drugset / Trial / NCT04529538
Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines
Phase 1
Completed
226 enrolled
PATH
Bill and Melinda Gates Foundation · collabCenters for Disease Control and Prevention · collabThe Emmes Company, LLC · collabViroclinics Biosciences B.V. · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study is to assess the safety (primary objective), the ability to trigger the production of antibodies (immunogenicity; a secondary objective) and presence of vaccine virus in the stool (fecal shedding; a secondary objective) of two novel oral polio vaccines (nOPV), novel oral poliomyelitis vaccine type 1 (nOPV1) and novel oral poliomyelitis vaccine type 3 (nOPV3), as compared to Sabin strain monovalent oral poliomyelitis vaccine (mOPV) controls, in healthy adults.
Timeline
- Start
- 2021-03-26
- Primary completion
- 2023-02-17
- Completion
- 2023-02-17
Publications
- Mercer LD, Sena AC, Colgate ER, Crothers JW, Wright PF, Al-Ibrahim M, Tritama E, Vincent A, Mainou BA, Zhang Y, Konopka-Anstadt J, Bandyopadhyay AS, Fix A, Konz JO, Gast C. Safety and immunogenicity of novel live attenuated type 1 and type 3 oral poliomyelitis vaccines in healthy adults in the USA: a first-in-human, observer-masked, multicentre, phase 1 randomised controlled trial. Lancet Infect Dis. 2025 Dec;25(12):1363-1376. doi: 10.1016/S1473-3099(25)00285-3. Epub 2025 Aug 13.
- Thompson KM, Kalkowska DA, Kidd SE, Burns CC, Badizadegan K. Trade-offs of different poliovirus vaccine options for outbreak response in the United States and other countries that only use inactivated poliovirus vaccine (IPV) in routine immunization. Vaccine. 2024 Feb 6;42(4):819-827. doi: 10.1016/j.vaccine.2023.12.081. Epub 2024 Jan 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Novel Oral Polio Vaccine Type 1 | Vaccine | 0.1 ml | Oral |
| Subject | Novel Oral Polio Vaccine Type 3 | Vaccine | 0.1 ml | Oral |
| Comparator | Sabin Monovalent Oral Polio Vaccine Type 1 | Vaccine | 0.1 ml | Oral |
| Comparator | Sabin Monovalent Oral Polio Vaccine Type 3 | Vaccine | 0.1 ml | Oral |