3.4.3. HIV testing
In 2006, the US CDC published its Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings, which specifically mentions participants in HIV vaccine trials: “Recipients of preventive HIV vaccines might have vaccine-induced antibodies that are detectable by HIV antibody tests. Persons whose test results are HIV positive and who are identified as vaccine trial participants might not be infected with HIV and should be encouraged to contact or return to their trial site or an associated trial site for the confirmatory testing necessary to determine their HIV status” [14]. Similar considerations are expected to be included in the updated 2014 guidelines (personal communication to authors from Michele Owen, CDC).
Recommended: in-country health authorities to ensure that national guidelines for HIV testing identify VISR as a potential confounder for interpreting serological test results.
In the US, the FDA works with manufacturers to include the following language about VISR in package inserts for HIV serological tests: “A person who has antibodies to HIV-1 is presumed to be infected with the virus except that a person who has participated in an HIV vaccine study may develop antibodies to the vaccine and may or may not be infected with HIV.” The World Health Organization could play a role in helping to ensure that similar advisory language is implemented worldwide, e.g. through its prequalification processes for medicinal products, including diagnostic tests.
Recommended: test manufacturers to include language about the possibility of VISR interference with testing in package inserts for commercially available serological HIV tests worldwide.