An Open-Label, Phase III, Randomized Study of Pneumococcal Conjugate Vaccination in HIV, in Comparison to Polysaccharide Vaccine Boosting in Previously Vaccinated Patients
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 275
- Locations
- 6
- Primary Endpoint
- Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms
Study Overview
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 immunologic response to boosting can be elicited in patients previously vaccinated with PPV.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1
PCV, 210 patients
Intervention: pneumococcal conjugate vaccine (Biological)
Group 2
PPV, 110 patients
Intervention: pneumococcal polysaccharide vaccine (Biological)
Group 3
PCV, HIV-negative, 25 patients
Intervention: pneumococcal conjugate vaccine (Biological)
Outcomes
Primary Outcomes
Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms
Time Frame: Day 14, 60, and 180 after vaccination
The primary end point is greater than or equal to a 2-fold increase in the IgG level for at least 2 of the 4 serotypes on day 60, with levels greater than or equal to 1000 ng/mL.
Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination
Time Frame: Day 7 after vaccination
Secondary Outcomes
- Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response.(Day 60 after vaccination)
- Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV.(Day 14, 60, and 180 after vaccination)
- Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV.(Day 14, 60, and 180 after vaccination)
Investigators
Brian Agan
Deputy Science Director, IDCRP
Henry M. Jackson Foundation for the Advancement of Military Medicine