InfluenzaPhase 1/2NCT02522754
Development of an Intranasal Proteosome Influenza Vaccine
A Phase 1/2 study testing Experimental: Protesomal Vaccine 1 x 30 µg, Experimental: Protesomal Vaccine 2 x 30 µg and Experimental: Protesomal Vaccine 2 x 15 µg in people with Influenza, run by Hvivo.
Trial summary
A study to compare multiple dosage regimes of a protesomal intranasal vaccine. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Experimental: Protesomal Vaccine 1 x 30 µg, Experimental: Protesomal Vaccine 2 x 30 µg and Experimental: Protesomal Vaccine 2 x 15 µg
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Jan 2004
- 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
- Young healthy adults as determined by medical history, physical examination, serology (HIV and Hepatitis B and C) and clinical laboratory tests.
- Female subjects were required to provide of a history of reliable contraceptive practice.
- Susceptibility to A/Panama/2007/1999 (H3N2) (a serum reciprocal HAI titre ≤10) was confirmed at screening. -
Who cannot join
- asthma,
- hypersensitivity to mercurials or chicken eggs,
- anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration, * chronic nasopharyngeal complaints,
- abnormal electrocardiogram (ECG),
- febrile illness or significant symptoms of upper respiratory infection on the day of vaccination or between admission to quarantine and administration of the challenge inoculum.
- Subjects using medication or other products for rhinitis or nasal congestion,
- Subject who had received systemic glucocorticoids within 1 month, or cytotoxic or immunosuppressive drugs within 6 months of the study start.
- Subjects agreed not to smoke during the quarantine phase.
About this study
Official title: Study to Determine if Intranasal Proteosome-Adjuvanted Trivalent Influenza Vaccine is Safe, Immunogenic and Efficacious in the Influenza Human Viral Challenge Model
A study to compare multiple dosage regimes of a protesomal intranasal vaccine.
Read the detailed description
A Proteosome-adjuvanted trivalent inactivated influenza vaccine (P-TIV) administered intra-nasally was shown to be effective, safe, well tolerated, immunogenic - in both systemic and mucosal compartments - and effective at preventing influenza illness.
In two separate studies using the Human Viral Challenge Model, subjects were selected for susceptibility to A/Panama/2007/1999 (H3N2) virus and then dosed with one of three regimens: (A/New Caledonia/20/1999 (H1N1), A/Panama/2007/1999 (H3N2), B/Victoria/504/2000 or B/Shangdong/7/1997) or placebo via a nasal spray. One or two doses were given, 14 days apart, before subjects were challenged with ~8.5 x 105 EID¬50 of A/Panama/2007/1999 (H3N2) virus. Immune responses to the vaccine antigens were measured, namely serum IgG (via the aemagglutination inhibition assay (HAI)) and nasal wash secretory IgA (sIgA) antibodies (via ELISA). Viral titres in nasal washes and symptoms of influenza illness were assessed after viral challenge and compared.
- Conditions
- Influenza
- Being tested
- Placebo Protesomal Vaccine, Experimental: Protesomal Vaccine 1 x 30 µg, Experimental: Protesomal Vaccine 2 x 30 µg, Experimental: Protesomal Vaccine 2 x 15 µg
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Protesomal VaccineBiological
Also called Placebo
Intranasal vaccine Protesomal Vaccine
Experimental: Protesomal Vaccine 1 x 30 µgBiological
Experimental: Protesomal Vaccine 1 x 30 µg
Experimental: Protesomal Vaccine 2 x 30 µgBiological
Experimental: Protesomal Vaccine 2 x 30 µg
Experimental: Protesomal Vaccine 2 x 15 µgBiological
Experimental: Protesomal Vaccine 2 x 15 µg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Biological: Placebo Protesomal Vaccine |
| Protesomal Vaccine 1 x 30 µg | Experimental | Protesomal Vaccine 1 x 30 µg Receives: Biological: Experimental: Protesomal Vaccine 1 x 30 µg |
| Protesomal Vaccine 2 x 30 µg | Experimental | Protesomal Vaccine 2 x 30 µg Receives: Biological: Experimental: Protesomal Vaccine 2 x 30 µg |
| Protesomal Vaccine 2 x 15 µg | Experimental | Protesomal Vaccine 2 x 15 µg Receives: Biological: Experimental: Protesomal Vaccine 2 x 15 µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Influenza Like Illness in those with laboratory confirmed influenza
Measured: Within the duration of infection, approx 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJan 2002
- Primary completionJan 2004
- Study completionJan 2004
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvivo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, R Lambkin-Williams, Hvivo
- Investigators
- Rob Lambkin-Williams, PhD, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522754
- Sponsor's protocol ID
- IDB 004 IDB 005
- Status last verified
- Aug 2015
- First submitted
- 28 Jul 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lambkin-Williams R, Gelder C, Broughton R, Mallett CP, Gilbert AS, Mann A, He D, Oxford JS, Burt D. An Intranasal Proteosome-Adjuvanted Trivalent Influenza Vaccine Is Safe, Immunogenic & Efficacious in the Human Viral Influenza Challenge Model. Serum IgG & Mucosal IgA Are Important Correlates of Protection against Illness Associated with Infection. PLoS One. 2016 Dec 22;11(12):e0163089. doi: 10.1371/journal.pone.0163089. eCollection 2016.
