What question did this study set out to answer?

To evaluate the safety, tolerability, and immunogenicity of the live, attenuated Francisella tularensis vaccine strain administered to laboratory personnel at risk of occupational exposure.

January 11, 2023Open Access

Longitudinal phase 2 clinical trials of live, attenuated tularemia vaccine in otherwise healthy research laboratory workers operating in containment laboratories

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Authors

DSDavid Saunders BPBenjamin C. Pierson JHJeannine Haller

Discussion

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Overview

Sequential single-arm phase 2 trials demonstrate high immunogenicity and safety of live attenuated tularemia vaccine in laboratory workers, indicating robust potency from decades-old lots.

Key Points

To evaluate the safety, tolerability, and immunogenicity of the live, attenuated Francisella tularensis vaccine strain administered to laboratory personnel at risk of occupational exposure.
Conducted two sequential FDA-regulated, non-randomized, single-arm phase 2 protocols (IND 157: FY03-24 from 2004–2008 and FY07-15 from 2009–2017) in containment laboratory workers.
Administered a single dose of the Live Vaccine Strain (LVS) by skin scarification, offering a second dose at week 4 to non-responders.
Evaluated vaccine take reactions at the scarification site and seroconversion using microagglutination (MA) titers (>1:20 in FY03-24; ≥4-fold rise in FY07-15).
All participants (100%) across both protocols developed positive scarification take reactions, with 95.5% responding to the primary dose in protocol FY03-24.
Positive microagglutination titers (>1:20) were achieved in 98% of subjects (all but 3) in protocol FY03-24, mostly within 28 to 35 days post-vaccination.
A 4-fold or greater rise in microagglutination titer was documented in 95% of subjects in protocol FY07-15, confirming high immunogenicity despite the use of vaccine lots manufactured 20 to 30 years prior.

Cite This Study

Saunders et al. (2023) studied this question.

synapsesocial.com/papers/6aa623de014c9b816df4e132 https://doi.org/10.1101/2023.01.09.23284371

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January 11, 2023Open Access

Longitudinal phase 2 clinical trials of live, attenuated tularemia vaccine in otherwise healthy research laboratory workers operating in containment laboratories

View Full Paper

Ask AI

Bookmark

Authors

DSDavid Saunders BPBenjamin C. Pierson JHJeannine Haller

Discussion

Member takes

Overview

Sequential single-arm phase 2 trials demonstrate high immunogenicity and safety of live attenuated tularemia vaccine in laboratory workers, indicating robust potency from decades-old lots.

Key Points

To evaluate the safety, tolerability, and immunogenicity of the live, attenuated Francisella tularensis vaccine strain administered to laboratory personnel at risk of occupational exposure.
Conducted two sequential FDA-regulated, non-randomized, single-arm phase 2 protocols (IND 157: FY03-24 from 2004–2008 and FY07-15 from 2009–2017) in containment laboratory workers.
Administered a single dose of the Live Vaccine Strain (LVS) by skin scarification, offering a second dose at week 4 to non-responders.
Evaluated vaccine take reactions at the scarification site and seroconversion using microagglutination (MA) titers (>1:20 in FY03-24; ≥4-fold rise in FY07-15).
All participants (100%) across both protocols developed positive scarification take reactions, with 95.5% responding to the primary dose in protocol FY03-24.
Positive microagglutination titers (>1:20) were achieved in 98% of subjects (all but 3) in protocol FY03-24, mostly within 28 to 35 days post-vaccination.
A 4-fold or greater rise in microagglutination titer was documented in 95% of subjects in protocol FY07-15, confirming high immunogenicity despite the use of vaccine lots manufactured 20 to 30 years prior.

Cite This Study

Saunders et al. (2023) studied this question.

synapsesocial.com/papers/6aa623de014c9b816df4e132 https://doi.org/10.1101/2023.01.09.23284371

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