Pneumococcal InfectionEarly Phase 1NCT02558751
Pneumonia Vaccine in Aging HIV Positive Individuals
A Early Phase 1 study testing 23-valent pneumococcal polysaccharide vaccine and 13-valent pneumococcal conjugate vaccine in people with Pneumococcal Infection, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
The investigators hypothesized that vaccination with either the 23-valent pneumococcal polysaccharide vaccine (PPV23) alone or the 13-valent pneumococcal conjugate vaccine (PCV 13) followed by PPV23 results in similar antibody levels/functional activity and induce a similar pneumococcal polysaccharide (PPS)-specific B… Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infection
- What is being tested?
- 23-valent pneumococcal polysaccharide vaccine and 13-valent pneumococcal conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2015
- Phase
- Early 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV negative:
- never immunized with PCV13
- HIV positive:
- need for pneumococcal vaccination per standard of care
Who cannot join
- steroid use
- other immunosuppressive agents;
- pregnancy
- incapable of completing consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Toledo-Health Science Campus
Toledo, Ohio, 43614
About this study
Official title: Immune Response to Pneumococcal Vaccination in Aging HIV Positive Individuals
The investigators hypothesized that vaccination with either the 23-valent pneumococcal polysaccharide vaccine (PPV23) alone or the 13-valent pneumococcal conjugate vaccine (PCV 13) followed by PPV23 results in similar antibody levels/functional activity and induce a similar pneumococcal polysaccharide (PPS)-specific B cell response in HIV-positive individuals >50 years of age and HIV-negative persons>50 years of age. The investigators immunized the study group HIV+ persons>50 and controls (HIV negative >50 years) with PCV13 followed by PPV23 and HIV+>50 with PPV23 alone. The investigators examined immune responses to PPS23F and PPS14 on a quantitative and qualitative level using ELISA and opsonophagocytic assays (OPA).
To test the hypothesis that the levels of antigen specific B cells identified with PPS were comparable between the PPV23 and PCV13 vaccine recipients. Pre- and post-immunization peripheral blood samples were obtained. Extensive B cell phenotype analysis using fluorescent antibodies was used to characterize PPS-labeled B cells. Specific phenotypes were correlated with antibody levels and OPA and compared to historic populations immunized with PPV.
Read the detailed description
All potential study candidates were asked to fill out a questionnaire concerning their medical history and medications. This survey determined eligibility. If eligible, as part of the experimental protocol the HIV positive participants agreed to be randomized to PPV23 alone versus PCV13 followed 8 weeks later by PPV23 immunization and 3 to 5 blood draws around the time of immunization. The HIV negative control population agreed to immunization with PCV13 followed 8 weeks later by PPV23, not standard of care for this population, and 5 blood draws around the time of immunization. The investigators compared the effect of single dose pneumococcal polysaccharide vaccination versus PCV13 followed by PPV23 vaccination in HIV positive adults. Prior to 2012, the standard of care of HIV positive adults included vaccination with PPV23. In 2012, these recommendations changed and it was recommended that all HIV positive adults be vaccinated with PCV13 followed at least 8 weeks later by PPV23. The benefit of this vaccination protocol over PPV23 alone in HIV positive adults >50 years of age however had not been studied. As part of this study, all HIV positive adults>50 years of age and a CD4 count>200 who were due for pneumococcal vaccination as standard of care, were asked to participate in the study. Those who agreed and were eligible to participate were randomly assigned to receive PCV13 followed at least 8 weeks later with PPV23 or received a single vaccination with PPV23. As standard of care, all individuals who were due for their pneumococcal vaccine and were not eligible for the study received PCV13 followed by PPV23.
The HIV positive volunteers (n=37) agreed to (experimental part of the protocol):
- Be randomized to either vaccination with PCV13 followed by PPV23 OR PPV23 alone.
- Donate blood specimens at 3-5 different times: PPV23 group:day 0, day of vaccination: 2 mL, at day 7, 40 mL and at day 28-42 a one time sample of 2 mL PCV13/PPV23 group: day 0, day of vaccination with PCV13: 2 mL, at day 7, 40 mL and at day 56, day of PPPV23, 2 mL, day 63 a 40 mL sample and finally at day 90 a one time sample of 2 mL.
- Have blood samples subjected to antibody analysis (concentration and functional activity) and PPS-specific B cell phenotype and tumor necrosis factor receptors (TNFR) .
The HIV negative controls in the study (n=14) who agree to participate were vaccinated with the PCV13 followed by PPV23.This is NOT a vaccine regime recommended for healthy adults but is NOT contraindicated.
