H7HLAII DNA Influenza Vaccine

NCT06046092 | Unknown Phase 1 DMC

• 1 other identifier: 2022-500706-18-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess safety and immunogenicity of H7HLAII, a DNA vaccine encoding influenza hemagglutinin (HA) from influenza A/Shanghai/2/2013 (H7N9) directed to cells expressing human leukocyte antigen class II (HLAII) molecules, for prophylaxis of pandemic H7N9 influenza infection in healthy volunteers.

Conditions

Influenza A; Pandemic Influenza

Outcome Measures

Primary Outcomes (2)

• Solicited adverse events following vaccination

  Solicited injection site reactions: Redness, Swelling, Pain, Erythema, and Induration; Solicited systemic reactions: Fever, Sweating, Chill, Nausea, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, and Respiratory symptoms.

  10 days

• Abnormalities in physical examination, vital signs, and clinical laboratory tests

  Number of participants with aberrant results.

  6 months

Secondary Outcomes (2)

• Changes in virus neutralization assay titres relative to baseline

  6 months

• Changes in anti-H7 antibody levels relative to baseline

  6 months

Study Arms (1)

Vaccinated

EXPERIMENTAL

Participants will be allocated to one of 3 dose groups, each receiving two intradermal (i.d.) vaccinations with 0.12 mg, 0.60 mg, or 3.00 mg of H7HLAII, respectively.

Biological: H7HLAII

Interventions

H7HLAII BIOLOGICAL

DNA vaccine encoding influenza hemagglutinin (HA) from influenza A/Shanghai/2/2013 (H7N9) directed to cells expressing human leukocyte antigen class II (HLAII) molecules

Vaccinated

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Medical Conditions
• Ongoing or recent (\< 2 weeks) intercurrent febrile condition
• Previous reports of autoimmune disease
• Concurrent chronic active viral hepatitis B or C or HIV
• BMI\>30
• Persons with a history of anaphylaxis or serious reactions to a prior vaccination
• Persons with known hypersensitivity to any of the vaccine components
• Persons who have had a temperature \>38 °C during the previous 72 hours
• Persons who have had an acute respiratory infection during the last 7 days
• Persons who have abnormal electrocardiogram (ECG)
• Women who are pregnant or breast-feeding (women of child-bearing potential must have a negative pregnancy test at screening)
• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0372, Norway

RECRUITING

Related Publications (1)

• Grodeland G, Fredriksen AB, Loset GA, Vikse E, Fugger L, Bogen B. Antigen Targeting to Human HLA Class II Molecules Increases Efficacy of DNA Vaccination. J Immunol. 2016 Nov 1;197(9):3575-3585. doi: 10.4049/jimmunol.1600893. Epub 2016 Sep 26.

  PMID: 27671110 BACKGROUND

Study Officials

• Dag Kvale, MSc/PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gunnveig Grødeland, PhD

CONTACT

47 41667705; Gunnveig.Grodeland@medisin.uio.no

Dag Kvale, MD/PhD

CONTACT

+4795200709; Dag.Kvale@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Model Details: Open label, single arm dose escalation phase I trial

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: September 21, 2023
• Study Start: July 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)