Influenza (Pandemic)Phase 1NCT01594320
A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 1
A Phase 1 study testing Monovalent Avian Influenza VLP (H5N1) and Monovalent Avian Influenza VLP (H5N1); Adjuvant in people with Influenza (Pandemic), run by Novavax at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 1 in healthy, young adults. The study is divided down into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test article on Study Days 0 and 21. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza (Pandemic)
- What is being tested?
- Monovalent Avian Influenza VLP (H5N1) and Monovalent Avian Influenza VLP (H5N1); Adjuvant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2012to Aug 2013
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male or female, ≥18 and ≤49 years of age,
- Willing and able to give informed consent prior to study enrollment,
- Able to comply with study requirements, and
- Women must have a negative urine pregnancy test prior to each vaccination; will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity or prior surgical sterilization, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and intrauterine device (IUD).
Who cannot join
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care. Asymptomatic conditions (e.g., hypertension, dyslipidemia) that are being managed medically and that are not associated with evidence of end-organ damage are not exclusionary provided they are clinically stable (defined as no unscheduled medical interventions or change in medications for cause within 3 months).
- Any history of jaundice, or of hepatic injury due to drug (prescription, OTC, or illicit) or alcohol use or viral hepatitis; or the presence of hepatitis B surface antigen or hepatitis C antibody at screening.
- Any grade 1 or higher (as based on the Toxicity Grading Scale [TGS]) abnormality in ALT, AST, alkaline phosphatase or total bilirubin levels.
- Any grade 2 or higher (as based on the TGS) vital sign or clinical laboratory abnormality not specified in criterion 3 above. Note that any abnormal vital sign may be repeated at the Investigator's discretion.
- Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
- History of a serious reaction to prior influenza vaccination.
Show all 16Show fewer
- History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
- Received any vaccine in the 4 weeks preceding the study vaccination; or any A/H5N1 avian influenza vaccine at any time.
- Any known or suspected immunosuppressive condition, acquired or congenital, including HIV infection as determined by history and/or physical examination.
- Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
- Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration).
- Known disturbance of coagulation.
- Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
- Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
- Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Anaheim Clinical Trials
Anaheim, California, 92801
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Miami Research Associates
Miami, Florida, 33143
Broward Research Group
Pembroke Pines, Florida, 33026
Clinical Trials of Texas
San Antonio, Texas, 78229
About this study
Official title: A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Indonesia/05/05 (H5N1) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Young Adults With and Without Adjuvant 1.
The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 1 in healthy, young adults. The study is divided down into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts of the study.
- Conditions
- Influenza (Pandemic)
- Being tested
- Monovalent Avian Influenza VLP (H5N1), Monovalent Avian Influenza VLP (H5N1); Adjuvant, Saline placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monovalent Avian Influenza VLP (H5N1)Biological
Dose A without Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21
Monovalent Avian Influenza VLP (H5N1)Biological
Dose B without Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21
Monovalent Avian Influenza VLP (H5N1); AdjuvantBiological
Dose B with Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21
Monovalent Avian Influenza VLP (H5N1); AdjuvantBiological
Dose C with Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21
Monovalent Avian Influenza VLP (H5N1); AdjuvantBiological
Dose D with Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21
Saline placeboBiological
Placebo; Intramuscular, deltoid, Day 0 \& Day 21
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: Monovalent Avian Influenza VLP (H5N1) |
| Group B | Experimental | Not described Receives: Biological: Monovalent Avian Influenza VLP (H5N1) |
| Group C | Experimental | Not described Receives: Biological: Monovalent Avian Influenza VLP (H5N1); Adjuvant |
| Group D | Experimental | Not described Receives: Biological: Monovalent Avian Influenza VLP (H5N1); Adjuvant |
| Group E | Experimental | Not described Receives: Biological: Monovalent Avian Influenza VLP (H5N1); Adjuvant |
| Group F | Experimental | Not described Receives: Biological: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of solicited and unsolicited adverse events in H5N1 VLP antigen dose groups delivering HA with/without Adjuvant 1.
