A Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Efficacy and Immunogenicity of an Influenza A Vaccine (Vaccine FP-01.1) in Healthy Volunteers Following Virus Challenge
Overview
- Phase
- Phase 1
- Intervention
- Vaccine FP-01.1
- Conditions
- Influenza A
- Sponsor
- Immune Targeting Systems Ltd
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Safety
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to assess the safety, tolerability, efficacy, and immunogenicity of an influenza A vaccine (vaccine: FP-01.1), as compared to placebo, in healthy volunteers following a dose of influenza A virus.
Detailed Description
This study is designed to further investigate the safety and tolerability of FP-01.1 in healthy subjects and to explore the effect of prior vaccination with Vaccine FP-01.1 (250 μg/peptide) or placebo on the incidence, severity and duration of the signs and symptoms of influenza and the magnitude of viral load in nasal secretions and duration of viral shedding, after challenge with an A/California/H1N1 2009 influenza virus, in healthy male and female subjects. The study will also be used to provide additional information on the immunological responses (both humoral and cell-mediated immune \[CMI\] responses) following Vaccine FP-01.1 treatment and to investigate potential markers for protection against influenza A infection.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female aged 18 to 45 years inclusive, with a body mass index of 18.0 to 32.0 kg/m2 inclusive and body weight of 50.0 to 110.0 kg inclusive;
- •Subjects who are able and willing to give written informed consent to participate;
- •Healthy, as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical safety laboratory examinations at screening (Visit 2) and Day C-1 (prior to virus challenge), as determined by the Investigator;
- •Absent or low levels of detectable pre-existing antibodies to the challenge H1N1 virus (HI titre of ≤10) and predicted seasonal H3N2 virus (HI titre of ≤40) prior to vaccination;
- •Subjects who are non-smokers for at least 3 months preceding screening (Visit 2) and able to refrain from smoking until after the completion of Visit 9 \[Day C29\]);
- •Females of non-childbearing potential or female subjects of childbearing potential who are using 2 medically acceptable methods of contraception;
- •Comprehension of the study requirements, expressed availability for the required study period, and ability to be quarantined for up to 10 days and to attend the scheduled follow-up visits (Day C29 and Day 209);
- •Negative alcohol and urine drug screening tests on screening and prior to entering quarantine (Day C-1);
- •Being willing to adhere to the prohibitions and restrictions specified in this protocol.
Exclusion Criteria
- •Subjects who do not conform to the above inclusion criteria;
- •Receipt of any influenza vaccine after 31 August 2011;
- •Significant adulthood history of seasonal hay fever or a seasonal allergic rhinitis or perennial allergic rhinitis or chronic or nasal or sinus condition such as chronic sinusitis;
- •Abnormal nasal structure including septal deviation and nasal polyps;
- •History of asthma (childhood asthma allowed), bronchiectasis, emphysema, chronic obstructive pulmonary disease or any other chronic lung disease in the last 10 years;
- •Current use or use within the last 7 days from screening day (Visit 2) of intranasal corticosteroids;
- •Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiac/cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders; this includes, but is not limited to, institution of new surgical or medical treatment (for a chronic condition), or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed before first vaccination;
- •Subjects who do not agree to use medically acceptable methods of contraception;
- •Female subjects who are pregnant, trying to become pregnant or are breast feeding;
- •Diastolic blood pressure \<50 or \>90 mmHg, a systolic blood pressure \<100 or \>150 mmHg, a pulse \<40 or \>100 beats per minute (bpm) after resting for 5 minutes;
Arms & Interventions
Vaccine FP-01.1
Vaccine FP-01.1
Intervention: Vaccine FP-01.1
Vaccine FP-01.1
Vaccine FP-01.1
Intervention: Virus Challenge
Placebo
Placebo
Intervention: Placebo
Placebo
Placebo
Intervention: Virus Challenge
Outcomes
Primary Outcomes
Safety
Time Frame: Day 1 - 72
The safety evaluation will include adverse events (AEs), clinical laboratory safety tests, physical examinations, vital signs, 12-lead ECG parameters, spirometry and local injection site reactions.
Secondary Outcomes
- Efficacy(Day 44 - 52)
- Pharmacodynamics(Day 45 -52)
- Immunogenicity(Day 1-72)