HIV LipodystrophyEarly Phase 1NCT03039491
Immune Response to Pneumococcal Vaccination in Aging HIV Positive Adults
A Early Phase 1 study testing Pneumococcal polysaccharide vaccine 23 valent and 13 valent conjugated pneumococcal vaccine in people with HIV Lipodystrophy and Aging, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The investigators hypothesized that pneumococcal vaccination with either the 23-valent pneumococcal polysaccharide vaccine PPV-23 (Pneumovax-23) alone or the 13-valent pneumococcal conjugate vaccine PCV-13 (Prevnar-13) followed by PPV-23 results in a similar antibody levels/functional antibody activity and induce… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Lipodystrophy, Aging
- What is being tested?
- Pneumococcal polysaccharide vaccine 23 valent and 13 valent conjugated pneumococcal vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 30 Mar 2020
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Previous immunization with pneumococcal vaccine less than 5 years ago
- pregnancy and absence of contraceptive practice in women of childbearing age and breast feeding
- known anaphylaxis, hypersensitivity to the pneumonia vaccine
- those who received blood products or gammaglobulin in last 3 months
- inability to comprehend or sihn informed consent
- Medications known to affect immune function (chemotherapy, an angiotensin-converting-enzyme (ACE) inhibitors, corticosteroids, anti-TNFalpha agents)
- previous disease/present illness that may affect response to vaccination: previous pneumococcal disease, removal of spleen, auto-immune disease, end stage renal disease (ESRD) or end stage liver disease, cancer)
- significant (3x upper limit of normal) in complete blood count (CBC), chemistries, immunoglobulin levels
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Immune Response to Pneumococcal Vaccination in Aging HIV Positive Individuals
The investigators hypothesized that pneumococcal vaccination with either the 23-valent pneumococcal polysaccharide vaccine PPV-23 (Pneumovax-23) alone or the 13-valent pneumococcal conjugate vaccine PCV-13 (Prevnar-13) followed by PPV-23 results in a similar antibody levels/functional antibody activity and induce similar pneumococcal polysaccharide (PPS)-specific B cell response in HIV positive individuals > 50 years of age, HIV positive individuals 21-40 years of age as compared to HIV negative > 50 years of age. The investigators immunized the study groups HIV+ persons >50, HIV+ persons 21-40 and controls (HIV negative) with PCV 13 followed by PPV23 and HIV>50 with PPV alone and examined immune responses to polysaccharide (PPS) 23 (F),14, 3, 7 (F) and 19 (A) using polysaccharide specific ELISA and opsonophagocytic assays (OPA). 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 populations immunized with PPV
Read the detailed description
The purpose of this study is to learn more about how older people with HIV respond to the pneumococcal or pneumonia vaccine. Pneumonia occurs very frequently in in older persons AND in persons who are infected with HIV. Therefore, it is common practice to vaccinate against pneumonia in these patient populations. Because older patients with HIV fit both of these categories, it is believed that they are at an increased risk of pneumonia.
There are two types of pneumonia vaccines available for adults approved by the Federal Drug Administration (FDA). One is called the pneumococcal polysaccharide vaccine (PPV23) and protects against 23 different strains of the pneumonia bacteria. The other type of vaccine called the pneumococcal conjugate vaccine (PCV13) protects against different strains of the pneumonia bacteria.
