Randomized trial of type 1 and type 3 oral monovalent poliovirus vaccines in newborns in Africa.

The Global Polio Eradication Initiative aims to eradicate wild poliovirus by the end of 2012. Therefore, more-immunogenic polio vaccines, including monovalent oral poliovirus vaccines (mOPVs), are needed for supplemental immunization activities. This trial assessed the immunogenicity of monovalent types 1 and 3, compared with that of trivalent oral poliovirus vaccine (tOPV), in South Africa. We conducted a blinded, randomized, 4-arm controlled trial comparing the immunogenicity of a single dose of mOPV1 (from 2 manufacturers) and mOPV3 (from 1 manufacturer), given at birth, with the immunogenicity of tOPV. Eight hundred newborns were enrolled; 762 (95%) were included in the analysis. At 30 days after vaccine administration, seroconversion to poliovirus type 1 was 73.4% and 76.4% in the 2 mOPV1 arms, compared with 39.1% in the tOPV arm (P < .0000001), and seroconversion to poliovirus type 3 was 58.0% in the mOPV3 arm, compared with 21.2% in the tOPV arm (P < .0000001). The vaccines were well tolerated, and no adverse events were attributed to trial interventions. A dose of mOPV1 or mOPV3 at birth was superior to that of tOPV in inducing type-specific seroconversion in this sub-Saharan African population. Our results support continued use of mOPVs in supplemental immunization activities in countries where poliovirus types 1 or 3 circulate. Clinical Trials Registration. ISRCTN18107202.

Citation

Zainab Waggie, Hennie Geldenhuys, Roland W Sutter, Mariana Jacks, Humphrey Mulenga, Hassan Mahomed, Marwou De Kock, Willem Hanekom, Mark A Pallansch, Anna-Lea Kahn, Anthony H Burton, Meghana Sreevatsava, Gregory Hussey. Randomized trial of type 1 and type 3 oral monovalent poliovirus vaccines in newborns in Africa. The Journal of infectious diseases. 2012 Jan 15;205(2):228-36

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PMID: 22158680

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