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Vaccine Induced Sero-Positivity/Reactivity Resources

Additional resources related to the Enterprise Timely Topics in HIV Vaccines meeting on vaccine induced sero-positivity/reactivity are available below.

Reference

Summary

Directly addressing Social issues

Suthon V, Archawin R, Chanchai C, John L, Wichuda K, Wiroj P, Hansa T, Pathom S, Pongnuwat SN, Silaporn P, Wimala I.

Impact of HIV vaccination on laboratory diagnosis: case reports.

BMC Infect Dis. 2002 Sep 10;2:19.

Two Thai HIV vaccine trial participants were incarcerated, and enrolled in a research study in prison that included HIV testing. Repeatedly tested ab+, WB+ or ind, PCR neg. Eventually, history of HIV vaccine trial participation was elicited, and HIV test results recognized to be VISP.

Mark K, Maenza J, Garcia D, Louis K, Alexander S, Moore E, Broder G, Wakfield S, McElrath M.

Educating Community Medical Providers about HIV Vaccine Induced Sero-positivity.

Poster: AIDS Vaccine 2009. 

VISP education program for medical and HIV test providers in Seattle. Presentations, written materials and slides adapted into required Washington state training courses reaching hundreds of HIV service providers.  Community consultation emphasized the importance of ensuring that that VISP education is not misconstrued as anti-HIV testing.

Belshe RB, Clements ML, Keefer MC, et al.: Interpreting HIV sero-diagnostic test results in the 1990s: Social risks of HIV vaccine studies in uninfected volunteers. NIAID AIDS Vaccine Clinical Trials Group.

Ann Intern Med 1994;121(8):584–589. 

Description of HIV testing to differentiate between vaccine response and true infection. Anecdotal accounts of social harms related to VISP, including in a soldier in the US military.

Van Braeckel E, Koutsoukos M, Bourguignon P, Clement F, McNally L, Leroux-Roels G.

Vaccine-induced HIV sero-positivity: a problem on the rise. J Clin Virol. 2011 Apr;50(4):334-7. 

Report of VISP from an HIV vaccine trial testing a p17, 24, RT, Nef fusion protein (GSK). "Study participants received a letter explaining that future HIV testing can give false positive results, and a certificate of trial participation containing information for physicians on the content of the vaccine, together with contact details of the investigator and the sponsor".

Immune Response Characterization and Follow-up

Aboud S, Munseri P, Joachim A, Bakari M, Nilsson C, Buma D, Aris EA, Lyamuya EF, Brave A, Robb M, Marovich M, Michael N, Wahren B, Biberfeld G, Mhalu F, Sandstrom E, for the HIVIS study group.

Persistence of vaccine-induced antibodies following HIV-1 DNA prime MVA boost vaccination among healthy Tanzanian volunteers.

Poster: AIDS Vaccine 2011. 

Report of VISP in a DNA-MVA HIV vaccine trial in Tanzania. VISP remained present at 22 mos post-vaccine.

Cooper CJ, Metch B, Dragavon J, Coombs RW, Baden LR; NIAID HIV Vaccine Trials Network (HVTN) Vaccine-Induced Sero-positivity (VISP) Task Force.

Vaccine-induced HIV sero-positivity/reactivity in non-infected HIV vaccine recipients.

JAMA. 2010 Jul 21;304(3):275-83.

Comprehensive analysis of 10 years of data from ~2000 participants enrolled in 27 HIV vaccine trials testing 25 different HIV vaccines administered alone or in various combinations..

"VISP is … common but highly variable, depending on the immunogenicity of the vaccine product, the HIV gene inserts, and the HIV testing kit used". VISP can be durable, present at 15 years post-vaccination.

Durier C, Desaint C, Silbermann B, Lelievre J-D, Slama L, Morineau-Le Houssine P, Cuzin L, Poizot-Martin I, Aboulker J-P, Launay O for the ANRS COV1-COHVAC Study Group.

Long term vaccine-induced HIV sero-positivity among HIV uninfected healthy volunteers in ANRS COV1-COHVAC cohort

Poster: CROI March 2011. 

Report of ANRS-COV1 CHOVAC, a study to evaluate the long term persistence of VISP in over 400 ANRS HIV vaccine trial participants.

Quirk EK, Mogg R, Brown DD, Lally MA, Mehrotra DV, DiNubile MJ, Robertson MN.

HIV sero-conversion without infection after receipt of adenovirus-vectored HIV type 1 vaccine.

Clin Infect Dis. 2008 Dec 15;47(12):1593-9.

Report of VISP in recipients of Mrk Ad5 HIV vaccines. Frequency of VISP was affected by vaccine dose and baseline anti-vector immunity.

Silbermann B, Tod M, Desaint C, Pialoux G, Petitprez K, Slama L, Poncelet H, Moreau C, Mazarin V, Heshmati F, Salmon-Ceron D, Guillet JG, Launay O.

Short communication: Long-term persistence of vaccine-induced HIV sero-positivity among healthy volunteers.

AIDS Res Hum Retroviruses. 2008 Nov;24(11):1445-8. 

Report of persistent VISP in ~75 individuals enrolled in several ANRS HIV vaccine trials testing rgp160 and/or ALVAC-HIV. "volunteers must be informed prior to trial enrollment of the risk of persistent vaccine-induced HIV sero-positivity and the potential psychological and social consequences. They should be offered long-term follow-up to monitor their serological evolution and to evaluate the consequences of their participation in such trials."

Technical aspects of Testing

Jentsch U, Lunga P, Lacey C, Weber J, Cairns J, Pinheiro G, Joseph S, Stevens W, McCormack S.

The Implementation and Appraisal of a Novel Confirmatory HIV-1 Testing Algorithm in the Microbicides Development Programme 301 Trial (MDP301).

PLoS ONE 2012 7(9): e42322.

Report of HIV screening tests for a microbicide trial in Africa. HIV antibody-positivity in 1 individual was eventually clarified as being due to VISP.

Khurana S, Needham J, Mathieson B, Rodriguez-Chavez IR, Catanzaro AT, Bailer RT, Kim J, Polonis V, Cooper DA, Guerin J, Peterson ML, Gurwith M, Nguyen N, Graham BS, Golding H.

Human immunodeficiency virus (HIV) vaccine trials: a novel assay for differential diagnosis of HIV infections in the face of vaccine-generated antibodies.

J Virol. 2006 Mar;80(5):2092-9.

Report on development of an antibody-based test to distinguish between VISP and HIV infection. Samples from several HIV vaccine trials were analyzed.

Peel S, Manak M, Rice K, Quick E, Malia J, Beale Y

HIV Testing Algorithms in the Laboratory: Performance of the U.S. Army HIV Diagnostics Algorithm.

Oral Abstract:  HIV Diagnostics Conference December 2012 

Summary of the US Army HIV diagnostic algorithm as applied to over 17 million HIV screening tests performed from 1990 to June 2011.

HIV TEST PACKAGE INSERT

Oraquick INHOME HIV Test,  Package Insert, Orasure Technologies, Inc, Bethlehem, PA (2012). 

16. What can cause a false positive result?

 …If you have participated in a HIV vaccine clinical trial …"

 

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