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Norwalk Virus
Norwalk virus is a live attenuated viral vaccine candidate that stimulates immune responses against norovirus infection.
Norwalk virus is a live attenuated viral vaccine candidate that stimulates immune responses against norovirus infection. Used for Prevention of norovirus gastroenteritis.
At a glance
| Generic name | Norwalk Virus |
|---|---|
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Drug class | Live attenuated vaccine |
| Modality | Biologic |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Norwalk virus vaccine works by introducing a weakened or modified form of the norovirus to train the immune system to recognize and respond to natural norovirus infection. This approach aims to generate both humoral (antibody) and cellular immune responses that provide protection against acute gastroenteritis caused by norovirus. The vaccine is designed to prevent infection or reduce disease severity upon exposure to wild-type norovirus.
Approved indications
- Prevention of norovirus gastroenteritis
Common side effects
- Gastrointestinal symptoms (mild)
- Fever
- Fatigue
Key clinical trials
- Norovirus Challenge Study (PHASE1, PHASE2)
- Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model (PHASE1)
- Norovirus Bivalent-Vaccine Efficacy Study (PHASE1, PHASE2)
- Norwalk Vaccine Study (PHASE1, PHASE2)
- Phase 1 Norwalk Vaccine Study (PHASE1)
- New Challenge Pool of Norwalk Virus Inoculum (PHASE1)
- Infectivity of Norovirus in Shellfish Treated With High Hydrostatic Pressure Processing-Human Challenge Study (NA)
- Infectivity of Norovirus in Groundwater-Human Challenge Study (NA)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |