Influenza APhase 1/2NCT02071329
Safety, Tolerability, Efficacy and Immunogenicity of an Influenza A Vaccine (FP-01.1) in Healthy Volunteers Following Virus Challenge
A Phase 1/2 study testing Vaccine FP-01.1 and Virus Challenge in people with Influenza A, run by Immune Targeting Systems Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A
- What is being tested?
- Vaccine FP-01.1 and Virus Challenge
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Dec 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
- Forced expiratory volume at one second (FEV1) ≤90% of predicted FEV1;
- Blood haemoglobin A1c >6.0%;
- Positive serology for human immunodeficiency virus (HIV) 1 or HIV 2, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies;
- Cancer or treatment for cancer, within 5 years of Visit 2, excluding basal cell carcinoma of the skin, which is allowed;
- Presence of immunosuppression or any medical condition that may be associated with impaired immune responsiveness, including, but not limited to, diabetes mellitus and inflammatory bowel disease;
- Presently receiving or a history of receiving during the 3-month period prior to screening, any medications or other treatments that may adversely affect the immune system such as allergy injections, immune globulin, interferon (IFN), immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable) azathioprine or mercaptopurine; topical corticosteroids, except intranasal, will be allowed;
- Anticipated presence of a household contact with documented severe immunosuppression (including but not limited to HIV, anyone who has haematological malignancy or is taking immunosuppressant medication), either as a result of disease and/or therapy within 2 weeks following discharge from the virus challenge quarantine period;
- Anticipated presence of a household contact age 5 years or younger, within 2 weeks following discharge from the virus challenge quarantine period;
- Anticipated presence of a household contact age 65 years or older, within 2 weeks following discharge from the virus challenge quarantine period;
- Anticipated presence of a household contact with diagnosed emphysema, chronic obstructive pulmonary disease, severe lung disease or any organ or bone marrow transplant, within 2 weeks following discharge from the virus challenge quarantine period;
- Current professional activity as a carer or healthcare worker;
- Anticipated presence of a pregnant household contact, within 2 weeks following discharge from the virus challenge quarantine period;
- History of Guillain-Barré syndrome;
- History of drug or chemical/alcohol abuse in the year before the study (Visit 2);
- Receipt of any investigational virus product or any investigational product (IMP) within 3 months prior to first vaccination, or currently enrolled in any investigational drug study or intends to enrol in such a study within the ensuing study period;
- Receipt of blood or blood products 6 months prior to first vaccination or planned administration during the study period;
- Blood donation in the 3 months prior to screening (Visit 2);
- Acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness with or without fever (as determined by the Investigator through medical history and physical examination), or presence of a fever (>37.7ºC oral temperature);
- Elevated white cell count >9.5 x 109/L, absolute neutrophil count >6.9 x 109/L or serum C-reactive protein concentration >10.0 mg/L at screening (Visit 2) or Day C-1;
- Any condition that, in the opinion of the Investigator, might interfere with the primary study objective;
- Known or suspected intolerance or hypersensitivity to the IMP or closely related compounds, known allergy to egg or egg protein or any of the stated excipients;
- Known or suspected intolerance or hypersensitivity to Tamiflu or Relenza;
- Subject with suspected recent (≤6 months) experience of influenza-like illness (fever [>37.7ºC] and cough and/or sore throat >2 days, in the absence of a known cause other than influenza);
- Subjects who have significant scarring, tattoos, abrasions, cuts or infections, that in the opinion of the Investigator could interfere with evaluation of injection site local reactions, over the deltoid region of both arms as these will be the dose site;
- Subjects who are vegans or have medical dietary restrictions;
- Subjects who cannot communicate reliably with the Investigator.
- Randomised subjects who have completed the vaccination phase of the study (Day 1 to Day 36) will be excluded from proceeding to the virus challenge part of the study under the following conditions:
- Subjects have not received 2 administrations of Vaccine FP-01.1 or placebo per protocol;
- Positive HI titre on Day 29 (defined as HI titre >20 for the H1N1 challenge virus);
- Presence of any mild, moderate or severe influenza symptoms or signs as assessed by the subject scoring card or targeted physical examination prior to dosing;
- An oral temperature >37.7°C on Day C-1 or Day C1 prior to dosing.
- Any subjects who meet the criteria listed above must not be challenged.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quintiles Drug Research Unit at Guy's Hospital
London
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Influenza A
- Being tested
- Vaccine FP-01.1, Placebo, Virus Challenge
- Keywords
- FP-01.1, Influenza A, Flu, Vaccine, Virus, H1N1, Challenge
- Medical subject headings
- Influenza, Human, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine FP-01.1Drug
PlaceboDrug
Virus ChallengeOther
Also called Live, wild-type A/California/H1N1 2009
| Study group | Role | What they receive |
|---|---|---|
| Vaccine FP-01.1 | Experimental | Vaccine FP-01.1 Receives: Drug: Vaccine FP-01.1; Other: Virus Challenge |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo; Other: Virus Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
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.
Measured: Day 1 - 72
Secondary outcomes (3)
Efficacy
To compare the incidence, severity and duration of signs and symptoms of influenza-like illness after virus challenge between subjects pre-vaccinated with Vaccine FP-01.1 and subjects pre-vaccinated with placebo.
Measured: Day 44 - 52
Pharmacodynamics
To compare the incidence, magnitude and duration of viral shedding after virus challenge between subjects pre-vaccinated with Vaccine FP-01.1 and subjects pre-vaccinated with placebo.
Measured: Day 45 -52
Immunogenicity
To assess magnitude, breadth and kinetics of immune response to FP-01.1
Measured: Day 1-72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immune Targeting Systems Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071329
- Sponsor's protocol ID
- FP-01.1_CS_04
- Other IDs
- 2013-004612-22
- Status last verified
- Oct 2016
- First submitted
- 21 Feb 2014
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02071329
- Acronym / sponsor ID
- FP-01.1_CS_04
- Conditions
- Influenza A
- Keywords
- FP-01.1, Influenza A, Flu, Vaccine, Virus, H1N1, Challenge
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Immune Targeting Systems LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine FP-01.1 | Experimental | Drug: Vaccine FP-01.1, Other: Virus ChallengeVaccine FP-01.1 |
| Placebo | Placebo comparator | Drug: Placebo, Other: Virus ChallengePlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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]);
Key exclusion criteria (42 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccine FP-01.1 | Drug | Vaccine FP-01.1 |
| Placebo | Drug | Placebo |
| Virus ChallengeAlso: Live, wild-type A/California/H1N1 2009 | Other | Placebo, Vaccine FP-01.1 |
Primary outcome
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.
3 secondary outcomes
Efficacy
Time frame: Day 44 - 52
Pharmacodynamics
Time frame: Day 45 -52
Immunogenicity
Time frame: Day 1-72
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vaccine FP-01.1 and Virus Challenge in people with Influenza A, run by Immune Targeting Systems Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Day 1 - 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.