TAK-214 a vaccine candidate uses virus-like particle (VLP) antigens, which are proteins that precisely mimic the outer surface of norovirus. The vaccine includes antigens from genotypes GI.1 and GII.4, to represent both of the genogroups that cause the majority of human illness.
TAK-214 is indicated to prevent moderate or severe acute gastroenteritis (AGE) due to norovirus, a common intestinal infection marked by watery diarrhea, vomiting, abdominal cramps, nausea and sometimes fever that may lead to clinically significant dehydration.
The vaccine candidate is administered as an intramuscular injection.
It is the only clinical-stage vaccine against norovirus under investigation at this time.
November 6, 2019: Study status was changed to Active, not recruiting. A Phase 2 clinical study is currently ongoing to evaluate descriptively the long-term immunogenicity of at least 1 NoV (TAK-214) vaccine administration.
Clinical Trial NCT03039790: Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults (Active)
- The drug being tested in this Phase 2 study is called NoV vaccine. NoV vaccine is being tested for protection against acute gastroenteritis (AGE) due to norovirus.
- The study will enroll a 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 a maximum of 5 years after primary NoV vaccination. Participants will have a maximum of 4 visits over 3 years.
Clinical Trial NCT02153112: Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine in Children (Completed)
- The vaccine being tested in this study is called norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine with aluminum hydroxide.
- The norovirus vaccine is being tested to assess different formulations of the vaccine that will then be further developed. This study will look at the number of antibodies to norovirus formed in children, toddlers and infants who are administered different formulations of the norovirus vaccine.
- The study enrolled 840 patients. Participants will be randomly assigned (by chance) to one of ten treatment groups—which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).
- In 6–12 month-old infants and children up to 4 years of age, robust immune responses to the bivalent norovirus VLP vaccine candidates were observed; the highest HBGA responses in both age cohorts were observed after two doses of the 50/150 μg formulation.
- Further clinical evaluation of these formulations is underway in infants < 6 months of age.
Clinical Trial NCT01609257: Norovirus Bivalent-Vaccine Efficacy Study (Completed)
- The purpose of this Phase 1/2 study is to determine whether the norovirus vaccine is effective in preventing acute gastroenteritis due to the experimental human Norovirus GII.4 challenge dose. The purpose is also to evaluate the safety of the vaccine and the immunogenicity of the vaccine.
- Takeda has published results of this challenge study, which showed that the candidate vaccine is generally well-tolerated, and had a clinically relevant impact on the symptoms and severity of norovirus illness after challenge.