Poliovirus Vaccine Trial in Bangladesh
Summary
This randomized clinical trial will assess the immune response in infants following administration of three types of oral poliovirus vaccine trivalent OPV (tOPV), monovalent OPV type 1 (mOPV1), bivalent OPV types 1 and 3 (bOPV) using two different schedules: a short schedule with administration at two week intervals and the usual schedule at four week intervals. The results of this study will guide the Global Polio Eradication Program in the implementation of new strategies that may: 1) improve the quality of the response to outbreaks following importation of wild poliovirus type 1 by shortening the interval at which several OPV doses are provided; 2) prevent alternate outbreaks of type 1 and type 3 poliovirus by using bOPV in outbreak responses in countries with weak routine immunization systems; and 3) prevent the emergence of type 2 vaccine-derived poliovirus through the replacement of tOPV with bOPV in immunization campaigns and routine immunization programs.
Timeline
- Start
- 2012-05
- Primary completion
- 2012-12
- Completion
- 2012-12
Publications
- Emperador DM, Velasquez DE, Estivariz CF, Lopman B, Jiang B, Parashar U, Anand A, Zaman K. Interference of Monovalent, Bivalent, and Trivalent Oral Poliovirus Vaccines on Monovalent Rotavirus Vaccine Immunogenicity in Rural Bangladesh. Clin Infect Dis. 2016 Jan 15;62(2):150-6. doi: 10.1093/cid/civ807. Epub 2015 Sep 8.
- Estivariz CF, Anand A, Gary HE Jr, Rahman M, Islam J, Bari TI, Wassilak SG, Chu SY, Weldon WC, Pallansch MA, Heffelfinger JD, Luby SP, Zaman K. Immunogenicity of three doses of bivalent, trivalent, or type 1 monovalent oral poliovirus vaccines with a 2 week interval between doses in Bangladesh: an open-label, non-inferiority, randomised, controlled trial. Lancet Infect Dis. 2015 Aug;15(8):898-904. doi: 10.1016/S1473-3099(15)00094-8. Epub 2015 Jun 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bivalent OPV | Vaccine | — | Oral |
| Comparator | Monovalent OPV | Vaccine | — | Oral |
| Comparator | Trivalent OPV | Vaccine | — | Oral |
Indications
No indication recorded.