InfluenzaPhase 1NCT01181336
Phase 1b Influenza Vaccine 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 study is to see whether a single vaccination (injection) with the investigational influenza vaccine is safe in healthy subjects. The study is also designed to evaluate four different dose formulations of the vaccine to see which gives the best immune response. Read more about this study
- Who is it for?
- Ages 18 to 40 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
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2010to Jul 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must have a BMI >18.5 and ≤ 28.5 kg/m2.
- Subject must have no clinically significant abnormal findings, as judged by the Investigator, on the physical examination, ECG, medical history or clinical laboratory results during screening.
- Subject must be a non-user of tobacco products, or smoke ≤ 10 cigarettes per day (minimum 6 months prior to first dose).
- Subject must have a negative urine screen for drugs of abuse and a negative alcohol breath test at screening and check-in.
- Subject must refrain from consuming alcohol for 72 hours prior to each dose.
- Subject must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator.
- Subject must give voluntary written informed consent to participate in this trial.
Who cannot join
- Subject must not have previous influenza vaccination within the 12 months prior to test drug vaccination.
- Subject must not have had an influenza like illness within the 3 months prior to test drug vaccination.
- Subject must not have a history or presence of significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, haematological or renal disorder.
- Subject must not have an oral temperature >38°C on day of vaccination (otherwise subject maybe be re-assigned to a subsequent cohort).
- Subject must not suffer from an inherited or acquired immunodeficiency.
- Subject must not suffer from a disease or be undergoing treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (>800µg/day beclometasone or equivalent), radiation treatment, cytotoxic drugs or non-steroidal anti-inflammatory drugs.
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- Subject must not have a serologically positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Subject must not have a history of severe allergic reactions and/or anaphylaxis.
- Subject must not have any arm rash or tattoos which could confound the interpretation of any injection site reactions.
- Subject must not have participated in a previous clinical trial within 90 days prior to the first vaccination.
- Subject must not have donated blood or plasma more within 90 days prior to the first vaccination.
- Subject must not have donated bone marrow within 6 months prior to the first dose.
- Subject must not have received administration of immunoglobulins and/or any blood products within 90 days prior to the first vaccination, or any planned administration during the study period.
- Subject must not use any prescription medication within 14 days prior to the first vaccination.
- Subject must not use over-the-counter (OTC) medication 7 days prior to the first vaccination. Exceptions are described below under the heading 9.4.1.
- Subject must not have received any vaccine within the 30 days prior to the first dose, and must agree not to receive any other vaccine (other than any vaccine indicated for standard of care, for example, tetanus vaccine) for the duration of this study i.e 21 days post initial FLU-v vaccination.
- Subject must not have a history of alcohol or drug abuse within 2 years prior to the first dose.
- Subject must not have any condition which, in the judgement of the Investigator, precludes inclusion into the study.
- Subjects must not donate sperm up to 90 days postdose, and those whose partner is of child-bearing potential will be advised to remain sexually inactive or use a dual method of birth control (e.g. condom together with spermicidal agent, IUD or hormonal contraception) for at least 90 days postdose.
- Subject must not be a direct employee of the study site, monitoring CRO or Sponsor.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quintiles Drug Research Unit at Guy's Hospital
London, SE1 1YR
About this study
Official title: A Single Centre, Randomised, Double Blind, Phase 1 Study of the Safety, Tolerability, and Immunogenicity of an Influenza Vaccine Candidate (FLU-v)
The purpose of this study is to see whether a single vaccination (injection) with the investigational influenza vaccine is safe in healthy subjects. The study is also designed to evaluate four different dose formulations of the vaccine to see which gives the best immune response.
Read the detailed description
Prophylactic vaccination against influenza is indicated for "at risk" populations including patients suffering from chronic respiratory diseases (including asthma), chronic heart disease, chronic renal failure, diabetes mellitus and immunosuppression due to disease or treatment. Vaccination of the elderly (>65 years) and the residents of nursing homes is also recommended. The current influenza vaccines available contain subunits from two influenza A viruses and an influenza B virus and consist either of inactivated whole virus or subunits of haemagglutinin and neuraminidase.
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.
This study will be the initial exploration of FLU-v in humans, and aims to assess the safety, tolerability, and immunogenicity in healthy subjects.
