Safety Study of FluMist With and Without Ampligen

Summary

The purpose of this study is to evaluate FluMist with and without Ampligen in healthy volunteers.

Timeline

Start

2012-04

Primary completion

2014-09

Completion

2015-08

Publications

• Background Ichinohe T, Tamura S, Kawaguchi A, Ninomiya A, Imai M, Itamura S, Odagiri T, Tashiro M, Takahashi H, Sawa H, Mitchell WM, Strayer DR, Carter WA, Chiba J, Kurata T, Sata T, Hasegawa H. Cross-protection against H5N1 influenza virus infection is afforded by intranasal inoculation with seasonal trivalent inactivated influenza vaccine. J Infect Dis. 2007 Nov 1;196(9):1313-20. doi: 10.1086/521304. Epub 2007 Oct 5.
• Background Ichinohe T, Ainai A, Ami Y, Nagata N, Iwata N, Kawaguchi A, Suzaki Y, Odagiri T, Tashiro M, Takahashi H, Strayer DR, Carter WA, Chiba J, Tamura S, Sata T, Kurata T, Hasegawa H. Intranasal administration of adjuvant-combined vaccine protects monkeys from challenge with the highly pathogenic influenza A H5N1 virus. J Med Virol. 2010 Oct;82(10):1754-61. doi: 10.1002/jmv.21824.
• Results Overton ET, Goepfert PA, Cunningham P, Carter WA, Horvath J, Young D, Strayer DR. Intranasal seasonal influenza vaccine and a TLR-3 agonist, rintatolimod, induced cross-reactive IgA antibody formation against avian H5N1 and H7N9 influenza HA in humans. Vaccine. 2014 Sep 22;32(42):5490-5. doi: 10.1016/j.vaccine.2014.07.078. Epub 2014 Aug 13.

Drugs

Indications