InfluenzaPhase 2NCT00754455
Evaluate the Safety and Immunogenicity of a Seasonal Influenza VLP Vaccine (Recombinant) in Healthy Adults
A Phase 2 study testing Influenza VLP Vaccine (recombinant) in people with Influenza, run by Novavax at 4 sites in United States.
Trial summary
A Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine (recombinant) in Healthy Adults. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza VLP Vaccine (recombinant)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 317 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2008to Mar 2009
- Phase
- Phase 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female 18 to 49 years of age at the time of the vaccination.
- Informed consent must be obtained from the subject prior to beginning any study specific procedures indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol.
- Available by telephone.
- Free of obvious health problems or chronic illnesses (i.e., recent exacerbation or acute episode of chronic illness in the last 3 months) as established by medical history, review of systems and clinical examination before entering the study. This includes any mental condition that would interfere with subject self-assessment. Subjects with pre-existing stable disease, defined as no significant disease diagnosed in the month prior to study vaccine receipt and disease not requiring significant change in therapy or hospitalization for worsening disease 3 months before receipt of study vaccine are eligible.
- If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception) for 3 months prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for three months after vaccination.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Has received any other licensed vaccines within 4 weeks prior to enrollment in this study or expected receipt of any vaccination before the final immune response blood collection.
- Has received any influenza vaccine within the prior 6 month period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. The use of inhaled and nasal steroids will be permitted.
- Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
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- Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever ≥ 100.5º F.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Major congenital defects or serious chronic illness.
- History of any neurological disorders or seizures, with the exception of febrile seizures during childhood.
- Pregnant or lactating female.
- Females planning to become pregnant or planning to discontinue contraceptive precautions within 60 days of enrollment in this study.
- Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Benchmark Research
Austin, Texas, 78705
The Center for Pharmacuetical Research
Kansas City, Missouri, 64114
University Clinical Research
Pembroke Pines, Florida, 33024
Omega Medical Research
Warwick, Rhode Island, 02886
About this study
Official title: A Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant) in Healthy Adults
A Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine (recombinant) in Healthy Adults.
Study Objectives:
Read more
Primary:
- To assess the tolerability and safety of Influenza VLP Vaccine
- To assess the immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers to each of the three component viral strains
Secondary:
- To evaluate the cross-strain immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers against drifted strains
- To quantify antibody against neuraminidase and hemagglutinin following administration of Influenza VLP Vaccine
- To assess cell-mediated immune (CMI) responses to Influenza VLP Vaccine as quantified by interferon-gamma (IFNg) and Granzyme-B produced by peripheral blood mononuclear cells (PBMCs).
Read the detailed description
Study Design:
This is a Phase 2a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of three dose levels (low, middle or high) of Influenza VLP Vaccine or placebo in healthy adults(18 to 49 years of age).
Eligible subjects will provide a blood sample for baseline evaluation of immunological measures followed by a single intramuscular (IM) injection of Influenza VLP Vaccine or placebo (Day 1).
Subjects will be monitored in the clinic for a period of at least 30 minutes following vaccination for the occurrence of adverse events including local injection site reactions and systemic responses. For 7 days following vaccination and beginning the day of vaccination, subjects will maintain a symptom diary for daily recording of injection-site reactions as well as generalized systemic reactions including measurement of body temperature. Clinic staff will contact the subjects by telephone 2 days post vaccination (Day 3) to check for adverse events and to answer any questions related to collection of symptom diary information. Subjects will return to the clinic 7 days following vaccination (Day 8) for safety evaluation that will include a review of diary card information. A subset of subjects will additionally return to the clinic 10-14 days following vaccination (Days 11-15) to provide a blood sample for evaluation of cell-mediated immune (CMI) responses. All subjects will return to the clinic 21 days following injection (Day 22) for a safety evaluation and to provide a blood sample for measurement of humoral immunological parameters. A final safety evaluation (telephone contact) will occur at approximately 6 months following vaccination (Day 181).
The study will be conducted as a parallel group design with a total of approximately 300 subjects (18 to 49 years of age) randomly assigned to one of 4 treatment arms (high, middle, low and placebo) in a 2:2:1:1 ratio. The following is a summary of subject allocation to treatment:
Subject Allocation Treatment Condition Number of Subjects High dose vaccine/ 0.5 mL - 100 Middle dose vaccine/ 0.5 mL - 100 Low dose vaccine/ 0.5 mL - 50 Placebo (0.5 mL) - 50
- Conditions
- Influenza
- Being tested
- Influenza VLP Vaccine (recombinant), 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.
Influenza VLP Vaccine (recombinant)Biological
Single injection Day 0; 0.5mL
PlaceboBiological
Placebo as a single injection of 0.5 mL.
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Not described Receives: Biological: Influenza VLP Vaccine (recombinant) |
| Mid dose | Experimental | Not described Receives: Biological: Influenza VLP Vaccine (recombinant) |
| High dose | Experimental | Not described Receives: Biological: Influenza VLP Vaccine (recombinant) |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the tolerability and safety of Influenza VLP Vaccine
Measured: 6 Months
To assess the immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers to each of the component viral strains
Measured: Day 22
Secondary outcomes (3)
To evaluate cross-strain immunogenicity as measured by HAI titers against drifted strains
Measured: Day 22
To quantify antibody responses against neuraminidase and hemagglutinin
Measured: Day 22
To assess cell-mediated immune (CMI) responses to Influenza VLP Vaccine
Measured: Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novavax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John E Ervin, M.D., Principal investigator, The Center for Pharmaceutical ResearchLaurence Chu, M.D., Principal investigator, Benchmark ResearchLarry Gilderman, D.O., Principal investigator, University Clinical ResearchDavid L Freid, M.D., Principal investigator, Omega Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754455
- Sponsor's protocol ID
- NVX 755.201
- Status last verified
- Jul 2013
- First submitted
- 16 Sep 2008
- Last updated
- 18 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant) in Healthy Adults
- ClinicalTrials.gov ID
- NCT00754455
- Acronym / sponsor ID
- NVX 755.201
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- NovavaxIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 18 Sep 2008 (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 Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine (recombinant) in Healthy Adults.