Subjects will be randomised to receive either Low Dose or High Dose FLU-v with or without adjuvant, or placebo with or without adjuvant. Twenty-four (24) subjects will be randomized to Low Dose and 24 subjects to High Dose. To mitigate risk, a staggered dosing approach will be used. One subject will receive Low Dose FLU-v without adjuvant, and one subject will receive placebo without adjuvant, followed 6 hours later by one subject receiving Low Dose FLU-v with adjuvant, and one subject receiving placebo with adjuvant. All 4 subjects will be observed overnight. At least 72 hours later and in the absence of any clinically-significant safety signals (as determined by a Safety Review Committee) the remaining 20 subjects of the Low Dose group will be dosed. If deemed appropriate by the Safety Review Committee a second sentinel cohort of 4 subjects will be observed overnight prior to completing the remaining subjects of the Low Dose group. Following a satisfactory review of safety data from the combined Low Dose cohorts, subjects in the High Dose group will be vaccinated using the same staggered dosing approach as used in Low Dose.
- Conditions
- Influenza
- Being tested
- Influenza vaccine (FLU-v), FLU-v Control
- Keywords
- Safety, Tolerability, Immunogenicity, Influenza, 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
Also called FLU-v
Comparison of different dosages of FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection of (Low Dose / High Dose with adjuvant / water for injection)
FLU-v ControlBiological
Adjuvant only or water for injection only Administration: a single subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Experimental | FLU-v Low Dose with adjuvant. FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection.
10 subjects. Receives: Biological: Influenza vaccine (FLU-v) |
| Group 3 | Experimental | FLU-v High Dose with water for injection. FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection.
10 subjects. Receives: Biological: Influenza vaccine (FLU-v) |
| Group 4 | Experimental | High Dose FLU-v with adjuvant FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection. 10 subjects Receives: Biological: Influenza vaccine (FLU-v) |
| Group 1 | Experimental | FLU-v Low Dose with water for injection FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection 10 subjects Receives: Biological: Influenza vaccine (FLU-v) |
| Control Group | Placebo comparator | Placebo with adjuvant (4 subjects) or Placebo without adjuvant (4 subjects) Receives: Biological: FLU-v Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of FLU-v
The safety and tolerability of two dose levels of FLU-v and the effect of the adjuvant on the safety and tolerability of FLU-v will be assessed by, Clinical signs and symptoms from physical exam and ECG; Adverse events (including local and systemic AEs); Laboratory safety (haematology, serum clinical chemistry, urinalysis); and Vital signs (blood pressure, heart rate, temperature, respiratory rate)
Measured: Measurements will be taken at screening, then up to 21 days post-vaccination
Secondary outcomes (1)
Immunogenicity of FLU-v
The immunogenicity of FLU-v with and without adjuvant will be measured by Serum IgG2 (assessed by enzyme-linked immunosorbant assay (ELISA)) and IFN-γ in isolated peripheral blood mononuclear cells (PBMC).
Measured: Measurements will be taken on Days 1 and 21 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PepTcell Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stuart Robinson, Dr, Study director, PepTcell Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181336
- Sponsor's protocol ID
- FLU-v-001
- Status last verified
- Oct 2010
- First submitted
- 12 Aug 2010
- Last updated
- 15 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Pleguezuelos O, Robinson S, Stoloff GA, Caparros-Wanderley W. Synthetic Influenza vaccine (FLU-v) stimulates cell mediated immunity in a double-blind, randomised, placebo-controlled Phase I trial. Vaccine. 2012 Jun 29;30(31):4655-60. doi: 10.1016/j.vaccine.2012.04.089. Epub 2012 May 8.
PubMed 22575166
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Randomised, Double Blind, Phase 1 Study of the Safety, Tolerability, and Immunogenicity of an Influenza Vaccine Candidate (FLU-v)
- ClinicalTrials.gov ID
- NCT01181336
- Acronym / sponsor ID
- FLU-v-001
- Conditions
- Influenza
- Keywords
- Safety, Tolerability, Immunogenicity, Influenza, Virus, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- PepTcell LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 13 Aug 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 study is to see whether a single vaccination (injection) with the investigational influenza vaccine is safe in healthy subjects. The study is also designed to evaluate four different dose formulations of the vaccine to see which gives the best immune response.
Detailed description
Prophylactic vaccination against influenza is indicated for "at risk" populations including patients suffering from chronic respiratory diseases (including asthma), chronic heart disease, chronic renal failure, diabetes mellitus and immunosuppression due to disease or treatment. Vaccination of the elderly (>65 years) and the residents of nursing homes is also recommended. The current influenza vaccines available contain subunits from two influenza A viruses and an influenza B virus and consist either of inactivated whole virus or subunits of haemagglutinin and neuraminidase.
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.
