Pertussis (Tdap) Vaccination in Pregnancy

October 22, 2019 updated by: Elke Leuridan, MD, PhD, Universiteit Antwerpen

Impact of Pertussis Vaccination in Pregnancy on Maternal Protection Offered to Young Infants

Despite good vaccination coverage, included in national immunization programs in developed countries, the number of reported pertussis cases is rising, also in very young infants. Current immunization strategies fail to protect infants too young to be immunized with the licensed vaccine. Different strategies are possible to close the gap of susceptibility between the loss of maternal antibodies and protection by vaccination. The main aim of the present study is to measure the influence of an adult pertussis booster in pregnant women, on the titer and duration of maternal antibodies in their infants. Early humoral immunity will be assessed and the influence on vaccine response of the infant measured. The present study offers the opportunity to have new insights in neonatal immunological mechanisms against pertussis and a better understanding in strategies to protect infants against pertussis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2610
        • Centre for the Evaluation of Vaccination
  • Vietnam
      • Hanoi, Vietnam, 10000
        • National Institute of Hygien and Epidemiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged 18-35 years
  • Willing to be immunized during pregnancy OR
  • Received already a pertussis vaccination during pregnancy, as advised by gynaecologist or general practitioner.
  • Age matched controls will be identified in the same time period in the recruiting hospital.
  • Availability for follow-up visits and phone call access through 16 months following delivery
  • Willing to have infant immunized with hexavalent vaccine at 8.12 and 16 weeks and 15 months of age (= normal Belgian schedule) with pediatrician, the general practitioner or at the Centre for the Evaluation of Vaccination.
  • In the 18th-32nd week of a pregnancy at low risk for complications as determined by the obstetrician

Exclusion Criteria:Women:

  • Serious underlying medical condition
  • History of a febrile illness (>= 38° Celsius) 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 tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine absorbed (Tdap) immunization in the last 10 years
  • Receipt of a vaccine, blood product (excluding Rhogam) or experimental medicine within the 4 weeks prior to injection through 4 weeks following injection
  • Receipt of or plans to receive influenza vaccine within the 4weeks prior to or following injection. One month interval should be respected in order to evaluate eventual Adverse events following one of both vaccines (fever, local symptoms).
  • High risk for serious obstetrical complication
  • Anything in the opinion of the investigator that would put the participant at risk.

Exclusion criteria for the offspring:

  • Serious underlying medical condition
  • No signed informed consent by both parents
  • Severe reactions to any vaccine
  • Anything in the opinion of the investigator that would put the participant at risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
50 unvaccinated pregnant women
Active Comparator: Pertussis vaccine (Boostrix®, GSK Biologicals, Rixensart)
50 pregnant women vaccinated with pertussis vaccine
Biological: Pertussis vaccine
Vaccination during pregnancy with a pertussis containing vaccine
Other Names:
  • Boostrix®, GSK Biologicals, Rixensart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Does vaccination of pregnant women with a combined vaccine Tetanus, diphtheria and acellular pertussis (Tdap), induce sufficiently high maternal antibody concentration in the newborns infants to possibly protect them until their own vaccination starts
Time Frame: 16 months

  1. What are the concentrations of IgG against Pertussis Toxin (anti-PT), Filamentous Haemagglutinin (anti-FHA), Fimbriae (anti-Fim) and pertactin (anti-PRN):

    1. in women during pregnancy and at delivery after vaccination with TdaP
    2. in children at birth (cord), before starting vaccination (week 8), one month after primary course of three doses (week 20) and before and after the fourth pertussis vaccine dose (at month 15 and 16)
  2. What are the concentrations of anti-tetanus and anti-diphtheria IgG antibodies at all mentioned time points, to evaluate interference when administering several antigens and to evaluate the influence of maternal antibodies on vaccine response to tetanus and diphtheria in infants
16 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine associated (Severe) Adverse Events ((S)AE) in pregnant women and children during the study time
Time Frame: 16 months
Vaccine associated (Severe) Adverse Events ((S)AE) in pregnant women and children during the study time
16 months
Infant growth measurement at all time points
Time Frame: 16 months
Infant growth measurement at all time points
16 months
Assessment of pneumococcal immune response in infants whose mothers received Tdap vaccination during pregnancy
Time Frame: 12 months
The present trial on pertussis vaccination during pregnancy, offers the opportunity to add evidence for a possible blunting effect of infant immune responses to pneumococcal infant vaccination after maternal Tdap vaccination. Pneumococcal antibodies will be measured in serum samples taken from infants after a primary series of 2 pneumococcal vaccine doses (2 and 4 months of age) and after a third vaccine dose (at 12 months of age). Infants are born from either vaccinated or unvaccinated mothers.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiteit Antwerpen

Collaborators

National Institute of Hygiene and Epidemiology, Vietnam

Investigators

  • Principal Investigator: Elke Leuridan, MD, PhD, Universiteit Antwerpen
  • Principal Investigator: Thu Ha Thi Hoang, MD PhD, National Institute for Hygiene and Epidemiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 21, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (Estimate)

October 3, 2012

Study Record Updates

Last Update Posted (Actual)

October 24, 2019

Last Update Submitted That Met QC Criteria

October 22, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cev001
  • 2011-001936-45 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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