Study Objectives:
Primary:
- To assess the tolerability and safety of Influenza VLP Vaccine
- To assess the immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers to each of the three component viral strains
Secondary:
- To evaluate the cross-strain immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers against drifted strains
- To quantify antibody against neuraminidase and hemagglutinin following administration of Influenza VLP Vaccine
- To assess cell-mediated immune (CMI) responses to Influenza VLP Vaccine as quantified by interferon-gamma (IFNg) and Granzyme-B produced by peripheral blood mononuclear cells (PBMCs).
Detailed description
Study Design:
This is a Phase 2a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of three dose levels (low, middle or high) of Influenza VLP Vaccine or placebo in healthy adults(18 to 49 years of age).
Eligible subjects will provide a blood sample for baseline evaluation of immunological measures followed by a single intramuscular (IM) injection of Influenza VLP Vaccine or placebo (Day 1).
Subjects will be monitored in the clinic for a period of at least 30 minutes following vaccination for the occurrence of adverse events including local injection site reactions and systemic responses. For 7 days following vaccination and beginning the day of vaccination, subjects will maintain a symptom diary for daily recording of injection-site reactions as well as generalized systemic reactions including measurement of body temperature. Clinic staff will contact the subjects by telephone 2 days post vaccination (Day 3) to check for adverse events and to answer any questions related to collection of symptom diary information. Subjects will return to the clinic 7 days following vaccination (Day 8) for safety evaluation that will include a review of diary card information. A subset of subjects will additionally return to the clinic 10-14 days following vaccination (Days 11-15) to provide a blood sample for evaluation of cell-mediated immune (CMI) responses. All subjects will return to the clinic 21 days following injection (Day 22) for a safety evaluation and to provide a blood sample for measurement of humoral immunological parameters. A final safety evaluation (telephone contact) will occur at approximately 6 months following vaccination (Day 181).
The study will be conducted as a parallel group design with a total of approximately 300 subjects (18 to 49 years of age) randomly assigned to one of 4 treatment arms (high, middle, low and placebo) in a 2:2:1:1 ratio. The following is a summary of subject allocation to treatment:
Subject Allocation Treatment Condition Number of Subjects High dose vaccine/ 0.5 mL - 100 Middle dose vaccine/ 0.5 mL - 100 Low dose vaccine/ 0.5 mL - 50 Placebo (0.5 mL) - 50
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Biological: Influenza VLP Vaccine (recombinant) |
| Mid dose | Experimental | Biological: Influenza VLP Vaccine (recombinant) |
| High dose | Experimental | Biological: Influenza VLP Vaccine (recombinant) |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female 18 to 49 years of age at the time of the vaccination.
- Informed consent must be obtained from the subject prior to beginning any study specific procedures indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol.
- Available by telephone.
- Free of obvious health problems or chronic illnesses (i.e., recent exacerbation or acute episode of chronic illness in the last 3 months) as established by medical history, review of systems and clinical examination before entering the study. This includes any mental condition that would interfere with subject self-assessment. Subjects with pre-existing stable disease, defined as no significant disease diagnosed in the month prior to study vaccine receipt and disease not requiring significant change in therapy or hospitalization for worsening disease 3 months before receipt of study vaccine are eligible.
- If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception) for 3 months prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for three months after vaccination.
Key exclusion criteria (13 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Has received any other licensed vaccines within 4 weeks prior to enrollment in this study or expected receipt of any vaccination before the final immune response blood collection.
- Has received any influenza vaccine within the prior 6 month period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. The use of inhaled and nasal steroids will be permitted.
- Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
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 VLP Vaccine (recombinant)Single injection Day 0; 0.5mL | Biological | High dose, Low dose, Mid dose |
| PlaceboPlacebo as a single injection of 0.5 mL. | Biological | Placebo |
Primary outcome
To assess the tolerability and safety of Influenza VLP Vaccine
Time frame: 6 Months
To assess the immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers to each of the component viral strains
Time frame: Day 22
3 secondary outcomes
To evaluate cross-strain immunogenicity as measured by HAI titers against drifted strains
Time frame: Day 22
To quantify antibody responses against neuraminidase and hemagglutinin
Time frame: Day 22
To assess cell-mediated immune (CMI) responses to Influenza VLP Vaccine
Time frame: Day 11
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 18 Jul 2013.
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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.
John E Ervin, M.D. principal investigator
The Center for Pharmaceutical Research
Laurence Chu, M.D. principal investigator
Benchmark Research
Larry Gilderman, D.O. principal investigator
University Clinical Research
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Influenza VLP Vaccine (recombinant) in people with Influenza, run by Novavax at 4 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 5 inclusion and 13 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 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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 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?
To assess the tolerability and safety of Influenza VLP Vaccine (time frame: 6 Months). The study lists 2 primary outcomes in all. 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 18 Jul 2013.