AsthmaPhase 1NCT02719379
Immune Response to Pneumococcal Polysaccharide Vaccine (23-valent) Predicts Asthma Status and Outcomes in Late Adolescents With Asthma
A Phase 1 study testing Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23) in people with Asthma, run by Rohit Divekar at 1 site in United States.
Trial summary
Advisory Committee for Immunization Practices (ACIP) from the Centers for Disease Control (CDC) recommends that children (6-18 years) and adults (≥19 years old) with chronic lung condition such as asthma or cigarette smoking be vaccinated with Pneumococcal vaccine (PPSV23). Read more about this study
- Who is it for?
- Ages 19 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jun 2017
- Phase
- Phase 1
- 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 19 to 20 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Reside in Olmsted County, Minnesota (defined by Olmsted County address in medical record within one year prior to last follow-up date as of data abstraction)
- Receive medical care from Mayo Clinic clinical practice
- Signed research authorization for using medical record for research
Who cannot join
- Diagnosis of an immunodeficiency (primary and secondary)
- Previous or current diagnosis of a Rheumatological disorders (Rheumatoid arthritis, Lupus, Sjögren, and vasculitis), cancer (chronic lymphocytic leukemia, non-Hodgkin lymphoma, and B-cell malignancy), diabetes, active infection (pneumonia, otitis media, HIV, and EBV), other chronic diseases (multiple sclerosis, etc), renal disease such nephritic syndrome, and protein losing enteropathy
- Current or previous use (within the last 6 months) of systemic corticosteroids, and other immunosuppressive agents (cyclosporin, methotrexate, and mycophenolic acid)
- Vaccination of PPSV-23 (receiving childhood pneumococcal vaccination during infancy is eligible for this study)
- Pregnancy
- Enrollment will be delayed 2 weeks for those subjects that can be included but have upper respiratory infection or viral illness to allow for natural resolution.
Trial locations and contacts
1 site in 1 country.
About this study
Advisory Committee for Immunization Practices (ACIP) from the Centers for Disease Control (CDC) recommends that children (6-18 years) and adults (≥19 years old) with chronic lung condition such as asthma or cigarette smoking be vaccinated with Pneumococcal vaccine (PPSV23). The purpose of this study is to increase awareness of vaccination to late adolescents with asthma and smokers (social aspect of study), and to recommend vaccination (which is the clinical aspect). Individuals who agree to receiving vaccine will be enrolled in research to determine whether late adolescents with and without asthma (smokers) have distinctive pneumococcal vaccine response patterns and whether such patterns are associated with subsequent variance in asthma outcomes.
- Conditions
- Asthma
- Being tested
- Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)Biological
Also called Pneumovax
| Study group | Role | What they receive |
|---|---|---|
| Asthmatics | Experimental | 19-20 year old asthmatics who agree to participate in study will have serum collected for analysis. PPSV23 vaccine [Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)] will be offered per the ACIP/CDC guidelines. Those who agree to receive the vaccine will have a second draw for serum 4-6 weeks post vaccination for immunization response. They will also be follow up after 1 year to assess for asthma control and outcomes. This arm will additionally allow for comparison of asthma outcomes and vaccine response Receives: Biological: Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23) |
| Non-asthmatics | Active comparator | 19-20 year old non-asthmatic smokers who agree to participate in study will have serum collected for analysis. PPSV23 vaccine [Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)] will be offered per the ACIP/CDC guidelines. Those who agree to receive the vaccine will have a second draw for serum 4-6 weeks post vaccination for immunization response. This arm will allow for comparison of vaccine response between asthmatics and non-asthmatics (smokers) Receives: Biological: Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23) |
| Asthmatics - Serum Stored | Other | Once the accrual for the experimental arm is met, 19-20 year old asthmatics who wish to participate in study will have serum collected for analysis. PPSV23 vaccine [Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)] will be offered per the ACIP/CDC guidelines. This arm will allow for study of baseline vaccine titers to pneumococcus in asthmatics at same time increase the vaccine uptake in the community. Receives: Biological: Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in asthma Control Status
Change in asthma control status will be assessed at end of 1 year follow up. Included would be Asthma Control Test (ACT) Score
Measured: approximately 1 year
Secondary outcomes (1)
Comparison of PPSV23 vaccine serotype specific antibody response between asthmatic and non-asthmatic smokers
Vaccine response in form of serotype titers to pneumococcal antigens will be measured 4-6 weeks after vaccination and post vaccine titers will be compared with pre-vaccine titers between asthmatics and non-asthmatics (smokers)
Measured: Vaccine response will be measured at 4 to 6 weeks after administration of vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rohit Divekar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rohit Divekar, Mayo Clinic
- Investigators
- Rohit Divekar, MBBS, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719379
- Sponsor's protocol ID
- 15-005581
- Status last verified
- Oct 2017
- First submitted
- 14 Mar 2016
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response to Pneumococcal Polysaccharide Vaccine (23-valent) Predicts Asthma Status and Outcomes in Late Adolescents With Asthma
- ClinicalTrials.gov ID
- NCT02719379
- Acronym / sponsor ID
- 15-005581
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rohit DivekarUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 25 Mar 2016 (estimated)
- 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.
