InfluenzaPhase 1NCT01226758
Influenza Vaccine Challenge Study in Healthy Subjects
A Phase 1 study testing Influenza vaccine (FLU-v) in people with Influenza, run by PepTcell Limited at 1 site in United Kingdom.
Trial summary
The purpose of this research is to study the safety, tolerability and effectiveness of the investigational influenza vaccine in healthy volunteers infected with an attenuated influenza A virus. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza vaccine (FLU-v)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Dec 2010
- Phase
- Phase 1
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- General good health determined by a screening evaluation ≤120 days prior to IMP administration and on the day of admittance to quarantine
- Using methods of contraception, (e.g. spermicidal gel plus condom) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child in the three months following study drug administration.
- Negative HIV, hepatitis B and C antibody screens
- Negative class A drugs, alcohol and nicotine screen
- Seronegative (≤10 HAI) for challenge virus
- Have not been vaccinated for influenza virus since 2006 (as determined in the medical history) or had a known influenza-like illness in the current season, defined as in the last 12 months
Who cannot join
- Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness, including but not exclusive to the conditions listed in Appendix 2, that in the view of the Investigator is associated with increased risk of complications of respiratory viral illness
- Abnormal pulmonary function as evidenced by clinically significant abnormalities in spirometry
- Presence of household member or close contact who is: less than 3 years of age; known immunodeficient; receiving immunosuppressants; undergoing/soon to undergo chemotherapy; diagnosed with emphysema or COPD; is elderly residing in a nursing home; severe lung disease or medical condition; received a transplant (bone marrow or solid organ)
- History of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any aetiology
- Any laboratory test or ECG which is abnormal and deemed by the investigator to be clinically significant
- Venous access inadequate for phlebotomy demands
Show all 23Show fewer
- Regular daily smokers during the 6 months prior to study entry or those who have a significant history of any tobacco use at any time
- Subject is diabetic
- History or evidence of autoimmune disease or known impaired immune responsiveness
- Recent and/or recurrent history of autonomic dysfunction
- Receipt of systemic glucocorticoids, antiviral drugs, immunoglobulins or blood transfusions within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months prior to vaccination. Receipt of any systemic chemotherapy agent at any time
- Presence of any febrile illness or symptoms of upper or lower tract respiratory infection in the 28 days prior to viral inoculation
- Any anatomic or neurological abnormality impairing the gag reflex or associated with an increased risk of aspiration, or history suggestive of such a problem or any abnormality significantly altering the anatomy of the nose or nasopharynx
- Known IgA deficiency, immotile cilia syndrome, or Kartagener's syndrome
- Nasal or sinus surgery within 30 days prior to vaccination
- Significant history of seasonal hay fever or a seasonal allergic rhinitis (SAR), or perennial allergic rhinitis (PAR), or chronic nasal or sinus condition
- Acute and/or chronic use of any medication or other product for symptoms of rhinitis or nasal congestion or for any chronic nasopharyngeal complaint, or chronic use of any intranasal medication for any indication
- Use of any prescription drugs, herbal supplements, within 4 weeks prior to vaccine administration
- Receipt of any investigational drug within 3 months, or prior participation in a clinical trial of any influenza vaccine, medication or experimental Influenza viral challenge delivered directly to the respiratory tract within 1 year
- Previous exposure to the IMP or similar substance
- History of multiple and recurring allergies and/or adverse reaction to any components of the IMP and challenge virus preparation
- History of allergy or intolerance to the following drugs: oseltamivir or zanamivir.
- Allergic to gentamicin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Double-blind, Placebo-controlled, Phase 1b Trial to Evaluate the Safety, Tolerability and Protective Efficacy of the Influenza Vaccine Candidate, FLU-v, in an Influenza Challenge Model
The purpose of this research is to study the safety, tolerability and effectiveness of the investigational influenza vaccine in healthy volunteers infected with an attenuated influenza A virus.
Read the detailed description
The investigational influenza vaccine (FLU-v) contains multiple highly conserved T cell epitopes that are present on most influenza viruses, which have been identified as reactive in different human leukocyte antigen (HLA) populations; thus making it unlikely that anybody in the vaccinated population would be unable to mount an immune response to at least one of the epitopes contained in the vaccine.
In this study up to 44 will be vaccinated with the FLU-v experimental vaccine or a placebo in a 1:1 ratio. Volunteers will attend a screening visit, a vaccination visit, a 10-11 day overnight stay in a quarantine facility, and a follow-up visit to the P1 clinic.
Three weeks after being vaccinated with FLU-v or placebo, 30 volunteers will be taken to a Quarantine Unit to be exposed to the attenuated H3N2 study virus and then monitored by study physicians and nurses for a 10-11 day period. The other 14 volunteers will be held in reserve as back-ups. If fewer than 30 of the volunteers who travel to the Quarantine Unit are eligible to be exposed to the study virus, then volunteers who have been kept in reserve will be used.
Following discharge from the Quarantine Unit, volunteers will attend one study follow-up visit, 28 days after exposure to the study virus. Assessments will take place and samples will be taken from volunteers.