Measured: Day 42
Secondary outcomes (1)
Measurement of HAI antibody seroconversion rates and GMT achieved by a constant H5N1 VLP antigen dose alone and in combination with Adjuvant 1.
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza (Pandemic)Studies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novavax
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Nigel Thomas, Ph.D, Study director, Novavax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594320
- Sponsor's protocol ID
- NVX778.P101
- Status last verified
- Feb 2014
- First submitted
- 2 May 2012
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Indonesia/05/05 (H5N1) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Young Adults With and Without Adjuvant 1.
- ClinicalTrials.gov ID
- NCT01594320
- Acronym / sponsor ID
- NVX778.P101
- Conditions
- Influenza (Pandemic)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- NovavaxIndustry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Study start
- Apr 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 May 2012 (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 evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 1 in healthy, young adults. The study is divided down into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Monovalent Avian Influenza VLP (H5N1) |
| Group B | Experimental | Biological: Monovalent Avian Influenza VLP (H5N1) |
| Group C | Experimental | Biological: Monovalent Avian Influenza VLP (H5N1); Adjuvant |
| Group D | Experimental | Biological: Monovalent Avian Influenza VLP (H5N1); Adjuvant |
| Group E | Experimental | Biological: Monovalent Avian Influenza VLP (H5N1); Adjuvant |
| Group F | Experimental | Biological: Saline placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult male or female, ≥18 and ≤49 years of age,
- Willing and able to give informed consent prior to study enrollment,
- Able to comply with study requirements, and
- Women must have a negative urine pregnancy test prior to each vaccination; will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity or prior surgical sterilization, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and intrauterine device (IUD).
Key exclusion criteria (16 listed)
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care. Asymptomatic conditions (e.g., hypertension, dyslipidemia) that are being managed medically and that are not associated with evidence of end-organ damage are not exclusionary provided they are clinically stable (defined as no unscheduled medical interventions or change in medications for cause within 3 months).
- Any history of jaundice, or of hepatic injury due to drug (prescription, OTC, or illicit) or alcohol use or viral hepatitis; or the presence of hepatitis B surface antigen or hepatitis C antibody at screening.
- Any grade 1 or higher (as based on the Toxicity Grading Scale [TGS]) abnormality in ALT, AST, alkaline phosphatase or total bilirubin levels.
- Any grade 2 or higher (as based on the TGS) vital sign or clinical laboratory abnormality not specified in criterion 3 above. Note that any abnormal vital sign may be repeated at the Investigator's discretion.
- Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
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 |
|---|---|---|
| Monovalent Avian Influenza VLP (H5N1)Dose A without Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21 | Biological | Group A |
| Monovalent Avian Influenza VLP (H5N1)Dose B without Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21 | Biological | Group B |
| Monovalent Avian Influenza VLP (H5N1); AdjuvantDose B with Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21 | Biological | Group C |
| Monovalent Avian Influenza VLP (H5N1); AdjuvantDose C with Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21 | Biological | Group D |
| Monovalent Avian Influenza VLP (H5N1); AdjuvantDose D with Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21 | Biological | Group E |
| Saline placeboPlacebo; Intramuscular, deltoid, Day 0 \& Day 21 | Biological | Group F |
Primary outcome
Number of solicited and unsolicited adverse events in H5N1 VLP antigen dose groups delivering HA with/without Adjuvant 1.
Time frame: Day 42
1 secondary outcome
Measurement of HAI antibody seroconversion rates and GMT achieved by a constant H5N1 VLP antigen dose alone and in combination with Adjuvant 1.
Time frame: Day 42
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 6 Feb 2014.
- Related InfoLink provided by the sponsor.
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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.
Nigel Thomas, Ph.D study director
Novavax
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Monovalent Avian Influenza VLP (H5N1) and Monovalent Avian Influenza VLP (H5N1); Adjuvant in people with Influenza (Pandemic), run by Novavax at 5 sites in United States.
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 4 inclusion and 16 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 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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. 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?
Number of solicited and unsolicited adverse events in H5N1 VLP antigen dose groups delivering HA with/without Adjuvant 1. (time frame: Day 42). 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 6 Feb 2014.