Infection Clinical Trial
Phase 1, Randomized Controlled Dose Escalation, Safety and Immunogenicity Study of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine Adjuvanted With Monophosphoryl Lipid A (MPL) and Aluminum Hydroxide (AlOH) in Adults
|Start date||September 2010|
|Completion date||January 2013|
Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four
dosage levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with
monophosphoryl lipid A (MPL) and aluminum hydroxide (AlOH) compared to controls. Subjects
will receive two doses, by intramuscular (IM) injection, 28 days apart.
The hypotheses for this study are:
- The incidence of adverse events after vaccination with IM Norovirus Bivalent VLP Vaccine will be similar to the incidence of adverse events after other IM vaccines including CERVARIX® which contains MPL and AlOH.
- Two doses of IM Norovirus Bivalent VLP Vaccine will be more immunogenic than one dose.
- The post-vaccination serum antibody responses, the number of antibody secreting cells (ASC), including homing markers, and memory B-cell responses directed against norovirus antigens will be increased after IM Norovirus Bivalent VLP Vaccine compared to controls.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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