Altimmune Announces Initial Single-Dose Data from Its NasoShield Phase 1 Study
Studies funded by BARDA
The study included 145 healthy volunteers. Four single-dose cohorts of 30 subjects each were randomized to receive either one dose of NasoShield in amounts of 1x108 virus particles (vp), 1x109 vp, 1x1010 vp or 1x1011 vp, three doses of the currently licensed anthrax vaccine, or placebo. Based on initial data from the single-dose cohorts, NasoShield was safe and well-tolerated with no serious adverse events. The study also showed limited immunogenicity, possibly indicating that like other anthrax vaccines, NasoShield may require more than one dose.
“We were pleased to see NasoShield had a nearly identical safety profile compared to placebo in this first in man study and much better tolerated than BioThrax®, which uses a three dose schedule and is the only licensed anthrax vaccine. Additionally, with the ease of nasal delivery, no need for an adjuvant and ability for longer storage at refrigerated and room temperatures, we believe NasoShield remains the best anthrax vaccine candidate in development,” said
The NasoShield program is funded through a contract (HHSO100201600008C) with the
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Source: Altimmune, Inc.