Broadening inclusion of vulnerable populations in HIV vaccine trials

References

• John-Stewart G, Mbori-Ngacha D, Epkini R. Breast-feeding and transmission of HIV-1. J. Acquir. Immune Defic. Syndr.35, 196–202 (2004).
   PubMed Web of Science ®Google Scholar
• Breastfeeding and HIV International Transmission Study Group (BHITS). Late postnatal transmission of HIV-1 in breast-fed children: an individual patient data meta-analysis. J. Infect. Dis.189, 2154–2166 (2004).
   Google Scholar
• De Cock KM, Fowler MG, Mercier E et al. Prevention of mother-to-child HIV transmission in resource-poor countries: translating research into policy and practice JAMA283, 1175–1182 (2000).
   PubMed Web of Science ®Google Scholar
• Nduati R, John G, Mbori-Ngacha D et al. Effect of breastfeeding and formula feeding on transmission of HIV-1: a randomized clinical trial. JAMA283(9), 1167–1174 (2000).
   PubMed Web of Science ®Google Scholar
• Safrit JT. HIV vaccines in infants and children: past trials, present plans and future perspectives. Curr. Mol. Med.3, 303–312 (2003).
   PubMed Web of Science ®Google Scholar
• Gall SA. Maternal immunization to protect the mother and neonate. Expert Rev. Vaccines4, 813–818 (2005).
   PubMed Web of Science ®Google Scholar
• Adkins B. Neonatal T cell function. J. Pediatr. Gastroenterol. Nutr.40, S5–S7 (2005).
   Google Scholar
• Hofmann-Lehmann R, Rasmussen RA, Vlasak J et al. Passive immunization against oral AIDS virus transmission: an approach to prevent mother-to-infant HIV-1 transmission? J. Med. Primatol.30(4), 190–196 (2001).
   PubMed Web of Science ®Google Scholar
• Lambert JS. HIV vaccines in infants and children. Pediatric Drugs7, 267–276 (2005).
   PubMedGoogle Scholar
• Rasmussen RA, Hofmann-Lehman R, Montefiori DC et al. DNA prime/protein boost vaccine strategy in neonatal macaques against simian human immunodeficiency virus. J. Med. Primatol.31, 40–60 (2002).
   PubMed Web of Science ®Google Scholar
• Van Rompay KK, Greenier JL, Cole KS. Immunization of newborn rhesus macaques with simian immunodeficiency virus (SIV) vaccines prolongs survival after oral challenge with virulent SIVmac251. J. Virol.77, 179–190 (2003).
   PubMed Web of Science ®Google Scholar
• Van Rompay KK, Abel K, Lawson JR et al. Attenuated poxvirus-based simian immunodeficiency virus (SIV) vaccines given in infancy partially protect infant and juvenile macaques against repeated oral challenge with virulent SIV. J. Acquir. Immune Defic. Syndr.38, 124–134 (2005).
   PubMed Web of Science ®Google Scholar
• Lambert JS, McNamara J, Katz SL et al. Safety and immunogenicity of HIV recombinant envelope vaccines in HIV-infected infants and children. National Institutes of Health-sponsored Pediatric AIDS Clinical Trials Group (ACTG-218). J. Acquir. Immune Defic. Syndr. Hum. Retrovirol.19, 451–461 (1998).
   PubMedGoogle Scholar
• Borkowsky W, Wara D, Fenton T et al. Lymphoproliferative responses to recombinant HIV-1 envelope antigens in neonates and infants receiving gp120 vaccines. AIDS Clinical Trial Group 230 Collaborators. J. Infect. Dis.181, 890–896 (2000).
   PubMed Web of Science ®Google Scholar
• McFarland E, Johnson D, Muresan P et al. Safety and cell-mediated immune responses to prime–boost immunization with ALVAC HIV vaccine and Aidsvax B/B in newborns of HIV-infected mothers (PACTG 326). Presented at: Conference on Retroviruses and Opportunistic Infections. Boston, MA, USA, 22–25 February 2005.
   Google Scholar
• Glezen WP. Effect of maternal antibodies on the infant immune response. Vaccine21, 3389–3392 (2003).
   PubMed Web of Science ®Google Scholar
• Shetty AK. Perinatally acquired HIV-1 infection: prevention and evaluation of HIV-exposed infants. Semin. Pediatr. Infect. Dis.16, 282–295 (2005).
   PubMedGoogle Scholar
• Zheng B-J, Ng M-H, He L-F et al. Therapeutic efficacy of hepatitis B surface antigen–antibodies-recombinant DNA composite in HBsAg transgenic mice. Vaccine19(30), 4219–4225 (2001).
   PubMed Web of Science ®Google Scholar
• US CDC. Deaths: preliminary data for 2002. In: National Vital Statistics Reports. 54(19), 1–52 (2006).
   Google Scholar
• Verthelyi D. Sex hormones as immunomodulators in health and disease. Int. Immunopharmacol.1, 983–993 (2001).
