Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2010-06-30
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FLU-v with adjuvant
Influenza vaccine (FLU-v)
FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences) and adjuvant. Administered by single subcutaneous injection.
Placebo
Adjuvant only placebo
Placebo (adjuvant only)
Single subcutaneous injection of adjuvant
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Influenza vaccine (FLU-v)
FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences) and adjuvant. Administered by single subcutaneous injection.
Placebo (adjuvant only)
Single subcutaneous injection of adjuvant
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
45 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
PepTcell Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anthony Gilbert, MBBCh, MICR
Role: PRINCIPAL_INVESTIGATOR
Retroscreen Virology Limited
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Retroscreen Virology Limited
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Pleguezuelos 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FLU-v-002
Identifier Type: -
Identifier Source: org_study_id