CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
rBV A/Bbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03676634
NCT03676634Phase 2Completed
CompareCT.gov

Tolerability and Immunogenicity of a Single 40-µg Dose of Recombinant Botulinum Vaccine A/B (rBV A/B) for the Production of BabyBIG® in Volunteers With Existing Botulinum Immunity

California Department of Public Health·interventional·Posted Sep 19, 2018·Updated Oct 19, 2021

In Brief

A Phase 2 clinical trial evaluating rBV A/B for Botulism. Completed, enrolled 32 participants across 2 sites.

Detailed Summary

This Phase 2, open-label, uncontrolled study designed to evaluate safety, tolerability, and immunogenicity of a single dose of rBV A/B in healthy participants previously immunized with pentavalent botulinum toxoid (or pentavalent botulinum toxoid and rBV A/B) for occupational protection will be conducted to collect source plasma for potential use in the production of BabyBIG and to evaluate safety and immunogenicity of the vaccine in these participants over a 12-week period, with a follow-up safety assessment at 6 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBotulism
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 19, 2018
Enrollment StartMar 7, 2019
Primary CompletionApr 25, 2020
Study CompletionJul 3, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.8 years ago

Interventions

rBV A/Bbiological

Recombinant Botulinum Vaccine A/B, rBV A/B