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OpenTrials
Completed

NCT Number: NCT02408926

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

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.

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Key information

Conditions

Pertussis Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Gram-Negative Bacterial Infections Infections Respiratory Tract Diseases Respiratory Tract Infections Whooping Cough

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Chulalongkorn University

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Boostrix

Biological

Pregnant women will be vaccinated with an acellular pertussis containing vaccine between 27 and 36 weeks of gestation.

Other names: Acellular pertussis containing vaccine

Infanrix hexa

Biological

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 names: Acellular pertussis containing vaccine

Quinvaxem

Biological

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 names: Whole cell pertussis containing vaccine

OPV

Biological

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 names: Oral Polio Vaccine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • Chulalongkorn University
  • Institut Pasteur de Lille
  • Thrasher Research Fund

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2015
Registry last updated
Oct 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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