Thus as part of the experimental procedure for these individuals they will:
- Receive the FDA approved PCV13 and PPV23
- Blood samples were obtained at day 0, day of vaccination with PCV13: 2 mL, at day 7, 40 mL and at day 56, day of PPPV23, 2 mL, day 63 a 40 mL sample and finally at day 90 a one time sample of 2 mL.
- Blood samples were analyzed for antibody concentration, functional activity and PPS-specific B cell phenotype and TNFR.
In summary,the investigators studied 3 populations, all were between 50-65 years of age:
Group 1: HIV positive CD4>200 vaccinated with PPV23 Group 2: HIV positive CD4> 200 vaccinated with PCV13 followed 8 weeks later by PPV23 Group 3: HIV negative vaccinated with PCV13/PPV23.
- Conditions
- Pneumococcal Infection
- Being tested
- 23-valent pneumococcal polysaccharide vaccine, 13-valent pneumococcal conjugate vaccine
- Keywords
- pneumococcal conjugate vaccine, aging HIV
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
23-valent pneumococcal polysaccharide vaccineBiological
Also called PPV23 or Pneumovax
One standard adult dose of the 23-valent pneumococcal polysaccharide vaccine
13-valent pneumococcal conjugate vaccineBiological
Also called PCV13 or Prevnar 13
One dose of the 13-valent pneumococcal conjugate vaccine, PCV13, followed 8 weeks later by one dose of the 23-valent pneumococcal polysaccharide vaccine, PPV23.
| Study group | Role | What they receive |
|---|---|---|
| HIV positive PPV23 | Active comparator | HIV-positive individuals 50-65 years of age immunized with one dose of the 23-valent pneumococcal polysaccharide vaccine, PPV23 Receives: Biological: 23-valent pneumococcal polysaccharide vaccine |
| HIV positive PCV13/PPV23 | Active comparator | HIV-positive individual 50-65 years of age, Intervention: one dose of 13-valent pneumococcal conjugate vaccine,PCV13, followed 8 weeks later with one dose of 23-valent pneumococcal polysaccharide vaccine, PPV23 Receives: Biological: 23-valent pneumococcal polysaccharide vaccine; Biological: 13-valent pneumococcal conjugate vaccine |
| HIV negative PCV13/PPV23 | Active comparator | HIV-negative individual 50-65 years of age, Intervention: one dose of 13-valent pneumococcal conjugate vaccine,PCV13, followed 8 weeks later with one dose of 23-valent pneumococcal polysaccharide vaccine, PPV23 Receives: Biological: 23-valent pneumococcal polysaccharide vaccine; Biological: 13-valent pneumococcal conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response measured by ELISA (ug/ml)
Measured: Change in ug/ml from day 0 to day 30
Opsonophagocytic antibody activity measured by opsonophagocytic assay (OPA titer)
Measured: Change in OPA titer from day 0 to day 30
Antibody response measured by ELISA (ug/ml)
Measured: Change in ug/ml from day 0 to day 90
Opsonophagocytic antibody activity measured by opsonophagocytic assay (OPA titer)
Measured: Change in OPA titer from day 0 to day 90
Secondary outcomes (17)
B cell phenotype of PPS-specific B cells expressing CD27+IgM+: flowcytometry (%)
Measured: Change from day 0 to day 7 in %
Serum C-reactive protein (ng/ml)
Measured: day 0
Flow cytometry : percentage cells expressing BAFF-R on surface (%)
Measured: Change from day 0 to day 7
Flow cytometry : percentage cells expressing BAFF-R on surface (%)
Measured: Change from day 56 to day 63
B cell phenotype of PPS-specific B cells expressing CD27IgM: flowcytometry (%)
Measured: Change from day 56 to day 63 (%)
Serum IL-6 level (pg/ml)
Measured: Day 0
Serum sCD27 (U/ml)
Measured: Day 0
Serum sCD30 (U/ml)
Measured: Day 0
Serum BAFF concentration (pg/ml)
Measured: Day 0
Serum TACI concentration (pg/ml)
Measured: Day 0
Serum BCMA concentration (pg/ml)
Measured: Day 0
Flow cytometry : percentage cells expressing CD40 on surface (%)
Measured: Change from day 0 to day 7 (%)
Flow cytometry : percentage cells expressing CD40 on surface (%)
Measured: Change from day 56 to day 63 (%)
Flow cytometry : percentage cells expressing CD21 on surface (%)
Measured: Change from day 0 to day 7 (%)
Flow cytometry : percentage cells expressing CD21 on surface (%)
Measured: Change from day 56 to day 63 (%)
Flow cytometry : percentage cells expressing TACI on surface (%)
Measured: Change from day 0 to day 7 (%)
Flow cytometry : percentage cells expressing TACI on surface (%)
Measured: Change from day 56 to day 63 (%)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startJul 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal InfectionStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Maria AJ Westerink, M.D., Principal investigator, University of Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558751
- Sponsor's protocol ID
- R01AG045973
- Other IDs
- R01AG045973
- Status last verified
- Sep 2015
- First submitted
- 16 Sep 2015
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ballet JJ, Sulcebe G, Couderc LJ, Danon F, Rabian C, Lathrop M, Clauvel JP, Seligmann M. Impaired anti-pneumococcal antibody response in patients with AIDS-related persistent generalized lymphadenopathy. Clin Exp Immunol. 1987 Jun;68(3):479-87.
