Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting

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.