Pneumococcal Infections Clinical Trial
Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of GEN-004, a Pneumococcal Protein Subunit Vaccine, on Colonization Following Intranasal Challenge With S. Pneumoniae
This is a randomized, double-blind, placebo-controlled study. Eligible subjects will be
randomized in a 1:1 ratio to receive GEN-004 with adjuvant or placebo. Each subject will
receive up to 3 doses at 4 week intervals.
Following the third dose, subjects will be inoculated intranasally with S. pneumoniae
serotype 6B. Nasal washes to identify S. pneumoniae colonization will be obtained
pre-inoculation, and then 2, 7 and 14 days after inoculation.
Subjects will also be monitored for safety and tolerability throughout the dosing period, and
then for 12 months after their last dose.
The purpose of this study is to evaluate the effectiveness of GEN-004 in reducing
colonization rates and magnitude of colonization following the S. pneumoniae challenge.
n/a
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