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Virus Therapy

Botulinum Vaccine for Botulism

Phase 2
Waitlist Available
Research Sponsored by California Department of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are 18 to 69 years old at the time of consent
To be considered of non-childbearing potential, participants must be menopausal or surgically sterile
Must not have
Have certain inflammatory, vasculitic, or rheumatic diseases
Have clinically confirmed hepatic or renal insufficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 to week 12
Awards & highlights
No Placebo-Only Group

Summary

This trial will test safety, tolerability, and effectiveness of a botulinum vaccine in healthy participants, with a 6-month follow-up.

Who is the study for?
This trial is for healthy adults aged 18-69 who have been immunized with pentavalent botulinum toxoid for work safety. They must not be pregnant, agree to birth control, and can't donate blood outside the study until after Week 12. Participants need personal health insurance and should commit to study requirements including a home diary post-vaccination.
What is being tested?
The trial tests the safety and immune response of a single dose of rBV A/B in individuals previously vaccinated against botulism for occupational reasons. It's an open-label Phase 2 study without a control group, tracking participants over 12 weeks with a follow-up at six months.
What are the potential side effects?
Potential side effects are not detailed but will include any adverse reactions experienced by participants following vaccination. These could range from mild injection site reactions to more serious systemic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 69 years old.
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I am either menopausal or have been surgically sterilized.
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I have received a botulinum toxoid vaccine for work safety under specific research permissions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an inflammatory, vasculitic, or rheumatic disease.
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I have liver or kidney problems.
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My blood pressure is not controlled by medication.
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I have a condition that causes seizures.
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I have been seriously ill or had a fever of 100.4°F or higher in the last 3 days.
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I have a nerve or muscle disorder.
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I have moderate to severe asthma or another serious lung condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Subjects Achieving Equal to or Greater Than 4-Fold Increase in Neutralizing Antibody Concentration (NAC)
Secondary study objectives
Proportion of Subjects Achieving 2-Fold Increase in Area Under the Plasma Concentration-Time Curve in Neutralizing Antibody Concentration (NAC)
Proportion of Subjects Achieving Equal to or Greater Than 3-Fold Increase in Neutralizing Antibody Concentration (NAC)
Other study objectives
Volume of Plasma Collected with Anti-Botulinum Toxin Type A and Anti-Botulinum Toxin Type B Antibody Titers

Side effects data

From 2015 Phase 2 trial • 45 Patients • NCT01701999
75%
Injection site pain*
63%
Injection site erythema*
38%
Injection site swelling*
38%
Injection site pruritus*
13%
Injection site anaesthesia*
13%
Upper respiratory tract infection
13%
Diarrhoea
13%
Lymphopenia
13%
Neutropenia
13%
Blood urine present
13%
Musculoskeletal pain*
13%
Rash papular
13%
Injection site papule
13%
Injection site reaction*
13%
Platelet count decreased
13%
Haemaglobin decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Initial Safety and Immunogenicity (Part 1)
Safety, Immunogenicity, and Plasma Collection (Part 2)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: VaccineExperimental Treatment1 Intervention
rBV A/B
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rBV A/B
2013
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

California Department of Public HealthLead Sponsor
5 Previous Clinical Trials
5,510 Total Patients Enrolled
2 Trials studying Botulism
77 Patients Enrolled for Botulism
~18 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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