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Results Study remains blinded. Transient local and systemic reactogenicity occurred, without vaccine-related serious adverse events to date. Gag p24-specific IgG was induced in 9/15 (60%, 9 received vaccine plus adjuvant) volunteers in both low dose and mid dose groups at weeks 4, 8, 12, and 16. IgG titers were higher in the mid dose group and responses persisted for at least 6 months after last low dose immunization. Gag-specific CD4+ T cells were also detected following immunizations. IL-2 and TNF-a were the predominant cytokines. For CD4+ cells producing IL-2 or TNF-a, the response rates ranged from 33 to 46% (5-7/15 volunteers, 9 received vaccine plus adjuvant) and 8 to 40% (1-6/15 volunteers) post-vaccination in the low and mid dose groups respectively. Among positive responders, the median magnitude across visits ranged from 0.09% to 0.23% in the low dose group and from 0.06% to 0.17% in the mid dose group.

In vivo targeting of HIV gag to dendritic cells in combination with poly ICLC is safe and immunogenic in healthy volunteers