Immunogenicity and Safety of 13-Valent Pneumococcal Conjugate Vaccine in HIV-Infected Adults Previously Vaccinated With Pneumococcal Polysaccharide Vaccine.
BACKGROUND
Persons with human immunodeficiency virus (HIV) infection are at increased risk of pneumococcal disease. We evaluated the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine (PCV13) in this population.


METHODS
HIV-infected persons ≥ 18 years of age who were previously vaccinated with ≥ 1 dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23) and had CD4 cell counts ≥ 200 cells/mm(3) and HIV viral loads <50 000 copies/mL were enrolled in this 3-dose PCV13 open-label study.


RESULTS
A total of 329 subjects received ≥ 1 dose, and 279 received 3 doses administered at 6-month intervals. Increases in anticapsular polysaccharide immunoglobulin G concentrations and opsonophagocytic antibody titers were demonstrated 1 month after each of the 3 doses of PCV13. Antibody levels were generally similar after each dose. The responses were similar whether subjects had previously received 1 or ≥ 2 doses of PPSV23. Pain at the injection-site was the most common local reaction. Severe injection site or systemic events were uncommon.


CONCLUSIONS
Vaccination with PCV13 induces anticapsular immunoglobulin G and opsonophagocytic antibody responses in HIV-infected adults with prior PPSV23 vaccination and CD4 cell counts ≥ 200 cells/mm(3). The observations support the use of PCV13 in this population.


BACKGROUND
NCT00963235.
Weill Cornell Medical College, New York, New York.
Marshall J
MJ
Glesby
Pfizer Inc, Collegeville, Pennsylvania.
Wendy
W
Watson
Central Texas Clinical Research, Austin.
Cynthia
C
Brinson
University of Kentucky Medical Center, Lexington.
Richard N
RN
Greenberg
Quest Clinical Research, San Francisco, California.
Jacob P
JP
Lalezari
Baystate Medical Center, Springfield, Massachusetts.
Daniel
D
Skiest
inVentiv Health Clinical, Princeton, New Jersey.
Vani
V
Sundaraiyer
Pfizer Inc, Pearl River, New York.
Robert
R
Natuk
Pfizer Inc, Pearl River, New York.
Alejandra
A
Gurtman
Pfizer Inc, Pearl River, New York.
Daniel A
DA
Scott
Pfizer Inc, Pearl River, New York.
Emilio A
EA
Emini
Pfizer Inc, Pearl River, New York.
William C
WC
Gruber
Pfizer GmbH, Berlin, Germany.
Beate
B
Schmoele-Thoma
D000328:Adult; D000368:Aged; D000907:Antibodies, Bacterial / Q000097:blood; D001770:Blood Bactericidal Activity; D018791:CD4 Lymphocyte Count; D005260:Female; D006678:HIV / Q000302:isolation & purification; D015658:HIV Infections / Q000276:immunology*; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D008297:Male; D008875:Middle Aged; D009895:Opsonin Proteins / Q000097:blood; D010587:Phagocytosis; D011008:Pneumococcal Infections / Q000276:immunology / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D019562:Viral Load; D055815:Young Adult
C538862:13-valent pneumococcal vaccine; D000907:Antibodies, Bacterial; D007074:Immunoglobulin G; D009895:Opsonin Proteins; D022242:Pneumococcal Vaccines
adult; human immunodeficiency virus; immunogenicity; pneumococcal conjugate vaccine; pneumococcal polysaccharide vaccine