title: The safety and tolerability of an HIV-1 DNA prime-protein boost vaccine (DP6-001) in healthy adult volunteers.
abstract: 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.
authors.affiliation: Center for Infectious Disease and Vaccine Research, University of Massachusetts Medical School, Worcester, MA, USA. jsk07@health.state.ny.us
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Kennedy
authors.forename: Mary
authors.initials: M
authors.lastname: Co
authors.forename: Sharone
authors.initials: S
authors.lastname: Green
authors.forename: Karen
authors.initials: K
authors.lastname: Longtine
authors.forename: Jaclyn
authors.initials: J
authors.lastname: Longtine
authors.forename: Melissa A
authors.initials: MA
authors.lastname: O'Neill
authors.forename: Janice P
authors.initials: JP
authors.lastname: Adams
authors.forename: Alan L
authors.initials: AL
authors.lastname: Rothman
authors.forename: Qiao
authors.initials: Q
authors.lastname: Yu
authors.forename: Renita
authors.initials: R
authors.lastname: Johnson-Leva
authors.forename: Ranajit
authors.initials: R
authors.lastname: Pal
authors.forename: Shixia
authors.initials: S
authors.lastname: Wang
authors.forename: Shan
authors.initials: S
authors.lastname: Lu
authors.forename: Phillip
authors.initials: P
authors.lastname: Markham
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000328:Adult; D005260:Female; D006805:Human Experimentation; D006801:Humans; D006968:Hypersensitivity, Delayed / Q000209:etiology; D007117:Immunization, Secondary / Q000009:adverse effects*; D008297:Male; D012503:Saponins / Q000008:administration & dosage; D012867:Skin / Q000473:pathology; D019444:Vaccines, DNA / Q000008:administration & dosage / Q000009:adverse effects*; D022223:Vaccines, Subunit / Q000008:administration & dosage / Q000009:adverse effects; D014657:Vasculitis / Q000209:etiology
chemical_list: D016915:AIDS Vaccines; D000276:Adjuvants, Immunologic; D012503:Saponins; D019444:Vaccines, DNA; D022223:Vaccines, Subunit; C078785:saponin QA-21V1