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NCT06112834
Tolerability and Immunogenicity of a Single 40-ug Dose of rBV A/B for the Production of BabyBIG®
Phase 2 trial testing rBV A/B in Botulism in 25 participants. Completed in 2 June 2025.
2 June 2025
Quick facts
| Lead sponsor | California Department of Public Health |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 25 |
| Start date | 9 July 2024 |
| Primary completion | 2 June 2025 |
| Estimated completion | 2 June 2025 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- rBV A/B — full drug profile →
Conditions studied
- Botulism — all drugs for Botulism →
Sponsor
California Department of Public Health
Who can join
Adults 18 to 69, any sex, with Botulism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06112834
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of rBV A/B
Trials testing the same drug.
- NCT03676634 — Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG® · Phase 2 · completed
Other California Department of Public Health trials
Trials by the same sponsor.
- NCT03676634 — Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG® · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06112834 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by California Department of Public Health
- Last refreshed: 13 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06112834.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing