The safety and tolerability of an HIV-1 DNA prime-protein boost vaccine (DP6-001) in healthy adult volunteers
Center for Infectious Disease and Vaccine Research; Department of Anesthesiology
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.
DOI of Published Version
Vaccine. 2008 Aug 18;26(35):4420-4. Epub 2008 Jun 25. Link to article on publisher's site
Kennedy, Jeffrey S.; Co, Mary Dawn T.; Green, Sharone; Longtine, Karen J.; Longtine, Jaclyn K.; O'Neill, Melissa A.; Adams, Janice P.; Rothman, Alan L.; Yu, Qiao; Johnson-Leva, Renita; Pal, Ranajit; Wang, Shixia; Lu, Shan; and Markham, Phillip, "The safety and tolerability of an HIV-1 DNA prime-protein boost vaccine (DP6-001) in healthy adult volunteers" (2008). Open Access Articles. 1959.