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

Pertussis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408926
• Other study ID #: cev002
• Status: Completed
• Phase: Phase 4
• Start date: April 2015
• Est. completion date: August 2018

Study information

• Verified date: October 2019
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pertussis
• Whooping Cough

Intervention

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

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Bangkok

Sponsors (4)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Chulalongkorn University, Institut Pasteur de Lille, Thrasher Research Fund

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	kinetics of Pertussis toxin (PT) IgG titers in infants	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	from birth until 19 months of age
Primary	kinetics of Filamentous haemagglutinin (FHA) IgG titers in infants	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	from birth until 19 months of age
Primary	kinetics of Pertactin (Prn) IgG titers in infants	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	from birth until 19 months of age
Secondary	Functionality of the maternal anti-PT IgG antibodies in the infants as assessed with a newly validated luminescence based assay	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	At birth
Secondary	Functionality of the anti-PT IgG antibodies in the infants after vaccination assessed with a newly validated luminescence based assay	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	At month 7 and month 19
Secondary	Efficacy of the transplacental transport of IgG as assessed by the ratio of cord and maternal titers of IgG antibodies	Efficacy as assessed by the ratio of cord and maternal titers of IgG antibodies	Birth