Studies & testing: Information on HIV vaccine studies and how to choose an accurate HIV test for people who may have VISP.
Upon receiving a prophylactic HIV vaccine, study participants will generate antibodies that bind to HIV‑1 proteins included in standard HIV serological tests.
Antibody-based tests, such as enzyme immunoassays (EIAs), Western blots, and rapid tests (including self-tests) are used globally as HIV screening tests because they are relatively inexpensive, easy to perform in many settings, and reliable.1 Health care providers using these assays without awareness for VISP could interpret a positive result as a true HIV infection.1 To avoid errors in the interpretation of test results (eg, “false positive” results), tests that detect viral components directly, such as PCR, must be used instead of or in addition to standard HIV screening tests.
Following administration of different experimental prophylactic HIV‑1 vaccines, VISP incidence varied from very low (no VISP) to very high (nearly 100%) at the end of the studies, depending on the specific vaccine administered and screening test used.2 The duration of VISP over time also varied from a few years to more than 2 decades.2,3 The Johnson & Johnson investigational HIV-1 vaccine regimen resulted in a prevalence of approximately 90% VISP at 120 weeks after the first vaccination.4 In addition, in an unpublished follow-up from the same study, VISP was still more than 90% prevalent at 6.5 years after the first vaccination.
References
1. Colón W, et al. HIV diagnostics and vaccines: it takes two to tango. J Infect Dis. 2024. doi: 10.1093/infdis/jiae113
2. Voronin Y, et al. HIV vaccine-induced sero-reactivity: a challenge for trial participants, researchers, and physicians. Vaccine. 2015. doi: 10.1016/j.vaccine.2014.10.040
3. Durier C, et al. Long-term safety and vaccine-induced seropositivity in healthy volunteers from HIV vaccine trials. AIDS. 2019. doi: 10.1097/QAD.0000000000002310
4. Lavreys L. Vaccine-induced seropositivity/reactivity (VISP/R) in participants of the APPROACH study (HIV-V-A004). Presented at: HIV Vaccine Trials Network (HVTN) Annual Meeting; October 19, 2022; Seattle, WA, USA.
Get testing: Find contact information for the Johnson & Johnson study in which your patient participated, and get testing provided at no cost to eligible former study participants.
If your patient has received an investigational HIV‑1 vaccine in one of the Johnson & Johnson studies, they might have VISP.
If your patient has received a Johnson & Johnson investigational HIV-1 vaccine, please see the list of contacts for HIV testing. Testing is provided at no cost to eligible former participants through the contacts provided. Depending on the country, there may be a reimbursement program for providers.
A list of clinical studies with an investigational prophylactic HIV-1 vaccine conducted by Johnson & Johnson, formerly known as Janssen Vaccines & Prevention B.V., is available at the link below.