Immune Response to Pneumococcal Vaccination in Aging HIV Positive Adults

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Brief Title

Immune Response to Pneumococcal Vaccination in Aging HIV Positive Adults

Official Title

Immune Response to Pneumococcal Vaccination in Aging HIV Positive Individuals

Brief 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 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:

        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

        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.

Study Phase

Early Phase 1

Study Type


Primary Outcome

Antibody response

Secondary Outcome

 PPS-specific B cell phenotype


HIV Lipodystrophy


Pneumococcal polysaccharide vaccine 23 valent

Study Arms / Comparison Groups

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


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

September 1, 2015

Completion Date

March 30, 2020

Primary Completion Date

March 30, 2020

Eligibility Criteria

        Inclusion Criteria:HIV+ 21-40 years of age HIV+ 50-65 years of age HIV- 50-65 years of age


        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




21 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Maria A. Julia Westerink, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID

MUSC vaccine study

Responsible Party


Study Sponsor

Medical University of South Carolina

Study Sponsor

Maria A. Julia Westerink, MD, Principal Investigator, Medical University of South Carolina

Verification Date

June 2020