Pneumococcal InfectionEarly Phase 1NCT02515240
Immune Response to Pneumococcal Vaccination in HIV Infected Individuals
A Early Phase 1 study testing PPV23 in people with Pneumococcal Infection, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
The purpose of the study. To characterize the immune response to the pneumococcal vaccine in HIV positive individuals and to dissect the most appropriate timing and frequency of vaccination. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infection
- What is being tested?
- PPV23
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Mar 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV negative:
- never immunized with PPV23
- HIV positive:
- need for PPV23 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
The purpose of the study. To characterize the immune response to the pneumococcal vaccine in HIV positive individuals and to dissect the most appropriate timing and frequency of vaccination.
Read the detailed description
All potential study candidates will be asked to fill out a questionnaire concerning their medical history and medications. This survey will determine eligibility. If eligible, as part of the experimental protocol the HIV positive participants will agree to be randomized to immediate vs. delayed pneumococcal immunization and 3 blood draws around the time of immunization. The HIV negative control population will agree to immunization with pneumococcal polysaccharide vaccine (PPV), not standard of care for this population, and 3 blood draws around the time of immunization. The investigators will study the effect of pneumococcal vaccination in HIV positive adults. At the present time it is recommended that all HIV positive individuals receive the pneumococcal vaccine at the time of diagnosis with those with cluster of differentiation (CD4) count <200 to be vaccinated either immediately or alternatively, treated with highly active antiretroviral therapy (HAART) for 6 months followed by PPV. All patients are recommended to be re-vaccinated at 5 years. This is the standard of care. It is however unclear how the HIV positive patients respond to PPV. In the 1st part of the study, Part I, newly diagnosed HIV positive individuals will be recruited. As standard of care, these individuals will receive the pneumococcal vaccine regardless of their participation in this study. Those that agree to participate in the study will be grouped according to their CD4 count: >500, 200-500 or <200. Those with a CD4 count <200 will be randomly assigned to receive the vaccine immediately or to receive HAART for 6 months prior to vaccination, this is in accordance with the present recommendations, either immediate vaccination or giving HAART for 6 months prior to vaccination is considered acceptable.. Thus ALL HIV positive individuals will receive the vaccine as presently recommended. The HIV positive volunteers agree to (experimental part of the protocol):
- Be randomized to either immediate vaccination vs. 6 months after start of HAART if the CD4 count is <200
- Donate blood specimens at 3 different times: day 0, day of vaccination: 2 mL, at day 7, 40 mL and at day 28-42 a one time sample of 2 mL.
- Have their blood samples subjected to antibody analysis (concentration and functional activity) and antibody gene usage analysis There will be 4 HIV positive groups in this part of the study: CD4>500, CD4 200-500, CD4 < 200 immediate vaccination and CD4 <200, delayed vaccination.
There will be 19 individuals per group. The HIV negative controls in Part I of the study (n=19) who agree to participate will also be vaccinated with the pneumococcal vaccine. This is NOT a vaccine recommended for healthy adults but is NOT contra-indicated.
Thus as part of the experimental procedure for these individuals they will:
- Receive the FDA approved pneumococcal vaccine
- Blood samples will be obtained at day 0: 2 mL, day 7 40 mL and day 28-42, one time sample of 2 mL.
- Blood samples will be analyzed for antibody concentration, functional activity and gene family usage.
In summary, we will study a total of 5 groups in Part I:
Group 1: HIV positive CD4>500 Group 2: HIV positive CD4 200-500 Group 3: HIV positive CD4 < 200 immediate vaccination Group 4: HIV positive CD4<200 delayed (6 months) vaccination Group 5: HIV negative In part II of the study the investigators will evaluate the effect of a second pneumococcal vaccination, which is presently recommended, in HIV positive individuals, to be received 5 years after the first vaccination. Again, only those HIV positive individuals who are due for their second pneumovax will be asked to participate. They will be grouped according to their CD4 counts as CD4 >500 or CD4 200-500. Thus ALL HIV positive individuals will receive the vaccine as recommended.
