drugset / Trial / NCT04974294
PREVENTING PNEUMOcoccal Disease Through Vaccination (Study 2)
RandomizedCrossoverQuadruple-blindPrevention
Summary
To determine the effect of PCV-13 and PPV-23 vaccination versus control on experimental pneumococcal colonisation of 2 clades of serotypes 3 and 6B at 1 month and 6 months post vaccination respectively, using the EHPC model.
Timeline
- Start
- 2021-07-28
- Primary completion
- 2023-07-31
- Completion
- 2023-12-31
Publications
- Liatsikos K, Hyder-Wright A, Davies K, El Safadi D, Farrar M, Goncalves A, Gonzalez-Dias P, Gordon SB, Howard A, Lesosky M, Liu X, Mitsi E, Myerscough C, Nyazika TK, Pollard AJ, Reine J, Robinson RE, Solorzano C, Urban BC, Zhang Y, Lahuerta M, Theilacker C, Catusse J, Begier E, Tan Y, Jodar L, Gessner BD, Collins A, Ferreira DM; PNEUMO 2 study group. The effect of pneumococcal conjugate vaccine and pneumococcal polysaccharide vaccine on nasopharyngeal colonisation following human infection challenge with serotype 3 and serotype 6B (PREVENTING PNEUMO 2): a double-masked, randomised, controlled, phase 4 trial. Lancet Microbe. 2026 Mar;7(3):101267. doi: 10.1016/j.lanmic.2025.101267. Epub 2026 Feb 13.
- Liatsikos K, Hyder-Wright A, Pojar S, Chen T, Wang D, Davies K, Myerscough C, Reine J, Robinson RE, Urban B, Mitsi E, Solorzano C, Gordon SB, Quinn A, Pan K, Anderson AS, Theilacker C, Begier E, Gessner BD, Collins A, Ferreira DM; PNEUMO 2 study group. Protocol for a phase IV double-blind randomised controlled trial to investigate the effect of the 13-valent pneumococcal conjugate vaccine and the 23-valent pneumococcal polysaccharide vaccine on pneumococcal colonisation using the experimental human pneumococcal challenge model in healthy adults (PREVENTING PNEUMO 2). BMJ Open. 2022 Jul 7;12(7):e062109. doi: 10.1136/bmjopen-2022-062109.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pneumovax 23 | Vaccine | — | Intramuscular |
| Comparator | Prevnar 13 | Vaccine | — | Intramuscular |