PubMed 3652522Janoff EN, Douglas JM Jr, Gabriel M, Blaser MJ, Davidson AJ, Cohn DL, Judson FN. Class-specific antibody response to pneumococcal capsular polysaccharides in men infected with human immunodeficiency virus type 1. J Infect Dis. 1988 Nov;158(5):983-90. doi: 10.1093/infdis/158.5.983.
PubMed 3183430Klein RS, Selwyn PA, Maude D, Pollard C, Freeman K, Schiffman G. Response to pneumococcal vaccine among asymptomatic heterosexual partners of persons with AIDS and intravenous drug users infected with human immunodeficiency virus. J Infect Dis. 1989 Nov;160(5):826-31. doi: 10.1093/infdis/160.5.826.
PubMed 2572650Kroon FP, van Dissel JT, Ravensbergen E, Nibbering PH, van Furth R. Enhanced antibody response to pneumococcal polysaccharide vaccine after prior immunization with conjugate pneumococcal vaccine in HIV-infected adults. Vaccine. 2000 Nov 22;19(7-8):886-94. doi: 10.1016/s0264-410x(00)00232-2.
PubMed 11115712Rodriguez-Barradas MC, Musher DM, Lahart C, Lacke C, Groover J, Watson D, Baughn R, Cate T, Crofoot G. Antibody to capsular polysaccharides of Streptococcus pneumoniae after vaccination of human immunodeficiency virus-infected subjects with 23-valent pneumococcal vaccine. J Infect Dis. 1992 Mar;165(3):553-6. doi: 10.1093/infdis/165.3.553.
PubMed 1347058
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response to Pneumococcal Vaccination in Aging HIV Positive Individuals
- ClinicalTrials.gov ID
- NCT02558751
- Acronym / sponsor ID
- R01AG045973
- Conditions
- Pneumococcal Infection
- Keywords
- pneumococcal conjugate vaccine, aging HIV
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Sep 2015 (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 investigators hypothesized that vaccination with either the 23-valent pneumococcal polysaccharide vaccine (PPV23) alone or the 13-valent pneumococcal conjugate vaccine (PCV 13) followed by PPV23 results in similar antibody levels/functional activity and induce a similar pneumococcal polysaccharide (PPS)-specific B cell response in HIV-positive individuals >50 years of age and HIV-negative persons>50 years of age. The investigators immunized the study group HIV+ persons>50 and controls (HIV negative >50 years) with PCV13 followed by PPV23 and HIV+>50 with PPV23 alone. The investigators examined immune responses to PPS23F and PPS14 on a quantitative and qualitative level using ELISA and opsonophagocytic assays (OPA).
To test the hypothesis that the levels of antigen specific B cells identified with PPS were comparable between the PPV23 and PCV13 vaccine recipients. Pre- and post-immunization peripheral blood samples were obtained. Extensive B cell phenotype analysis using fluorescent antibodies was used to characterize PPS-labeled B cells. Specific phenotypes were correlated with antibody levels and OPA and compared to historic populations immunized with PPV.
Detailed description
All potential study candidates were asked to fill out a questionnaire concerning their medical history and medications. This survey determined eligibility. If eligible, as part of the experimental protocol the HIV positive participants agreed to be randomized to PPV23 alone versus PCV13 followed 8 weeks later by PPV23 immunization and 3 to 5 blood draws around the time of immunization. The HIV negative control population agreed to immunization with PCV13 followed 8 weeks later by PPV23, not standard of care for this population, and 5 blood draws around the time of immunization. The investigators compared the effect of single dose pneumococcal polysaccharide vaccination versus PCV13 followed by PPV23 vaccination in HIV positive adults. Prior to 2012, the standard of care of HIV positive adults included vaccination with PPV23. In 2012, these recommendations changed and it was recommended that all HIV positive adults be vaccinated with PCV13 followed at least 8 weeks later by PPV23. The benefit of this vaccination protocol over PPV23 alone in HIV positive adults >50 years of age however had not been studied. As part of this study, all HIV positive adults>50 years of age and a CD4 count>200 who were due for pneumococcal vaccination as standard of care, were asked to participate in the study. Those who agreed and were eligible to participate were randomly assigned to receive PCV13 followed at least 8 weeks later with PPV23 or received a single vaccination with PPV23. As standard of care, all individuals who were due for their pneumococcal vaccine and were not eligible for the study received PCV13 followed by PPV23.
