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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 to week 12

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 to week 12

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of Subjects Achieving Equal to or Greater Than 4-Fold Increase in Neutralizing Antibody Concentration (NAC)

Secondary outcome measures

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 outcome measures

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%

Neutropenia

13%

Upper respiratory tract infection

13%

Diarrhoea

13%

Musculoskeletal pain*

13%

Blood urine present

13%

Lymphopenia

13%

Rash papular

13%

Injection site anaesthesia*

13%

Injection site papule

13%

Injection site reaction*

13%

Platelet count decreased

13%

Haemaglobin decreased

100%

80%

60%

40%

20%

Study treatment Arm

Initial Safety and Immunogenicity (Part 1)

Safety, Immunogenicity, and Plasma Collection (Part 2)

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

California Department of Public HealthLead Sponsor

5 Previous Clinical Trials

7,193 Total Patients Enrolled

2 Trials studying Botulism

77 Patients Enrolled for Botulism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What groups of people are eligible to participate in this clinical study?

"For admittance into this clinical trial, individuals must present with botulism and be of a mature age (between 18 and 69 years). The study is hoping to enrol roughly 30 participants."

Answered by AI

What assurance can be given of the safety of this Vaccine for recipients?

"Drawing on the insights of our Power team, Vaccine had a safety rating of 2. This suggests that while there is available data to back its safety profile, efficacy has yet to be proven through clinical trials."

Answered by AI

Does the study accept seniors over 75 years of age?

"This trial is open to participants aged 18-69. There are also 1 trials for individuals younger than the age of consent and 3 studies dedicated to those above 65 years old."

Answered by AI

Does this experiment continue to seek participants?

"The clinicaltrials.gov platform verifies that this medical trial is not presently accepting participants; the study was initially posted on June 1st 2024 and last updated on October 31st 2023. However, there are 4 other studies actively recruiting candidates at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tolerability and Immunogenicity of a Single 40-ug Dose of rBV A/B for the Production of BabyBIG®

2024. "Tolerability and Immunogenicity of a Single 40-ug Dose of rBV A/B for the Production of BabyBIG®". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06112834.