H7HLAII DNA vaccine for influenza prevention
An Open Label, Dose Escalation Phase I Trial to Assess Safety and Immunogenicity of the H7HLAII DNA Vaccine, Encoding Influenza Hemagglutinin H7 Directed to HLA Class II, for Prophylaxis of Pandemic Influenza Infection in Healthy Volunteers
This study is testing a new DNA vaccine for the H7N9 flu strain to see if it can safely help healthy people build strong protection against the virus.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Oslo) |
| Trial ID | NCT06046092 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and immune response of the H7HLAII DNA vaccine, which targets the H7N9 influenza strain. The vaccine is designed to be produced rapidly, addressing the slow production issues of traditional influenza vaccines. By genetically linking the influenza hemagglutinin to a targeting unit, it aims to enhance immunogenicity and induce strong antibody responses. The study will involve healthy volunteers who meet specific eligibility criteria and will assess the vaccine's effectiveness in generating protective antibodies against the H7N9 strain.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults without any underlying health conditions or medication requirements.
Not a fit: Patients with existing health issues or those requiring medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could provide a rapid and effective means of preventing pandemic influenza infections.
How similar studies have performed: Previous studies have shown promise with similar DNA vaccine approaches, particularly in animal models, but this specific vaccine is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Dag Kvale, MSc/PhD — Oslo University Hospital
- Study coordinator: Gunnveig Grødeland, PhD
- Email: Gunnveig.Grodeland@medisin.uio.no
- Phone: 47 41667705
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.