- Conditions
- Influenza
- Being tested
- Influenza vaccine (FLU-v), Placebo (adjuvant only)
- Keywords
- Safety, Tolerability, Efficacy, Influenza, Flu, Virus, Vaccine
- 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.
Influenza vaccine (FLU-v)Biological
FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences) and adjuvant. Administered by single subcutaneous injection.
Placebo (adjuvant only)Biological
Single subcutaneous injection of adjuvant
| Study group | Role | What they receive |
|---|---|---|
| FLU-v with adjuvant | Experimental | Not described Receives: Biological: Influenza vaccine (FLU-v) |
| Placebo | Placebo comparator | Adjuvant only placebo Receives: Biological: Placebo (adjuvant only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
The primary safety endpoint for the vaccination phase of the study is the evaluation of all AEs occurring up to Day 28 (final follow-up). AE details will be collected by subject questioning and review of a subject self-assessment diary card (completed for Days -21 to -14) at the clinic visit on Day -2
Measured: Day -21 to Day 28
Secondary outcomes (5)
Safety of FLU-v
The Safety of FLU-v will be assessed by recording:
Area under the curve (AUC) of composite symptom score in the 6 days after inoculation (Days 0 to 5 inclusive; Physical examination; Clinical chemistry, haematology and urinalysis; Vital signs (blood pressure (BP), heart rate (HR) and respiration rate (RR)); Electrocardiogram; Oral temperature; and Concomitant medications.
Measured: Days -21 to 28
Post-innoculation symptoms
Exploratory Endpoints - Symptoms measured by:
Time to peak of composite symptom score, duration, and time to resolution of composite score from peak; Peak severity symptom composite score in the 6 days after inoculation; Duration of upper respiratory infection (URI) symptoms after influenza viral inoculation; Occurrence of URI symptoms 1) with and 2) without fever; and occurrence of any influenza-like illness with or without fever.
Measured: Days 0 to 28
Post-innoculation virology
Exploratory endpoint - Virology will be measured by recording an analysing:
Area under the curve (AUC) of influenza viral shedding in the 6 days after inoculation; Time to peak of influenza viral shedding, duration, and time to resolution of influenza viral shedding from peak; Peak of influenza viral shedding in the 6 days after inoculation.
Measured: 6 days following inoculation
Post-innoculation fever
Exploratory endpoint - Post-innoculation fever will be assessed by:
Area under the curve (AUC)and peak of fever; Duration of fever, time to peak fever, and time from peak to resolution of fever; Occurrence and duration of clinical illness with and without documented fever; Total tissue count and total mucus weight; Total number of individual tissues and total mucous weights; and humoral and cell-mediated immune responses to vaccine, pre-influenza challenge.
Measured: Days -21 to 28
Protective Efficacy (PE)
Protective Efficacy measured by the proportion of cases prevented by the vaccine relative to placebo (the difference in attack rate for placebo vaccinated minus FLU-v vaccinated subjects divided by the placebo vaccinated group attack rate).
Measured: Day 1 to 5 post-viral challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepTcell Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Gilbert, MBBCh, MICR, Principal investigator, Retroscreen Virology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226758
- Sponsor's protocol ID
- FLU-v-002
- Status last verified
- Nov 2012
- First submitted
- 21 Oct 2010
- Last updated
- 2 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pleguezuelos O, Robinson S, Fernandez A, Stoloff GA, Caparros-Wanderley W. Meta-Analysis and Potential Role of Preexisting Heterosubtypic Cellular Immunity Based on Variations in Disease Severity Outcomes for Influenza Live Viral Challenges in Humans. Clin Vaccine Immunol. 2015 Aug;22(8):949-56. doi: 10.1128/CVI.00101-15. Epub 2015 Jun 17.
PubMed 26084515Pleguezuelos O, Robinson S, Fernandez A, Stoloff GA, Mann A, Gilbert A, Balaratnam G, Wilkinson T, Lambkin-Williams R, Oxford J, Caparros-Wanderley W. A Synthetic Influenza Virus Vaccine Induces a Cellular Immune Response That Correlates with Reduction in Symptomatology and Virus Shedding in a Randomized Phase Ib Live-Virus Challenge in Humans. Clin Vaccine Immunol. 2015 Jul;22(7):828-35. doi: 10.1128/CVI.00098-15. Epub 2015 May 20.
PubMed 25994549
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blind, Placebo-controlled, Phase 1b Trial to Evaluate the Safety, Tolerability and Protective Efficacy of the Influenza Vaccine Candidate, FLU-v, in an Influenza Challenge Model
- ClinicalTrials.gov ID
- NCT01226758
- Acronym / sponsor ID
- FLU-v-002
- Conditions
- Influenza
- Keywords
- Safety, Tolerability, Efficacy, Influenza, Flu, Virus, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- PepTcell LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Oct 2010 (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 research is to study the safety, tolerability and effectiveness of the investigational influenza vaccine in healthy volunteers infected with an attenuated influenza A virus.
