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

Primary Purpose

Pertussis

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Boostrix
Infanrix hexa
Quinvaxem
OPV
Sponsored by
Universiteit Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pertussis focused on measuring Pertussis, Pregnancy, Humoral immune response, Functionality, Vaccination

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
March 23, 2015
Last Updated
October 22, 2019
Sponsor
Universiteit Antwerpen
Collaborators
Chulalongkorn University, Institut Pasteur de Lille, Thrasher Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT02408926
Brief Title
Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand
Official Title
Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
Collaborators
Chulalongkorn University, Institut Pasteur de Lille, Thrasher Research Fund

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pertussis
Keywords
Pertussis, Pregnancy, Humoral immune response, Functionality, Vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
370 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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).
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Boostrix
Other Intervention Name(s)
Acellular pertussis containing vaccine
Intervention Description
Pregnant women will be vaccinated with an acellular pertussis containing vaccine between 27 and 36 weeks of gestation.
Intervention Type
Biological
Intervention Name(s)
Infanrix hexa
Other Intervention Name(s)
Acellular pertussis containing vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Quinvaxem
Other Intervention Name(s)
Whole cell pertussis containing vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
OPV
Other Intervention Name(s)
Oral Polio Vaccine
Intervention Description
Children from group B will be vaccinated with OPV vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.
Primary Outcome Measure Information:
Title
kinetics of Pertussis toxin (PT) IgG titers in infants
Description
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
Time Frame
from birth until 19 months of age
Title
kinetics of Filamentous haemagglutinin (FHA) IgG titers in infants
Description
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
Time Frame
from birth until 19 months of age
Title
kinetics of Pertactin (Prn) IgG titers in infants
Description
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
Time Frame
from birth until 19 months of age
Secondary Outcome Measure Information:
Title
Functionality of the maternal anti-PT IgG antibodies in the infants as assessed with a newly validated luminescence based assay
Description
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
Time Frame
At birth
Title
Functionality of the anti-PT IgG antibodies in the infants after vaccination assessed with a newly validated luminescence based assay
Description
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
Time Frame
At month 7 and month 19
Title
Efficacy of the transplacental transport of IgG as assessed by the ratio of cord and maternal titers of IgG antibodies
Description
Efficacy as assessed by the ratio of cord and maternal titers of IgG antibodies
Time Frame
Birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elke Leuridan, MD PhD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
35135700
Citation
Hu S, Logan N, Puenpa J, Wanlapakorn N, Vongpunsawad S, Poovorawan Y, Willett BJ, Hosie MJ. Evaluation of the effect of maternally derived antibody on response to MMR vaccine in Thai infants. Vaccine. 2022 Mar 1;40(10):1439-1447. doi: 10.1016/j.vaccine.2022.01.049. Epub 2022 Feb 5.
Results Reference
derived
PubMed Identifier
32331806
Citation
Wanlapakorn N, Puenpa J, Thongmee T, Srimuan D, Thatsanathorn T, Vongpunsawad S, Poovorawan Y. Antibodies to measles, mumps, and rubella virus in Thai children after two-dose vaccination at 9 months and 2.5 years: A longitudinal study. Vaccine. 2020 May 19;38(24):4016-4023. doi: 10.1016/j.vaccine.2020.04.013. Epub 2020 Apr 21.
Results Reference
derived
PubMed Identifier
31418814
Citation
Wanlapakorn N, Maertens K, Vongpunsawad S, Puenpa J, Tran TMP, Hens N, Van Damme P, Thiriard A, Raze D, Locht C, Poovorawan Y, Leuridan E. Quantity and Quality of Antibodies After Acellular Versus Whole-cell Pertussis Vaccines in Infants Born to Mothers Who Received Tetanus, Diphtheria, and Acellular Pertussis Vaccine During Pregnancy: A Randomized Trial. Clin Infect Dis. 2020 Jun 24;71(1):72-80. doi: 10.1093/cid/ciz778.
Results Reference
derived

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

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