H7HLAII DNA Influenza Vaccine

Launched by OSLO UNIVERSITY HOSPITAL · Sep 13, 2023

Keywords

ClinConnect Summary

The H7HLAII DNA Influenza Vaccine trial is studying a new vaccine intended to help protect against a specific type of flu, known as the H7N9 strain. This is important because H7N9 can cause serious illness during pandemics. The trial aims to find out if the vaccine is safe and if it can effectively stimulate the body’s immune response to fight the virus. They are currently looking for healthy volunteers aged between 65 and 74 years to participate.

To be eligible for this trial, participants must be in good health, meaning they should not have any ongoing medical issues or take medications regularly. Women who can become pregnant need to use effective birth control during the study and will have to take a pregnancy test before receiving the vaccine. If you decide to participate, you can expect to attend several scheduled visits where you will receive the vaccine and be monitored for any side effects. This study not only seeks to advance our understanding of flu vaccines but also hopes to contribute to better protection against future flu outbreaks.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy subjects, as concluded from the medical history, physical examination test including normal vital signs, and clinical judgment, without the need for medication.
• • For women with childbearing potential (WOCBP), defined as fertile following menarche and until becoming post-menopausal (i.e. no menses for 12 months without an alternative medical cause) unless permanently sterile by hysterectomy, bilateral salpingectomy and bilateral oophorectomy: Must use a highly effective contraceptive measures (from 4 weeks prior to the first vaccination until 4 weeks after the second vaccination), and a negative urine pregnancy test before administration of each dose of vaccine. Must agree to not donate eggs during the study and the first three months after their last study visit.
• • Able to understand and willing to sign the Informed Consent Form (ICF), which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• • Subjects able to understand and comply with the study protocol, including being able to attend the scheduled visits.
• Exclusion Criteria:
• • Medical Conditions
• • 1. Ongoing or recent (\< 2 weeks) intercurrent febrile condition
• • 2. Previous reports of autoimmune disease
• • 3. Concurrent chronic active viral hepatitis B or C or HIV
• • 4. BMI\>30
• • 5. Persons with a history of anaphylaxis or serious reactions to a prior vaccination
• • 6. Persons with known hypersensitivity to any of the vaccine components
• • 7. Persons who have had a temperature \>38 °C during the previous 72 hours
• • 8. Persons who have had an acute respiratory infection during the last 7 days
• • 9. Persons who have abnormal electrocardiogram (ECG)
• • 10. Women who are pregnant or breast-feeding (women of child-bearing potential must have a negative pregnancy test at screening)
• • 11. Have received any vaccination within the last month
• • Prior/Concomitant Therapy 12. Currently taking anti-inflammatory or immunosuppressive drugs 13. Currently taking antibiotics, steroids, phenytoin, chemotherapy, or other immunosuppressive drugs
• • Prior/Concurrent Clinical Study Experience 14. Persons who have participated in another clinical trial during the last month
• • Diagnostic assessments 15. Abnormal values of the hematologic and clinical chemistry parameters, as judged by the Investigator, including creatinine, AST, ALT (SGPT), bilirubin and alkaline phosphatase values above normal reference values 16. Positive autoantibodies (anti-nuclear antigens, rheumatoid factor) 17. Serum IgG and IgM lower or higher than the normal reference levels 18. Positive serology tests for hepatitis B or C with detectable hepatitis B HBsAg or DNA, or hepatitis C RNA 19. Positive HIV serology test