Until 2012, it was recommended that all HIV-positive adults receive PPV23 when diagnosed with HIV and again 5 years later. More recently, the guidelines have changed to all HIV-positive adults are to receive PCV13, followed later with PPV23. At this point in time, it is not clear which regimen works better in aging HIV positive adults. Investigators are doing this study to compare the effectiveness of each vaccine regimen in aging HIV positive adults compared to healthy adults. Although several studies show short-term efficacy or increased antibody response in HIV+ persons with this vaccine, others do not, in either HIV+ population or in elderly. Large efficacy trials necessary to establish clinical superiority of PCV compared to PPV will likely not be conducted, particularly in the aging HIV+ population. It is therefore essential to define immune responses to conjugated and free-polysaccharide preparations by examining traditional antibody and functional levels as well as B cell subsets, critically affected by aging and HIV. Will either PCV or PPV elicit an immune response compatible with protection in this population? Based on persistent B cell perturbations in HAART-treated persons, it is hypothesized that immunization of aging HIV+ persons with PPV23 will be as effective as a PCV13 containing regimen on a quantitative, qualitative, B and T cell level and that the magnitude of this response will be related to the degree of chronic inflammation. The proposed studies are highly significant as they will define the B and T cell responses to a TI-2 and T-cell dependent form of pneumococcal vaccine in the aging HIV+ population. These data will provide the necessary basis for development of a rational vaccination approach, including the potential use of novel adjuvant. In this study the investigators will:
- Test the hypothesis that vaccination with either PPV alone (TI-2) or a PCV containing regimen (TD) results in similar antibody levels/functional activity, that are determined by levels of chronic inflammation in aging HIV+. The investigators will immunize the study group HIV+ persons 50-65 and controls (HIV+21-40 and HIV- 50-65 years) with PCV13 followed by PPV23 and HIV+ 50-65 and HIV- 50-65 with PPV alone. The investigators will examine immune responses to pneumococcal polysaccharides (PPS) 23 (F), 14, 3, 7 (F) and 19 (A) on a quantitative and qualitative level using ELISA and opsonophagocytic assays (OPA) and correlate the response to the degree of inflammation measured in each participant.
- To test the hypothesis that the levels of antigen specific B cells identified with PPS will be comparable between the PPV and PCV vaccine recipients. Pre- and post-immunization peripheral blood samples will be obtained. Extensive phenotype analysis using antibodies against cluster of differentiation (CD)19, 20, 21, 27, 38, 40, immunoglobulin M (IgM) , B-cell activating factor (BAFF), trans-membrane activator and calcium modulator and cyclophilin ligand interactor (TACI), and B-cell maturation antigen (BCMA) markers will be used to characterize PPS-labeled B cells. Specific phenotypes will be correlated with antibody levels, OPA and inflammatory markers and compared to the control populations immunized with PPV.
- Conditions
- HIV Lipodystrophy, Aging
- Being tested
- Pneumococcal polysaccharide vaccine 23 valent, 13 valent conjugated pneumococcal vaccine
- Keywords
- pneumococcal vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal polysaccharide vaccine 23 valentBiological
Also called Pneumovax
This is the pneumococcal vaccine consisting of the capsular polysaccharides of 23 serotypes of Streptococcus pneumoniae
13 valent conjugated pneumococcal vaccineBiological
Also called Prevnar 13
This is the pneumococcal vaccine consisting of the capsular polysaccharides of 13 serotypes of Streptococcus pneumoniae conjugated to non-toxic diphtheria carrier protein 197
| Study group | Role | What they receive |
|---|---|---|
| HIV+ 50-65, CD4>200 PCV/PPV | Experimental | HIV+ individuals , 50-65 years of age with a nadir cluster of differentiation (CD) 4 count >200 to receive PCV13 vaccine followed 8 weeks later by PPV23
Intervention: 13 valent Pneumococcal conjugate vaccine (PCV13) followed 8 weeks later by 23 valent pneumococcal polysaccharide vaccine Receives: Biological: Pneumococcal polysaccharide vaccine 23 valent; Biological: 13 valent conjugated pneumococcal vaccine |
| HIV+ 50-65, CD4<200 PCV/PPV | Experimental | HIV+ individuals , 50-65 years of age with a nadir CD4 count <200 to receive PCV13 vaccine followed 8 weeks later by PPV23
Intervention: 13 valent Pneumococcal conjugate vaccine (PCV13) followed 8 weeks later by 23 valent pneumococcal polysaccharide vaccine Receives: Biological: Pneumococcal polysaccharide vaccine 23 valent; Biological: 13 valent conjugated pneumococcal vaccine |
| HIV+ 50-65, CD4>200 PPV | Experimental | HIV+ individuals , 50-65 years of age with a nadir CD4 count >200 to receive PPV23 only
Intervention: 23 valent pneumococcal polysaccharide vaccine only Receives: Biological: Pneumococcal polysaccharide vaccine 23 valent |
| HIV+ 50-65, CD4<200 PCV | Experimental | HIV+ individuals , 50-65 years of age with a nadir CD4 count <200 to receive PPV23 only
Intervention: 23 valent pneumococcal polysaccharide vaccine only Receives: Biological: Pneumococcal polysaccharide vaccine 23 valent |
| HIV- 50-65, PCV/PPV | Active comparator | HIV- individuals , 50-65 years of age immunized with PCV13 followed by PPV23
Intervention: 13 valent Pneumococcal conjugate vaccine (PCV13) followed 8 weeks later by 23 valent pneumococcal polysaccharide vaccine Receives: Biological: Pneumococcal polysaccharide vaccine 23 valent; Biological: 13 valent conjugated pneumococcal vaccine |
| HIV- 50-65, PPV | Active comparator | HIV- individuals, 50-65 years of age immunized with PPV23 only.
