The safety and tolerability of an HIV-1 DNA prime-protein boost vaccine (DP6-001) in healthy adult volunteers

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Center for Infectious Disease and Vaccine Research; Department of Anesthesiology

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AIDS Vaccines; Adjuvants, Immunologic; Adult; Female; Human Experimentation; Humans; Hypersensitivity, Delayed; Immunization, Secondary; Male; Saponins; Skin; Vaccines, DNA; Vaccines, Subunit; Vasculitis


Life Sciences | Medicine and Health Sciences


This report describes the safety observations following administration of a polyvalent DNA prime-protein boost HIV-1 vaccine formulated with adjuvant QS21. Local injection site reactions were the most common (65% of subjects), and included type IV delayed-type hypersensitivity (DTH) reactions at prior DNA inoculation sites in 12 of 28 (43%) subjects following protein vaccination. Systemic reactions revealed two cases of vasculitis temporally related to inoculation with recombinant Env protein+QS21 adjuvant. Questions remain regarding the cause of the vasculitis, but the unique DTH observation may have contributed to the high level of immune responses previously reported for this vaccine.

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Citation: Vaccine. 2008 Aug 18;26(35):4420-4. Epub 2008 Jun 25. Link to article on publisher's site

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