Influenza A Subtype H5N1 InfectionPhase 1NCT01657929
H5-VLP + GLA-AF Vaccine Trial in Healthy Adult Volunteers
A Phase 1 study testing H5-VLP + GLA-AF, H5-VLP alone and H5-VLP + Alhydrogel(R) in people with Influenza A Subtype H5N1 Infection, run by Access to Advanced Health Institute (AAHI) at 3 sites in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of pandemic influenza. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A Subtype H5N1 Infection
- What is being tested?
- H5-VLP + GLA-AF, H5-VLP alone and H5-VLP + Alhydrogel(R)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2012to Jan 2014
- 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
- Males and females 18 to 49 years of age.
- Must be in good general health as confirmed by a medical history and physical exam, vital signs, and screening laboratories conducted no more than 30 days prior to study injection administration.
- Female subjects of childbearing potential, regardless of birth control history, must have a negative serum pregnancy test at screening, a negative urine pregnancy test on the day of each study injection, must not be breast-feeding or lactating, and are required to consistently use one of the following methods of contraception through the first three months of the study: hormonal (e.g. oral, transdermal, intravaginal, implant, or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); abstinence (as confirmed by the investigator); or bilateral tubal ligation (if no conception post-procedure). These precautions are necessary due to unknown effects that H5-VLP + GLA AF or H5-VLP alone might have in a fetus or newborn infant. The subject must have no plan to become pregnant during the first three months of the study period. Females who are post-menopausal (no spotting at all) for at least one (1) year will not require a pregnancy test.
- The following screening laboratory blood tests must have values within the normal ranges (as provided by each clinical site) or not clinically significant as determined by the Principal Investigator (or designated sub-investigator) and Medical Monitor (all test results must be within 30 days prior to first study injection): sodium, potassium, BUN, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, fasting glucose, fasting lipid panel, total WBC count, hemoglobin, and platelet count.
- The following serology tests must be negative: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
- Negative urine test for recreational drugs and alcohol per Clinical Research Unit standards.
Show all 10Show fewer
- Urinalysis not clinically significant as determined by the study clinician.
- In the opinion of the Investigator, must show comprehension of the study requirements, competence and willingness to provide written, informed consent for participation after reading the informed consent form. The subject must have adequate opportunity to discuss the study with an Investigator or qualified designee.
- Must be capable of completing a study memory aid in English.
- Must be able and willing to attend all evaluation visits, be reachable by telephone on a consistent basis by the study site personnel, and have a permanent address.
Who cannot join
- Previous exposure to H5N1 vaccines or experimental products containing GLA-AF.
- History of allergy to any of the constituents of H5-VLP (H5N1) + Alhydrogel (aluminum hydroxide) vaccine.
- Participation in another experimental protocol or receipt of any investigational or non-registered products within the past 3 months or planned use during the study period. Subjects may not participate in any other drug study while participating in this study.
- Treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as prednisone; high dose inhaled steroids) or cytotoxic therapies (e.g., chemotherapy drugs or radiation) within the past 6 months.
- Received a blood transfusion or immunoglobulin within the past 3 months.
- Donated blood products (platelets, whole blood, plasma, etc.) within past 1 month.
Show all 26Show fewer
- Poor venous access.
- Administration of any vaccine (including any other influenza vaccine) within a 30 day period prior to study enrollment, or planned administration of any vaccines within the period from the first study injection up to blood sampling at Day 42 or within 30 days prior to blood sampling at Day 189. Immunization on an emergency basis of a tetanus and diphtheria toxoids adsorbed for adult use (Td) will be allowed provided the vaccine is not administered within two weeks prior to study injection administration. Receipt of any other emergency immunizations (e.g. rabies) will result in a case-by-case review of continued participation.
- History of autoimmune disease or other causes of immunosuppressive states.
- Any confirmed or suspected immunosuppressive condition or immunodeficiency including history of human immunodeficiency virus (HIV) infection or presence of lymphoproliferative disease.
- History or evidence of any acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic, or renal disorders, controlled hypertension), or use of medication that, in the opinion of the Principal Investigator (or designated sub-investigator), may interfere with the evaluation of the safety or immunogenicity of the vaccine.
- Cancer or treatment for cancer within 3 years of study injection administration. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. Persons with treated and uncomplicated basal cell carcinoma of the skin are eligible.
- Presence of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. "Uncontrolled" is defined as:
- Requiring a new medical or surgical treatment within one month prior to study vaccine administration
- Requiring a change in medication dosage in one month prior to test article administration due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or
- Hospitalization or an event fulfilling the definition of a serious adverse event within one month prior to test article administration
- Rash, tattoos or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation.
- BMI <18 or >30 kg/m2.
- Hypertension (systolic ≥150 mmHg or diastolic ≥90 mmHg).
- Resting pulse rate <40 bpm or >100 bpm.