The HIV positive volunteers (n=37) agreed to (experimental part of the protocol):
- Be randomized to either vaccination with PCV13 followed by PPV23 OR PPV23 alone.
- Donate blood specimens at 3-5 different times: PPV23 group:day 0, day of vaccination: 2 mL, at day 7, 40 mL and at day 28-42 a one time sample of 2 mL PCV13/PPV23 group: day 0, day of vaccination with PCV13: 2 mL, at day 7, 40 mL and at day 56, day of PPPV23, 2 mL, day 63 a 40 mL sample and finally at day 90 a one time sample of 2 mL.
- Have blood samples subjected to antibody analysis (concentration and functional activity) and PPS-specific B cell phenotype and tumor necrosis factor receptors (TNFR) .
The HIV negative controls in the study (n=14) who agree to participate were vaccinated with the PCV13 followed by PPV23.This is NOT a vaccine regime recommended for healthy adults but is NOT contraindicated.
Thus as part of the experimental procedure for these individuals they will:
- Receive the FDA approved PCV13 and PPV23
- Blood samples were obtained at day 0, day of vaccination with PCV13: 2 mL, at day 7, 40 mL and at day 56, day of PPPV23, 2 mL, day 63 a 40 mL sample and finally at day 90 a one time sample of 2 mL.
- Blood samples were analyzed for antibody concentration, functional activity and PPS-specific B cell phenotype and TNFR.
In summary,the investigators studied 3 populations, all were between 50-65 years of age:
Group 1: HIV positive CD4>200 vaccinated with PPV23 Group 2: HIV positive CD4> 200 vaccinated with PCV13 followed 8 weeks later by PPV23 Group 3: HIV negative vaccinated with PCV13/PPV23.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV positive PPV23 | Active comparator | Biological: 23-valent pneumococcal polysaccharide vaccineHIV-positive individuals 50-65 years of age immunized with one dose of the 23-valent pneumococcal polysaccharide vaccine, PPV23 |
| HIV positive PCV13/PPV23 | Active comparator | Biological: 23-valent pneumococcal polysaccharide vaccine, Biological: 13-valent pneumococcal conjugate vaccineHIV-positive individual 50-65 years of age, Intervention: one dose of 13-valent pneumococcal conjugate vaccine,PCV13, followed 8 weeks later with one dose of 23-valent pneumococcal polysaccharide vaccine, PPV23 |
| HIV negative PCV13/PPV23 | Active comparator | Biological: 23-valent pneumococcal polysaccharide vaccine, Biological: 13-valent pneumococcal conjugate vaccineHIV-negative individual 50-65 years of age, Intervention: one dose of 13-valent pneumococcal conjugate vaccine,PCV13, followed 8 weeks later with one dose of 23-valent pneumococcal polysaccharide vaccine, PPV23 |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV negative:
- never immunized with PCV13
- HIV positive:
- need for pneumococcal vaccination per standard of care
Key exclusion criteria (4 listed)
- steroid use
- other immunosuppressive agents;
- pregnancy
- incapable of completing consent form
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 |
|---|---|---|
| 23-valent pneumococcal polysaccharide vaccineAlso: PPV23 or PneumovaxOne standard adult dose of the 23-valent pneumococcal polysaccharide vaccine | Biological | HIV negative PCV13/PPV23, HIV positive PCV13/PPV23, HIV positive PPV23 |
| 13-valent pneumococcal conjugate vaccineAlso: PCV13 or Prevnar 13One dose of the 13-valent pneumococcal conjugate vaccine, PCV13, followed 8 weeks later by one dose of the 23-valent pneumococcal polysaccharide vaccine, PPV23. | Biological | HIV negative PCV13/PPV23, HIV positive PCV13/PPV23 |
Primary outcome
Antibody response measured by ELISA (ug/ml)
Time frame: Change in ug/ml from day 0 to day 30
Opsonophagocytic antibody activity measured by opsonophagocytic assay (OPA titer)
Time frame: Change in OPA titer from day 0 to day 30
Antibody response measured by ELISA (ug/ml)
Time frame: Change in ug/ml from day 0 to day 90
Opsonophagocytic antibody activity measured by opsonophagocytic assay (OPA titer)
Time frame: Change in OPA titer from day 0 to day 90
17 secondary outcomes
