PertussisPhase 4NCT04543669
Adacel® Booster Vaccination for CMI Assay Development
A Phase 4 study testing Adacel® in people with Pertussis, run by Dalhousie University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pertussis
- What is being tested?
- Adacel®
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jul 2017to 20 Sep 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adacel® (TdaP-Tetanus, Diphtheria, Acellular Pertussis) Booster Vaccination of Acellular Pertussis Vaccine-primed Individuals for Cell Mediated Immunity Assay Development
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.
Read the detailed description
Pertussis, known as "whooping cough", is caused by the bacterium Bordetella pertussis which was discovered over a century ago. Human vaccines were developed in the subsequent two decades and routine childhood immunization has been practiced for over 60 years. Yet, B. pertussis remains a significant cause of morbidity in children and adults worldwide. Globally, about 20-40 million cases of pertussis are reported each year, with about 400,000 cases being fatal. The incidence of pertussis is highest and the severity the greatest in children under 6 months of age. Vaccination and natural infection are not protective for life, and the reason is unclear. The epidemiologic features of B. pertussis infections in older individuals who are only partially immune from prior infections and immunizations are not well understood. Clarification is important, in light of studies that suggest that pertussis is a cause of prolonged cough illness in adults who serve as the reservoir of B. pertussis and are the major source of infection for infants in whom the disease has substantial morbidity and mortality. With the considerable increase in cases and outbreaks, there is an imminent need for improved immunogenic and efficacious pertussis vaccines, paired with the best tools to evaluate vaccines and vaccine programs.
VaxDesign has proposed two studies for acellular vaccine primed (acP) versus whole cell vaccine primed (wcP) donors, to further develop and validate a number of practical assays for use as biomarkers and to define a baseline readout for pertussis vaccinations from these two cohorts. In addition, these assays will be optimized to use the small blood volumes that are routinely available from clinical studies. In contrast to measuring humoral immune responses, the cell mediated immune response (CMI) is a substantially more challenging parameter to assess and thus the sample volumes required for the study must be large enough to allow the multiple different assessments. In this study, samples will be taken to evaluate transcriptomics, and humoral and cellular immunity over a one month period following vaccination. The collaboration with the Canadian Center for Vaccinology (CCfV) offers a unique opportunity of easily accessing acellular vaccine primed individuals.
- Conditions
- Pertussis
- Being tested
- Adacel®
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adacel®Biological
Vaccine for TdaP-Tetanus, diphtheria, acellular pertussis
| Study group | Role | What they receive |
|---|---|---|
| Adacel® | Experimental | All participants will receive one booster dose of commercially available Adacel® (TdaP-Tetanus, diphtheria, acellular pertussis) vaccine Receives: Biological: Adacel® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine best assay to evaluate CMI responses post-vaccination: CD4 T-cell proliferation
% CD4+CTV-T cells analyzed by flow cytometry
Measured: 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
Measured: Days -14 to 28
Determine optimal time point for sample collection: CD4 T-cell responses
% CD4+CTV-cytokine+T cells analyzed by flow cytometry
Measured: Days -14 to 28
Determine optimal time point for sample collection: CD8 T-cell responses
% CD8+ CTV-cytokine+T cells analyzed by flow cytometry
Measured: Days -14 to 28
Secondary outcomes (2)
Transcriptomic profiling of host - B. pertussis antigen interactions: B-cell plasmablasts
ASC per 106 PBMCs (ELISpot)
Measured: Days -7, 7, 14, and 28
Transcriptomic profiling of host - B. pertussis antigen interactions: B-cell plasmablasts
% CD19+ CD38+ CD27+ cells
Measured: Days -7, 7, 14, and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start12 Jul 2017
- Primary completion20 Sep 2017
- Study completion20 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company, VaxDesign Corporation
- Responsible party
- Principal investigator, Scott Halperin, Dalhousie University
- Investigators
- Scott A Halperin, MD, Principal investigator, Dalhousie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543669
