MHSC
Senior Moderator
Early clinical trials show H7N9 flu vaccine safe, immunogenic
An adjuvanted H7N9 avian flu vaccine produced by Novavax, of Gaithersburg, Md., was well tolerated and immunogenic in a phase 1/2 clinical trial, the company said in a news release yesterday.
The randomized, placebo-controlled study of Novavax's virus-like particle (VLP) H7N9 vaccine candidate involved 610 volunteers. The trial tested VLP H7N9 vaccine with and without the company's Matrix-M adjuvant to boost immune response. Subjects received two doses of either placebo, 15 milligrams (mcg) of H7N9 VLP alone, or 3.75, 7.5, or 15 mcg of H7N9 VLP with Matrix-M.
The safety profile of the vaccine with and without Matrix-M was similar to the company's previous experience with another saponin-based adjuvant, according to the release. Novavax reported similar antibody response after two doses comparable to levels reported in prior studies with another saponin adjuvant.
"The vaccine also elicited anti-neuraminidase (NAI) antibodies against N9, with 89 to 100% sero-response rates in the adjuvanted vaccine groups, and greater than 11-fold increases in geometric mean titers," the company said. The company did not specify how it measured serologic response rates.
Novavax also said that the trial demonstrated dose-sparing possibilities, as even the 3.75-mcg dose with adjuvant induced immune response greater than the 15-mcg dose without adjuvant.
The Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services in 2011 awarded Novavax a contract worth up to $179 million for the advanced development of recombinant flu vaccine products and manufacturing capabilities as part of pandemic preparedness. This has included tests of its VLP influenza vaccines.
http://www.cidrap.umn.edu/news-perspective/2014/09/news-scan-sep-24-2014
An adjuvanted H7N9 avian flu vaccine produced by Novavax, of Gaithersburg, Md., was well tolerated and immunogenic in a phase 1/2 clinical trial, the company said in a news release yesterday.
The randomized, placebo-controlled study of Novavax's virus-like particle (VLP) H7N9 vaccine candidate involved 610 volunteers. The trial tested VLP H7N9 vaccine with and without the company's Matrix-M adjuvant to boost immune response. Subjects received two doses of either placebo, 15 milligrams (mcg) of H7N9 VLP alone, or 3.75, 7.5, or 15 mcg of H7N9 VLP with Matrix-M.
The safety profile of the vaccine with and without Matrix-M was similar to the company's previous experience with another saponin-based adjuvant, according to the release. Novavax reported similar antibody response after two doses comparable to levels reported in prior studies with another saponin adjuvant.
"The vaccine also elicited anti-neuraminidase (NAI) antibodies against N9, with 89 to 100% sero-response rates in the adjuvanted vaccine groups, and greater than 11-fold increases in geometric mean titers," the company said. The company did not specify how it measured serologic response rates.
Novavax also said that the trial demonstrated dose-sparing possibilities, as even the 3.75-mcg dose with adjuvant induced immune response greater than the 15-mcg dose without adjuvant.
The Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services in 2011 awarded Novavax a contract worth up to $179 million for the advanced development of recombinant flu vaccine products and manufacturing capabilities as part of pandemic preparedness. This has included tests of its VLP influenza vaccines.
http://www.cidrap.umn.edu/news-perspective/2014/09/news-scan-sep-24-2014