The HIV positive volunteers solely agree to;
- Donate blood specimens at 3 different occasions: day 0, day of vaccination: 2 mL, at day 7, 40 mL and at day 28-42 a one time sample of 2 mL.
- Have their blood samples subjected to antibody analysis (concentration and functional activity) and antibody gene usage analysis There will be 2 HIV positive groups: CD4>500 and CD4 count 200-500. There will be 19 individuals per group.
The HIV negative controls in Part II of the study who agree to participate will be recruited from the population of individuals previously vaccinated with pneumovax. They will also be vaccinated for the second time with the pneumococcal vaccine, 5 years after the first vaccination. This is NOT a vaccine recommended for healthy adults but is NOT contra-indicated. Thus as part of the experimental procedure for these individuals they will:
- Receive the FDA approved pneumococcal vaccine
- Blood samples will be obtained at day 0: 2 mL, day 7 40 mL and day 28-42 one time sample of 2 mL.
- Blood samples will be analyzed for antibody concentration, functional activity and gene family usage.
In summary, we will study 3 groups in Part II of the study Group 6: HIV positive CD4>500, 2nd PPV Group 7: HIV positive CD4 200-500, 2nd PPV Group 8: HIV negative, 2nd PPV.
- Conditions
- Pneumococcal Infection
- Being tested
- PPV23
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPV23Biological
Also called 23 valent pneumococcal polysaccharide vaccine
23 valent pneumococcal polysaccharide vaccine in Healthy adults.
| Study group | Role | What they receive |
|---|---|---|
| healthy controls | Active comparator | healthy individuals, HIV negative, 19-50 yrs if age, immunized with one shot of PPV23 vaccine. Receives: Biological: PPV23 |
| newly diagnosed HIV >200 | Active comparator | Newly diagnosed HIV positive patients with CD4 count >200, immunized with one shot of PPV23 vaccine. Receives: Biological: PPV23 |
| newly diagnosed HIV <200 | Active comparator | Newly diagnosed HIVpositive patients with CD4 count <200, immediately immunized with one shot of PPV23 vaccine. Receives: Biological: PPV23 |
| newly diagnosed HIV <200 delayed | Active comparator | Newly diagnosed HIV positive patients with CD4 count <200 delayed immunization with one shot of PPV23 vaccine, treated for 6-12 months with Highly Active Anti-Retroviral Therapy (HAART) first. Receives: Biological: PPV23 |
| HAART experienced HIV>200 | Active comparator | HIV positive, on HAART treatment for 5 years, nadir CD4 count <200, but at present CD4 count is >200, immunized with one shot of PPV23 vaccine. Receives: Biological: PPV23 |
| HAART experienced HIV<200 | Active comparator | HIVpositive, on HAART treatment for 5 years, nadir CD4 count <200, and at present CD4 count is <200, immunized with one shot of PPV23 vaccine. Receives: Biological: PPV23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody activity and response by opsonophagocytic assay (OPT) and ELISA (ug/ml)
Measured: Day 0 and day 30 of vaccination
Secondary outcomes (2)
Polysaccharide-specific B cell phenotype: percentage naive or memory B cell distribution flow cytometry
Measured: Day 0 and Day7 of vaccination
Flow cytometry : percentage cells expressing tumor necrosis factor receptors on surface
Measured: Day 0 and Day7 of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startJul 2010
- Primary completionJun 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)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
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Julie MA Westerink, MD, Principal investigator, University of Toledo-HSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515240
- Sponsor's protocol ID
- HIV PPV23
- Other IDs
- 5R01AI081558
- Status last verified
- Jul 2015
- First submitted
- 7 Jul 2015
- Last updated
- 7 Aug 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 11115712Loeliger AE, Rijkers GT, Aerts P, Been-Tiktak A, Hoepelman AI, van Dijk H, Borleffs JC. Deficient antipneumococcal polysaccharide responses in HIV-seropositive patients. FEMS Immunol Med Microbiol. 1995 Sep;12(1):33-41. doi: 10.1111/j.1574-695X.1995.tb00171.x.
PubMed 8580899Ochs HD, Junker AK, Collier AC, Virant FS, Handsfield HH, Wedgwood RJ. Abnormal antibody responses in patients with persistent generalized lymphadenopathy. J Clin Immunol. 1988 Jan;8(1):57-63. doi: 10.1007/BF00915157.
PubMed 2966810Opravil M, Fierz W, Matter L, Blaser J, Luthy R. Poor antibody response after tetanus and pneumococcal vaccination in immunocompromised, HIV-infected patients. Clin Exp Immunol. 1991 May;84(2):185-9. doi: 10.1111/j.1365-2249.1991.tb08146.x.
PubMed 2025948Ragni MV, Ruben FL, Winkelstein A, Spero JA, Bontempo FA, Lewis JH. Antibody responses to immunization of patients with hemophilia with and without evidence of human immunodeficiency virus (human T-lymphotropic virus type III) infection. J Lab Clin Med. 1987 May;109(5):545-9.
PubMed 3572201Rodriguez-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 1347058Unsworth DJ, Rowen D, Carne C, Sonnex C, Baglin T, Brown DL. Defective IgG2 response to Pneumovax in HIV seropositive patients. Genitourin Med. 1993 Oct;69(5):373-6. doi: 10.1136/sti.69.5.373.
PubMed 8244356Berberian L, Goodglick L, Kipps TJ, Braun J. Immunoglobulin VH3 gene products: natural ligands for HIV gp120. Science. 1993 Sep 17;261(5128):1588-91. doi: 10.1126/science.7690497.
PubMed 7690497Berberian L, Shukla J, Jefferis R, Braun J. Effects of HIV infection on VH3 (D12 idiotope) B cells in vivo. J Acquir Immune Defic Syndr (1988). 1994 Jul;7(7):641-6.
PubMed 8207642Karray S, Zouali M. Identification of the B cell superantigen-binding site of HIV-1 gp120. Proc Natl Acad Sci U S A. 1997 Feb 18;94(4):1356-60. doi: 10.1073/pnas.94.4.1356.
PubMed 9037057Townsley-Fuchs J, Neshat MS, Margolin DH, Braun J, Goodglick L. HIV-1 gp120: a novel viral B cell superantigen. Int Rev Immunol. 1997;14(4):325-38. doi: 10.3109/08830189709116523.
PubMed 9186784Muller S, Kohler H. B cell superantigens in HIV-1 infection. Int Rev Immunol. 1997;14(4):339-49. doi: 10.3109/08830189709116524.
PubMed 9186785
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response to Pneumococcal Vaccination in HIV Infected Individuals
- ClinicalTrials.gov ID
- NCT02515240
- Acronym / sponsor ID
- HIV PPV23
- Conditions
- Pneumococcal Infection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Aug 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 purpose of the study. To characterize the immune response to the pneumococcal vaccine in HIV positive individuals and to dissect the most appropriate timing and frequency of vaccination.
Detailed description
All potential study candidates will be asked to fill out a questionnaire concerning their medical history and medications. This survey will determine eligibility. If eligible, as part of the experimental protocol the HIV positive participants will agree to be randomized to immediate vs. delayed pneumococcal immunization and 3 blood draws around the time of immunization. The HIV negative control population will agree to immunization with pneumococcal polysaccharide vaccine (PPV), not standard of care for this population, and 3 blood draws around the time of immunization. The investigators will study the effect of pneumococcal vaccination in HIV positive adults. At the present time it is recommended that all HIV positive individuals receive the pneumococcal vaccine at the time of diagnosis with those with cluster of differentiation (CD4) count <200 to be vaccinated either immediately or alternatively, treated with highly active antiretroviral therapy (HAART) for 6 months followed by PPV. All patients are recommended to be re-vaccinated at 5 years. This is the standard of care. It is however unclear how the HIV positive patients respond to PPV. In the 1st part of the study, Part I, newly diagnosed HIV positive individuals will be recruited. As standard of care, these individuals will receive the pneumococcal vaccine regardless of their participation in this study. Those that agree to participate in the study will be grouped according to their CD4 count: >500, 200-500 or <200. Those with a CD4 count <200 will be randomly assigned to receive the vaccine immediately or to receive HAART for 6 months prior to vaccination, this is in accordance with the present recommendations, either immediate vaccination or giving HAART for 6 months prior to vaccination is considered acceptable.. Thus ALL HIV positive individuals will receive the vaccine as presently recommended. The HIV positive volunteers agree to (experimental part of the protocol):
- Be randomized to either immediate vaccination vs. 6 months after start of HAART if the CD4 count is <200
- Donate blood specimens at 3 different times: day 0, day of vaccination: 2 mL, at day 7, 40 mL and at day 28-42 a one time sample of 2 mL.
