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Objective:  Toll-like receptor-3 agonist Poly-ICLC has been known to activate immune cells and induce HIV replication in pre-clinical experiments. In this study we investigated if Poly-ICLC could be used for disrupting HIV latency while simultaneously enhancing innate immune responses.   Design:  This was a randomized, placebo-controlled, double-blinded trial in aviremic, cART-treated HIV-infected subjects. Participants ( n  = 15) were randomized 3:1 to receive two consecutive daily doses of Poly-ICLC (1.4 mg subcutaneously) vs. placebo. Subjects were observed for adverse events, immune activation, and viral replication.   Methods:  Besides primary outcomes of safety and tolerability, several longitudinal immune parameters were evaluated including immune cell phenotype and function via flowcytometry, ELISA, and transcriptional profiling. PCR assays for plasma HIV-1 RNA, CD4 +  T cell-associated HIV-1 RNA, and proviral DNA were performed to measure HIV reservoirs and latency.   Results:  Poly-ICLC was overall safe and well-tolerated. Poly-ICLC-related adverse events were Grade 1/2, with the exception of one Grade 3 neutropenia which was short-lived. Mild Injection site reactions were observed in nearly all participants in the Poly-ICLC arm. Transcriptional analyses revealed upregulation of innate immune pathways in PBMCs following Poly-ICLC treatment, including strong interferon signaling accompanied by transient increases in circulating IP-10 (CXCL10) levels. These responses generally peaked by 24–48 h after the first injection and returned to baseline by day 8. CD4 +  T cell number and phenotype were unchanged, plasma viral control was maintained and no significant effect on HIV reservoirs was observed.   Conclusions:  These finding suggest that Poly-ICLC could be safely used for inducing transient innate immune responses in treated HIV +  subjects indicating promise as an adjuvant for HIV therapeutic vaccines.   Trial Registration:   www.ClinicalTrials.gov , identifier: NCT02071095.

frontiers in immunology

Poly-ICLC, a TLR3 Agonist, Induces Transient Innate Immune Responses in Patients With Treated HIV-Infection: A Randomized Double-Blinded Placebo Controlled Trial