B cell phenotype of PPS-specific B cells expressing CD27+IgM+: flowcytometry (%)
Time frame: Change from day 0 to day 7 in %
Serum C-reactive protein (ng/ml)
Time frame: day 0
Flow cytometry : percentage cells expressing BAFF-R on surface (%)
Time frame: Change from day 0 to day 7
Flow cytometry : percentage cells expressing BAFF-R on surface (%)
Time frame: Change from day 56 to day 63
B cell phenotype of PPS-specific B cells expressing CD27IgM: flowcytometry (%)
Time frame: Change from day 56 to day 63 (%)
Serum IL-6 level (pg/ml)
Time frame: Day 0
Serum sCD27 (U/ml)
Time frame: Day 0
Serum sCD30 (U/ml)
Time frame: Day 0
Serum BAFF concentration (pg/ml)
Time frame: Day 0
Serum TACI concentration (pg/ml)
Time frame: Day 0
Serum BCMA concentration (pg/ml)
Time frame: Day 0
Flow cytometry : percentage cells expressing CD40 on surface (%)
Time frame: Change from day 0 to day 7 (%)
Flow cytometry : percentage cells expressing CD40 on surface (%)
Time frame: Change from day 56 to day 63 (%)
Flow cytometry : percentage cells expressing CD21 on surface (%)
Time frame: Change from day 0 to day 7 (%)
Flow cytometry : percentage cells expressing CD21 on surface (%)
Time frame: Change from day 56 to day 63 (%)
Flow cytometry : percentage cells expressing TACI on surface (%)
Time frame: Change from day 0 to day 7 (%)
Flow cytometry : percentage cells expressing TACI on surface (%)
Time frame: Change from day 56 to day 63 (%)
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 24 Sep 2015.
- Results publication: PubMed 3652522Ballet JJ, Sulcebe G, Couderc LJ, Danon F, Rabian C, Lathrop M, Clauvel JP, Seligmann M. Impaired anti-pneumococcal antibody response in patients with AIDS-related persistent generalized lymphadenopathy. Clin Exp Immunol. 1987 Jun;68(3):479-87.
- Results publication: PubMed 3183430Janoff EN, Douglas JM Jr, Gabriel M, Blaser MJ, Davidson AJ, Cohn DL, Judson FN. Class-specific antibody response to pneumococcal capsular polysaccharides in men infected with human immunodeficiency virus type 1. J Infect Dis. 1988 Nov;158(5):983-90. doi: 10.1093/infdis/158.5.983.
- Results publication: PubMed 2572650Klein RS, Selwyn PA, Maude D, Pollard C, Freeman K, Schiffman G. Response to pneumococcal vaccine among asymptomatic heterosexual partners of persons with AIDS and intravenous drug users infected with human immunodeficiency virus. J Infect Dis. 1989 Nov;160(5):826-31. doi: 10.1093/infdis/160.5.826.
- Results publication: PubMed 11115712Kroon FP, van Dissel JT, Ravensbergen E, Nibbering PH, van Furth R. Enhanced antibody response to pneumococcal polysaccharide vaccine after prior immunization with conjugate pneumococcal vaccine in HIV-infected adults. Vaccine. 2000 Nov 22;19(7-8):886-94. doi: 10.1016/s0264-410x(00)00232-2.
- Results publication: PubMed 1347058Rodriguez-Barradas MC, Musher DM, Lahart C, Lacke C, Groover J, Watson D, Baughn R, Cate T, Crofoot G. Antibody to capsular polysaccharides of Streptococcus pneumoniae after vaccination of human immunodeficiency virus-infected subjects with 23-valent pneumococcal vaccine. J Infect Dis. 1992 Mar;165(3):553-6. doi: 10.1093/infdis/165.3.553.
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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.
Maria AJ Westerink, M.D. principal investigator
University of Toledo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 23-valent pneumococcal polysaccharide vaccine and 13-valent pneumococcal conjugate vaccine in people with Pneumococcal Infection, run by University of Toledo Health Science Campus 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 4 inclusion and 4 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 24 Sep 2015. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Antibody response measured by ELISA (ug/ml) (time frame: Change in ug/ml from day 0 to day 30). 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?
On the ClinicalTrials.gov record for NCT02558751, which also lists 5 linked publications.
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 24 Sep 2015.