Pandemic InfluenzaPhase 1/2NCT00519389
Safety, Reactogenicity and Immunogenicity of an H5N1 VLP
A Phase 1/2 study testing H5N1 VLP Vaccine in people with Pandemic Influenza, run by Novavax at 1 site in United States.
Trial summary
This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pandemic Influenza
- What is being tested?
- H5N1 VLP Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Nov 2008
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female 18 to 40 years of age at the time of the vaccination.
- Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visits and completion of the data collection tool).
- Available by telephone.
- Free of obvious health problems as established by medical history and clinical examination before entering the study.
- 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 30 days prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for two months after completion of vaccination.
- Must provide written, informed consent.
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.
- Has received any influenza vaccine within the prior 12 month period.
- Has received any investigational vaccine designed for protection against avian influenza.
- 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.
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- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthcare Discoveries, Inc.
San Antonio, Texas, 78209
About this study
Official title: A Phase I/IIa Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of an H5N1 Virus-Like Particle (VLP) Influenza Vaccine (Recombinant)
This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.
- Conditions
- Pandemic Influenza
- Being tested
- H5N1 VLP Vaccine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H5N1 VLP VaccineBiological
Two doses - Day 0 \& Day 28
PlaceboBiological
Two doses - Day 0 \& Day 28
| Study group | Role | What they receive |
|---|---|---|
| Low dose H5N1 VLP Vaccine | Experimental | Not described Receives: Biological: H5N1 VLP Vaccine |
| Mid dose H5N1 VLP Vaccine | Experimental | Not described Receives: Biological: H5N1 VLP Vaccine |
| High dose H5N1 VLP Vaccine | Experimental | Not described Receives: Biological: H5N1 VLP Vaccine |
| 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.
Safety and reactogenicity of H5N1 VLP Vaccine
Measured: 6 months
Secondary outcomes (1)
Immunogenicity of H5N1 VLP Influenza vaccine
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pandemic 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novavax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Atiee, M.D., Principal investigator, Healthcare Discoveries, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519389
- Sponsor's protocol ID
- H5N1 VLP-1
- Status last verified
- Mar 2012
- First submitted
- 20 Aug 2007
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of an H5N1 Virus-Like Particle (VLP) Influenza Vaccine (Recombinant)
- ClinicalTrials.gov ID
- NCT00519389
- Acronym / sponsor ID
- H5N1 VLP-1
- Conditions
- Pandemic Influenza
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- NovavaxIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 22 Aug 2007 (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.
This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose H5N1 VLP Vaccine | Experimental | Biological: H5N1 VLP Vaccine |
| Mid dose H5N1 VLP Vaccine | Experimental | Biological: H5N1 VLP Vaccine |
| High dose H5N1 VLP Vaccine | Experimental | Biological: H5N1 VLP Vaccine |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female 18 to 40 years of age at the time of the vaccination.
- Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visits and completion of the data collection tool).
- Available by telephone.
- Free of obvious health problems as established by medical history and clinical examination before entering the study.
- 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 30 days prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for two months after completion of vaccination.
Key exclusion criteria (11 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.
- Has received any influenza vaccine within the prior 12 month period.
- Has received any investigational vaccine designed for protection against avian influenza.
- 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.
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 |
|---|---|---|
| H5N1 VLP VaccineTwo doses - Day 0 \& Day 28 | Biological | High dose H5N1 VLP Vaccine, Low dose H5N1 VLP Vaccine, Mid dose H5N1 VLP Vaccine |
| PlaceboTwo doses - Day 0 \& Day 28 | Biological | Placebo |
Primary outcome
Safety and reactogenicity of H5N1 VLP Vaccine
Time frame: 6 months
1 secondary outcome
Immunogenicity of H5N1 VLP Influenza vaccine
Time frame: 6 months
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 21 Jun 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.
George Atiee, M.D. principal investigator
Healthcare Discoveries, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing H5N1 VLP Vaccine in people with Pandemic Influenza, run by Novavax at 1 site 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 6 inclusion and 11 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 21 Jun 2013. 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 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 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?
Safety and reactogenicity of H5N1 VLP Vaccine (time frame: 6 months). 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 21 Jun 2013.