A Phase IIb trial to examine the immune system response and safety of the FLU-v vaccine administered to healthy adults

Phase 1

• Conditions: Influenza A and/or B; MedDRA version: 19.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-001932-38-NL
• Lead Sponsor: PepTcell Limited (trading as SEEK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-20
• Study Completion: 2017-07-18
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

- Healthy males or healthy non-pregnant females (as indicated by a negative blood pregnancy test done during the screening visit) between the ages of 18 and 60 years, inclusive;
- Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to one year) and men must agree to practice appropriate contraception (a combination of barrier and hormonal methods for women and a condom for men) from screening and until at least 30 days (up to Study Day 51 for females) and 90 days (up to Study Day 111 for males), after the last vaccination.
- A subject is in good health, as determined by a comprehensive clinical assessment {vital signs (heart rate, blood pressure, oral temperature)}, blood chemistry test (electrolytes, renal/kidney function, liver function, C-reactive
protein, complete blood count), medical history, general physical examination, self-reported illness} and the clinical judgment of the investigator;
- Able to understand and comply with planned study procedures;
- Provides signed informed consent form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 222
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Has a known allergy to any of the components of the vaccine.
- Has a history of severe reaction following immunization.
- Persons with immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy.
- Women who have a positive pregnancy test during the screening visit or who are breastfeeding.
- Has a history of any of the following (reported by subjects):
o Acute disseminated encephalomyelitis (ADEM);
o Neoplastic disease – current or previous;
o Asthma or severe allergic disease;
o Bleeding disorders
o Chronic Hepatitis B and/or C infection;
o Chronic liver disease;
o Diabetes mellitus;
o Guillain-Barré syndrome;
o HIV;
o Rheumatoid arthritis or other autoimmune diseases;
o Severe renal disease;
o Transplant recipients;
o Unstable or progressive neurological disorders.
- Receipt of medicines/treatments that may affect evaluation of immunogenicity such as:
o Oral or parenteral steroids, high-dose inhaled steroids (greater than 800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs (azathioprine (Imuran), cyclosporine (Neoral, Sandimmune, SangCya); monoclonal antibodies such as basiliximab (Simulect), daclizumab (Zinbryta), infliximab (Remicade), rituximab (MabThera), alemtuzumab (Campath and Lemtrada), omalizumab (Xolair), abatacept (Orencia), adalimumab (Humira and Exemptia) and etanercept (Enbrel)basiliximab (Simulect), daclizumab (Zenapax), and muromonab (Orthoclone OKT3); corticosteroids such as prednisone (Deltasone, Orasone); tacrolimus (Prograf, Advagraf, Protopic); Glatiramer acetate (Copaxone); Mycopehnolate (Cellcept); Sirolimus (Rapamune); (within 6 months of vaccination in this study)
o Immunoglobulin or other blood products (within 3 months of vaccination
in this study);
o An experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month of vaccination in this study, or expects to receive an experimental agent (during the study period).
o Influenza antiviral medication (within 4 weeks of vaccination in this study).
- Has received any influenza vaccine within 6 months of vaccination in this study
- Has influenza-like illness (a sudden onset of symptoms and at least one of the four systemic symptoms-fever or feverishness, malaise, headache, myalgia and at least one of the three respiratory symptoms-cough, sore throat, shortness of breath) or acute respiratory infection (a sudden onset of symptoms and at least one of the four respiratory symptoms-cough, sore throat, shortness of breath, coryza (Rhinitis) and a clinician’s judgement that the illness is due to
an infection) within 6 months prior to vaccination in this study. These symptoms must have stopped the subject from carrying out their normal daily activities such as attending work or school for a period of at least 3 days.
- Has an acute illness, including an oral temperature greater than 38 degrees Celsius, within 1 week of vaccination.
- Has a history of alcohol or drug abuse within the last 2 years deemed unsuitable for inclusion by the investigator.
- Any abnormal haematology values and/or serum chemistries judged by the Investigator as clinically significant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified