关键词:
POLIO -- Prevention
COMPARATIVE studies
FECES
IMMUNIZATION
RESEARCH methodology
MEDICAL cooperation
MEDICAL protocols
POLIOMYELITIS vaccine
RESEARCH
VIRAL antibodies
VIRAL physiology
EVALUATION research
RANDOMIZED controlled trials
TREATMENT effectiveness
RESEARCH subjects (Persons)
摘要:
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 log(2) titres) to poliovirus serotypes land 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 ***, number NCT01841671, and is dosed 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