PubMed 28005959
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Determine if Intranasal Proteosome-Adjuvanted Trivalent Influenza Vaccine is Safe, Immunogenic and Efficacious in the Influenza Human Viral Challenge Model
- ClinicalTrials.gov ID
- NCT02522754
- Acronym / sponsor ID
- IDB 004 IDB 005
- Conditions
- Influenza
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- HvivoIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2002
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 13 Aug 2015 (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.
A study to compare multiple dosage regimes of a protesomal intranasal vaccine.
Detailed description
A Proteosome-adjuvanted trivalent inactivated influenza vaccine (P-TIV) administered intra-nasally was shown to be effective, safe, well tolerated, immunogenic - in both systemic and mucosal compartments - and effective at preventing influenza illness.
In two separate studies using the Human Viral Challenge Model, subjects were selected for susceptibility to A/Panama/2007/1999 (H3N2) virus and then dosed with one of three regimens: (A/New Caledonia/20/1999 (H1N1), A/Panama/2007/1999 (H3N2), B/Victoria/504/2000 or B/Shangdong/7/1997) or placebo via a nasal spray. One or two doses were given, 14 days apart, before subjects were challenged with ~8.5 x 105 EID¬50 of A/Panama/2007/1999 (H3N2) virus. Immune responses to the vaccine antigens were measured, namely serum IgG (via the aemagglutination inhibition assay (HAI)) and nasal wash secretory IgA (sIgA) antibodies (via ELISA). Viral titres in nasal washes and symptoms of influenza illness were assessed after viral challenge and compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Placebo Protesomal VaccinePlacebo |
| Protesomal Vaccine 1 x 30 µg | Experimental | Biological: Experimental: Protesomal Vaccine 1 x 30 µgProtesomal Vaccine 1 x 30 µg |
| Protesomal Vaccine 2 x 30 µg | Experimental | Biological: Experimental: Protesomal Vaccine 2 x 30 µgProtesomal Vaccine 2 x 30 µg |
| Protesomal Vaccine 2 x 15 µg | Experimental | Biological: Experimental: Protesomal Vaccine 2 x 15 µgProtesomal Vaccine 2 x 15 µg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Young healthy adults as determined by medical history, physical examination, serology (HIV and Hepatitis B and C) and clinical laboratory tests.
- Female subjects were required to provide of a history of reliable contraceptive practice.
- Susceptibility to A/Panama/2007/1999 (H3N2) (a serum reciprocal HAI titre ≤10) was confirmed at screening. -
Key exclusion criteria (8 listed)
- asthma,
- hypersensitivity to mercurials or chicken eggs,
- anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration, * chronic nasopharyngeal complaints,
- abnormal electrocardiogram (ECG),
- febrile illness or significant symptoms of upper respiratory infection on the day of vaccination or between admission to quarantine and administration of the challenge inoculum.
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 |
|---|---|---|
| Placebo Protesomal VaccineAlso: PlaceboIntranasal vaccine Protesomal Vaccine | Biological | Placebo |
| Experimental: Protesomal Vaccine 1 x 30 µgExperimental: Protesomal Vaccine 1 x 30 µg | Biological | Protesomal Vaccine 1 x 30 µg |
| Experimental: Protesomal Vaccine 2 x 30 µgExperimental: Protesomal Vaccine 2 x 30 µg | Biological | Protesomal Vaccine 2 x 30 µg |
| Experimental: Protesomal Vaccine 2 x 15 µgExperimental: Protesomal Vaccine 2 x 15 µg | Biological | Protesomal Vaccine 2 x 15 µg |
Primary outcome
Reduction in Influenza Like Illness in those with laboratory confirmed influenza
Time frame: Within the duration of infection, approx 10 days
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 13 Aug 2015.
- Derived from this study: PubMed 28005959Lambkin-Williams R, Gelder C, Broughton R, Mallett CP, Gilbert AS, Mann A, He D, Oxford JS, Burt D. An Intranasal Proteosome-Adjuvanted Trivalent Influenza Vaccine Is Safe, Immunogenic & Efficacious in the Human Viral Influenza Challenge Model. Serum IgG & Mucosal IgA Are Important Correlates of Protection against Illness Associated with Infection. PLoS One. 2016 Dec 22;11(12):e0163089. doi: 10.1371/journal.pone.0163089. eCollection 2016.
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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.
Rob Lambkin-Williams, PhD principal investigator
PI
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Experimental: Protesomal Vaccine 1 x 30 µg, Experimental: Protesomal Vaccine 2 x 30 µg and Experimental: Protesomal Vaccine 2 x 15 µg in people with Influenza, run by Hvivo.
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 3 inclusion and 8 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 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Reduction in Influenza Like Illness in those with laboratory confirmed influenza (time frame: Within the duration of infection, approx 10 days). 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 NCT02522754, 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 13 Aug 2015.