Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting - Full Text View

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
Information provided by:	Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:	NCT00622843

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 III

MedlinePlus related topics: AIDS Pneumonia

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines Aluminum Aluminum phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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 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: Measured at day 14, day 60 and day 180 after vaccination. ] [ Designated as safety issue: No ]

Estimated Enrollment:	345
Study Start Date:	December 2002
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental 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.
Group 2: Active Comparator 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.
Group 3: Active Comparator 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.

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:

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.
HIV-positive (except 25 HIV-negative persons as control group).
Age between 18 and 60 years of age.
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:

Prior allergic reaction to the PPV
Allergic to components of PCV, including diphtheria toxin.
Pregnant or lactating females as defined by history or positive HCG urine test.
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
History of splenectomy
Temperature of >38C
Inability to ambulate for more than 1000 meters secondary to fatigue, pain or weakness.
Patients in whom IM vaccination is not possible because of disease or medication. (e.g. hemophilia, coumadin therapy).
Patients diagnosed with HIV wasting disease
Viral load over 50,000 copies/ml.
History or evidence of recent illicit drug or alcohol abuse.
Use of immunosuppressive agents, to include corticosteroids and cancer chemotherapeutic agents.

Inclusion Criteria for HIV negative subjects:

HIV-negative by HIV ELISA within the last 12 months
Age between 18 and 60 years of age.
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:

Prior PCV and/or PPV vaccination.
Prior allergic reaction to the PPV
Allergic to components of PCV, including diphtheria toxin.
Pregnant or lactating females as defined by history or positive HCG urine test.
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
History of splenectomy
Temperature of >38C
Inability to ambulate for more than 1000 meters secondary to fatigue, pain or weakness.
Patients in whom IM vaccination is not possible because of disease or medication. (e.g. hemophilia, coumadin therapy).
History or evidence of recent illicit drug or alcohol abuse.
Use of immunosuppressive agents, to include corticosteroids and cancer chemotherapeutic agents.
Works in chain of command of primary/associate investigators.

Contacts and Locations

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:

Braden Hale, MD, MPH

NMCSD

More Information

Responsible Party:	IDCRP ( Braden Hale, MD )
Study ID Numbers:	RV150 Prevnar
Study First Received:	February 13, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00622843
Health Authority:	United States: Institutional Review Board

Keywords provided by Uniformed Services University of the Health Sciences:

pneumococcal conjugate vaccine
polysaccharide vaccine
PPV
PCV

Streptococcus pneumoniae
Prevnar
Pneumovax
HIV

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Respiratory Tract Infections
Respiratory Tract Diseases
HIV Infections
Lung Diseases

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Aluminum phosphate
Retroviridae Infections
Immunologic Deficiency Syndromes
Pneumonia

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009