- Any medical or neuropsychiatric condition which, in the Investigator's opinion, would render the subject incompetent to provide informed consent or unable to provide valid safety observations and reporting.
- Known or suspected alcohol or drug abuse within the past 6 months.
- Chronic smoker (> 20 pack years).
- History of allergy to tobacco or eggs.
- Subjects with a history of previous anaphylaxis or severe allergic reaction to vaccines, or unknown allergens.
- Subjects who are unlikely to cooperate with the requirements of the study protocol.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Covance, Inc.
Dallas, Texas, 75247
Covance, Inc.
Daytona Beach, Florida, 32117
Covance, Inc.
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Randomized Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the H5-VLP + GLA-AF Pandemic Influenza Vaccine in Healthy Adult Subjects
The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of pandemic influenza. The vaccine, identified as H5-VLP + GLA-AF, consists of a recombinant influenza virus H5 protein (hemagglutinin from A/Indonesia/5/2005) produced in a plant-based expression system assembling into virus-like particles together with the adjuvant GLA-AF.
- Conditions
- Influenza A Subtype H5N1 Infection
- Being tested
- H5-VLP + GLA-AF, H5-VLP alone, H5-VLP + Alhydrogel(R), Licensed H5N1 vaccine
- Keywords
- Influenza, Avian, H5N1, H5-VLP, GLA, GLA-AF
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H5-VLP + GLA-AFBiological
H5-VLP antigen and GLA-AF adjuvant. 2 injections at Days 0, and 21.
H5-VLP aloneBiological
H5-VLP antigen alone. 2 injections at Days 0, and 21.
H5-VLP + Alhydrogel(R)Biological
H5-VLP antigen and Alhydrogel(R) adjuvant. 2 injections at Days 0, and 21.
Licensed H5N1 vaccineBiological
Licensed H5N1 vaccine. 2 injections given on Days 0 and 21.
| Study group | Role | What they receive |
|---|---|---|
| 20 µg H5-VLP + 2.5 µg GLA-AF given ID | Experimental | Not described Receives: Biological: H5-VLP + GLA-AF |
| 20 µg H5-VLP + 2.5 µg GLA-AF given IM | Experimental | Not described Receives: Biological: H5-VLP + GLA-AF |
| 20 µg H5-VLP alone given ID | Active comparator | Not described Receives: Biological: H5-VLP alone |
| 20 µg H5-VLP + 1 mg Alhydrogel(R) given IM | Active comparator | Not described Receives: Biological: H5-VLP + Alhydrogel(R) |
| 90 µg licensed H5N1 vaccine | Active comparator | Not described Receives: Biological: Licensed H5N1 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients experiencing adverse events
To evaluate the safety and tolerability of 20 μg of H5-VLP together with 2.5 μg of GLA-AF compared to 20 µg of H5-VLP alone, 20 µg of H5-VLP with 1 mg Alhydrogel(R), or a licensed H5N1 vaccine following intramuscular or intradermal administration on Days 0 and 21. The safety assessments will be based on local and systemic reactions, including reported adverse events, changes in laboratory values, and changes in vital signs. The severity and relationship to treatment will be recorded for all adverse events.
Measured: 385 days
Secondary outcomes (1)
Immunogenicity
To assess the immunogenicity of H5-VLP + GLA-AF compared to H5-VLP alone, H5-VLP + Alhydrogel, or a licensed H5N1 vaccine following intramuscular or intradermal administration by evaluating humoral and cellular responses to H5-VLP at specified timepoints.
Measured: Days 0, 7, 10, 21, 28, 31, 42, and 189
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza A Subtype H5N1 InfectionStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access to Advanced Health Institute (AAHI)
- Sponsor type
- University, hospital or other
- Collaborators
- Medicago, Defense Advanced Research Projects Agency
- Responsible party
- Sponsor
- Investigators
- Franco Piazza, MD, MPH, Study director, Access to Advanced Health Institute (AAHI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657929
- Sponsor's protocol ID
- IDRI-FPVPX-112
- Status last verified
- Feb 2014
- First submitted
- 2 Aug 2012
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the H5-VLP + GLA-AF Pandemic Influenza Vaccine in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01657929
- Acronym / sponsor ID
- IDRI-FPVPX-112
- Conditions
- Influenza A Subtype H5N1 Infection
- Keywords
- Influenza, Avian, H5N1, H5-VLP, GLA, GLA-AF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Access to Advanced Health Institute (AAHI)University, hospital or other
- Collaborators
- Medicago, Defense Advanced Research Projects Agency
- Study start
- Sep 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Aug 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 determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of pandemic influenza. The vaccine, identified as H5-VLP + GLA-AF, consists of a recombinant influenza virus H5 protein (hemagglutinin from A/Indonesia/5/2005) produced in a plant-based expression system assembling into virus-like particles together with the adjuvant GLA-AF.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 20 µg H5-VLP + 2.5 µg GLA-AF given ID | Experimental | Biological: H5-VLP + GLA-AF |
| 20 µg H5-VLP + 2.5 µg GLA-AF given IM | Experimental | Biological: H5-VLP + GLA-AF |
| 20 µg H5-VLP alone given ID | Active comparator | Biological: H5-VLP alone |
| 20 µg H5-VLP + 1 mg Alhydrogel(R) given IM | Active comparator | Biological: H5-VLP + Alhydrogel(R) |
| 90 µg licensed H5N1 vaccine | Active comparator | Biological: Licensed H5N1 vaccine |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Males and females 18 to 49 years of age.
- Must be in good general health as confirmed by a medical history and physical exam, vital signs, and screening laboratories conducted no more than 30 days prior to study injection administration.
- Female subjects of childbearing potential, regardless of birth control history, must have a negative serum pregnancy test at screening, a negative urine pregnancy test on the day of each study injection, must not be breast-feeding or lactating, and are required to consistently use one of the following methods of contraception through the first three months of the study: hormonal (e.g. oral, transdermal, intravaginal, implant, or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); abstinence (as confirmed by the investigator); or bilateral tubal ligation (if no conception post-procedure). These precautions are necessary due to unknown effects that H5-VLP + GLA AF or H5-VLP alone might have in a fetus or newborn infant. The subject must have no plan to become pregnant during the first three months of the study period. Females who are post-menopausal (no spotting at all) for at least one (1) year will not require a pregnancy test.
- The following screening laboratory blood tests must have values within the normal ranges (as provided by each clinical site) or not clinically significant as determined by the Principal Investigator (or designated sub-investigator) and Medical Monitor (all test results must be within 30 days prior to first study injection): sodium, potassium, BUN, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, fasting glucose, fasting lipid panel, total WBC count, hemoglobin, and platelet count.
- The following serology tests must be negative: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
Key exclusion criteria (26 listed)
- Previous exposure to H5N1 vaccines or experimental products containing GLA-AF.
- History of allergy to any of the constituents of H5-VLP (H5N1) + Alhydrogel (aluminum hydroxide) vaccine.
- Participation in another experimental protocol or receipt of any investigational or non-registered products within the past 3 months or planned use during the study period. Subjects may not participate in any other drug study while participating in this study.
- Treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as prednisone; high dose inhaled steroids) or cytotoxic therapies (e.g., chemotherapy drugs or radiation) within the past 6 months.
- Received a blood transfusion or immunoglobulin within the past 3 months.
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 |
|---|---|---|
| H5-VLP + GLA-AFH5-VLP antigen and GLA-AF adjuvant. 2 injections at Days 0, and 21. | Biological | 20 µg H5-VLP + 2.5 µg GLA-AF given ID, 20 µg H5-VLP + 2.5 µg GLA-AF given IM |
| H5-VLP aloneH5-VLP antigen alone. 2 injections at Days 0, and 21. | Biological | 20 µg H5-VLP alone given ID |
| H5-VLP + Alhydrogel(R)H5-VLP antigen and Alhydrogel(R) adjuvant. 2 injections at Days 0, and 21. | Biological | 20 µg H5-VLP + 1 mg Alhydrogel(R) given IM |
| Licensed H5N1 vaccineLicensed H5N1 vaccine. 2 injections given on Days 0 and 21. | Biological | 90 µg licensed H5N1 vaccine |
Primary outcome
Number of patients experiencing adverse events
Time frame: 385 days
To evaluate the safety and tolerability of 20 μg of H5-VLP together with 2.5 μg of GLA-AF compared to 20 µg of H5-VLP alone, 20 µg of H5-VLP with 1 mg Alhydrogel(R), or a licensed H5N1 vaccine following intramuscular or intradermal administration on Days 0 and 21. The safety assessments will be based on local and systemic reactions, including reported adverse events, changes in laboratory values, and changes in vital signs. The severity and relationship to treatment will be recorded for all adverse events.
1 secondary outcome
Immunogenicity
Time frame: Days 0, 7, 10, 21, 28, 31, 42, and 189
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 26 Feb 2014.
Related trials for Influenza A Subtype H5N1 Infection
RecruitingPhase 1/2
Safety and Immunogenicity of the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented and Adjuvanted) in Adults and Older Adults
Avian Influenza A Virus
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.
Franco Piazza, MD, MPH study director
Access to Advanced Health Institute (AAHI)
3 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 H5-VLP + GLA-AF, H5-VLP alone and H5-VLP + Alhydrogel(R) in people with Influenza A Subtype H5N1 Infection, run by Access to Advanced Health Institute (AAHI) at 3 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 10 inclusion and 26 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 26 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 3 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 patients experiencing adverse events (time frame: 385 days). 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 26 Feb 2014.