Phase 3
N=229
Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting
HIV Infections · Streptococcus Pneumoniae
Bottom Line
View on ClinicalTrials.gov: NCT00622843 ↗Enrolled (actual)
229
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms — 67; 23; 22; 37 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pneumococcal conjugate vaccine (Biological); pneumococcal polysaccharide vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms |
67; 23; 22; 37; 11; 16 | — |
| PRIMARY Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination |
80; 50; 1; 36; 17; 13 | — |
| SECONDARY Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV. |
40.17; 14.66; 13.20; 22.57; 29.65; 12.22 | — |
| SECONDARY Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response. |
8; 5; 22; 13; 38; 12 | — |
| SECONDARY Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV. |
-0.02; 0.03; -0.05; 0.08; -0.03; 0.01 | — |
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 immunologic response to boosting can be elicited in patients previously vaccinated with PPV.
Eligibility Criteria
Inclusion Criteria for HIV positive subjects:
- At least one prior PPV ≥ 3 and 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.
Data sourced from ClinicalTrials.gov (NCT00622843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.