Pertussis Maternal Immunization Study

NCT00553228 | Completed Phase 2 DMC

• 1 other identifier: DAL07-01
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess whether immunization against pertussis in the mid third trimester of pregnancy provides passive protection to the infant by transfer of IgG transplacentally and by transfer of secretory IgA (and possibly IgG) in breast milk, sufficient to protect the infant against pertussis disease in the critical neonatal period, without suppressing the infant's immune response to active immunization and disease

Conditions

Pregnant Women

Keywords

maternal immunization; whooping cough; pertussis

Outcome Measures

Primary Outcomes (1)

• Comparison of serum IgG antibody levels against PT, FHA, PRN, FIM between Tdap and Td groups

  birth, 2, 4, 6, 7, 12, and 13 months of age

Secondary Outcomes (1)

• Safety of Tdap in pregnancy including pregnancy outcome and developmental assessment.

  developmental screening at 1 year of age

Study Arms (2)

group I

EXPERIMENTAL

Tdap

Biological: Tdap

group 2

ACTIVE COMPARATOR

Td

Biological: Td

Interventions

Tdap BIOLOGICAL

0.5 mL IM once at visit #2

Also known as: Adacel

group I

Td BIOLOGICAL

0.5 mL IM once at visit #2

Also known as: Diphtheria and tetanus toxoids, adsorbed

group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women 18 years of age and over.
• Women who, at ≥30-\<32 weeks gestation, are at low risk for complications as determined by the obstetrical algorithm for identification of eligible subjects and the obstetrical risk assessment form.
• Signed, informed consent.

You may not qualify if:

• Failure to meet eligibility criteria as determined by the obstetrical algorithm for identification of eligible subjects and the obstetrical risk assessment form.
• History of significant medical disorder (such as bleeding disorders, cancer, autoimmune disease, immunodeficiency (including HIV-infected individuals, transplant recipients), seizure disorder or significant psychiatric illness, drug or alcohol dependence).
• Receipt of any high-dose daily corticosteroids (inhaled steroids are acceptable) within 2 weeks of study entry. High dose is defined as a dose of ≥20 mg of prednisone daily or equivalent.
• History of physician-diagnosed or laboratory-confirmed pertussis within the past 5 years.
• Personal history (verbal or documented) of ever having received Tdap.
• Personal history (verbal or documented) of having received Td immunization within the past 2 years.
• History of febrile illness (\>37.8ºC orally) within the past 72 hours (immunization may be deferred).
• History of sensitivity to any component of Tdap.
• Receipt of blood products or immunoglobulin within 3 months of study entry (except RH-negative women who receive immunoglobulin during pregnancy are eligible).
• Receipt of any vaccines within 2 weeks of study vaccine (except influenza vaccine which may be given concurrently).
• Failure to give written, informed consent.

Sponsors & Collaborators

• Scott Halperin: lead
• IWK Health Centre: collaborator
• Sanofi Pasteur, a Sanofi Company: collaborator

Study Sites (1)

Clinical Trial Research Center - Canadian Center for Vaccinology

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (2)

• Brousseau N, Angers-Goulet ME, Bastien R, Ye L, Sadarangani M, Halperin SA. Vaccination during pregnancy and modulation of IgG response to pertussis vaccines in infants: The impact of different vaccine formulations. Vaccine. 2024 Apr 2;42(9):2138-2143. doi: 10.1016/j.vaccine.2024.03.015. Epub 2024 Mar 8.

  PMID: 38461048 DERIVED

• Halperin SA, Langley JM, Ye L, MacKinnon-Cameron D, Elsherif M, Allen VM, Smith B, Halperin BA, McNeil SA, Vanderkooi OG, Dwinnell S, Wilson RD, Tapiero B, Boucher M, Le Saux N, Gruslin A, Vaudry W, Chandra S, Dobson S, Money D. A Randomized Controlled Trial of the Safety and Immunogenicity of Tetanus, Diphtheria, and Acellular Pertussis Vaccine Immunization During Pregnancy and Subsequent Infant Immune Response. Clin Infect Dis. 2018 Sep 14;67(7):1063-1071. doi: 10.1093/cid/ciy244.

  PMID: 30010773 DERIVED

Related Links

• Canadian Center for Vaccinology Home Page

MeSH Terms

Conditions

Whooping Cough

Interventions

adacel; Tetanus Toxoid

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Scott A Halperin, MD

  Dalhousie Univeristy - Canadian Center for Vaccinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Scott Halperin

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 5, 2007
• Study Start: November 1, 2007
• Primary Completion: December 9, 2015
• Study Completion: December 9, 2015
• Last Updated: August 27, 2020

Record last verified: 2020-08

Locations

CA (1)