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Trial record 13 of 300 for:    "Whooping cough"

Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand

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ClinicalTrials.gov Identifier: NCT02408926
Recruitment Status : Unknown
Verified May 2015 by Elke Leuridan, MD, PhD, Universiteit Antwerpen.
Recruitment status was:  Recruiting
First Posted : April 6, 2015
Last Update Posted : May 27, 2015
Sponsor:
Collaborators:
Chulalongkorn University
Institut Pasteur de Lille
Thrasher Research Fund
Information provided by (Responsible Party):
Elke Leuridan, MD, PhD, Universiteit Antwerpen

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.


Condition or disease Intervention/treatment Phase
Pertussis Biological: Boostrix Biological: Infanrix hexa Biological: Quinvaxem Biological: OPV Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand
Study Start Date : April 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Whooping Cough

Arm Intervention/treatment
Experimental: Group A
Women will be vaccinated with an acellular pertussis containing vaccine (Boostrix) between 27 and 36 weeks of gestation. Children born from these mothers will be vaccinated according to the official recommendations in Thailand at 2, 4, 6 and 18 months with a hexavalent acellular pertussis containing vaccine (Infanrix hexa).
Biological: Boostrix
Pregnant women will be vaccinated with an acellular pertussis containing vaccine between 27 and 36 weeks of gestation.
Other Name: Acellular pertussis containing vaccine

Biological: Infanrix hexa
Children from group A will be vaccinated with an acellular pertussis containing vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.
Other Name: Acellular pertussis containing vaccine

Active Comparator: Group B
Women will be vaccinated with an acellular pertussis containing vaccine (Boostrix) between 27 and 36 weeks of gestation. Children born from these mothers will be vaccinated according to the official recommendations in Thailand at 2, 4, 6 and 18 months with a pentavalent whole cell pertussis containing vaccine (Quinvaxem). OPV (oral poliovirus vaccine) will also be administered at 2, 4, 6 and 18 months.
Biological: Boostrix
Pregnant women will be vaccinated with an acellular pertussis containing vaccine between 27 and 36 weeks of gestation.
Other Name: Acellular pertussis containing vaccine

Biological: Quinvaxem
Children from group B will be vaccinated with a whole cell pertussis containing vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.
Other Name: Whole cell pertussis containing vaccine

Biological: OPV
Children from group B will be vaccinated with OPV vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.
Other Name: Oral Polio Vaccine




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing to be immunized with a pertussis containing vaccine during pregnancy
  • Intend to be available for follow-up visits and phone call through 19 months postpartum
  • Willing to have infant immunized with a pertussis containing vaccine at 2, 4, 6 months and 18 months of age according to EPI (Expanded Programme of Immunization) and receiving (randomized) either acellular pertussis (aP) (study vaccine) or a whole cell pertussis (wP) vaccine. Consent for participation of the child is needed by both married parents or by a single unmarried other.
  • At low risk for pregnancy related complications as determined by the investigator and a second trimester ultrasound with no significant abnormalities.

Exclusion Criteria:

Pregnant subjects

  • Multiple pregnancies
  • Serious obstetrical risk
  • Serious underlying medical condition
  • Significant mental illness
  • History of febrile illness (greater than or equal to 38°C) within the past 72 hours before injection
  • Previous severe reaction to any vaccine
  • Receipt of tetanus-diphtheria toxoid immunization within the past 1 month Receipt of an pertussis containing vaccine (Tdap) in the last 5 years
  • Receipt of a vaccine, blood product (excluding Rhogam) within the 4 weeks prior to injection through 4 weeks following injection and IVIG (Intravenous Immunoglobulins) within 12 weeks period. One month interval should be respected with another vaccine (except influenza) in orde to evaluate Adverse events following one or both vaccines (fever, local symptoms)
  • Receipt of an experimental drug during pregnancy
  • Anything in the opinion of the investigator that would prevent women from completing the study or put the woman at risk

Infants

  • Preterm delivery before 37 weeks of gestation
  • Serious underlying medical condition
  • Children suffering from primary humoral immune disorders; suffering from primary cellular immune deficiencies and disorders from the complete cascade
  • No informed consent from one or both married parents
  • Severe reactions to any vaccine
  • Anything in the opinion of the investigator that would prevent children from completing the study or put the child at risk

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408926


Contacts
Contact: Elke Leuridan, MD, PhD 032652885 ext 0032 elke.leuridan@uantwerpen.be
Contact: Yong Poovorawan, MD, PhD 2564909 ext 662 Yong.P@chula.ac.th

Locations
Thailand
Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Yong Poovorawan, MD, PhD    2564909 ext 662    Yong.P@chula.ac.th   
Principal Investigator: Yong Poovorawan, MD, PhD         
Sponsors and Collaborators
Universiteit Antwerpen
Chulalongkorn University
Institut Pasteur de Lille
Thrasher Research Fund
Investigators
Principal Investigator: Elke Leuridan, MD PhD Universiteit Antwerpen

Responsible Party: Elke Leuridan, MD, PhD, Prof., MD, PhD, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT02408926     History of Changes
Other Study ID Numbers: cev002
First Posted: April 6, 2015    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Elke Leuridan, MD, PhD, Universiteit Antwerpen:
Pertussis
Pregnancy
Humoral immune response
Functionality
Vaccination

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs