Pertussis (Tdap) Vaccination in Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Universiteit Antwerpen
Sponsor:
Collaborator:
Belgian Scientific Institute for Public Health
Information provided by (Responsible Party):
Elke Leuridan, MD, PhD, Universiteit Antwerpen
ClinicalTrials.gov Identifier:
NCT01698346
First received: September 21, 2012
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Pertussis
Pregnancy
Biological: Pertussis containing vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Pertussis Vaccination in Pregnancy on Maternal Protection Offered to Young Infants

Resource links provided by NLM:


Further study details as provided by Universiteit Antwerpen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Vaccine associated (Severe) Adverse Events ((S)AE) in pregnant women and children during the study time [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
    Vaccine associated (Severe) Adverse Events ((S)AE) in pregnant women and children during the study time

  • Infant growth measurement at all time points [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
    Infant growth measurement at all time points


Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
The control group will exist in 50 pregnant women receiving no booster vaccination during pregnancy.
Active Comparator: Pertussis vaccine (Boostrix®, GSK Biologicals, Rixensart)
The target population is 50 pregnant women, who will be offered a combined pertussis containing vaccine (Boostrix®, GSK Biologicals, Rixensart) during the second/earlt third trimester of pregnancy (18-32 weeks).
Biological: Pertussis containing vaccine
Other Name: Boostrix®, GSK Biologicals, Rixensart

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698346

Contacts
Contact: Elke Leuridan, MD, PhD 0032 3 2652885 elke.leuridan@ua.ac.be
Contact: Pierre Van Damme, MD, PhD 0032 3 265 pierre.vandamme@ua.ac.be

Locations
Belgium
Centre for the Evaluation of Vaccination Recruiting
Antwerp, Belgium, 2610
Principal Investigator: Elke Leuridan, MD, PhD         
Sponsors and Collaborators
Universiteit Antwerpen
Belgian Scientific Institute for Public Health
Investigators
Principal Investigator: Elke Leuridan, MD, PhD Universiteit Antwerpen
  More Information

No publications provided

Responsible Party: Elke Leuridan, MD, PhD, MD, PhD, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT01698346     History of Changes
Other Study ID Numbers: cev001, 2011-001936-45
Study First Received: September 21, 2012
Last Updated: September 28, 2012
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Universiteit Antwerpen:
Pertussis
Infants
Vaccination
Pregnancy

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014