Immune Response to Pneumococcal Vaccination in Aging HIV Positive Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2020-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pneumonia Vaccine in Aging HIV Positive Individuals

NCT02558751

Pneumococcal Infection

COMPLETED EARLY_PHASE1

Antibodies and Memory Cells Role After Different Pneumococcal Vaccines in HIV Adults

NCT02357823

HIV Pneumococcal Infections

WITHDRAWN

Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Among HIV-infected Adults

NCT03838497

Streptococcal Pneumonia HIV/AIDS

COMPLETED PHASE4

Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS

NCT00963235

HIV Infections Pneumococcal Infections

COMPLETED PHASE3

Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine

NCT00962780

HIV Infections Pneumococcal Infections

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. 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.
2. 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

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Lipodystrophy Aging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HIV+ 50-65, CD4>200 PCV/PPV

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

Group Type EXPERIMENTAL

Pneumococcal polysaccharide vaccine 23 valent

Intervention Type BIOLOGICAL

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 23 serotypes of Streptococcus pneumoniae

13 valent conjugated pneumococcal vaccine

Intervention Type BIOLOGICAL

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 13 serotypes of Streptococcus pneumoniae conjugated to non-toxic diphtheria carrier protein 197

HIV+ 50-65, CD4<200 PCV/PPV

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

Group Type EXPERIMENTAL

Pneumococcal polysaccharide vaccine 23 valent

Intervention Type BIOLOGICAL

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 23 serotypes of Streptococcus pneumoniae

13 valent conjugated pneumococcal vaccine

Intervention Type BIOLOGICAL

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 13 serotypes of Streptococcus pneumoniae conjugated to non-toxic diphtheria carrier protein 197

HIV+ 50-65, CD4>200 PPV

HIV+ individuals , 50-65 years of age with a nadir CD4 count \>200 to receive PPV23 only

Intervention: 23 valent pneumococcal polysaccharide vaccine only

Group Type EXPERIMENTAL

Pneumococcal polysaccharide vaccine 23 valent

Intervention Type BIOLOGICAL

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 23 serotypes of Streptococcus pneumoniae

HIV+ 50-65, CD4<200 PCV

HIV+ individuals , 50-65 years of age with a nadir CD4 count \<200 to receive PPV23 only

Intervention: 23 valent pneumococcal polysaccharide vaccine only

Group Type EXPERIMENTAL

Pneumococcal polysaccharide vaccine 23 valent

Intervention Type BIOLOGICAL

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 23 serotypes of Streptococcus pneumoniae

HIV- 50-65, PCV/PPV

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

Group Type ACTIVE_COMPARATOR

Pneumococcal polysaccharide vaccine 23 valent

Intervention Type BIOLOGICAL

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 23 serotypes of Streptococcus pneumoniae

13 valent conjugated pneumococcal vaccine

Intervention Type BIOLOGICAL

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 13 serotypes of Streptococcus pneumoniae conjugated to non-toxic diphtheria carrier protein 197

HIV- 50-65, PPV

HIV- individuals, 50-65 years of age immunized with PPV23 only.

Intervention: 23 valent pneumococcal polysaccharide vaccine only

Group Type ACTIVE_COMPARATOR

Pneumococcal polysaccharide vaccine 23 valent

Intervention Type BIOLOGICAL

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 23 serotypes of Streptococcus pneumoniae

HIV+ 21-40, CD4>200 PCV/PPV

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

Group Type ACTIVE_COMPARATOR

Pneumococcal polysaccharide vaccine 23 valent

Intervention Type BIOLOGICAL

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 23 serotypes of Streptococcus pneumoniae

13 valent conjugated pneumococcal vaccine

Intervention Type BIOLOGICAL

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 13 serotypes of Streptococcus pneumoniae conjugated to non-toxic diphtheria carrier protein 197

HIV+ 21-40, CD4<200 PCV/PPV

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

Group Type ACTIVE_COMPARATOR

Pneumococcal polysaccharide vaccine 23 valent

Intervention Type BIOLOGICAL

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 23 serotypes of Streptococcus pneumoniae

13 valent conjugated pneumococcal vaccine

Intervention Type BIOLOGICAL

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 13 serotypes of Streptococcus pneumoniae conjugated to non-toxic diphtheria carrier protein 197

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pneumococcal polysaccharide vaccine 23 valent

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 23 serotypes of Streptococcus pneumoniae

Intervention Type BIOLOGICAL

13 valent conjugated pneumococcal vaccine

This is the pneumococcal vaccine consisting of the capsular polysaccharides of 13 serotypes of Streptococcus pneumoniae conjugated to non-toxic diphtheria carrier protein 197

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pneumovax Prevnar 13

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-

Exclusion Criteria

* 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes