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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by 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 ] [ 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 ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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
US Military HIV Research Program
Investigators
Principal Investigator: Nancy Crum-Cianflone, MD, MPH NMCSD
  More Information

No publications provided by Uniformed Services University of the Health Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Health Authority: United States: Federal Government

Keywords provided by 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
Acquired Immunodeficiency Syndrome
Pneumonia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 16, 2014