- Have their blood samples subjected to antibody analysis (concentration and functional activity) and antibody gene usage analysis There will be 4 HIV positive groups in this part of the study: CD4>500, CD4 200-500, CD4 < 200 immediate vaccination and CD4 <200, delayed vaccination.
There will be 19 individuals per group. The HIV negative controls in Part I of the study (n=19) who agree to participate will also be vaccinated with the pneumococcal vaccine. This is NOT a vaccine recommended for healthy adults but is NOT contra-indicated.
Thus as part of the experimental procedure for these individuals they will:
- Receive the FDA approved pneumococcal vaccine
- Blood samples will be obtained at day 0: 2 mL, day 7 40 mL and day 28-42, one time sample of 2 mL.
- Blood samples will be analyzed for antibody concentration, functional activity and gene family usage.
In summary, we will study a total of 5 groups in Part I:
Group 1: HIV positive CD4>500 Group 2: HIV positive CD4 200-500 Group 3: HIV positive CD4 < 200 immediate vaccination Group 4: HIV positive CD4<200 delayed (6 months) vaccination Group 5: HIV negative In part II of the study the investigators will evaluate the effect of a second pneumococcal vaccination, which is presently recommended, in HIV positive individuals, to be received 5 years after the first vaccination. Again, only those HIV positive individuals who are due for their second pneumovax will be asked to participate. They will be grouped according to their CD4 counts as CD4 >500 or CD4 200-500. Thus ALL HIV positive individuals will receive the vaccine as recommended.
The HIV positive volunteers solely agree to;
- Donate blood specimens at 3 different occasions: day 0, day of vaccination: 2 mL, at day 7, 40 mL and at day 28-42 a one time sample of 2 mL.
- Have their blood samples subjected to antibody analysis (concentration and functional activity) and antibody gene usage analysis There will be 2 HIV positive groups: CD4>500 and CD4 count 200-500. There will be 19 individuals per group.
The HIV negative controls in Part II of the study who agree to participate will be recruited from the population of individuals previously vaccinated with pneumovax. They will also be vaccinated for the second time with the pneumococcal vaccine, 5 years after the first vaccination. This is NOT a vaccine recommended for healthy adults but is NOT contra-indicated. Thus as part of the experimental procedure for these individuals they will:
- Receive the FDA approved pneumococcal vaccine
- Blood samples will be obtained at day 0: 2 mL, day 7 40 mL and day 28-42 one time sample of 2 mL.
- Blood samples will be analyzed for antibody concentration, functional activity and gene family usage.