Intervention: 23 valent pneumococcal polysaccharide vaccine only Receives: Biological: Pneumococcal polysaccharide vaccine 23 valent |
| HIV+ 21-40, CD4>200 PCV/PPV | Active comparator | HIV+ individuals , 21-40 years of age with a nadir CD4 count >200 to receive PCV13 vaccine followed 8 weeks later by PPV23
Intervention: 13 valent Pneumococcal conjugate vaccine (PCV13) followed 8 weeks later by 23 valent pneumococcal polysaccharide vaccine Receives: Biological: Pneumococcal polysaccharide vaccine 23 valent; Biological: 13 valent conjugated pneumococcal vaccine |
| HIV+ 21-40, CD4<200 PCV/PPV | Active comparator | HIV+ individuals , 21-40 years of age with a nadir CD4 count <200 to receive PCV13 vaccine followed 8 weeks later by PPV23
Intervention: 13 valent Pneumococcal conjugate vaccine (PCV13) followed 8 weeks later by 23 valent pneumococcal polysaccharide vaccine Receives: Biological: Pneumococcal polysaccharide vaccine 23 valent; Biological: 13 valent conjugated pneumococcal vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response
Measure antibody response by ELISA (ug/mL)
Measured: Change in ug/mL from day 0 to 30 days after receipt of PPV23
opsonophagocytic antibody activity
opsonophagocytic antibody response measured by opsonophagocytic assay (OPA)
Measured: Change in opsonophagocytic titer from day 0 to 30 days after receipt of PPV23
Secondary outcomes (20)
PPS-specific B cell phenotype
Measure: B cell phenotype of PPS-specific B cells expressing CD27+IgM+: flowcytometry (%)
Measured: Change from day 0 to day 7 post-vaccination
PPS-specific B cell phenotype
Measure: B cell phenotype of PPS-specific B cells expressing CD27+IgM+: flowcytometry (%)
Measured: Change from day 56 to day 63 post-vaccination
Expression of TACI on PPS-specific B cells
Measure:Flow cytometry: percentage of PPS-specific B cells expressing TACI on their surface (%)
Measured: change from day 0 to day 7
Expression of TACI on PPS-specific B cells
Measure:Flow cytometry: percentage of PPS-specific B cells expressing TACI on their surface (%)
Measured: change from day 56 to day 63
Expression of BAFFR on PPS-specific B cells
Measure:Flow cytometry: percentage of PPS-specific B cells expressing BAFFR on their surface (%)
Measured: change from day 0 to day 7
Expression of BAFFR on PPS-specific B cells
Measure:Flow cytometry: percentage of PPS-specific B cells expressing BAFFR on their surface (%)
Measured: change from day 56 to day 63
Expression of BCMA on PPS-specific B cells
Measure:Flow cytometry: percentage of PPS-specific B cells expressing BAFFR on their surface (%)
Measured: change from day 0 to day 7
Expression of BCMA on PPS-specific B cells
Measure:Flow cytometry: percentage of PPS-specific B cells expressing BAFFR on their surface (%)
Measured: change from day 7 to day 63
Expression of CD40 on PPS-specific B cells
Measure:Flow cytometry: percentage of PPS-specific B cells expressing CD40 on their surface (%)
Measured: change from day 0 to day 7
Expression of CD40 on PPS-specific B cells
Measure:Flow cytometry: percentage of PPS-specific B cells expressing CD40 on their surface (%)
Measured: change from day 56 to day 63
