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Immunogenicity, Safety, and Predictors of Response After a Pneumococcal Conjugate and Pneumococcal Polysaccharide Vaccine Series in Human Immunodeficiency Virus-Infected Children Receiving Highly Active Antiretroviral Therapy

Abzug, Mark J. MD*; Pelton, Stephen I. MD; Song, Lin-Ye PhD; Fenton, Terence EdD; Levin, Myron J. MD*; Nachman, Sharon A. MD§; Borkowsky, William MD; Rosenblatt, Howard M. MD; Marcinak, John F. MD#; Dieudonne, Arry MD**; Abrams, Elaine J. MD††; Pathak, Indu MD‡‡for the Pediatric AIDS Clinical Trials Group P1024 Protocol Team

The Pediatric Infectious Disease Journal: October 2006 - Volume 25 - Issue 10 - p 920-929
doi: 10.1097/01.inf.0000237830.33228.c3
Original Studies

Background: The immunogenicity and safety of 2 doses of pneumococcal conjugate vaccine (PCV) and 1 dose of pneumococcal polysaccharide vaccine (PPV) were evaluated in human immunodeficiency virus (HIV)-infected children receiving highly active antiretroviral therapy (HAART).

Methods: Children 2 to <19 years, receiving stable HAART for ≥3–6 months, with HIV RNA PCR <30,000–60,000 copies/mL, received 2 doses of PCV and 1 dose of PPV at sequential 8-week intervals. Antibodies to pneumococcal serotypes (STs) 1 (PPV only) and 6B, 14, 19F, and 23F (PCV and PPV) were measured by ELISA.

Results: Two hundred sixty-three subjects were enrolled, of whom 225 met criteria for inclusion in the primary dataset. Antibody concentrations were low at entry, despite previous PPV in 75%. After vaccination, 76%–96% had concentrations ≥0.5 μg/mL and 62–88% ≥1.0 μg/mL to the 5 STs (geometric mean concentrations [GMCs] = 1.44–4.25 μg/mL). Incremental gains in antibody concentration occurred with each vaccine dose. Predictors of response included higher antibody concentration at entry, higher immune stratum (based on nadir CD4% before HAART and CD4% at screening), lower entry viral RNA, longer duration of the entry HAART regimen, and age <7 years. Response was more consistently related to screening CD4% than nadir CD4%. Seven percent had vaccine-related grade 3 events, most of which were local reactions.

Conclusions: Two PCVs and 1 PPV were immunogenic and safe in HIV-infected children 2 to <19 years who were receiving HAART. Responses were suggestive of functional immune reconstitution. Immunologic status based on nadir and, especially, current CD4% and control of HIV viremia were independent determinants of response.

Supplemental Digital Content is Available in the Text.

From the *University of Colorado School of Medicine and The Children's Hospital, Denver, CO; †Boston University School of Medicine and Boston Medical Center, Boston, MA; ‡Statistical and Data Analysis Center, Harvard School of Public Health, Boston, MA; §State University of New York at Stony Brook, Stony Brook, NY; ∥New York University Medical Center and Bellevue Hospital, New York, NY; ¶Baylor College of Medicine and Texas Children's Hospital, Houston, TX; #University of Chicago Comer Children's Hospital, Chicago, IL; **UMDNJ-New Jersey Medical School, Newark, NJ; ††Harlem Hospital Center, Columbia University, New York, NY; and the ‡‡Metropolitan Hospital Center, New York, NY.

Accepted for publication July 14, 2006.

This paper was supported in part by the Pediatric AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Disease and the Pediatric/Perinatal HIV Clinical Trials Network of the National Institute of Child Health and Human Development (NIAID sites supported by NIAID contract U01AI41089 and NICHD sites supported by NICHD contract N01-HD-3-3345). Also supported in part by the General Clinical Research Center Units funded by the National Center for Research Resources, National Institutes of Health. Wyeth-Ayerst Global Pharmaceuticals and GlaxoSmithKline Pharmaceuticals provided study vaccines.

Data presented in part at the Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, September 2003 (abstract #1548) and the Annual Meeting of the Infectious Disease Society of America, San Diego, CA, October 2003 (abstract #908).

Address for correspondence: Mark J. Abzug, MD, Pediatric Infectious Diseases, Box B055, The Children's Hospital, 1056 E. 19th Avenue, Denver, CO 80218. E-mail: abzug.mark@tchden.org.

© 2006 Lippincott Williams & Wilkins, Inc.