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Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG®

NCT03676634 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-10-19

Study results available
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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.

Conditions

  • Botulism

Interventions

BIOLOGICAL

rBV A/B

Recombinant Botulinum Vaccine A/B, rBV A/B

Sponsors & Collaborators

  • California Department of Public Health

    lead OTHER

Principal Investigators

  • Stephen Arnon, M.D., M.P.H. · California Department of Public Health

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-07
Primary Completion
2020-04-25
Completion
2020-07-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03676634 on ClinicalTrials.gov