Expression of cluster of differentiation 21 (CD21) on PPS-specific B cells
Measure:Flow cytometry: percentage of PPS-specific B cells expressing CD21 on their surface (%)
Measured: change from day 0 to day 7
Expression of CD21 on PPS-specific B cells
Measure:Flow cytometry: percentage of PPS-specific B cells expressing CD21 on their surface (%)
Measured: change from day 56 to day 63
Serum interleukin-6 (IL-6)
Measure serum levels IL-6
Measured: Day 0
Serum BAFF
Measure serum levels BAFF
Measured: Day 0
Serum APRIL
Measure serum levels APRIL
Measured: Day 0
Serum IL-10
Measure serum levels IL-10
Measured: Day 0
Serum IL-1(RA)
Measure serum levels IL-1RA
Measured: Day 0
Serum IL-1(B)
Measure serum levels IL-1B
Measured: Day 0
Serum IL-8
Measure serum levels IL-8
Measured: Day 0
Serum TNFalpha
Measure serum levels TNFalpha
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start1 Sep 2015
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HIV LipodystrophyStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria A. Julia Westerink, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039491
- Sponsor's protocol ID
- MUSC vaccine study
- Status last verified
- Jun 2020
- First submitted
- 30 Jan 2017
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be made available once analysis is completed through publications in peer reviewed journals.
Publications
Crum-Cianflone NF, Huppler Hullsiek K, Roediger M, Ganesan A, Patel S, Landrum ML, Weintrob A, Agan BK, Medina S, Rahkola J, Hale BR, Janoff EN; Infectious Disease Clinical Research Program HIV Working Group. A randomized clinical trial comparing revaccination with pneumococcal conjugate vaccine to polysaccharide vaccine among HIV-infected adults. J Infect Dis. 2010 Oct 1;202(7):1114-25. doi: 10.1086/656147.
PubMed 20795819de Roux A, Schmole-Thoma B, Siber GR, Hackell JG, Kuhnke A, Ahlers N, Baker SA, Razmpour A, Emini EA, Fernsten PD, Gruber WC, Lockhart S, Burkhardt O, Welte T, Lode HM. Comparison of pneumococcal conjugate polysaccharide and free polysaccharide vaccines in elderly adults: conjugate vaccine elicits improved antibacterial immune responses and immunological memory. Clin Infect Dis. 2008 Apr 1;46(7):1015-23. doi: 10.1086/529142.
PubMed 18444818French N, Gordon SB, Mwalukomo T, White SA, Mwafulirwa G, Longwe H, Mwaiponya M, Zijlstra EE, Molyneux ME, Gilks CF. A trial of a 7-valent pneumococcal conjugate vaccine in HIV-infected adults. N Engl J Med. 2010 Mar 4;362(9):812-22. doi: 10.1056/NEJMoa0903029.
PubMed 20200385Baxendale HE, Keating SM, Johnson M, Southern J, Miller E, Goldblatt D. The early kinetics of circulating pneumococcal-specific memory B cells following pneumococcal conjugate and plain polysaccharide vaccines in the elderly. Vaccine. 2010 Jul 5;28(30):4763-70. doi: 10.1016/j.vaccine.2010.04.103. Epub 2010 May 14.
PubMed 20471437Penaranda M, Payeras A, Cambra A, Mila J, Riera M; Majorcan Pneumococcal Study Group. Conjugate and polysaccharide pneumococcal vaccines do not improve initial response of the polysaccharide vaccine in HIV-infected adults. AIDS. 2010 May 15;24(8):1226-8. doi: 10.1097/QAD.0b013e3283389de5.
