Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting

This study has been completed.
Sponsor:
Collaborators:
Infectious Diseases Clinical Research Program
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

February 13, 2008
October 7, 2014
December 2002
July 2013   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
The measure of PPV and PCV efficacy will be assessed by the level of serotype-specific antibody levels, measured by ELISA. [ Time Frame: Measured at day 14, day 60 and day 180 after vaccination. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00622843 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting
An Open-Label, Phase III, Randomized Study of Pneumococcal Conjugate Vaccination in HIV, in Comparison to Polysaccharide Vaccine Boosting in Previously Vaccinated Patients

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • HIV Infections
  • Streptococcus Pneumoniae
  • 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
  • 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
  • Experimental: Group 1
    PCV, 210 patients
    Intervention: Biological: pneumococcal conjugate vaccine
  • Active Comparator: Group 2
    PPV, 110 patients
    Intervention: Biological: pneumococcal polysaccharide vaccine
  • Active Comparator: Group 3
    PPV, HIV-negative, 25 patients
    Intervention: Biological: pneumococcal polysaccharide vaccine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
275
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00622843
RV150 Prevnar
Yes
Dr. Nancy Crum-Cianflone, Uniformed Services University of the Health Sciences
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
Principal Investigator: Nancy Crum-Cianflone, MD, MPH NMCSD
Uniformed Services University of the Health Sciences
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP