Trial reportFrontiers in immunology2026
Therapeutic HIV-1 Tat vaccination promotes durable immune reconstitution and reservoir reduction in ART-treated adults with clade C infection: a 12-year follow-up study.
Trial report in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase Il, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Immunogenicity and Safety of a Therapeutic, Recombinant, Biologically Active HIV-1 Tat Protein Vaccine in HIV-Infected, Anti-Tat Negative, ARV-Treated Adult Volunteers
A Roll-over Observational Study for the Extended Follow-up of the Volunteers of the ISS T-003 Trial (ISS T-003 EF-UP)
A Roll-Over Observational Study for the Extended Follow-Up of the Volunteers of the ISS T-003 Trial (ISS T-003 EF-UP2020)
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Authors and funding
22 authors.
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Abstract
Introduction: Antiretroviral therapy (ART) suppresses HIV replication but fails to eradicate viral reservoirs or fully restore immune competence. Therapeutic vaccination targeting HIV-1 Tat, a key viral protein persistently expressed also during ART, may enhance immune reconstitution and limit reservoir maintenance. Long-term data in individuals infected with HIV-1 clade C, particularly in sub-Saharan Africa, are lacking. Methods: We conducted a 12-year extended follow-up of 161 ART-treated adults previously enrolled in a randomized, placebo-controlled phase 2 trial of therapeutic HIV-1 Tat vaccination in South Africa (ISS T-003; SANCTR n. DOH-27-0211-3351; ClinicalTrials.gov: NCT01513135). No booster immunizations were administered. Longitudinal outcomes included anti-Tat antibody (Ab) persistence, CD4 Results: Ninety-seven percent of vaccinees developed anti-Tat Abs after immunization, and 70% were still positive at the beginning of the extended follow-up (3 years). Among these, 39% maintained Ab responses for their entire observation period (median duration 4 years), and 17 participants (20%) remained anti-Tat Ab seropositive up to year 12. Moreover, both Ab durability and peak titers were greater in vaccinees than in naturally occurring antibodies in seroconverter placebos. Compared with placebo, Tat vaccination was associated with earlier and sustained CD4 Discussion: Therapeutic HIV-1 Tat vaccination induces long-lasting immunological benefits that extend beyond viral suppression achieved by ART alone, promoting durable immune reconstitution and progressive reservoir decay in clade C infection. These findings confirm results from a long-term follow-up of a parallel phase 2 trial in Italy, and both support Tat vaccination as a potential ART-intensifying strategy, particularly in populations with advanced immunosuppression or imperfect ART adherence. Trial registration: SANCTR n. DOH-27-0615-4948 and ClinicalTrials.gov: NCT02712489; and SANCTR n. DOH-27-072022-7347 and ClinicalTrials.gov: NCT05680948.
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