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Norovirus vaccine safe, demonstrated immunogenicity
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SAN FRANCISCO — New data presented at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy suggest that a norovirus vaccine may be on the horizon.
John Treanor, MD, professor of medicine at the University of Rochester in New York, and colleagues conducted a study of an intramuscular bivalent norovirus vaccine-like particle (VLP) vaccine. The vaccine contained 50 mcg of a GI.1 VLP and 50 mcg of a GII.4 cVLP, as well as an adjuvant of 0.05 mg of monophosphoryl lipid A.
The randomized, double blind, placebo-controlled study included 73 adults: 35 aged 18 to 49 years, 19 aged 50 to 64 years and 19 aged 65 to 85 years. The participants were randomly assigned to receive two doses of vaccine or saline 4 weeks apart. The researchers analyzed local and systemic symptoms, unsolicited symptoms and adverse events. They also measured norovirus antibodies before vaccination and on days 7, 21, 28, 35 and 56 after vaccination. In addition, they measured antibody persistence at 6 months and 1 year.
After the first dose, antibody response to both the GI.1 and GII.4 VLPs were increased, but the second dose did not boost increases in immunity. Among adults aged 18 to 49 years, antibodies against the GI.1 VLP increased 118-fold. In adults aged 50 to 64 years, the antibodies increased 83-fold, and in adults aged 65 to 85 years, the antibodies increased 24-fold.
Antibodies against the GII.4 VLP increased by 49-fold among adults aged 18 to 49 years. Among adults aged 50 to 64 years, the antibodies increased 25-fold, and among adults aged 65 to 85 years, the antibodies increased ninefold. At day 393, increased antibodies persisted in adults aged 18 to 49 years for both GI.1 and GII.4.
Injection pain and tenderness were the most common symptoms. No participant experienced fever or vaccine-related adverse events.
For more information:
Treanor J. #G-1048. Presented at: 52nd ICAAC; Sept. 9-12, 2012; San Francisco.
Disclosure: The researchers report financial relationships with GlaxoSmithKline, Immune Targeting Systems, Ligocyte Pharmaceuticals, Novartis Sanofi, Pfizer, Protein Sciences and Roche.