PubMed 20299956Khaskhely N, Mosakowski J, Thompson RS, Khuder S, Smithson SL, Westerink MA. Phenotypic analysis of pneumococcal polysaccharide-specific B cells. J Immunol. 2012 Mar 1;188(5):2455-63. doi: 10.4049/jimmunol.1102809. Epub 2012 Jan 23.
PubMed 22271652Happe M, Samuvel DJ, Ohtola JA, Korte JE, Westerink MAJ. Race-related differences in functional antibody response to pneumococcal vaccination in HIV-infected individuals. Vaccine. 2019 Mar 14;37(12):1622-1629. doi: 10.1016/j.vaccine.2019.01.084. Epub 2019 Feb 21.
PubMed 30797636
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. 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
- NCT03039491
- Acronym / sponsor ID
- MUSC vaccine study
- Conditions
- HIV Lipodystrophy, Aging
- Keywords
- pneumococcal vaccination
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 1 Feb 2017 (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 pneumococcal vaccination with either the 23-valent pneumococcal polysaccharide vaccine PPV-23 (Pneumovax-23) alone or the 13-valent pneumococcal conjugate vaccine PCV-13 (Prevnar-13) followed by PPV-23 results in a similar antibody levels/functional antibody activity and induce similar pneumococcal polysaccharide (PPS)-specific B cell response in HIV positive individuals > 50 years of age, HIV positive individuals 21-40 years of age as compared to HIV negative > 50 years of age. The investigators immunized the study groups HIV+ persons >50, HIV+ persons 21-40 and controls (HIV negative) with PCV 13 followed by PPV23 and HIV>50 with PPV alone and examined immune responses to polysaccharide (PPS) 23 (F),14, 3, 7 (F) and 19 (A) using polysaccharide specific ELISA and opsonophagocytic assays (OPA). 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 populations immunized with PPV
Detailed description
The purpose of this study is to learn more about how older people with HIV respond to the pneumococcal or pneumonia vaccine. Pneumonia occurs very frequently in in older persons AND in persons who are infected with HIV. Therefore, it is common practice to vaccinate against pneumonia in these patient populations. Because older patients with HIV fit both of these categories, it is believed that they are at an increased risk of pneumonia.
There are two types of pneumonia vaccines available for adults approved by the Federal Drug Administration (FDA). One is called the pneumococcal polysaccharide vaccine (PPV23) and protects against 23 different strains of the pneumonia bacteria. The other type of vaccine called the pneumococcal conjugate vaccine (PCV13) protects against different strains of the pneumonia bacteria.
Until 2012, it was recommended that all HIV-positive adults receive PPV23 when diagnosed with HIV and again 5 years later. More recently, the guidelines have changed to all HIV-positive adults are to receive PCV13, followed later with PPV23. At this point in time, it is not clear which regimen works better in aging HIV positive adults. Investigators are doing this study to compare the effectiveness of each vaccine regimen in aging HIV positive adults compared to healthy adults. Although several studies show short-term efficacy or increased antibody response in HIV+ persons with this vaccine, others do not, in either HIV+ population or in elderly. Large efficacy trials necessary to establish clinical superiority of PCV compared to PPV will likely not be conducted, particularly in the aging HIV+ population. It is therefore essential to define immune responses to conjugated and free-polysaccharide preparations by examining traditional antibody and functional levels as well as B cell subsets, critically affected by aging and HIV. Will either PCV or PPV elicit an immune response compatible with protection in this population? Based on persistent B cell perturbations in HAART-treated persons, it is hypothesized that immunization of aging HIV+ persons with PPV23 will be as effective as a PCV13 containing regimen on a quantitative, qualitative, B and T cell level and that the magnitude of this response will be related to the degree of chronic inflammation. The proposed studies are highly significant as they will define the B and T cell responses to a TI-2 and T-cell dependent form of pneumococcal vaccine in the aging HIV+ population. These data will provide the necessary basis for development of a rational vaccination approach, including the potential use of novel adjuvant. In this study the investigators will:
- Test the hypothesis that vaccination with either PPV alone (TI-2) or a PCV containing regimen (TD) results in similar antibody levels/functional activity, that are determined by levels of chronic inflammation in aging HIV+. The investigators will immunize the study group HIV+ persons 50-65 and controls (HIV+21-40 and HIV- 50-65 years) with PCV13 followed by PPV23 and HIV+ 50-65 and HIV- 50-65 with PPV alone. The investigators will examine immune responses to pneumococcal polysaccharides (PPS) 23 (F), 14, 3, 7 (F) and 19 (A) on a quantitative and qualitative level using ELISA and opsonophagocytic assays (OPA) and correlate the response to the degree of inflammation measured in each participant.
