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Clinical Trials

MainTitle

Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting

This study has been completed
Sponsor
Uniformed Services University of the Health Sciences

Collaborator
Infectious Diseases Clinical Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
US Military HIV Research Program

Information provided by (Responsible Party)
Dr. Nancy Crum-Cianflone, Uniformed Services University of the Health Sciences

ClinicalTrials.gov Identifier
NCT00622843

First received: February 13, 2008
Last updated: October 7, 2014
Last Verified: October 2014
History of Changes
Purpose

Purpose

Purpose: To study the immune response of the newly licensed pneumococcal conjugate vaccine (PCV) in comparison to the pneumococcal polysaccharide vaccine (PPV) to determine if a significantly better immunologic response to boosting can be elicited in patients previously vaccinated with PPV.

Condition Intervention Phase
HIV Infections
Streptococcus Pneumoniae

Biological : pneumococcal conjugate vaccine
Biological : pneumococcal polysaccharide vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: An Open-Label, Phase III, Randomized Study of Pneumococcal Conjugate Vaccination in HIV, in Comparison to Polysaccharide Vaccine Boosting in Previously Vaccinated Patients

Further study details as provided by Dr. Nancy Crum-Cianflone, Uniformed Services University of the Health Sciences:

Primary Outcome Measures

  • The measure of PPV and PCV efficacy will be assessed by the level of serotype-specific antibody levels, measured by ELISA. [ Time Frame: Day 14 after vaccination ]
  • The measure of PPV and PCV efficacy will be assessed by the level of serotype-specific antibody levels, measured by ELISA. [ Time Frame: Day 60 after vaccination ]
  • The measure of PPV and PCV efficacy will be assessed by the level of serotype-specific antibody levels, measured by ELISA. [ Time Frame: Day 180 after vaccination ]

Enrollment: 275
Study Start Date: December 2002
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Group 1
PCV, 210 patients
Biological: pneumococcal conjugate vaccine
    Prevnar is manufactured as a liquid preparation. Each 0.5 mL dose is formulated to contain:
    • 2 μg of each saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 μg of serotype 6B per dose (16 μg total saccharide); approximately 20 μg of CRM197 carrier protein; and 0.125 mg of aluminum per 0.5 mL dose as aluminum phosphate adjuvant. After shaking, the vaccine is a homogeneous, white suspension.

    Other Name: PCV
    Active Comparator: Group 2
    PPV, 110 patients
    Biological: pneumococcal polysaccharide vaccine

    PNEUMOVAX 23 is manufactured according to methods developed by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25 μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.

    Other Name: PPV
    Active Comparator: Group 3
    PPV, HIV-negative, 25 patients
    Biological: pneumococcal polysaccharide vaccine

    PNEUMOVAX 23 is manufactured according to methods developed by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25 μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.

    Other Name: PPV
    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years to 60 Years  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: Yes  

    Criteria

    Inclusion Criteria for HIV positive subjects:

      1. At least one prior PPV ≥ 3 and < 8 years ago, while HIV positive. There is no upper limit to the number of previously received PPVs.
      2. HIV-positive (except 25 HIV-negative persons as control group).
      3. Age between 18 and 60 years of age.
      4. Availability of patient to remain within the immediate area for the period of the study and be able to comply with protocol requirements.

      Exclusion Criteria for HIV positive subjects:
      1. Prior allergic reaction to the PPV
      2. Allergic to components of PCV, including diphtheria toxin.
      3. Pregnant or lactating females as defined by history or positive HCG urine test.
      4. History of chronic viral hepatitis or biochemical evidence to include pretreatment AST or ALT values greater than 3 fold higher than upper limit of normal, or a creatinine of greater than 1.8 mg/dl
      5. History of splenectomy
      6. Temperature of >38C
      7. Inability to ambulate for more than 1000 meters secondary to fatigue, pain or weakness.
      8. Patients in whom IM vaccination is not possible because of disease or medication. (e.g. hemophilia, coumadin therapy).
      9. Patients diagnosed with HIV wasting disease
      10. Viral load over 50,000 copies/ml.
      11. History or evidence of recent illicit drug or alcohol abuse.
      12. Use of immunosuppressive agents, to include corticosteroids and cancer chemotherapeutic agents.

      Inclusion Criteria for HIV negative subjects:
      1. HIV-negative by HIV ELISA within the last 12 months
      2. Age between 18 and 60 years of age.
      3. Availability of patient to remain within the immediate area for the period of the study and be able to comply with protocol requirements.

      Exclusion Criteria for HIV negative subjects:
      1. Prior PCV and/or PPV vaccination.
      2. Prior allergic reaction to the PPV
      3. Allergic to components of PCV, including diphtheria toxin.
      4. Pregnant or lactating females as defined by history or positive HCG urine test.
      5. History of chronic viral hepatitis or biochemical evidence to include pretreatment AST or ALT values greater than 3 fold higher than upper limit of normal, or a creatinine of greater than 1.8 mg/dl
      6. History of splenectomy
      7. Temperature of >38C
      8. Inability to ambulate for more than 1000 meters secondary to fatigue, pain or weakness.
      9. Patients in whom IM vaccination is not possible because of disease or medication. (e.g. hemophilia, coumadin therapy).
      10. History or evidence of recent illicit drug or alcohol abuse.
      11. Use of immunosuppressive agents, to include corticosteroids and cancer chemotherapeutic agents.
      12. Works in chain of command of primary/associate investigators.

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT00622843

    Locations

    United States, California
    Naval Medical Center San Diego
    San Diego, California, United States, 92134
    United States, District of Columbia
    Walter Reed Army Medical Center
    Washington, District of Columbia, United States, 20307
    United States, Hawaii
    Tripler Army Medical Center
    Tripler AMC, Hawaii, United States, 96859
    United States, Maryland
    National Naval Medical Center
    Bethesda, Maryland, United States, 20814
    United States, Texas
    San Antonio Military Medical Center
    Lackland AFB, Texas, United States, 78236
    United States, Virginia
    Naval Medical Center Portsmouth
    Portsmouth, Virginia, United States, 23708

    Sponsors and Collaborators

    Uniformed Services University of the Health Sciences
    Infectious Diseases Clinical Research Program
    National Institute of Allergy and Infectious Diseases (NIAID)
    US Military HIV Research Program

    Investigators

    Principal Investigator: Nancy Crum-Cianflone, MD, MPH NMCSD
    More Information

    More Information


    Responsible Party: Dr. Nancy Crum-Cianflone, Research Physician, Uniformed Services University of the Health Sciences  
    ClinicalTrials.gov Identifier: NCT00622843   History of Changes  
    Other Study ID Numbers: RV150 Prevnar  
    Study First Received: February 13, 2008  
    Last Updated: October 7, 2014  

    Keywords provided by Dr. Nancy Crum-Cianflone, Uniformed Services University of the Health Sciences:

    pneumococcal conjugate vaccine
    polysaccharide vaccine
    PPV
    PCV
    Streptococcus pneumoniae
    Prevnar
    Pneumovax
    HIV

    Additional relevant MeSH terms:
    HIV Infections
    Pneumonia
    Vaccines
    Heptavalent Pneumococcal Conjugate Vaccine

    ClinicalTrials.gov processed this data on October 23, 2017
    This information is provided by ClinicalTrials.gov.