Smokers, Elderly, Asthma, COPD, Recurrent InfectionsNCT02726347
Pneumococcal Post-Vaccination Titers
A study testing PPV-23 in people with Smokers, Elderly, Asthma, COPD, Recurrent Infections, run by National Jewish Health at 1 site in United States.
Trial summary
The study is looking at the pneumonia vaccine and the immune system response to this vaccine. The information gathered from this study may be important for your doctor to take care of patients with smoking histories, immune deficiency, asthma, Chronic Obstructive Pulmonary Disease (COPD), or elderly patients. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Smokers, Elderly, Asthma, COPD, Recurrent Infections
- What is being tested?
- PPV-23
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Apr 2018
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent will be administered to individuals from 5 cohorts each with 28 subjects for a total of 140 subjects. The cohorts will be:
- smokers between the ages of 19-80.
- elderly individuals, defined as subjects age 50 years or older, without a history of frequent infections, COPD or asthma.
- COPD subjects between the age of 19 and 80, without a history of recurrent bacterial infections.
- Asthmatics between the ages of 19 and 80, without a history of recurrent bacterial infections.
- individuals between the age of 19 and 80 who have a history of frequent bacterial infections and are being evaluated for humoral immunodeficiency.
Who cannot join
- The following groups will be excluded:
- Subjects who are currently receiving or have ever received immunoglobulin replacement therapy.
- subjects who are on immune suppressive agents.
- Subjects who are on chronic steroids or have received an intramuscular injection of steroids in the three months prior to enrollment or oral/intravenous steroids within a month of enrollment or two or more prednisone bursts in the past year.
- subjects on antiepileptic agents.
- Subjects who have received the pneumococcal polysaccharide vaccine, PPV-23 6) Pregnant women
Trial locations and contacts
1 site in 1 country.
Flavia Hoyte, MD contact
United States1 site, 1 recruiting
- Recruiting
National Jewish Health
Denver, Colorado, 80206
NJH CTRC Program Administrator, 303-398-1409
About this study
The study is looking at the pneumonia vaccine and the immune system response to this vaccine. The information gathered from this study may be important for your doctor to take care of patients with smoking histories, immune deficiency, asthma, Chronic Obstructive Pulmonary Disease (COPD), or elderly patients. It is important that your immune system builds a strong defense to the vaccine so that you are better able to fight a bacterium that can cause pneumonia. Some disease prevent the immune system from building a strong defense and these patients will not benefit from the vaccine.
Read the detailed description
One hundred forty subjects will have pre-vaccination titers checked for the 23 serotypes in the PPV-23 vaccine. They will then receive the vaccine. All subjects will be given the vaccination as standard of care. Approximately 4 weeks following immunization, the subjects will have post-vaccination titers checked to the same serotypes checked prior to vaccination.
- Being tested
- PPV-23
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Reinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPV-23Biological
Also called polysaccharide pneumococcal vaccine
one hundred forty subjects will have pre-vaccination titers checked. All will be given vaccination as standard of care. Approximately 4 weeks later subjects will have post-vaccination titers checked for the same serotypes.
| Study group | Role | What they receive |
|---|---|---|
| Smokers between the ages of 19-80 | Active comparator | current smokers between the ages of 19 and 80 Receives: Biological: PPV-23 |
| elderly individuals (over age 50) | Active comparator | elderly individuals, defined as subjects age 50 years or older, without a history of frequent infections, COPD, or asthma Receives: Biological: PPV-23 |
| COPD subjects | Active comparator | COPD subjects between the age of 19 and 80, without history of recurrent bacterial infections. Receives: Biological: PPV-23 |
| Asthmatics subjects | Active comparator | Asthmatics between the ages of 19 and 80 Receives: Biological: PPV-23 |
| Subjects with recurrent bacterial infections | Active comparator | Individuals between the age of 19 and 80 who have a history of frequent bacterial infections and are being evaluated for humoral immunodeficiency Receives: Biological: PPV-23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from pre-to post-vaccination antibody titer
Evaluate the immune response in the 5 groups of subjects
Measured: day one- day of vaccine and one month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smokers, Elderly, Asthma, COPD, Recurrent InfectionsStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavia Hoyte, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726347
- Sponsor's protocol ID
- HS-2953
- Status last verified
- Sep 2017
- First submitted
- 29 Mar 2016
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumococcal Post-Vaccination Titers
- ClinicalTrials.gov ID
- NCT02726347
- Acronym / sponsor ID
- HS-2953
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 1 Apr 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.
The study is looking at the pneumonia vaccine and the immune system response to this vaccine. The information gathered from this study may be important for your doctor to take care of patients with smoking histories, immune deficiency, asthma, Chronic Obstructive Pulmonary Disease (COPD), or elderly patients. It is important that your immune system builds a strong defense to the vaccine so that you are better able to fight a bacterium that can cause pneumonia. Some disease prevent the immune system from building a strong defense and these patients will not benefit from the vaccine.
Detailed description
One hundred forty subjects will have pre-vaccination titers checked for the 23 serotypes in the PPV-23 vaccine. They will then receive the vaccine. All subjects will be given the vaccination as standard of care. Approximately 4 weeks following immunization, the subjects will have post-vaccination titers checked to the same serotypes checked prior to vaccination.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Smokers between the ages of 19-80 | Active comparator | Biological: PPV-23current smokers between the ages of 19 and 80 |
| elderly individuals (over age 50) | Active comparator | Biological: PPV-23elderly individuals, defined as subjects age 50 years or older, without a history of frequent infections, COPD, or asthma |
| COPD subjects | Active comparator | Biological: PPV-23COPD subjects between the age of 19 and 80, without history of recurrent bacterial infections. |
| Asthmatics subjects | Active comparator | Biological: PPV-23Asthmatics between the ages of 19 and 80 |
| Subjects with recurrent bacterial infections | Active comparator | Biological: PPV-23Individuals between the age of 19 and 80 who have a history of frequent bacterial infections and are being evaluated for humoral immunodeficiency |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent will be administered to individuals from 5 cohorts each with 28 subjects for a total of 140 subjects. The cohorts will be:
- smokers between the ages of 19-80.
- elderly individuals, defined as subjects age 50 years or older, without a history of frequent infections, COPD or asthma.
- COPD subjects between the age of 19 and 80, without a history of recurrent bacterial infections.
- Asthmatics between the ages of 19 and 80, without a history of recurrent bacterial infections.
Key exclusion criteria (6 listed)
- Subjects who are currently receiving or have ever received immunoglobulin replacement therapy.
- subjects who are on immune suppressive agents.
- Subjects who are on chronic steroids or have received an intramuscular injection of steroids in the three months prior to enrollment or oral/intravenous steroids within a month of enrollment or two or more prednisone bursts in the past year.
- subjects on antiepileptic agents.
- Subjects who have received the pneumococcal polysaccharide vaccine, PPV-23 6) Pregnant women
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 |
|---|---|---|
| PPV-23Also: polysaccharide pneumococcal vaccineone hundred forty subjects will have pre-vaccination titers checked. All will be given vaccination as standard of care. Approximately 4 weeks later subjects will have post-vaccination titers checked for the same serotypes. | Biological | Asthmatics subjects, COPD subjects, Smokers between the ages of 19-80, Subjects with recurrent bacterial infections, elderly individuals (over age 50) |
Primary outcome
Change from pre-to post-vaccination antibody titer
Time frame: day one- day of vaccine and one month later
Evaluate the immune response in the 5 groups of subjects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
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.
Flavia Hoyte, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPV-23 in people with Smokers, Elderly, Asthma, COPD, Recurrent Infections, run by National Jewish Health 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 6 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: status not confirmed, as of the sponsor's last update on 14 Sep 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flavia Hoyte, MD (hoytef@njhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from pre-to post-vaccination antibody titer (time frame: day one- day of vaccine and one month later). 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 14 Sep 2017; AzTrials last refreshed its copy on 28 Oct 2026.