Clinical evaluation of a vaccinia-vectored Hantaan virus vaccine

Autor: Alan L. Schmaljohn, Stephen A. Harrison, Connie S. Schmaljohn, David J. McClain, Peter L. Summers
Rok vydání: 2000
Předmět:
Zdroj: Journal of Medical Virology. 60:77-85
ISSN: 1096-9071
0146-6615
DOI: 10.1002/(sici)1096-9071(200001)60:1<77::aid-jmv13>3.0.co;2-s
Popis: We evaluated a vaccinia-vectored vaccine for hemorrhagic fever with renal syndrome in clinical trials. A Phase I dose-escalation study in 16 volunteers divided into four groups demonstrated that subcutaneous inoculation of approximately 10(7) plaque-forming units of the recombinant virus was safe and immunogenic. Vaccination of a fifth group of 12 volunteers indicated that neutralizing antibody titers to both vaccinia virus and Hantaan virus were enhanced after a second inoculation. Comparing two routes of vaccination showed that scarification effectively induced neutralizing antibodies in vaccinia virus-naive volunteers but that subcutaneous inoculation was superior to scarification in vaccinia virus-immune individuals. A Phase II, double-blinded, placebo-controlled clinical trial was conducted among 142 volunteers. Two subcutaneous vaccinations were administered at 4-week intervals. Neutralizing antibodies to Hantaan virus or to vaccinia virus were detected in 72% or 98% of vaccinia virus-naive volunteers, respectively. In contrast, only 26% of the vaccinia virus-immune volunteers developed neutralizing antibody responses to Hantaan virus. J. Med. Virol. 60:77-85, 2000. Published 2000 Wiley-Liss, Inc.
Databáze: OpenAIRE