Clinical Trial: Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand
Brief Summary:
Young infants are most vulnerable to severe disease and even death when infected with Bordetella pertussis. The current vaccines and vaccination programs do not guarantee protection of neonates from this disease. Maternal acquired pertussis-specific antibodies show low concentrations with short persistence in newborns creating a susceptibility gap for infection between birth and the first vaccinations. A possible strategy to protect infants from birth is pertussis vaccination during pregnancy, which will increase the amount of passively transferred maternal antibodies.
However, little is known regarding the effect of high titers of maternal antibodies on the infants immune responses to different pertussis vaccines (whole cell versus acellular). Humoral immune responses will be assessed in infants receiving whole cell versus infants receiving acellular pertussis vaccines. Functionality of the antibodies will also be analyzed.
Detailed Summary:
Sponsor: Universiteit Antwerpen
Current Primary Outcome:
- kinetics of Pertussis toxin (PT) IgG titers in infants [ Time Frame: from birth until 19 months of age ]Measurement of anti- Pertussis Toxin (PT) immunoglobulin (IgG) antibodies at several time points following maternal vaccination during pregnancy and after infant immunization (priming and boosting) with an acellular or whole cell pertussis containing vaccine
- kinetics of Filamentous haemagglutinin (FHA) IgG titers in infants [ Time Frame: from birth until 19 months of age ]Measurement of anti- Filamentous Haemmaglutinin (FHA) immunoglobulin (IgG) antibodies at several time points following maternal vaccination during pregnancy and after infant immunization (priming and boosting) with an acellular or whole cell pertussis containing vaccine
- kinetics of Pertactin (Prn) IgG titers in infants [ Time Frame: from birth until 19 months of age ]Measurement of anti- Pertactin (Prn) immunoglobulin (IgG) antibodies at several time points following maternal vaccination during pregnancy and after infant immunization (priming and boosting) with an acellular or whole cell pertussis containing vaccine
Original Primary Outcome:
- kinetics of Pertussis toxin (PT) IgG titers in infants [ Time Frame: from birth until 19 months of age ]Measurement of anti- Pertussis Toxin (PT) immunoglobulin (IgG) antibodies at several time points following maternal vaccination during pregnancy and after infant immunization (priming and boosting) with an acellular or whole cell pertussis containing vaccine
- kinetics of Filamentous haemagglutinin (FHA) IgG titers in infants [ Time Frame: from birth until 19 months of age ]Measurement of anti- Filamentous Haemmaglutinin (FHA) immunoglobulin (IgG) antibodies at several time points following maternal vaccination during pregnancy and after infant immunization (priming and boosting) with an acellular or whole cell pertussis containing vaccine
- kinetics of Pertactin (Prn) IgG titers in infants [ Time Frame: from birth until 19 months of age ]Measurement of anti- Pertactin (Prn) immunoglobulin (IgG) antibodies at several time points following maternal vaccination during pregnancy and after infant immunization (priming and boosting) with an acellular or whole cell pertussis containing vaccine
- kinetics of Fimbriae (Fim) IgG titers in infants [ Time Frame: from birth until 19 months of age ]Measurement of anti- Fimbriae (FIM) immunoglobulin (IgG) antibodies at several time points following maternal vaccination during pregnancy and after infant immunization (priming and boosting) with an acellular or whole cell pertussis containing vaccine
Current Secondary Outcome:
- Functionality of the maternal anti-PT IgG antibodies in the infants as assessed with a newly validated luminescence based assay [ Time Frame: At birth ]functionality of the passively acquired anti-PT antibodies in infants following maternal vaccination during pregnancy with an acellular pertussis containing vaccine (Boostrix), as assessed with a newly validated luminescence based assay
- Functionality of the anti-PT IgG antibodies in the infants after vaccination assessed with a newly validated luminescence based assay [ Time Frame: At month 7 and month 19 ]To measure the functionality of the anti-PT antibodies in infants vaccinated with either an acellular pertussis containing vaccine (Infanrix hexa) or a whole cell pertussis vaccine (Quinvaxem), after maternal vacicnation during pregnancy, assessed with a newly validated luminescence based assay
- Efficacy of the transplacental transport of IgG as assessed by the ratio of cord and maternal titers of IgG antibodies [ Time Frame: Birth ]Efficacy as assessed by the ratio of cord and maternal titers of IgG antibodies
Original Secondary Outcome:
- Functionality of the maternal anti-PT IgG antibodies in the infants as assessed with a newly validated luminescence based assay [ Time Frame: At birth ]functionality of the passively acquired anti-PT antibodies in infants following maternal vaccination during pregnancy with an acellular pertussis containing vaccine (Adacel), as assessed with a newly validated luminescence based assay
- Functionality of the anti-PT IgG antibodies in the infants after vaccination assessed with a newly validated luminescence based assay [ Time Frame: At month 7 and month 19 ]To measure the functionality of the anti-PT antibodies in infants vaccinated with either an acellular pertussis containing vaccine ( Hexaxim) or a whole cell pertussis vaccine (Quinvaxem), after maternal vacicnation during pregnancy, assessed with a newly validated luminescence based assay
- Efficacy of the transplacental transport of IgG as assessed by the ratio of cord and maternal titers of IgG antibodies [ Time Frame: Birth ]Efficacy as assessed by the ratio of cord and maternal titers of IgG antibodies
Information By: Universiteit Antwerpen
Dates:
Date Received: March 23, 2015
Date Started: April 2015
Date Completion: April 2018
Last Updated: May 26, 2015
Last Verified: May 2015