- To test the hypothesis that the levels of antigen specific B cells identified with PPS will be comparable between the PPV and PCV vaccine recipients. Pre- and post-immunization peripheral blood samples will be obtained. Extensive phenotype analysis using antibodies against cluster of differentiation (CD)19, 20, 21, 27, 38, 40, immunoglobulin M (IgM) , B-cell activating factor (BAFF), trans-membrane activator and calcium modulator and cyclophilin ligand interactor (TACI), and B-cell maturation antigen (BCMA) markers will be used to characterize PPS-labeled B cells. Specific phenotypes will be correlated with antibody levels, OPA and inflammatory markers and compared to the control populations immunized with PPV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| HIV+ 50-65, CD4>200 PCV/PPV | Experimental | Biological: Pneumococcal polysaccharide vaccine 23 valent, Biological: 13 valent conjugated pneumococcal vaccineHIV+ individuals , 50-65 years of age with a nadir cluster of differentiation (CD) 4 count >200 to receive PCV13 vaccine followed 8 weeks later by PPV23 Intervention: 13 valent Pneumococcal conjugate vaccine (PCV13) followed 8 weeks later by 23 valent pneumococcal polysaccharide vaccine |
| HIV+ 50-65, CD4<200 PCV/PPV | Experimental | Biological: Pneumococcal polysaccharide vaccine 23 valent, Biological: 13 valent conjugated pneumococcal vaccineHIV+ individuals , 50-65 years of age with a nadir CD4 count <200 to receive PCV13 vaccine followed 8 weeks later by PPV23 Intervention: 13 valent Pneumococcal conjugate vaccine (PCV13) followed 8 weeks later by 23 valent pneumococcal polysaccharide vaccine |
| HIV+ 50-65, CD4>200 PPV | Experimental | Biological: Pneumococcal polysaccharide vaccine 23 valentHIV+ individuals , 50-65 years of age with a nadir CD4 count >200 to receive PPV23 only Intervention: 23 valent pneumococcal polysaccharide vaccine only |
| HIV+ 50-65, CD4<200 PCV | Experimental | Biological: Pneumococcal polysaccharide vaccine 23 valentHIV+ individuals , 50-65 years of age with a nadir CD4 count <200 to receive PPV23 only Intervention: 23 valent pneumococcal polysaccharide vaccine only |
| HIV- 50-65, PCV/PPV | Active comparator | Biological: Pneumococcal polysaccharide vaccine 23 valent, Biological: 13 valent conjugated pneumococcal vaccineHIV- individuals , 50-65 years of age immunized with PCV13 followed by PPV23 Intervention: 13 valent Pneumococcal conjugate vaccine (PCV13) followed 8 weeks later by 23 valent pneumococcal polysaccharide vaccine |
| HIV- 50-65, PPV | Active comparator | Biological: Pneumococcal polysaccharide vaccine 23 valentHIV- individuals, 50-65 years of age immunized with PPV23 only. Intervention: 23 valent pneumococcal polysaccharide vaccine only |
| HIV+ 21-40, CD4>200 PCV/PPV | Active comparator | Biological: Pneumococcal polysaccharide vaccine 23 valent, Biological: 13 valent conjugated pneumococcal vaccineHIV+ individuals , 21-40 years of age with a nadir CD4 count >200 to receive PCV13 vaccine followed 8 weeks later by PPV23 Intervention: 13 valent Pneumococcal conjugate vaccine (PCV13) followed 8 weeks later by 23 valent pneumococcal polysaccharide vaccine |
