The safety and tolerability of an HIV-1 DNA prime-protein boost vaccine (DP6-001) in healthy adult volunteers.
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.
Kennedy
Jeffrey S
JS
Center for Infectious Disease and Vaccine Research, University of Massachusetts Medical School, Worcester, MA, USA. jsk07@health.state.ny.us
Co
Mary
M
Green
Sharone
S
Longtine
Karen
K
Longtine
Jaclyn
J
O'Neill
Melissa A
MA
Adams
Janice P
JP
Rothman
Alan L
AL
Yu
Qiao
Q
Johnson-Leva
Renita
R
Pal
Ranajit
R
Wang
Shixia
S
Lu
Shan
S
Markham
Phillip
P
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
D016915:AIDS Vaccines; D000276:Adjuvants, Immunologic; D012503:Saponins; D019444:Vaccines, DNA; D022223:Vaccines, Subunit; C078785:saponin QA-21V1