In short
Clinical trials investigating A/TURKEY/TURKEY/1/05 (H5N1)-LIKE STRAIN (NIBRG-23) are studying avian influenza vaccine immunity in adults. The main goals are to measure immune response, including safety-related study outcomes only as stated in the trial data, and to compare responses to avian and seasonal influenza vaccines. The trial is in Phase 3 and includes about 300 participants.
Key points
- Clinical trials investigating A/TURKEY/TURKEY/1/05 (H5N1)-LIKE STRAIN (NIBRG-23) are focused on avian influenza vaccine immunity. The available trial is a Phase 3 interventional study with 300 planned participants. It also includes seasonal influenza, showing that the study looks at immune responses across both avian and seasonal flu vaccines. The main endpoint is seroconversion after the second dose, measured with a microneutralization test. The brief summary also says the study evaluates both humoral and cell-mediated immune responses against the H5N1 2.3.4.4b clade.
Trial overview
The available clinical trial for A/TURKEY/TURKEY/1/05 (H5N1)-LIKE STRAIN (NIBRG-23) is titled Avian influenza vaccine immunity. It is an interventional study, which means researchers give study vaccines and then measure the body’s response. The trial is Authorised and planned for 300 participants.
Study objectives and endpoints
The main objective is to evaluate the humoral and cell-mediated immune responses induced by the customized avian influenza vaccine, with focus on the H5N1 2.3.4.4b clade. Humoral response means antibody-based protection, while cell-mediated response means immune cells are also being studied. The primary endpoint is the seroconversion proportion in all study subjects 3 weeks after the second dose, given at least 21 days after the first dose, and this is assessed by the microneutralization test.
Who can participate
The trial record does not give detailed inclusion or exclusion rules. What is clear from the record is that the study plans to include all study subjects in the final measurement of the main endpoint. The planned enrollment is 300, which shows the study is designed for a moderate-sized group.
Trial design and phase
This study is in Phase 3, which is a later stage of clinical research. Phase 3 studies usually involve more people than early studies and help researchers understand immune response results in a broader group. The study is focused on vaccine immunity rather than treatment of active illness.
Outcome measures in simple terms
Seroconversion means the blood test changes in a way that shows the body has made a measurable immune response after vaccination. In this trial, the researchers measure that response after the second dose, which is given at least 21 days after the first dose. The microneutralization test is the lab method used to check whether the antibodies can block the virus in the test setting.
Vaccine and condition context
The trial covers avian influenza and seasonal influenza. The intervention list includes several influenza vaccine products, including a zoonotic influenza vaccine for H5N1 and other seasonal influenza vaccines used for comparison. The brief summary states that the study is designed to evaluate immune responses against the H5N1 2.3.4.4b clade.