Safety, reactogenicity and immunogenicity of Francisella tularensis live vaccine strain in humans.
We evaluated the safety, reactogenicity and immunogenicity of escalating doses of a new Francisella tularensis Live Vaccine Strain (LVS) lot by scarification (SCAR) or subcutaneously (SQ) in humans. Subjects (N=10/group) received one dose of LVS via SCAR at 10(5),10(7) or 10(9)cfu/ml or SQ at 10(2), 10(3),10(4) or 10(5)cfu/ml; 14 subjects received placebo. All doses/routes were well tolerated. When compared to placebo, vaccination with 10(7) SCAR and 10(9) SCAR resulted in significantly higher serologic response frequencies, as measured by ELISA for IgG, IgM, IgA and microagglutination; whereas vaccination with 10(5) SCAR, 10(7) SCAR 10(9) SCAR and 10(5) SQ elicited a significantly higher interferon-gamma response frequency.
El Sahly
H M
HM
Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, United States. hanae@bcm.edu
Atmar
R L
RL
Patel
S M
SM
Wells
J M
JM
Cate
T
T
Ho
M
M
Guo
K
K
Pasetti
M F
MF
Lewis
D E
DE
Sztein
M B
MB
Keitel
W A
WA
D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D001428:Bacterial Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005260:Female; D005604:Francisella tularensis / Q000276:immunology*; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007074:Immunoglobulin G / Q000097:blood; D007075:Immunoglobulin M / Q000097:blood; D007279:Injections, Subcutaneous; D007371:Interferon-gamma / Q000097:blood; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
D000907:Antibodies, Bacterial; D001428:Bacterial Vaccines; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D010919:Placebos; D014613:Vaccines, Attenuated; D007371:Interferon-gamma