Detailed description
The investigational influenza vaccine (FLU-v) contains multiple highly conserved T cell epitopes that are present on most influenza viruses, which have been identified as reactive in different human leukocyte antigen (HLA) populations; thus making it unlikely that anybody in the vaccinated population would be unable to mount an immune response to at least one of the epitopes contained in the vaccine.
In this study up to 44 will be vaccinated with the FLU-v experimental vaccine or a placebo in a 1:1 ratio. Volunteers will attend a screening visit, a vaccination visit, a 10-11 day overnight stay in a quarantine facility, and a follow-up visit to the P1 clinic.
Three weeks after being vaccinated with FLU-v or placebo, 30 volunteers will be taken to a Quarantine Unit to be exposed to the attenuated H3N2 study virus and then monitored by study physicians and nurses for a 10-11 day period. The other 14 volunteers will be held in reserve as back-ups. If fewer than 30 of the volunteers who travel to the Quarantine Unit are eligible to be exposed to the study virus, then volunteers who have been kept in reserve will be used.
Following discharge from the Quarantine Unit, volunteers will attend one study follow-up visit, 28 days after exposure to the study virus. Assessments will take place and samples will be taken from volunteers.
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 |
|---|---|---|
| FLU-v with adjuvant | Experimental | Biological: Influenza vaccine (FLU-v) |
| Placebo | Placebo comparator | Biological: Placebo (adjuvant only)Adjuvant only placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- General good health determined by a screening evaluation ≤120 days prior to IMP administration and on the day of admittance to quarantine
- Using methods of contraception, (e.g. spermicidal gel plus condom) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child in the three months following study drug administration.
- Negative HIV, hepatitis B and C antibody screens
- Negative class A drugs, alcohol and nicotine screen
- Seronegative (≤10 HAI) for challenge virus
Key exclusion criteria (23 listed)
- Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness, including but not exclusive to the conditions listed in Appendix 2, that in the view of the Investigator is associated with increased risk of complications of respiratory viral illness
- Abnormal pulmonary function as evidenced by clinically significant abnormalities in spirometry
- Presence of household member or close contact who is: less than 3 years of age; known immunodeficient; receiving immunosuppressants; undergoing/soon to undergo chemotherapy; diagnosed with emphysema or COPD; is elderly residing in a nursing home; severe lung disease or medical condition; received a transplant (bone marrow or solid organ)
- History of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any aetiology
- Any laboratory test or ECG which is abnormal and deemed by the investigator to be clinically significant
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 |
|---|---|---|
| Influenza vaccine (FLU-v)FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences) and adjuvant. Administered by single subcutaneous injection. | Biological | FLU-v with adjuvant |
| Placebo (adjuvant only)Single subcutaneous injection of adjuvant | Biological | Placebo |
Primary outcome
Adverse Events (AEs)
Time frame: Day -21 to Day 28
The primary safety endpoint for the vaccination phase of the study is the evaluation of all AEs occurring up to Day 28 (final follow-up). AE details will be collected by subject questioning and review of a subject self-assessment diary card (completed for Days -21 to -14) at the clinic visit on Day -2
5 secondary outcomes
Safety of FLU-v
Time frame: Days -21 to 28
Post-innoculation symptoms
Time frame: Days 0 to 28
Post-innoculation virology
Time frame: 6 days following inoculation
Post-innoculation fever
Time frame: Days -21 to 28
Protective Efficacy (PE)
Time frame: Day 1 to 5 post-viral challenge
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 2 Nov 2012.
- Derived from this study: PubMed 26084515Pleguezuelos O, Robinson S, Fernandez A, Stoloff GA, Caparros-Wanderley W. Meta-Analysis and Potential Role of Preexisting Heterosubtypic Cellular Immunity Based on Variations in Disease Severity Outcomes for Influenza Live Viral Challenges in Humans. Clin Vaccine Immunol. 2015 Aug;22(8):949-56. doi: 10.1128/CVI.00101-15. Epub 2015 Jun 17.
- Derived from this study: PubMed 25994549Pleguezuelos O, Robinson S, Fernandez A, Stoloff GA, Mann A, Gilbert A, Balaratnam G, Wilkinson T, Lambkin-Williams R, Oxford J, Caparros-Wanderley W. A Synthetic Influenza Virus Vaccine Induces a Cellular Immune Response That Correlates with Reduction in Symptomatology and Virus Shedding in a Randomized Phase Ib Live-Virus Challenge in Humans. Clin Vaccine Immunol. 2015 Jul;22(7):828-35. doi: 10.1128/CVI.00098-15. Epub 2015 May 20.
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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.
Anthony Gilbert, MBBCh, MICR principal investigator
Retroscreen Virology Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Influenza vaccine (FLU-v) in people with Influenza, run by PepTcell Limited 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 6 inclusion and 23 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 2 Nov 2012. 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 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.
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?
Adverse Events (AEs) (time frame: Day -21 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01226758, which also lists 2 linked publications.
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 2 Nov 2012.