| HIV+ 21-40, CD4<200 PCV/PPV | Active comparator | Biological: Pneumococcal polysaccharide vaccine 23 valent, Biological: 13 valent conjugated pneumococcal vaccineHIV+ individuals , 21-40 years of age with a nadir CD4 count <200 to receive PCV13 vaccine followed 8 weeks later by PPV23 Intervention: 13 valent Pneumococcal conjugate vaccine (PCV13) followed 8 weeks later by 23 valent pneumococcal polysaccharide vaccine |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Previous immunization with pneumococcal vaccine less than 5 years ago
- pregnancy and absence of contraceptive practice in women of childbearing age and breast feeding
- known anaphylaxis, hypersensitivity to the pneumonia vaccine
- those who received blood products or gammaglobulin in last 3 months
- inability to comprehend or sihn informed consent
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 |
|---|---|---|
| Pneumococcal polysaccharide vaccine 23 valentAlso: PneumovaxThis is the pneumococcal vaccine consisting of the capsular polysaccharides of 23 serotypes of Streptococcus pneumoniae | Biological | HIV+ 21-40, CD4<200 PCV/PPV, HIV+ 21-40, CD4>200 PCV/PPV, HIV+ 50-65, CD4<200 PCV, HIV+ 50-65, CD4<200 PCV/PPV, HIV+ 50-65, CD4>200 PCV/PPV, HIV+ 50-65, CD4>200 PPV, HIV- 50-65, PCV/PPV, HIV- 50-65, PPV |
| 13 valent conjugated pneumococcal vaccineAlso: Prevnar 13This is the pneumococcal vaccine consisting of the capsular polysaccharides of 13 serotypes of Streptococcus pneumoniae conjugated to non-toxic diphtheria carrier protein 197 | Biological | HIV+ 21-40, CD4<200 PCV/PPV, HIV+ 21-40, CD4>200 PCV/PPV, HIV+ 50-65, CD4<200 PCV/PPV, HIV+ 50-65, CD4>200 PCV/PPV, HIV- 50-65, PCV/PPV |
Primary outcome
Antibody response
Time frame: Change in ug/mL from day 0 to 30 days after receipt of PPV23
Measure antibody response by ELISA (ug/mL)
opsonophagocytic antibody activity
Time frame: Change in opsonophagocytic titer from day 0 to 30 days after receipt of PPV23
opsonophagocytic antibody response measured by opsonophagocytic assay (OPA)
20 secondary outcomes
PPS-specific B cell phenotype
Time frame: Change from day 0 to day 7 post-vaccination
PPS-specific B cell phenotype
Time frame: Change from day 56 to day 63 post-vaccination
Expression of TACI on PPS-specific B cells
Time frame: change from day 0 to day 7
Expression of TACI on PPS-specific B cells
Time frame: change from day 56 to day 63
Expression of BAFFR on PPS-specific B cells
Time frame: change from day 0 to day 7
Expression of BAFFR on PPS-specific B cells
Time frame: change from day 56 to day 63
Expression of BCMA on PPS-specific B cells
Time frame: change from day 0 to day 7
Expression of BCMA on PPS-specific B cells
Time frame: change from day 7 to day 63
Expression of CD40 on PPS-specific B cells
Time frame: change from day 0 to day 7
Expression of CD40 on PPS-specific B cells
Time frame: change from day 56 to day 63
Expression of cluster of differentiation 21 (CD21) on PPS-specific B cells
Time frame: change from day 0 to day 7
Expression of CD21 on PPS-specific B cells
Time frame: change from day 56 to day 63
Serum interleukin-6 (IL-6)
Time frame: Day 0
Serum BAFF
Time frame: Day 0
Serum APRIL
Time frame: Day 0
Serum IL-10
Time frame: Day 0
Serum IL-1(RA)
Time frame: Day 0
Serum IL-1(B)
Time frame: Day 0
Serum IL-8
Time frame: Day 0
Serum TNFalpha
Time frame: Day 0
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 16 Jun 2020.
