Status:
COMPLETED
Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting
Lead Sponsor:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborating Sponsors:
Infectious Diseases Clinical Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Streptococcus Pneumoniae
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00622843
Start Date
December 1 2002
End Date
July 1 2013
Last Update
June 8 2025
Active Locations (6)
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1
Naval Medical Center San Diego
San Diego, California, United States, 92134
2
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307
3
Tripler Army Medical Center
Tripler AMC, Hawaii, United States, 96859
4
National Naval Medical Center
Bethesda, Maryland, United States, 20814