Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting

Phase 3

Completed

• Conditions: HIV Infections; Streptococcus Pneumoniae
• Interventions: Biological: pneumococcal conjugate vaccine; Biological: pneumococcal polysaccharide vaccine

• Registration Number: NCT00622843
• Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-22
• Study First Posted: 2008-02-25
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2018-07-18
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Results First Posted: 2025-06-08
• Last Update Posted: 2025-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	pneumococcal conjugate vaccine	PCV, 210 patients
Group 2	pneumococcal polysaccharide vaccine	PPV, 110 patients
Group 3	pneumococcal conjugate vaccine	PCV, HIV-negative, 25 patients

Primary Outcome Measures

Name	Time	Method
Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms	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	Day 7 after vaccination

Secondary Outcome Measures

Name	Time	Method
Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response.	Day 60 after vaccination	Number with ≥ Successes, which is defined as: Success = 2-fold increase on Log10 scale -- if log10(Day 60) - log10(Screening) \> log10(2)
Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV.	Day 14, 60, and 180 after vaccination	The pairwise change in CD4+ cell count from the time of screening to each time frame (day 14, day 60 and day 180 post-vaccination) (CD4+ cell count at day 14/60/180 \[minus\] CD4+ cell count at screening).; Analysis Population Description (further details): not all participants completed each follow-up visit. Therefore, a different number of participants analyzed is noted for each visit day. For example, in Group 1, 131 participants completed the screening visit but only 129 completed Day 14, and only 123 completed Day 60, etc.
Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV.	Day 14, 60, and 180 after vaccination	The pairwise change in viral load from the time of screening to each time frame (day 14, day 60 and day 180 post-vaccination), similar to CD4 change above.

Trial Locations

Locations (6)

Naval Medical Center San Diego; 🇺🇸 San Diego, California, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

Tripler Army Medical Center; 🇺🇸 Tripler AMC, Hawaii, United States

National Naval Medical Center; 🇺🇸 Bethesda, Maryland, United States

San Antonio Military Medical Center; 🇺🇸 Lackland Air Force Base, Texas, United States

Naval Medical Center Portsmouth; 🇺🇸 Portsmouth, Virginia, United States