing antibody titers against rabies virus will be measured using the Rapid Fluorescent Focus Inhibition Test (RFFIT) on Day 0 (before administration of sPEP) and on Days 7 and 14 after sPEP vaccination.
A titre of ≥ 0.5 IU/mL is defined as adequate (WHO standard).
• Group 1: 21IM regimen, (N = 187): received PrEP at least 5 years ago through 1 x 1,0 mL IM injection (Day 0 and Day 7), with a 7-day interval between visits (interval of 5 to 56 days is allowed).
• Group 2: 2²ID regimen (N = 187): received PrEP at least 5 years ago through 2 x 0,1 mL ID injections (Day 0 and Day 7) with a 7-day interval between visits (interval of 5 to 56 days is allowed).
• Group 3: 1²ID regimen (N = 187): received PrEP at least 5 years ago through 2 x 0,1 mL ID injections on Day 0
All subjects will receive 1 x 1,0 mL IM injection of purified chick-embryo cell-culture rabies vaccine as sPEP (booster) at least five years after primary vaccination (PrEP).
Neutralizing antibody titers against rabies virus will be measured using the Rapid Fluorescent Focus Inhibition Test (RFFIT) on Day 0 (before administration of sPEP) and on Days 7 and 14 after sPEP vaccination.
A titre of ≥ 0.5 IU/mL is defined as adequate (WHO standard).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025-524765-24-00 | CTIS | None | View |