title: HIV vaccine-induced sero-reactivity: a challenge for trial participants, researchers, and physicians.
abstract: Antibody-inducing vaccines are a major focus in the preventive HIV vaccine field. Because the most common tests for HIV infection rely on detecting antibodies to HIV, they may also detect antibodies induced by a candidate HIV vaccine. The detection of vaccine-induced antibodies to HIV by serological tests is most commonly referred to as vaccine-induced sero-reactivity (VISR). VISR can be misinterpreted as a sign of HIV infection in a healthy study participant. In a participant who has developed vaccine-induced antibodies, accurate diagnosis of HIV infection (or lack thereof) may require specialized tests and algorithms (differential testing) that are usually not available in community settings. Organizations sponsoring clinical testing of preventive HIV vaccine candidates have an ethical obligation not only to inform healthy volunteers about the potential problems associated with participating in a clinical trial but also to help manage any resulting issues. This article explores the scope of VISR-related issues that become increasingly prevalent as the search for an effective HIV vaccine continues and will be paramount once a preventive vaccine is deployed. We also describe ways in which organizations conducting HIV vaccine trials have addressed these issues and outline areas where more work is needed.
authors: Yegor
authors: Y
authors: Voronin
authors: Helene
authors: H
authors: Zinszner
authors: Carissa
authors: C
authors: Karg
authors: Katie
authors: K
authors: Brooks
authors: Robert
authors: R
authors: Coombs
authors: John
authors: J
authors: Hural
authors: Renee
authors: R
authors: Holt
authors: Pat
authors: P
authors: Fast
authors: Mary
authors: M
authors: Allen
mesh_terms: D016915:AIDS Vaccines / Q000276:immunology*; D000163:Acquired Immunodeficiency Syndrome / Q000175:diagnosis / Q000276:immunology / Q000821:virology; D002986:Clinical Trials as Topic; D015483:HIV Antibodies / Q000097:blood / Q000276:immunology*; D006679:HIV Seropositivity / Q000276:immunology*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007258:Informed Consent; D000069078:Seroconversion / Q000187:drug effects*
chemical_list: D016915:AIDS Vaccines; D015483:HIV Antibodies
keywords: HIV; VISP; VISR; Vaccine; Vaccine-induced sero-positivity; Vaccine-induced sero-reactivity
references: Transfusion. 2013 Jan;53 Suppl 1:124S-130S
references: 23301964
references: Immunol Rev. 2013 Jul;254(1):225-44
references: 23772623
references: N Engl J Med. 2013 Jul 25;369(4):389-91
references: 23883384
references: PLoS One. 2014;9(2):e87572
references: 24504509
references: Clin Vaccine Immunol. 2014 Mar;21(3):391-8
references: 24403525
references: Hum Vaccin Immunother. 2014;10(3):714-23
references: 24374365
references: Hum Vaccin Immunother. 2014;10(6):1734-46
references: 24637946
references: J Acquir Immune Defic Syndr. 2001 Jan 1;26(1):63-71
references: 11176270
references: AIDS Res Hum Retroviruses. 2001 May 20;17(8):667-74
references: 11429107
references: J Infect Dis. 2003 Mar 15;187(6):879-86
references: 12660933
references: J Acquir Immune Defic Syndr. 2004 May 1;36(1):604-12
references: 15097304
references: J Virol. 2006 Mar;80(5):2092-9
references: 16474117
references: MMWR Recomm Rep. 2006 Sep 22;55(RR-14):1-17; quiz CE1-4
references: 16988643
references: J Acquir Immune Defic Syndr. 2006 Nov 1;43(3):304-12
references: 17019363
references: AIDS Res Hum Retroviruses. 2008 Nov;24(11):1445-8
references: 19000023
references: J Clin Microbiol. 2010 Jan;48(1):281-5
references: 19906903
references: JAMA. 2010 Jul 21;304(3):275-83
references: 20639561
references: N Engl J Med. 2012 Apr 5;366(14):1275-86
references: 22475592
references: Transfus Apher Sci. 2012 Jun;46(3):341-2
references: 22475543
references: PLoS One. 2012;7(8):e41936
references: 22870265