Phase 2 N=175 Randomized Quadruple-blind Prevention

A Randomised, Double-blind, Placebo-controlled Phase IIb Trial to Test FLU-v Vaccine

Influenza

Bottom Line

View on ClinicalTrials.gov: NCT02962908 ↗

Enrolled (actual)

175

Serious AEs

2.3%

Results posted

Apr 2019

Primary outcome: Primary: CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 42 — 0.5; 5.9; 1.0; 0.2 fold change — p=0.45

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: FLU-v (Biological); adjuvanted FLU-v (Biological); Saline (Biological); Adjuvanted placebo (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: PepTcell Limited
Primary completion: Jul 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 42	0.5; 5.9; 1.0; 0.2; 0.0; 5.0	0.45
PRIMARY CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 180	0.5; 4.4; 0.1; 0.9; 0.0; 0.6	0.62
PRIMARY Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine)	23; 40; 13; 8; 16; 33	0.80
PRIMARY Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA)	7; 38; 1; 2; 3; 22	0.25
PRIMARY IFN-gamma Responses Measured by ELISA	0.8; 59.0; 1.0; 1.0; 1.0; 27.3	0.59
PRIMARY Percentage of Responders on Day 42 and Day 180 for IFNgamma Secretion by PBMCs	28; 42; 10; 9; 22; 40	0.113
PRIMARY Solicited AEs	275; 485; 149; 147; 12; 13	—
SECONDARY Antibody Responses to FLU-v	499.11; 362.86; 331.16; 371.89; 2593.02; 8740.48	<0.001 sig
SECONDARY Th2 Cytokine Responses (IL-4)	NA; NA; NA; NA; NA; NA	—

Summary

FLU-v is a vaccine that aims to protect against a wide range of flu viruses. The purpose of this study is to measure the immune responses induced by FLU-v vaccine. This study will look at how safe FLU-v is when administered and how successful it is in preventing flu or reducing the severity of the flu symptoms. The study requires 222 healthy volunteers 18-60 years old. Participation in the study will take a maximum of 7 months and consists of 5 visits. During visit 1, subjects will be examined by a doctor to make sure they are eligible to enter the study. A 15ml blood sample (a tablespoon) will be taken to check general health followed by a general physical exam. Medical history and some personal information will be collected. Subjects that have received the traditional flu vaccine in the past 6 months, and those females who are pregnant or breastfeeding will not be allowed in the study. Subjects of childbearing age must agree to use effective contraceptive methods. At visit 2, subjects will be randomly allocated to one of the four treatment groups summarised below: * Treatment 1: FLU-v (test vaccine) at the start of the study (Day 0) and then again 21 days later * Treatment 2: FLU-v (test vaccine) with an additional substance added [known as Montanide ISA 51] which improves the effect of the test vaccine. Injection will be given on Day 0 and then Placebo (no test vaccine) alone 21 days later * Treatment 3: Placebo (no test vaccine) injection on Day 0 and then 21 days later * Treatment 4: Placebo (no test vaccine) with an additional substance added [known as Montanide ISA 51] on Day 0 and then Placebo (no test vaccine) alone 21 days later Treatment will be injected under the skin in the upper arm on day 0 (visit 2) and 21 days later (visit 3). Blood samples will be taken before treatment (day 0), and on days 42 (visit 4) and 180 (visit 5) to the immune responses induced by the vaccine. Subjects will be asked to complete a diary card to write down any side effects that they may experience after vaccination. Subjects will also be asked to complete another diary card to document any flu-like symptoms experienced between December 2016 and March 2017, this time is officially considered as the flu season. During this period, if the subject experiences flu-like symptoms, a collection of a nose and tonsil swab will be arranged by the study site to confirm whether they have the flu or not.

Eligibility Criteria

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

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):
Acute disseminated encephalomyelitis (ADEM);
Neoplastic disease - current or previous;
Asthma or severe allergic disease;
Bleeding disorders
Chronic Hepatitis B and/or C infection;
Chronic liver disease;
Diabetes mellitus;
Guillain-Barré syndrome;
HIV;
Rheumatoid arthritis or other autoimmune diseases;
Severe renal disease;
Transplant recipients;
Unstable or progressive neurological disorders.
Receipt of medicines/treatments that may affect evaluation of immunogenicity such as:
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)
Immunoglobulin or other blood products (plasma, blood cells, coagulation factors, haemoglobin)(within 3 months of vaccination in this study);
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).
Influenza antiviral medication (Amantadine (Symmetrel); Rimantadine (Flumadine); Zanamivir (Relenza), Oseltamivir (Tamiflu) (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 h

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Data sourced from ClinicalTrials.gov (NCT02962908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.