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Safety and Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in 2- to 10-year-old Human Immunodeficiency Virus-infected Children

Siberry, George K. MD, MPH*; Warshaw, Meredith G. MSS, MA; Williams, Paige L. MS, PhD; Spector, Stephen A. MD; Decker, Michael D. MD, MPH§; Jean-Philippe, Patrick MD; Yogev, Ram MD; Heckman, Barbara E. BS**; Manzella, Adam MA**; Roa, Jhoanna MD††; Nachman, Sharon MD‡,‡; Lujan-Zilbermann, Jorge MD§,§; for the IMPAACT P1065 Protocol Team

Pediatric Infectious Disease Journal: January 2012 - Volume 31 - Issue 1 - p 47–52
doi: 10.1097/INF.0b013e318236c67b
HIV Reports

Background: Human immunodeficiency virus (HIV)-infected children are at increased risk of meningococcal infection and poor response to quadrivalent meningococcal conjugate vaccine (MCV4), but MCV4 has not been studied in preadolescent HIV-infected children.

Methods: The P1065 trial enrolled 2- to 10-year-old HIV-infected children with CD4 ≥25% to receive MCV4 at entry and at week 24. Rates of response (≥4-fold increase in rabbit serum bactericidal antibody) against each meningococcal serogroup (A, C, Y, W-135), geometric mean titers, and rates of seroprotection (rabbit serum bactericidal antibody titer ≥1:128) were determined from sera obtained at entry and weeks 4, 24, 28, and 72. Adverse events were assessed for 6 weeks after each MCV4 dose.

Results: At entry, 47% of the 59 participants were male, 56% black, 31% Latino, median age was 6 years, 88% were receiving antiretroviral therapy, and 75% had viral load <400 copies/mL. There were no serious adverse events within 6 weeks after MCV4 doses; all vaccination reactions were mild. Response after a single MCV4 dose was high to serogroup A (92%) and W-135 (98%); responses improved after a second dose for serogroup C (43%–80%) (P < 0.0001) and Y (76%–84%) (P = 0.38). By week 72, seroprotection rates were 93%, 91%, 78%, and 46% for serogroups W-135, Y, A, and C, respectively.

Conclusions: Two doses of MCV4 were safe and immunogenic in 2- to 10-year-old HIV-infected children. The second dose increased the proportion of children who made a response to serogroup C. Seroprotection waned substantially for serogroups A and C within 1 year of last MCV4 dose.

From the *Pediatric, Adolescent, and Maternal AIDS Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD; †Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, MA; ‡Department of Pediatrics, Division of Infectious Diseases, University of California, San Diego, and Rady Children's Hospital San Diego, La Jolla, CA; §Sanofi Pasteur Inc., Swiftwater, PA; ¶Henry Jackson Foundation for the Advancement of Military Medicine, National Institute of Allergy and Infectious Diseases, Division of AIDS, Bethesda, MD; ∥Section of Pediatric, Adolescent and Maternal HIV Infection, Children's Memorial Hospital, Chicago, IL; **Frontier Science and Technology Research Foundation, Amherst, NY; ††Social & Scientific Systems, Inc, Silver Spring, MD; ‡‡Division of Infectious Diseases, Department of Pediatrics, SUNY Stony Brook, Stony Brook, NY; and §§University of South Florida College of Medicine, Tampa, FL.

Accepted for publication August 22, 2011.

Overall support for the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) was provided by the National Institute of Allergy and Infectious Diseases (NIAID) (U01 AI068632), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Institute of Mental Health (NIMH) (AI068632). This work was supported by the Statistical and Data Analysis Center at Harvard School of Public Health, under the National Institute of Allergy and Infectious Diseases cooperative agreement 5 U01 AI41110 with the Pediatric AIDS Clinical Trials Group (PACTG) and 1 U01 AI068616 with the IMPAACT Group. Support of the sites was provided by the National Institute of Allergy and Infectious Diseases (NIAID) and the NICHD International and Domestic Pediatric and Maternal HIV Clinical Trials Network funded by NICHD (contract number N01-DK-9–001/HHSN267200800001C). This project has also been supported with Federal funds from the National Institute of Allergies and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272200800014C. Sanofi Pasteur Inc. provided study vaccine and performed meningococcal serum bactericidal antibody activity assays.

M.D.D. is an employee of Sanofi Pasteur, manufacturer of the vaccine evaluated in this study. S.A.S. holds stock in Sanofi Pasteur, manufacturer of the vaccine evaluated in this study. The authors have no other funding or conflicts of interest to disclose.

The views expressed do not necessarily reflect the official policies of the Department of Health and Human Services, nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.

Address for correspondence: George K. Siberry, MD, MPH, Pediatric, Adolescent, and Maternal AIDS (PAMA) Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 6100 Executive Boulevard, Room 4B11H, Bethesda, MD. E-mail: siberryg@mail.nih.gov.

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© 2012 Lippincott Williams & Wilkins, Inc.