Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults
|ClinicalTrials.gov Identifier: NCT03039790|
Recruitment Status : Active, not recruiting
First Posted : February 1, 2017
Last Update Posted : November 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers Norovirus||Biological: NoV Vaccine||Phase 2|
The drug being tested in this study is called NoV vaccine. NoV vaccine is being tested for protection against acute gastroenteritis (AGE) due to norovirus.
The study will enroll maximum of 575 participants. Participants who previously received NoV vaccine in studies NOR-107, NOR-210 and NOR-204 will be enrolled. Participants from study NOR-107 will enter the study at the time of their 3rd year post-primary vaccination, and from studies NOR-210 and NOR-204, at their 2nd year post-primary vaccination. The duration of participation in the study will be different for each participant.
This multi-center trial will be conducted in Belgium and the United States. The overall time to participate in this study is maximum 5 years after primary NoV vaccination. Participants will have a maximum of 4 visits over 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||528 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Long-Term Immunogenicity Follow-up Trial of Adult and Elderly Subjects Who Have Previously Received an Intramuscular Injection of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine|
|Actual Study Start Date :||February 21, 2017|
|Estimated Primary Completion Date :||October 26, 2021|
|Estimated Study Completion Date :||October 26, 2021|
Experimental: NoV Vaccine
Participants who previously received NoV vaccine adjuvanted with aluminum as aluminum hydroxide or with monophosphoryl lipid A (MPL), injection, intramuscularly as planned in studies NOR-107, NOR-210 and NOR-204 will be assessed over 5 years post-primary vaccination. Vaccine formulations according to the parent trials: NOR-107, 210 and 204.
Biological: NoV Vaccine
No NoV vaccine injection administered.
- Geometric Mean Blocking Titers 50 percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies [ Time Frame: Up to 5 years post-primary vaccination ]GMBT50 of anti-norovirus GI. VLP antibody titers as measured by the histo-blood group antigen (HBGA) blocking assay.
- GMBT50 of Anti-norovirus GII.4 VLP Antibodies [ Time Frame: Up to 5 years post-primary vaccination ]GMBT50 of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA blocking assay.
- Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies [ Time Frame: Up to 5 years post-primary vaccination ]GMT of anti-norovirus GI.1 VLP antibody titers as measured by total immunoglobulin (pan-Ig) enzyme-linked immunoassay (ELISA).
- GMT of Anti-norovirus GII.4 VLP Antibodies [ Time Frame: Up to 5 years post-primary vaccination ]GMT of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039790
|United States, Alabama|
|Simon-Williamson Clinic/Synexus Clinical Research US, Inc|
|Birmingham, Alabama, United States, 35211|
|United States, Arizona|
|Synexus Clinical Research US, Inc./Fountain Hills Family Practice, P.C.|
|Fountain Hills, Arizona, United States, 85268|
|United States, Colorado|
|Synexus Clinical Research US, Inc/Southwest Family Medicine|
|Littleton, Colorado, United States, 80127|
|United States, Florida|
|Miami Research Associates|
|Miami, Florida, United States, 33143|
|United States, Kansas|
|Johnson County Clin-Trials|
|Lenexa, Kansas, United States, 66219|
|United States, Missouri|
|St. Louis University, School of Medicine|
|Saint Louis, Missouri, United States, 63106|
|United States, New York|
|Regional Clinical Research Inc.|
|Endwell, New York, United States, 13760|
|University of Rochester|
|Rochester, New York, United States, 14642|
|United States, Texas|
|Benchmark Research Austin|
|Austin, Texas, United States, 78705|
|Antwerpen, Belgium, 2610|
|Universitair Ziekenhuis Gent|
|Gent, Belgium, 9000|
|Study Director:||Medical Director||Takeda|