Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status and phase: Completed; Phase 3

Conditions: Streptococcus Pneumoniae; HIV Infections

Treatments: Biological: pneumococcal conjugate vaccine; Biological: pneumococcal polysaccharide vaccine

Study type: Interventional

Funder types: Other; NETWORK; Other U.S. Federal agency; NIH

Identifiers

NCT00622843

RV150 Prevnar

Details and patient eligibility

About

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.

Enrollment: 275 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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275 participants in 3 patient groups

Group 1

Experimental group

Description:

PCV, 210 patients

Treatment:

Biological: pneumococcal conjugate vaccine

Group 2

Active Comparator group

Description:

PPV, 110 patients

Treatment:

Biological: pneumococcal polysaccharide vaccine

Group 3

Active Comparator group

Description:

PCV, HIV-negative, 25 patients

Treatment:

Biological: pneumococcal conjugate vaccine