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Pertussis Maternal Immunization Study

Primary Purpose

Pregnant Women

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Tdap

About this trial

This is an interventional prevention trial for Pregnant Women focused on measuring maternal immunization, whooping cough, pertussis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Clinical Trial Research Center - Canadian Center for Vaccinology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group I

group 2

Arm Description

Tdap

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00553228

First Posted

November 2, 2007

Last Updated

August 25, 2020

Sponsor

Scott Halperin

Collaborators

IWK Health Centre, Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00553228

Brief Title

Pertussis Maternal Immunization Study

Official Title

Immunization of Women With Diphtheria and Tetanus Toxoids Combined With Acellular Pertussis (Tdap) During the Mid Third Trimester of Pregnancy: An Evaluation of the Potential for Immunological Protection for the Neonate

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

December 9, 2015 (Actual)

Study Completion Date

December 9, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Scott Halperin

Collaborators

IWK Health Centre, Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

The purpose of this study is to assess the potential of providing initial immunological protection to the neonate by providing passive placentally transferred serum antibodies and breast milk antibodies against pertussis antigens (PT, FHA, PRN, FIM). This will be accomplished by determining the rate of maternal antibody decline from time of immunization until 12 months postpartum by measuring antibody levels in serum, saliva, and breast milk at specified intervals; determining levels of antibody transferred to the neonate relative to the interval from immunization to delivery; comparing levels of transplacentally transferred antibody with those achieved after the first, second, and third dose of the primary immunization series; and determining whether maternal immunization interferes with active antibody production following licensed DTaP-IPV-Hib in infants of women immunized during the mid third trimester of pregnancy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnant Women

Keywords

maternal immunization, whooping cough, pertussis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

320 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group I

Arm Type

Experimental

Arm Description

Tdap

Arm Title

group 2

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Tdap

Other Intervention Name(s)

Adacel

Intervention Description

0.5 mL IM once at visit #2

Intervention Type

Biological

Intervention Name(s)

Other Intervention Name(s)

Diphtheria and tetanus toxoids, adsorbed

Intervention Description

0.5 mL IM once at visit #2

Primary Outcome Measure Information:

Title

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Time Frame

developmental screening at 1 year of age

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott A Halperin, MD

Organizational Affiliation

Dalhousie Univeristy - Canadian Center for Vaccinology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Trial Research Center - Canadian Center for Vaccinology

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3K 6R8

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

30010773

Citation

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.

Results Reference

derived

Links:

URL

http://centerforvaccinology.ca

Description

Canadian Center for Vaccinology Home Page

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Pertussis Maternal Immunization Study

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