drugset / Trial / NCT03751514
Bordetella Pertussis Colonisation Challenge Study
Unknown
80 enrolled
University of Southampton
Public Health England · collabUniversity Hospital Southampton NHS Foundation Trust · collab
Non-randomizedSingle-groupOpen-labelOther
Summary
This is a prospective controlled human challenge study consisting of two phases; Phase A: Development of a B. pertussis human challenge model; pilot to establish the standard inoculum Phase B: Development of a modified B. pertussis human challenge model
Timeline
- Start
- 2017-05-22
- Primary completion
- 2021-02-02
- Completion
- 2021-02-02
Publications
- de Graaf H, Gbesemete DF, Hill AR, Froberg J, Ibrahim MM, Dale AP, Laver JR, Gorringe AR, Faust SN, Kester KE, Buisman AM, Berbers GAM, Brummelman J, van Els CACM, Eleveld MJ, Diavatopoulos DA, Read RC. Safety, colonisation kinetics, transmissibility, and immune correlates of protection in healthy adults inoculated with Bordetella pertussis in England: a single-centre, open-label, phase 1, controlled human infection study. Lancet Microbe. 2026 Apr;7(4):101313. doi: 10.1016/j.lanmic.2025.101313. Epub 2026 Mar 23.
- Diks AM, de Graaf H, Teodosio C, Groenland RJ, de Mooij B, Ibrahim M, Hill AR, Read RC, van Dongen JJ, Berkowska MA; IMI-2 PERISCOPE Consortium. Distinct early cellular kinetics in participants protected against colonization upon Bordetella pertussis challenge. J Clin Invest. 2023 Mar 1;133(5):e163121. doi: 10.1172/JCI163121.
- de Graaf H, Ibrahim M, Hill AR, Gbesemete D, Vaughan AT, Gorringe A, Preston A, Buisman AM, Faust SN, Kester KE, Berbers GAM, Diavatopoulos DA, Read RC. Controlled Human Infection With Bordetella pertussis Induces Asymptomatic, Immunizing Colonization. Clin Infect Dis. 2020 Jul 11;71(2):403-411. doi: 10.1093/cid/ciz840.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | 500 mg | — |