Advisory Committee for Immunization Practices (ACIP) from the Centers for Disease Control (CDC) recommends that children (6-18 years) and adults (≥19 years old) with chronic lung condition such as asthma or cigarette smoking be vaccinated with Pneumococcal vaccine (PPSV23). The purpose of this study is to increase awareness of vaccination to late adolescents with asthma and smokers (social aspect of study), and to recommend vaccination (which is the clinical aspect). Individuals who agree to receiving vaccine will be enrolled in research to determine whether late adolescents with and without asthma (smokers) have distinctive pneumococcal vaccine response patterns and whether such patterns are associated with subsequent variance in asthma outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asthmatics | Experimental | Biological: Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)19-20 year old asthmatics who agree to participate in study will have serum collected for analysis. PPSV23 vaccine [Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)] will be offered per the ACIP/CDC guidelines. Those who agree to receive the vaccine will have a second draw for serum 4-6 weeks post vaccination for immunization response. They will also be follow up after 1 year to assess for asthma control and outcomes. This arm will additionally allow for comparison of asthma outcomes and vaccine response |
| Non-asthmatics | Active comparator | Biological: Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)19-20 year old non-asthmatic smokers who agree to participate in study will have serum collected for analysis. PPSV23 vaccine [Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)] will be offered per the ACIP/CDC guidelines. Those who agree to receive the vaccine will have a second draw for serum 4-6 weeks post vaccination for immunization response. This arm will allow for comparison of vaccine response between asthmatics and non-asthmatics (smokers) |
| Asthmatics - Serum Stored | Other | Biological: Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)Once the accrual for the experimental arm is met, 19-20 year old asthmatics who wish to participate in study will have serum collected for analysis. PPSV23 vaccine [Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)] will be offered per the ACIP/CDC guidelines. This arm will allow for study of baseline vaccine titers to pneumococcus in asthmatics at same time increase the vaccine uptake in the community. |
Who may qualify
- Ages
- 19 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Reside in Olmsted County, Minnesota (defined by Olmsted County address in medical record within one year prior to last follow-up date as of data abstraction)
- Receive medical care from Mayo Clinic clinical practice
- Signed research authorization for using medical record for research
Key exclusion criteria (6 listed)
- Diagnosis of an immunodeficiency (primary and secondary)
- Previous or current diagnosis of a Rheumatological disorders (Rheumatoid arthritis, Lupus, Sjögren, and vasculitis), cancer (chronic lymphocytic leukemia, non-Hodgkin lymphoma, and B-cell malignancy), diabetes, active infection (pneumonia, otitis media, HIV, and EBV), other chronic diseases (multiple sclerosis, etc), renal disease such nephritic syndrome, and protein losing enteropathy
- Current or previous use (within the last 6 months) of systemic corticosteroids, and other immunosuppressive agents (cyclosporin, methotrexate, and mycophenolic acid)
- Vaccination of PPSV-23 (receiving childhood pneumococcal vaccination during infancy is eligible for this study)
- Pregnancy
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 |
|---|---|---|
| Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)Also: Pneumovax | Biological | Asthmatics, Asthmatics - Serum Stored, Non-asthmatics |
Primary outcome
Change in asthma Control Status
Time frame: approximately 1 year
Change in asthma control status will be assessed at end of 1 year follow up. Included would be Asthma Control Test (ACT) Score
1 secondary outcome
Comparison of PPSV23 vaccine serotype specific antibody response between asthmatic and non-asthmatic smokers
Time frame: Vaccine response will be measured at 4 to 6 weeks after administration of vaccine
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 11 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Rohit Divekar, MBBS, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23) in people with Asthma, run by Rohit Divekar at 1 site in United States.
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 3 inclusion and 6 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 11 Oct 2017. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in asthma Control Status (time frame: approximately 1 year). 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 11 Oct 2017.