HIV vaccine-induced sero-reactivity: A challenge for trial participants, researchers, and physicians

Yegor Voronin*, Helene Zinszner, Carissa Karg, Katie Brooks, Robert Coombs, John Hural, Renee Holt, Pat Fast, Mary Allen, Michael Busch, Ulrich Fruth, Hana Golding, Surender Khurana, Joseph Mulenga, Sheila Peel, Marco Schito, Nomampondo Barnabas, Christopher Bentsen, Barney Graham, Glenda GrayAndrew Levin, Margaret McCluskey, Robert O'Connell, Bill Snow, Mark Ware

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

31 Scopus citations


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.

Original languageEnglish
Pages (from-to)1243-1249
Number of pages7
Issue number10
StatePublished - 3 Mar 2015
Externally publishedYes


  • HIV
  • VISP
  • VISR
  • Vaccine
  • Vaccine-induced sero-positivity
  • Vaccine-induced sero-reactivity


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