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

Autor: Ranajit Pal, Melissa A. O'Neill, Janice P. Adams, Shan Lu, Renita Johnson-Leva, Jaclyn K. Longtine, Mary Dawn T. Co, Phillip D. Markham, Sharone Green, Qiao Yu, Shixia Wang, Jeffrey S. Kennedy, Alan L. Rothman, Karen J. Longtine
Rok vydání: 2008
Předmět:
Zdroj: Vaccine. 26:4420-4424
ISSN: 0264-410X
DOI: 10.1016/j.vaccine.2008.05.090
Popis: 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.
Databáze: OpenAIRE