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A/TURKEY/TURKEY/1/05 (H5N1)-LIKE STRAIN (NIBRG-23)

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.

Table of Contents

Trial overview

The available clinical trial for A/TURKEY/TURKEY/1/05 (H5N1)-LIKE STRAIN (NIBRG-23) is titled Avian influenza vaccine immunity.[1] It is an interventional study, which means researchers give study vaccines and then measure the body’s response.[1] The trial is Authorised and planned for 300 participants.[1]

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.[1] Humoral response means antibody-based protection, while cell-mediated response means immune cells are also being studied.[1] 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.[1]

Who can participate

The trial record does not give detailed inclusion or exclusion rules.[1] What is clear from the record is that the study plans to include all study subjects in the final measurement of the main endpoint.[1] The planned enrollment is 300, which shows the study is designed for a moderate-sized group.[1]

Trial design and phase

This study is in Phase 3, which is a later stage of clinical research.[1] Phase 3 studies usually involve more people than early studies and help researchers understand immune response results in a broader group.[1] The study is focused on vaccine immunity rather than treatment of active illness.[1]

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.[1] In this trial, the researchers measure that response after the second dose, which is given at least 21 days after the first dose.[1] The microneutralization test is the lab method used to check whether the antibodies can block the virus in the test setting.[1]

Vaccine and condition context

The trial covers avian influenza and seasonal influenza.[1] The intervention list includes several influenza vaccine products, including a zoonotic influenza vaccine for H5N1 and other seasonal influenza vaccines used for comparison.[1] The brief summary states that the study is designed to evaluate immune responses against the H5N1 2.3.4.4b clade.[1]

Trial ID Phase Condition studied Status Enrollment
2023-509178-44-00 Phase 3 Avian influenza and seasonal influenza Authorised 300

FAQ

  • What is being studied in trials of A/TURKEY/TURKEY/1/05 (H5N1)-LIKE STRAIN (NIBRG-23)? The trial is studying vaccine immunity against avian influenza, with a focus on the H5N1 2.3.4.4b clade. It also looks at seasonal influenza vaccine responses.
  • Who can take part in this trial? The source data does not give full eligibility rules. It does show that the study includes all study subjects, with a planned enrollment of 300 people.
  • What phase is the trial in? This study is in Phase 3. That means it is a later-stage clinical trial that is usually used to study how well a vaccine response works in a larger group.
  • What outcome is the trial measuring? The primary outcome is seroconversion proportion. This means the study checks how many people develop a measurable antibody response after vaccination.
  • How is the immune response measured? The study measures seroconversion 3 weeks after the second dose, which is given at least 21 days after the first dose. The result is assessed by the microneutralization test.

Ongoing Clinical Trials on A/TURKEY/TURKEY/1/05 (H5N1)-LIKE STRAIN (NIBRG-23)

  • Study on Immune Responses to Avian Influenza Vaccine with A/Turkey/Turkey/1/05 (H5N1)-Like Strain in Patients with Avian and Seasonal Influenza

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

Glossary

  • Avian influenza: Flu that mainly affects birds, but some strains can also be studied in people through vaccine trials.
  • Seasonal influenza: The usual flu that spreads each year in the community.
  • H5N1: A type of influenza virus subtype that is being studied in this vaccine trial.
  • Clade: A group within a virus family that shares similar features. The trial focuses on the H5N1 2.3.4.4b clade.
  • Phase 3: A later stage of clinical research that usually tests a study in a larger number of people.
  • Enrollment: The number of people planned to join the study.
  • Interventional study: A study where researchers give a vaccine or treatment and then measure the results.
  • Seroconversion: A change in blood tests that shows the body has made antibodies after vaccination.
  • Antibodies: Proteins made by the immune system that help fight infection.
  • Microneutralization test: A lab test used to measure how well antibodies can block a virus.
  • Humoral immune response: The part of the immune response that involves antibodies in the blood.
  • Cell-mediated immune response: The part of the immune response that uses immune cells to help fight infection.

References