The authors thank the patients and their families for participating in this study, and also the research personnel for their assistance at the study sites.
Additional members of the P1065 Protocol Team include: Kenneth D. Braun, Jr., BA, Frontier Science and Technology Research Foundation, Amherst, NY; Greg Gilmet, MD, MPH, Sanofi Pasteur Inc., Swiftwater, PA; Adam Manzella, MA, Frontier Science and Technology Research Foundation, Amherst, NY; Donna Picard, RN, Department of Pediatrics, Lawrence Family Health Center/UMASS, Lawrence, MA; Paul Tran, RPh, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD; Scott Watson, RN, BS, Clinical Research Associate, Westat Inc., Rockville, MD.
Participating sites and site personnel include: 2802 NJ Medical School CRS (James Oleske, MD; Arlene Bardeguez, MD; Arry Dieudonne, MD; Linda Bettica, BSN); 3601 UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS (Nicole Falgout, RN, Joseph Geffen, Karin Nielsen, MD, MPH, Jaime Deville, MD); 3801 Texas Children's Hospital CRS (Chivon Jackson, RN, BSN; Shelley Buscher, RN, CMW; Faith Mingala, RN, BSN; Mary E. Paul, MD); 4101 Columbia IMPAACT CRS (Alice Higgins, RN, MPA; Andrea Jurgrau, RN, CPNP; Marc Foca, MD; Seydi Vasquez, RN); 4201 University of Miami Miller School of Medicine–Jackson Memorial Hospital (Gwendolyn B. Scott, MD; Charles D. Mitchell, MD; Patricia Bryan, RN; Claudia Florez, MD); 4601 UCSD Maternal Child and Adolescent HIV CRS (Rolando M. Viani, MD, MTP; Jeanne Manning, RN; Kim Norris, RN); 4701 DUMC Ped. CRS (Margaret Donnelly, PA; Joan Wilson, RN; Mary Jo Hassett, RN; Kathleen McGann, MD); 5012 NYU NY Site (Aditya Kaul, MD; Sulachni Chandwani, MD; William Borkowsky, MD; Nagamah Deygoo, MS); 5013 Jacobi Medical Center Bronx Site (Andrew Wiznia, MD; Marlene Burey, RN; Jorge Sansary, MD; Francisco Reinoso, RN); 5017 Seattle Children's Hospital Site (Ann J. Melvin, MD, MPH; Lisa M. Frenkel, MD; Joycelyn Thomas, RN, BSN); 5018 USF–Tampa Site (Denise Casey, RN; Carolyn Graisbery, RN; Gail Lewis, RN; Carina Rodriguez, MD); 5031 San Juan City Hospital PR Site (Midnela Acevedo-Flores, MD; Milagros González-Díaz, MD; Lizbeth Fábregas, BS, MS; Orlando Alonso, MD); 5040 SUNY Stony Brook Site (Denise Ferraro, RN, CCRC, BS; Erin Infanzon; Michele Kelly, RN, PNP); 5041 Children's Hopsital of Michigan Site (Ellen C. Moore, MD; Chokechai Rongkavilit, MD; Elizabeth Secord, MD; Ulyssa Hancock, RN, BSN); 5044 Howard University Washington DC Site (Sohail Rana, MD; Helga Finke-Castro, MD; Meseret Deressa, MD; Connie Nguyen, RPh); 5048 USC LA Site (James Homans, MD; Andrea Kovacs, MD; LaShonda Spencer, MD; Michael Neely, MD); 5051 University of Florida Jacksonville Site (Mobeen H. Rathore, MD; Nizar M. Araqa, MD; Kathy Thoma, MA; Chas Griggs, MEd, CCRP); 5052 University of Colorado Denver Site (Myron J. Levin, MD; Emily Barr, CPNP, CNM, MSN; Megan Canon; Jason Child, PharmD); 5055 South Florida CDC Ft. Lauderdale Site (Ana M. Puga, MD; Kathleen Graham, PharmD; Kevin Brown, RN; Carol Owens, RN); 5057 Strong Memorial Hospital Rochester NY Site (Geoffrey A. Weinberg, MD; Barbra Murante, RN, MS, PNP; Susan Laverty, RN; Francis Gigliotti, MD); 5090 Children's Hospital of Los Angeles Site (Marvin Belzer, MD; Johanna Olson, MD; Diane Tucker, MSN; Nancy Flores); 6501 St. Jude/UTHSC CRS (Jill Utech RN, MSN, CCRC; Nehali Patel, MD; Lennie Lott, RN; Aditya H. Gaur, MD); 6601 Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS (Irma Febo, MD; Licette Lugo, MD, Ruth Santos, RN; Maritza Cruz); 6701 The Children's Hospital of Philadelphia IMPAACT CRS (Steven D. Douglas, MD; Richard M. Rutstein, MD; Carol A. Vincent, CRNP, MSN; Patricia C. Coburn, RN, BSN); 6901 Bronx-Lebanon Hospital IMPAACT CRS (Aida Matias, RN; Mavis Dummitt, RN; Stefan Hagmann, MD; Murli Purswani, MD); 7301 WNE Maternal Pediatric Adolescent AIDS CRS (Richard Moriarty, MD; Katherine Luzuriaga, MD; Jesica Pagano-Therrien, RN); 4001 Chicago Children's Memorial Hospital (Ram Yogev, MD).
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) the NICHD International and Domestic Pediatric and Maternal HIV Clinical Trials Network funded by NICHD (contract number N01-DK-9-001/HHSN267200800001C). Additional support for this work was provided 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.