Adacel® Booster Vaccination for CMI Assay Development

NCT04543669 | Completed Phase 4

• 1 other identifier: SP1601
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Recruitment of individuals primed during childhood with TdaP (tetanus, diphtheria , acellular pertussis) vaccine, and administration of an Adacel booster with blood sample collection at various time points before and after vaccination. Collection of blood sample volumes will be large enough to allow assessment and comparison of multiple assays that evaluate cell-mediated immune (CMI) responses and other biomarkers following the administration of pertussis vaccinations. The ultimate objective would be to utilize these validated assays for evaluation of pertussis clinical trial results or development of new pertussis vaccine formulations.

Conditions

Pertussis

Outcome Measures

Primary Outcomes (4)

• Determine best assay to evaluate CMI responses post-vaccination: CD4 T-cell proliferation

  % CD4+CTV-T cells analyzed by flow cytometry

  Days -14 to 28

• Determine best assay to evaluate CMI responses post-vaccination: CD8 T-cell proliferation

  % CD8+ CTV-T cells analyzed by flow cytometry

  Days -14 to 28

• Determine optimal time point for sample collection: CD4 T-cell responses

  % CD4+CTV-cytokine+T cells analyzed by flow cytometry

  Days -14 to 28

• Determine optimal time point for sample collection: CD8 T-cell responses

  % CD8+ CTV-cytokine+T cells analyzed by flow cytometry

  Days -14 to 28

Secondary Outcomes (2)

• Transcriptomic profiling of host - B. pertussis antigen interactions: B-cell plasmablasts

  Days -7, 7, 14, and 28

• Transcriptomic profiling of host - B. pertussis antigen interactions: B-cell plasmablasts

  Days -7, 7, 14, and 28

Study Arms (1)

Adacel®

EXPERIMENTAL

All participants will receive one booster dose of commercially available Adacel® (TdaP-Tetanus, diphtheria, acellular pertussis) vaccine

Biological: Adacel®

Interventions

Adacel® BIOLOGICAL

Vaccine for TdaP-Tetanus, diphtheria, acellular pertussis

Adacel®

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥16years
• Primed during infancy with an acellular pertussis vaccine
• Good general health status, as determined by history no greater than 30 days prior to administration of the first test article
• Written informed consent provided
• If female of child-bearing potential, has a negative pregnancy test on the day of consent and has agreed to continue adequate contraception until after the last blood draw.

You may not qualify if:

• Not primed in infancy with an acellular pertussis vaccine
• History of anemia
• Underlying chronic medical condition requiring ongoing monitoring by a physician (e.g., diabetes, seizure disorder)
• Underlying cardiac and/or pulmonary disease including hypertension, angina, prior myocardial infection, asthma, emphysema, chronic bronchitis, and pulmonary tuberculosis
• Pregnant (known before or established at the time of screening using a urine-based test)
• Immunocompromised (reporting HIV/AIDS positive or receiving immunosuppressive therapy involving steroids)
• Vaccinated against pertussis within previous 5 years
• Refusing to get an Adacel® (TdaP) vaccination dose

Sponsors & Collaborators

• Dalhousie University: lead
• Sanofi Pasteur, a Sanofi Company: collaborator
• VaxDesign Corporation: collaborator

Study Sites (1)

Canadian Center for Vaccinology

Halifax, Nova Scotia, B3K 6R8, Canada

Location

MeSH Terms

Conditions

Whooping Cough

Interventions

adacel

Condition Hierarchy (Ancestors)

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

Study Officials

• Scott A Halperin, MD

  Dalhousie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Canadian Centre for Vaccinology

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: September 10, 2020
• Study Start: July 12, 2017
• Primary Completion: September 20, 2017
• Study Completion: September 20, 2017
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)