- Sponsor's protocol ID
- SP1601
- Status last verified
- Sep 2020
- First submitted
- 26 Apr 2017
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adacel® (TdaP-Tetanus, Diphtheria, Acellular Pertussis) Booster Vaccination of Acellular Pertussis Vaccine-primed Individuals for Cell Mediated Immunity Assay Development
- ClinicalTrials.gov ID
- NCT04543669
- Acronym / sponsor ID
- SP1601
- Conditions
- Pertussis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company, VaxDesign Corporation
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pertussis, known as "whooping cough", is caused by the bacterium Bordetella pertussis which was discovered over a century ago. Human vaccines were developed in the subsequent two decades and routine childhood immunization has been practiced for over 60 years. Yet, B. pertussis remains a significant cause of morbidity in children and adults worldwide. Globally, about 20-40 million cases of pertussis are reported each year, with about 400,000 cases being fatal. The incidence of pertussis is highest and the severity the greatest in children under 6 months of age. Vaccination and natural infection are not protective for life, and the reason is unclear. The epidemiologic features of B. pertussis infections in older individuals who are only partially immune from prior infections and immunizations are not well understood. Clarification is important, in light of studies that suggest that pertussis is a cause of prolonged cough illness in adults who serve as the reservoir of B. pertussis and are the major source of infection for infants in whom the disease has substantial morbidity and mortality. With the considerable increase in cases and outbreaks, there is an imminent need for improved immunogenic and efficacious pertussis vaccines, paired with the best tools to evaluate vaccines and vaccine programs.
VaxDesign has proposed two studies for acellular vaccine primed (acP) versus whole cell vaccine primed (wcP) donors, to further develop and validate a number of practical assays for use as biomarkers and to define a baseline readout for pertussis vaccinations from these two cohorts. In addition, these assays will be optimized to use the small blood volumes that are routinely available from clinical studies. In contrast to measuring humoral immune responses, the cell mediated immune response (CMI) is a substantially more challenging parameter to assess and thus the sample volumes required for the study must be large enough to allow the multiple different assessments. In this study, samples will be taken to evaluate transcriptomics, and humoral and cellular immunity over a one month period following vaccination. The collaboration with the Canadian Center for Vaccinology (CCfV) offers a unique opportunity of easily accessing acellular vaccine primed individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adacel® | Experimental | Biological: Adacel®All participants will receive one booster dose of commercially available Adacel® (TdaP-Tetanus, diphtheria, acellular pertussis) vaccine |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adacel®Vaccine for TdaP-Tetanus, diphtheria, acellular pertussis | Biological | Adacel® |
Primary outcome
Determine best assay to evaluate CMI responses post-vaccination: CD4 T-cell proliferation
Time frame: Days -14 to 28
% CD4+CTV-T cells analyzed by flow cytometry
Determine best assay to evaluate CMI responses post-vaccination: CD8 T-cell proliferation
Time frame: Days -14 to 28
% CD8+ CTV-T cells analyzed by flow cytometry
Determine optimal time point for sample collection: CD4 T-cell responses
Time frame: Days -14 to 28
% CD4+CTV-cytokine+T cells analyzed by flow cytometry
Determine optimal time point for sample collection: CD8 T-cell responses
Time frame: Days -14 to 28
% CD8+ CTV-cytokine+T cells analyzed by flow cytometry
2 secondary outcomes
Transcriptomic profiling of host - B. pertussis antigen interactions: B-cell plasmablasts
Time frame: Days -7, 7, 14, and 28
Transcriptomic profiling of host - B. pertussis antigen interactions: B-cell plasmablasts
Time frame: Days -7, 7, 14, and 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Pertussis
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott A Halperin, MD principal investigator
Dalhousie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adacel® in people with Pertussis, run by Dalhousie University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine best assay to evaluate CMI responses post-vaccination: CD4 T-cell proliferation (time frame: Days -14 to 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020; AzTrials last refreshed its copy on 1 Nov 2026.