- Background: PubMed 20795819Crum-Cianflone NF, Huppler Hullsiek K, Roediger M, Ganesan A, Patel S, Landrum ML, Weintrob A, Agan BK, Medina S, Rahkola J, Hale BR, Janoff EN; Infectious Disease Clinical Research Program HIV Working Group. A randomized clinical trial comparing revaccination with pneumococcal conjugate vaccine to polysaccharide vaccine among HIV-infected adults. J Infect Dis. 2010 Oct 1;202(7):1114-25. doi: 10.1086/656147.
- Background: PubMed 18444818de Roux A, Schmole-Thoma B, Siber GR, Hackell JG, Kuhnke A, Ahlers N, Baker SA, Razmpour A, Emini EA, Fernsten PD, Gruber WC, Lockhart S, Burkhardt O, Welte T, Lode HM. Comparison of pneumococcal conjugate polysaccharide and free polysaccharide vaccines in elderly adults: conjugate vaccine elicits improved antibacterial immune responses and immunological memory. Clin Infect Dis. 2008 Apr 1;46(7):1015-23. doi: 10.1086/529142.
- Background: PubMed 20200385French N, Gordon SB, Mwalukomo T, White SA, Mwafulirwa G, Longwe H, Mwaiponya M, Zijlstra EE, Molyneux ME, Gilks CF. A trial of a 7-valent pneumococcal conjugate vaccine in HIV-infected adults. N Engl J Med. 2010 Mar 4;362(9):812-22. doi: 10.1056/NEJMoa0903029.
- Background: PubMed 20471437Baxendale HE, Keating SM, Johnson M, Southern J, Miller E, Goldblatt D. The early kinetics of circulating pneumococcal-specific memory B cells following pneumococcal conjugate and plain polysaccharide vaccines in the elderly. Vaccine. 2010 Jul 5;28(30):4763-70. doi: 10.1016/j.vaccine.2010.04.103. Epub 2010 May 14.
- Background: PubMed 20299956Penaranda M, Payeras A, Cambra A, Mila J, Riera M; Majorcan Pneumococcal Study Group. Conjugate and polysaccharide pneumococcal vaccines do not improve initial response of the polysaccharide vaccine in HIV-infected adults. AIDS. 2010 May 15;24(8):1226-8. doi: 10.1097/QAD.0b013e3283389de5.
- Background: PubMed 22271652Khaskhely N, Mosakowski J, Thompson RS, Khuder S, Smithson SL, Westerink MA. Phenotypic analysis of pneumococcal polysaccharide-specific B cells. J Immunol. 2012 Mar 1;188(5):2455-63. doi: 10.4049/jimmunol.1102809. Epub 2012 Jan 23.
- Derived from this study: PubMed 30797636Happe M, Samuvel DJ, Ohtola JA, Korte JE, Westerink MAJ. Race-related differences in functional antibody response to pneumococcal vaccination in HIV-infected individuals. Vaccine. 2019 Mar 14;37(12):1622-1629. doi: 10.1016/j.vaccine.2019.01.084. Epub 2019 Feb 21.
- Individual participant dataSharing planned: Yes. The data will be made available once analysis is completed through publications in peer reviewed journals.
Related trials for HIV Lipodystrophy
RecruitingObservational study
The LD Lync Study - Natural History Study of Lipodystrophy Syndromes
Lipodystrophy (Genetic or Acquired, Non HIV)
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 A. Julia Westerink, MD principal investigator
Medical University of South Carolina
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 Pneumococcal polysaccharide vaccine 23 valent and 13 valent conjugated pneumococcal vaccine in people with HIV Lipodystrophy and Aging, run by Medical University of South Carolina 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 0 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 16 Jun 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 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 (time frame: Change in ug/mL from day 0 to 30 days after receipt of PPV23). The study lists 2 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 NCT03039491, which also lists 7 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 16 Jun 2020.