This study will be the initial exploration of FLU-v in humans, and aims to assess the safety, tolerability, and immunogenicity in healthy subjects.
Subjects will be randomised to receive either Low Dose or High Dose FLU-v with or without adjuvant, or placebo with or without adjuvant. Twenty-four (24) subjects will be randomized to Low Dose and 24 subjects to High Dose. To mitigate risk, a staggered dosing approach will be used. One subject will receive Low Dose FLU-v without adjuvant, and one subject will receive placebo without adjuvant, followed 6 hours later by one subject receiving Low Dose FLU-v with adjuvant, and one subject receiving placebo with adjuvant. All 4 subjects will be observed overnight. At least 72 hours later and in the absence of any clinically-significant safety signals (as determined by a Safety Review Committee) the remaining 20 subjects of the Low Dose group will be dosed. If deemed appropriate by the Safety Review Committee a second sentinel cohort of 4 subjects will be observed overnight prior to completing the remaining subjects of the Low Dose group. Following a satisfactory review of safety data from the combined Low Dose cohorts, subjects in the High Dose group will be vaccinated using the same staggered dosing approach as used in Low Dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Experimental | Biological: Influenza vaccine (FLU-v)FLU-v Low Dose with adjuvant. FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection. 10 subjects. |
| Group 3 | Experimental | Biological: Influenza vaccine (FLU-v)FLU-v High Dose with water for injection. FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection. 10 subjects. |
| Group 4 | Experimental | Biological: Influenza vaccine (FLU-v)High Dose FLU-v with adjuvant FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection. 10 subjects |
| Group 1 | Experimental | Biological: Influenza vaccine (FLU-v)FLU-v Low Dose with water for injection FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection 10 subjects |
| Control Group | Placebo comparator | Biological: FLU-v ControlPlacebo with adjuvant (4 subjects) or Placebo without adjuvant (4 subjects) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject must have a BMI >18.5 and ≤ 28.5 kg/m2.
- Subject must have no clinically significant abnormal findings, as judged by the Investigator, on the physical examination, ECG, medical history or clinical laboratory results during screening.
- Subject must be a non-user of tobacco products, or smoke ≤ 10 cigarettes per day (minimum 6 months prior to first dose).
- Subject must have a negative urine screen for drugs of abuse and a negative alcohol breath test at screening and check-in.
- Subject must refrain from consuming alcohol for 72 hours prior to each dose.
Key exclusion criteria (20 listed)
- Subject must not have previous influenza vaccination within the 12 months prior to test drug vaccination.
- Subject must not have had an influenza like illness within the 3 months prior to test drug vaccination.
- Subject must not have a history or presence of significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, haematological or renal disorder.
- Subject must not have an oral temperature >38°C on day of vaccination (otherwise subject maybe be re-assigned to a subsequent cohort).
- Subject must not suffer from an inherited or acquired immunodeficiency.
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)Also: FLU-vComparison of different dosages of FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection of (Low Dose / High Dose with adjuvant / water for injection) | Biological | Group 1, Group 2, Group 3, Group 4 |
| FLU-v ControlAdjuvant only or water for injection only Administration: a single subcutaneous injection | Biological | Control Group |
Primary outcome
Safety and tolerability of FLU-v
Time frame: Measurements will be taken at screening, then up to 21 days post-vaccination
The safety and tolerability of two dose levels of FLU-v and the effect of the adjuvant on the safety and tolerability of FLU-v will be assessed by, Clinical signs and symptoms from physical exam and ECG; Adverse events (including local and systemic AEs); Laboratory safety (haematology, serum clinical chemistry, urinalysis); and Vital signs (blood pressure, heart rate, temperature, respiratory rate)
1 secondary outcome
Immunogenicity of FLU-v
Time frame: Measurements will be taken on Days 1 and 21 post-vaccination
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 15 Oct 2010.
- Derived from this study: PubMed 22575166Pleguezuelos O, Robinson S, Stoloff GA, Caparros-Wanderley W. Synthetic Influenza vaccine (FLU-v) stimulates cell mediated immunity in a double-blind, randomised, placebo-controlled Phase I trial. Vaccine. 2012 Jun 29;30(31):4655-60. doi: 10.1016/j.vaccine.2012.04.089. Epub 2012 May 8.
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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.
Stuart Robinson, Dr study director
PepTcell 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 7 inclusion and 20 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 15 Oct 2010. 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?
Safety and tolerability of FLU-v (time frame: Measurements will be taken at screening, then up to 21 days post-vaccination). 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 NCT01181336, which also lists 1 linked publication.
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 15 Oct 2010.