Clinical evaluation of a vaccinia-vectored Hantaan virus vaccine.
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.
McClain
D J
DJ
Virology Division, United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, Frederick, MD 21702-5011, USA.
Summers
P L
PL
Harrison
S A
SA
Schmaljohn
A L
AL
Schmaljohn
C S
CS
D000914:Antibodies, Viral / Q000097:blood*; D004306:Dose-Response Relationship, Immunologic; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D005822:Genetic Vectors; D018063:Hantaan virus / Q000235:genetics / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary; D008213:Lymphocyte Activation; D009500:Neutralization Tests; D014611:Vaccination; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000276:immunology*; D014616:Vaccinia virus / Q000235:genetics*; D014765:Viral Vaccines / Q000008:administration & dosage / Q000235:genetics / Q000276:immunology*
D000914:Antibodies, Viral; D014614:Vaccines, Synthetic; D014765:Viral Vaccines