Botulinum Vaccine for Botulism

Overseen By Jessica M Khouri, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: California Department of Public Health

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Pregnancy, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on prescription immunosuppressive or immunomodulatory agents, you may need to stop them 3 months before enrolling and during the study, unless they are certain types of topical or injectable steroids.

What data supports the effectiveness of the treatment rBV A/B for botulism?

The rBV A/B vaccine is being developed to protect against botulism by creating antibodies that neutralize the toxins before they can harm nerve cells. Preclinical studies in animals showed that the vaccine is safe and did not cause significant side effects, supporting its use in human trials. ^{1 2 3 4 5}

Is the botulinum vaccine rBV A/B safe for humans?

The botulinum vaccine rBV A/B has been shown to be safe in animal studies, with no significant toxicity and only mild, temporary inflammation at the injection site. In early human trials, it was well tolerated and did not cause serious side effects. ^{1 3 4 6 7}

How is the rBV A/B vaccine different from other botulism treatments?

The rBV A/B vaccine is unique because it is a recombinant vaccine designed to protect against botulism by using purified proteins from two types of botulinum toxins, A and B, to stimulate the immune system. Unlike previous vaccines, it focuses on safety and effectiveness without the diminished potency and side effects seen in older vaccines. ^{1 2 3 4 8}

Eligibility Criteria

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.

Inclusion Criteria

I agree to keep a daily diary for 7 days after vaccination and report any severe side effects.

Participants of childbearing potential must have negative pregnancy test at screening and within 24 hours prior to vaccination, must agree to not become pregnant until after the last plasma donation or until after the Week 12 visit, and must agree to use at least one form of highly effective birth control

Are able to understand the requirements of the study, have provided written informed consent, and have agreed to abide by the study restrictions and return for the required assessments

Exclusion Criteria

I have a history of specific infectious diseases or viruses.

I have taken prescribed immune system altering drugs recently.

I have had chemotherapy in the last 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single 40-µg dose of rBV A/B and undergo plasmapheresis for source plasma collection

12 weeks

Multiple visits for monitoring and plasma collection

Follow-up

Participants are monitored for safety and immunogenicity after treatment

6 months

Treatment Details

Interventions

• rBV A/B

Trial Overview 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.

Participant Groups

Group I: Vaccine Experimental Treatment 1 Intervention

rBV A/B

Who Is Running the Clinical Trial?

California Department of Public Health

Lead Sponsor

Trials

7

Recruited

5,800+

References

1. England pubmed.ncbi.nlm.nih.gov

What next for botulism vaccine development? [2013]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Botulism and vaccines for its prevention. [2011]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of investigational recombinant botulinum vaccine, rBV A/B, in volunteers with pre-existing botulinum toxoid immunity. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Preclinical safety assessment of recombinant botulinum vaccine A/B (rBV A/B). [2012]

5. Netherlands pubmed.ncbi.nlm.nih.gov

[A patient with botulism caused by Clostridium botulinum type B]. [2010]

6. United States pubmed.ncbi.nlm.nih.gov

Botulinum neurotoxin vaccines: past, present, and future. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Inhalational botulism in rhesus macaques exposed to botulinum neurotoxin complex serotypes A1 and B1. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Recombinant C fragment of botulinum neurotoxin B serotype (rBoNTB (HC)) immune response and protection in the rhesus monkey. [2022]