   PubMed Web of Science ®Google Scholar
• Jaspan HB, Lawn SD, Safrit JT, Bekker LG. The maturing immune system: implications for development and testing HIV-1 vaccines for children and adolescents. AIDS20, 483–494 (2006).
   PubMed Web of Science ®Google Scholar
• Steinbrook R. One step forward, two steps back – will there ever be an AIDS vaccine? N. Engl. J. Med.357(26), 2653–2655 (2007).
   PubMed Web of Science ®Google Scholar
• Chesney MA, Chambers DB, Kahn JO. Risk behavior for HIV infection in participants in preventive HIV vaccine trials: a cautionary note. J. Acquir. Immune Defic. Syndr. Hum. Retrovirol.16, 266–271 (1997).
   PubMedGoogle Scholar
• Buchbinder SB, Li J, Mehrotra D et al. Risk behavior change among high risk volunteers enrolled in the STEP HIV vaccine efficacy trial (Merck V520 Protocol 023 / HVTN 502). Presented at: AIDS Vaccine 2007. Seattle, WA, USA, 20–23 August 2007.
   Google Scholar
• Kapogiannis BG, Lee SS. Rolling up our sleeves now to reap the benefits later: preparing the community for an adolescent HIV vaccine. Curr. Opin. HIV AIDS2, 375–384 (2007).
   PubMed Web of Science ®Google Scholar
• Strode A, Grant C, Slack C, Mushariwa M. How well does South Africa’s National Health Act regulate research involving children? South Africa Med. J.95, 265–268 (2005).
   PubMed Web of Science ®Google Scholar
• Martins RM, Bensabath G, Arraes LC et al. Multicenter study of the immunogenicity and safety of two recombinant vaccines against hepatitis B. Mem. Inst. Oswaldo Cruz99, 865–871 (2004).
   PubMed Web of Science ®Google Scholar
• Heron LG, Chant KG Jalaludin BB. A novel hepatitis B vaccination regimen for adolescents: two doses 12 months apart. Vaccine20, 3472–3476 (2002).
   PubMed Web of Science ®Google Scholar
• Levie K, Beran J, Collard F et al. Long term (24 months) follow-up of a hepatitis A and B vaccine, comparing a two and a three dose schedule in adolescents aged 12–15 years. Vaccine20, 2579–2584 (2002).
   PubMed Web of Science ®Google Scholar
• Foy HM, Cooney MK, Allan ID, et al. Influenza B virus vaccines in children and adults: adverse reactions, immune response, and observation in the field. J. Infect. Dis.143, 700–706 (1981).
   PubMed Web of Science ®Google Scholar
• Nolan T, Block L, Reisinger KS et al. Comparison of the immunogenicity and tolerability of a preventive quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine in male and female adolescents and young adults women. Presented at: 23rd Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Valencia, Spain, 18–20 May 2005.
   Google Scholar
• UNAIDS/WHO. AIDS epidemic update, December 2004. Available on request from: UNAIDS, 1211 Geneva 27, Switzerland (2004).
   Google Scholar
• Panda S. HIV in IDUs: should we bother? Int. J. Drug Policy.14, 83–85 (2003).
   Google Scholar
• WHO-UNAIDS HIV Vaccine Advisory Committee. Approaches to the development of broadly protective HIV vaccines: challenges posed by the genetic, biological and antigenic variability of HIV-1. AIDS15, W1–W25 (2001).
   Google Scholar
• Aceijas C, Stimson GV, Hickman M, Rhodes, T. Global overview of injecting drug use and HIV infection among injection drug users. AIDS18, 2295–2303 (2004).
   PubMed Web of Science ®Google Scholar
• Baral S, Sherman SG, Millson P, Beyrer C. Vaccine immunogenicity in injecting drug users: a systematic review. Lancet Infect. Dis.7(10), 667–674 (2007).
   PubMed Web of Science ®Google Scholar
• Lu Y, Brosio P, Lafaile M et al. Vaginal transmission of chimeric simian/human immunodeficiency viruses in rhesus macaques. J Virol.70, 3045–3056 (1996).
   PubMed Web of Science ®Google Scholar
• Johnson RP, Lifson JD, Czajak, SC et al. Highly attenuated vaccine strains of simian immunodeficiency virus protect against vaginal challenge: inverse relationship of degree of protection with level of attenuation. J Virol.73, 4953–4961 (1999).
   Google Scholar
• Hu DJ, Subbarao S, Vanichseni S et al. Higher viral loads and other risk factors associated with HIV-1 seroconversion during a period of high incidence among injection drug users in Bangkok. J. AIDS30, 240–247 (2002).
   PubMed Web of Science ®Google Scholar
• Thapinta D, Jenkins RA. Starting from scratch: program development and lessons learned from HIV vaccine trial counseling in Thailand. Contemp. Clin. Trials28, 409–22 (2007).
   PubMed Web of Science ®Google Scholar
• Van Griensven F, Keawkungwal J, Tappero J et al. Lack of increased HIV risk behavior among injection drug users participating in the AIDSVAX B/E HIV vaccine trial in Bangkok, Thailand. AIDS18, 295–301 (2004).
   PubMed Web of Science ®Google Scholar