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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
275
Prevnar is manufactured as a liquid preparation. Each 0.5 mL dose is formulated to contain: 2 μg of each saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 μg of serotype 6B per dose (16 μg total saccharide); approximately 20 μg of CRM197 carrier protein; and 0.125 mg of aluminum per 0.5 mL dose as aluminum phosphate adjuvant. After shaking, the vaccine is a homogeneous, white suspension.
PNEUMOVAX 23 is manufactured according to methods developed by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25 μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.
Naval Medical Center San Diego
San Diego, California, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Tripler Army Medical Center
Tripler AMC, Hawaii, United States
National Naval Medical Center
Bethesda, Maryland, United States
Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms
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.
Time frame: Day 14, 60, and 180 after vaccination
Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination
Time frame: Day 7 after vaccination
Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV.
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.
Time frame: Day 14, 60, and 180 after vaccination
Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response.
Number with ≥ Successes, which is defined as: Success = 2-fold increase on Log10 scale -- if log10(Day 60) - log10(Screening) \> log10(2)
Time frame: Day 60 after vaccination
Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV.
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.
Time frame: Day 14, 60, and 180 after vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
San Antonio Military Medical Center
Lackland Air Force Base, Texas, United States
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States