In summary, we will study 3 groups in Part II of the study Group 6: HIV positive CD4>500, 2nd PPV Group 7: HIV positive CD4 200-500, 2nd PPV Group 8: HIV negative, 2nd PPV.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| healthy controls | Active comparator | Biological: PPV23healthy individuals, HIV negative, 19-50 yrs if age, immunized with one shot of PPV23 vaccine. |
| newly diagnosed HIV >200 | Active comparator | Biological: PPV23Newly diagnosed HIV positive patients with CD4 count >200, immunized with one shot of PPV23 vaccine. |
| newly diagnosed HIV <200 | Active comparator | Biological: PPV23Newly diagnosed HIVpositive patients with CD4 count <200, immediately immunized with one shot of PPV23 vaccine. |
| newly diagnosed HIV <200 delayed | Active comparator | Biological: PPV23Newly diagnosed HIV positive patients with CD4 count <200 delayed immunization with one shot of PPV23 vaccine, treated for 6-12 months with Highly Active Anti-Retroviral Therapy (HAART) first. |
| HAART experienced HIV>200 | Active comparator | Biological: PPV23HIV positive, on HAART treatment for 5 years, nadir CD4 count <200, but at present CD4 count is >200, immunized with one shot of PPV23 vaccine. |
| HAART experienced HIV<200 | Active comparator | Biological: PPV23HIVpositive, on HAART treatment for 5 years, nadir CD4 count <200, and at present CD4 count is <200, immunized with one shot of PPV23 vaccine. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV negative:
- never immunized with PPV23
- HIV positive:
- need for PPV23 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 |
|---|---|---|
| PPV23Also: 23 valent pneumococcal polysaccharide vaccine23 valent pneumococcal polysaccharide vaccine in Healthy adults. | Biological | HAART experienced HIV<200, HAART experienced HIV>200, healthy controls, newly diagnosed HIV <200, newly diagnosed HIV <200 delayed, newly diagnosed HIV >200 |
Primary outcome
Antibody activity and response by opsonophagocytic assay (OPT) and ELISA (ug/ml)
Time frame: Day 0 and day 30 of vaccination
2 secondary outcomes
Polysaccharide-specific B cell phenotype: percentage naive or memory B cell distribution flow cytometry
Time frame: Day 0 and Day7 of vaccination
Flow cytometry : percentage cells expressing tumor necrosis factor receptors on surface
Time frame: Day 0 and Day7 of vaccination
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 7 Aug 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 8580899Loeliger AE, Rijkers GT, Aerts P, Been-Tiktak A, Hoepelman AI, van Dijk H, Borleffs JC. Deficient antipneumococcal polysaccharide responses in HIV-seropositive patients. FEMS Immunol Med Microbiol. 1995 Sep;12(1):33-41. doi: 10.1111/j.1574-695X.1995.tb00171.x.
- Results publication: PubMed 2966810Ochs HD, Junker AK, Collier AC, Virant FS, Handsfield HH, Wedgwood RJ. Abnormal antibody responses in patients with persistent generalized lymphadenopathy. J Clin Immunol. 1988 Jan;8(1):57-63. doi: 10.1007/BF00915157.
- Results publication: PubMed 2025948Opravil M, Fierz W, Matter L, Blaser J, Luthy R. Poor antibody response after tetanus and pneumococcal vaccination in immunocompromised, HIV-infected patients. Clin Exp Immunol. 1991 May;84(2):185-9. doi: 10.1111/j.1365-2249.1991.tb08146.x.
- Results publication: PubMed 3572201Ragni MV, Ruben FL, Winkelstein A, Spero JA, Bontempo FA, Lewis JH. Antibody responses to immunization of patients with hemophilia with and without evidence of human immunodeficiency virus (human T-lymphotropic virus type III) infection. J Lab Clin Med. 1987 May;109(5):545-9.
- 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.
- Results publication: PubMed 8244356Unsworth DJ, Rowen D, Carne C, Sonnex C, Baglin T, Brown DL. Defective IgG2 response to Pneumovax in HIV seropositive patients. Genitourin Med. 1993 Oct;69(5):373-6. doi: 10.1136/sti.69.5.373.
- Results publication: PubMed 7690497Berberian L, Goodglick L, Kipps TJ, Braun J. Immunoglobulin VH3 gene products: natural ligands for HIV gp120. Science. 1993 Sep 17;261(5128):1588-91. doi: 10.1126/science.7690497.
- Results publication: PubMed 8207642Berberian L, Shukla J, Jefferis R, Braun J. Effects of HIV infection on VH3 (D12 idiotope) B cells in vivo. J Acquir Immune Defic Syndr (1988). 1994 Jul;7(7):641-6.
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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.
Julie MA Westerink, MD principal investigator
University of Toledo-HSC
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 PPV23 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 7 Aug 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 activity and response by opsonophagocytic assay (OPT) and ELISA (ug/ml) (time frame: Day 0 and day 30 of vaccination). 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 NCT02515240, which also lists 17 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 7 Aug 2015.