Rapid Responses to 2 Virus-Like Particle Norovirus Vaccine Candidate Formulations in Healthy Adults: A Randomized Controlled Trial.

Autor:	Atmar, Robert L., Baehner, Frank, Cramer, Jakob P., Song, Eric, Borkowski, Astrid, Mendelman, Paul M., NOR-201 Study Group
Předmět:	NOROVIRUSES PUBLIC health -- Risk factors VACCINES VACCINATION IMMUNE response RESEARCH VIRAL vaccines HUMAN research subjects IMMUNOGLOBULINS VIRUSES CLINICAL trials TIME RESEARCH methodology IMMUNOMODULATORS EVALUATION research MEDICAL cooperation PLACEBOS INTRAMUSCULAR injections COMPARATIVE studies RANDOMIZED controlled trials NOROVIRUS diseases BLIND experiment RESEARCH funding RNA viruses VIRAL antibodies DRUG side effects
Zdroj:	Journal of Infectious Diseases; 9/15/2016, Vol. 214 Issue 6, p845-853, 9p
Abstrakt:	Background: Noroviruses pose a significant public health risk, particularly in very young individuals, older adults, and individuals with underlying conditions. We assessed 2 bivalent norovirus virus-like particle (VLP) vaccine candidate formulations in healthy adults aged 18-49 years.Methods: Enrolled subjects (n = 454) randomly assigned among 3 groups received intramuscular placebo (saline) or vaccines containing either 15 µg or 50 µg of GI.1 VLP and 50 µg GII.4 VLP (15/50 and 50/50 formulations) adjuvanted with monophosphoryl lipid A and Al(OH)3 We present safety and immunogenicity assessments up to 28 days after vaccination.Results: No vaccine-related serious adverse events or adverse events of special interest were reported. Reactions were mainly mild to moderate, the most frequent being transient pain, in 8%, 64%, and 73% of placebo, 15/50, and 50/50 groups, respectively; transient myalgia, headache, and fatigue were the commonest systemic adverse events. Subjects assessed per protocol (n = 442) displayed rapid immune responses to vaccination, peaking by days 7-10 and persisting through day 28. GI.1 responses were highest with the 50/50 formulation, but GII.4 responses were higher with the 15/50 formulation.Conclusions: Both candidate VLP vaccines were well tolerated and elicited robust immune responses by 7-10 days that persisted through day 28. The 15/50 formulation displayed the best balance of tolerability and immunogenicity.Clinical Trials Registration: NCT02142504. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
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