Inactivated poliovirus vaccine given alone or in a sequential schedule with bivalent oral poliovirus vaccine in Chilean infants: a randomised, controlled, open-label, phase 4, non-inferiority study

Summary Background Bivalent oral poliovirus vaccine (bOPV; types 1 and 3) is expected to replace trivalent OPV (tOPV) globally by April, 2016, preceded by the introduction of at least one dose of inactivated poliovirus vaccine (IPV) in routine immunisation programmes to eliminate vaccine-associated...

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Veröffentlicht in:The Lancet infectious diseases 2015-11, Vol.15 (11), p.1273-1282
Hauptverfasser: O'Ryan, Miguel, Prof, Bandyopadhyay, Ananda S, MBBS, Villena, Rodolfo, MD, Espinoza, Mónica, RN, Novoa, José, MD, Weldon, William C, PhD, Oberste, M Steven, PhD, Self, Steve, Prof, Borate, Bhavesh R, MBBS, Asturias, Edwin J, MD, Clemens, Ralf, MD, Orenstein, Walter, Prof, Jimeno, José, MD, Rüttimann, Ricardo, MD, Costa Clemens, Sue Ann, Prof
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Sprache:eng
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Zusammenfassung:Summary Background Bivalent oral poliovirus vaccine (bOPV; types 1 and 3) is expected to replace trivalent OPV (tOPV) globally by April, 2016, preceded by the introduction of at least one dose of inactivated poliovirus vaccine (IPV) in routine immunisation programmes to eliminate vaccine-associated or vaccine-derived poliomyelitis from serotype 2 poliovirus. Because data are needed on sequential IPV–bOPV schedules, we assessed the immunogenicity of two different IPV–bOPV schedules compared with an all-IPV schedule in infants. Methods We did a randomised, controlled, open-label, non-inferiority trial with healthy, full-term (>2·5 kg birthweight) infants aged 8 weeks (± 7 days) at six well-child clinics in Santiago, Chile. We used supplied lists to randomly assign infants (1:1:1) to receive three polio vaccinations (IPV by injection or bOPV as oral drops) at age 8, 16, and 24 weeks in one of three sequential schedules: IPV–bOPV–bOPV, IPV–IPV–bOPV, or IPV–IPV–IPV. We did the randomisation with blocks of 12 stratified by study site. All analyses were done in a masked manner. Co-primary outcomes were non-inferiority of the bOPV-containing schedules compared with the all-IPV schedule for seroconversion (within a 10% margin) and antibody titres (within two-thirds log2 titres) to poliovirus serotypes 1 and 3 at age 28 weeks, analysed in the per-protocol population. Secondary outcomes were seroconversion and titres to serotype 2 and faecal shedding for 4 weeks after a monovalent OPV type 2 challenge at age 28 weeks. Safety analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov , number NCT01841671 , and is closed to new participants. Findings Between April 25 and August 1, 2013, we assigned 570 infants to treatment: 190 to IPV–bOPV–bOPV, 192 to IPV–IPV–bOPV, and 188 to IPV–IPV–IPV. 564 (99%) were vaccinated and included in the intention-to-treat cohort, and 537 (94%) in the per-protocol analyses. In the IPV–bOPV–bOPV, IPV–IPV–bOPV, and IPV–IPV–IPV groups, respectively, the proportions of children with seroconversion to type 1 poliovirus were 166 (98·8%) of 168, 95% CI 95·8–99·7; 178 (100%), 97·9–100·0; and 175 (100%), 97·9–100·0. Proportions with seroconvsion to type 3 poliovirus were 163 (98·2%) of 166, 94·8–99·4; 177 (100%), 97·9–100·0, and 172 (98·9%) of 174, 95·9–99·7. Non-inferiority was thus shown for the bOPV-containing schedules compared with the all-IPV schedule, with no significant differences between gro
ISSN:1473-3099
1474-4457
DOI:10.1016/S1473-3099(15)00219-4