Bivalent Norovirus Vaccine Study
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.
|Gastroenteritis Infection||Biological: Bivalent Norovirus Vaccine Biological: Saline||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||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|
- Safety as determined by the occurrence of local and systemic signs and symptoms [ Time Frame: seven days after vaccination for local signs and symptoms and 28 days post each dose for other adverse events. One year followup after last dose for SAEs and significant new medical conditions. ]Safety as determined by the occurrence of local and systemic signs and symptoms within seven days after vaccination as self reported by subjects via memory aid (Days 0 through 7 post each dose) and incidence of abnormal hematology and serum chemistry laboratory values. Safety will also be assessed by occurrence of Serious Adverse Events (SAEs) and onset of any significant new medical conditions for 365 days following the last study vaccination.
- Immunogenicity [ Time Frame: 28 days post dose 1 and 28 days post dose 2 ]Immunogenicity as determined by geometric mean titers, geometric mean fold rises, and seroconversion rate (4-fold rises) of anti-Norovirus VLP IgG, IgA and IgM antibody titers against the G I.1 and GII.4 VLPs separately before and after each dose.
|Study Start Date:||September 2010|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Experimental: Norovirus Bivalent (GI.1 and GII.4) VLP Vaccine||
Biological: Bivalent Norovirus Vaccine
2 Doses 28 days apart Cohort A: 18-49 Years
Cohort A1: IM Norovirus Bivalent VLP Vaccine (5/5 mcg)
Cohort A2: IM Norovirus Bivalent VLP Vaccine (15/15 mcg)
Cohort A3: IM Norovirus Bivalent VLP Vaccine (50/50 mcg)
Cohort A4: IM Norovirus Bivalent VLP Vaccine (150/150 mcg)
Cohort B: 50-64 years IM Norovirus Bivalent VLP Vaccine at the chosen dose from Cohort A
Cohort C: 65-85 years IM Norvirus Bivalent VLP Vaccine at the chosen dosage from Cohort A
Cohort D: 18-49 Years of Age IM Norovirus Bivalent VLP Vaccine at the Chosen Dosage from Cohort A
|Placebo Comparator: Saline||
Two doses 28 days apart
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168401
|United States, Maryland|
|Navy Medical Research Center|
|Silver Springs, Maryland, United States, 20910|
|United States, Missouri|
|Saint Louis University|
|Saint Louis, Missouri, United States, 63104|
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|