Vaccine · 2016
Delayed BCG immunization does not alter antibody responses to EPI vaccines in HIV-exposed and -unexposed South African infants.
Клиническое исследование II фазыСтатьяРандомизированное исследованиеПоддержка правительства СШАПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Hesseling Anneke C, Blakney Anna K, Jones Christine E, Esser Monika M, de Beer Corena, Kuhn Louise, Cotton Mark F, Jaspan Heather B
Аннотация
BACKGROUND: Bacille Calmette-Guérin (BCG) is routinely given at birth in tuberculosis-endemic settings due to its protective effect against disseminated tuberculosis in infants. BCG is however contraindicated in HIV-infected infants. We investigated whether delaying BCG vaccination to 14 weeks of age affected vaccine-induced antibody responses to Haemophilus influenzae type b (Hib)-conjugate, pertussis, tetanus and Hepatitis B (HBV) vaccines, in HIV-exposed uninfected (HEU) and -unexposed uninfected (HUU) infants.
METHODS: Infants were randomized to receive BCG at birth or at 14 weeks of age. Blood was taken at 14, 24, and 52 weeks of age and analyzed for Hib, pertussis, tetanus and HBV specific antibodies.
RESULTS: BCG was given either at birth (106 infants, 51 HEU) or at 14 weeks of age (74 infants, 50 HEU). The timing of BCG vaccination did not influence the antibody response to any antigen studied. However, in a non-randomized comparison, HEU infants had higher Hib antibody concentrations at weeks 14 and 24 (p=0.001 and <0.001, respectively) and pertussis at week 24 (p=0.003). Conversely, HEU infants had lower antibody concentrations to HBV at 14 and 52 weeks (p=0.032 and p=0.031) with no differences in tetanus titres.
CONCLUSIONS: HIV exposure, but not the timing of BCG vaccination, was associated with antibody concentrations to Hib, pertussis, HBV and tetanus primary immunization.
CLINICAL TRIAL REGISTRATION: DOH-27-1106-1520.
METHODS: Infants were randomized to receive BCG at birth or at 14 weeks of age. Blood was taken at 14, 24, and 52 weeks of age and analyzed for Hib, pertussis, tetanus and HBV specific antibodies.
RESULTS: BCG was given either at birth (106 infants, 51 HEU) or at 14 weeks of age (74 infants, 50 HEU). The timing of BCG vaccination did not influence the antibody response to any antigen studied. However, in a non-randomized comparison, HEU infants had higher Hib antibody concentrations at weeks 14 and 24 (p=0.001 and <0.001, respectively) and pertussis at week 24 (p=0.003). Conversely, HEU infants had lower antibody concentrations to HBV at 14 and 52 weeks (p=0.032 and p=0.031) with no differences in tetanus titres.
CONCLUSIONS: HIV exposure, but not the timing of BCG vaccination, was associated with antibody concentrations to Hib, pertussis, HBV and tetanus primary immunization.
CLINICAL TRIAL REGISTRATION: DOH-27-1106-1520.
Предметные рубрики MeSH
Antibodies, BacterialAntibodies, ViralAntibody FormationBCG VaccineDiphtheria-Tetanus-Pertussis VaccineFemaleHIV InfectionsHaemophilus VaccinesHumansImmunization ScheduleInfantInfant, NewbornInfectious Disease Transmission, VerticalMalePoliovirus Vaccine, OralPregnancySingle-Blind MethodSouth AfricaTetanus ToxoidTime Factors