Safety, reactogenicity and immunogenicity of Francisella tularensis live vaccine strain in humans

H. M. El Sahly; R. L. Atmar; S. M. Patel; J. M. Wells; T. Cate; M. Ho; K. Guo; M. F. Pasetti; Dorothy E. Lewis; M. B. Sztein; W. A. Keitel

doi:10.1016/j.vaccine.2009.06.036

Safety, reactogenicity and immunogenicity of Francisella tularensis live vaccine strain in humans

H. M. El Sahly, R. L. Atmar, S. M. Patel, J. M. Wells, T. Cate, M. Ho, K. Guo, M. F. Pasetti, Dorothy E. Lewis, M. B. Sztein, W. A. Keitel

Research output: Contribution to journal › Article › peer-review

34 Scopus citations

Abstract

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 10⁵,10⁷ or 10⁹ cfu/ml or SQ at 10², 10³,10⁴ or 10⁵ cfu/ml; 14 subjects received placebo. All doses/routes were well tolerated. When compared to placebo, vaccination with 10⁷ SCAR and 10⁹ SCAR resulted in significantly higher serologic response frequencies, as measured by ELISA for IgG, IgM, IgA and microagglutination; whereas vaccination with 10⁵ SCAR, 10⁷ SCAR 10⁹ SCAR and 10⁵ SQ elicited a significantly higher interferon-γ response frequency.

Original language	English (US)
Pages (from-to)	4905-4911
Number of pages	7
Journal	Vaccine
Volume	27
Issue number	36
DOIs	https://doi.org/10.1016/j.vaccine.2009.06.036
State	Published - Aug 6 2009

Keywords

Clinical trial
Live vaccine strain
Safety and immunogenicity
Tularemia vaccine

ASJC Scopus subject areas

Molecular Medicine
Immunology and Microbiology(all)
veterinary(all)
Public Health, Environmental and Occupational Health
Infectious Diseases

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10.1016/j.vaccine.2009.06.036

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title = "Safety, reactogenicity and immunogenicity of Francisella tularensis live vaccine strain in humans",

abstract = "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 105,107 or 109 cfu/ml or SQ at 102, 103,104 or 105 cfu/ml; 14 subjects received placebo. All doses/routes were well tolerated. When compared to placebo, vaccination with 107 SCAR and 109 SCAR resulted in significantly higher serologic response frequencies, as measured by ELISA for IgG, IgM, IgA and microagglutination; whereas vaccination with 105 SCAR, 107 SCAR 109 SCAR and 105 SQ elicited a significantly higher interferon-γ response frequency.",

keywords = "Clinical trial, Live vaccine strain, Safety and immunogenicity, Tularemia vaccine",

author = "{El Sahly}, {H. M.} and Atmar, {R. L.} and Patel, {S. M.} and Wells, {J. M.} and T. Cate and M. Ho and K. Guo and Pasetti, {M. F.} and Lewis, {Dorothy E.} and Sztein, {M. B.} and Keitel, {W. A.}",

note = "Funding Information: Funding: Funding for the project was provided by The National Institute of Allergy and Infectious Diseases contracts N01-AI-25465 (Principal Investigator: Wendy A. Keitel) and N01-AI-30028 (Principal Investigator: Marcelo B. Sztein).",

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AU - Atmar, R. L.

AU - Patel, S. M.

AU - Wells, J. M.

AU - Cate, T.

AU - Ho, M.

AU - Guo, K.

AU - Pasetti, M. F.

AU - Lewis, Dorothy E.

AU - Sztein, M. B.

AU - Keitel, W. A.

N1 - Funding Information: Funding: Funding for the project was provided by The National Institute of Allergy and Infectious Diseases contracts N01-AI-25465 (Principal Investigator: Wendy A. Keitel) and N01-AI-30028 (Principal Investigator: Marcelo B. Sztein).

PY - 2009/8/6

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N2 - 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 105,107 or 109 cfu/ml or SQ at 102, 103,104 or 105 cfu/ml; 14 subjects received placebo. All doses/routes were well tolerated. When compared to placebo, vaccination with 107 SCAR and 109 SCAR resulted in significantly higher serologic response frequencies, as measured by ELISA for IgG, IgM, IgA and microagglutination; whereas vaccination with 105 SCAR, 107 SCAR 109 SCAR and 105 SQ elicited a significantly higher interferon-γ response frequency.

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Safety, reactogenicity and immunogenicity of Francisella tularensis live vaccine strain in humans

Abstract

Keywords

ASJC Scopus subject areas

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