InfluenzaPhase 1NCT02206464
H7 Influenza Prime-Boost Regimens in Healthy Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or With Monovalent Influenza Subunit Virion H7N9 Vaccine (MIV) as Prime With MIV Boost Compared to MIV Prime With MIV Boo...
A Phase 1 study testing A/Shanghai/02/2013 (H7N9) MIV and VRC-FLUDNA071-00-VP in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background:<TAB> Flu virus that causes disease in birds can sometimes spread to people. It can cause severe illness, even death. Vaccines are used to try to create resistance to such infections. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Influenza
- What is being tested?
- A/Shanghai/02/2013 (H7N9) MIV and VRC-FLUDNA071-00-VP
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2014to 7 Jan 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A subject must meet all of the following criteria:
- 18 to 60 years old.
- Available for clinic visits for up to 28 weeks after enrollment.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Willing to donate blood for sample storage to be used for future research.
- In good general health without clinically significant medical history.
Show all 18Show fewer
- Received a current seasonal influenza vaccine at least 2 weeks before enrollment.
- Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than or equal to 40 within the 56 days prior to enrollment.
- Laboratory Criteria within 56 days prior to enrollment:
- Hemoglobin within institutional normal limits
- White blood cells (WBC) and differential either within institutional normal range or accompanied by site physician approval
- Total lymphocyte count greater than or equal to 800 cells/mm3
- Platelets = 125,000 500,000/mm3
- Alanine aminotransferase (ALT) less than or equal to 1.25 x upper limit of normal (ULN)
- Serum creatinine less than or equal to .1 x ULN based on the institutional normal range
- Criteria applicable to women of childbearing potential:
- Negative human chorionic gonadotropin ( <=-HCG) pregnancy test (urine or serum) on day of enrollment
- Agree to use an effective means of birth control from 21 days prior to enrollment through 4 weeks after the second study vaccination
Who cannot join
- A subject will be excluded if one or more of the following conditions apply. Women Specific:
- Breast-feeding or planning to become pregnant while participating in the study
- Subject has received any of the following substances:
- More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
- Blood products within 16 weeks prior to enrollment
- Live attenuated vaccines within 4 weeks prior to initial study vaccine administration
Show all 28Show fewer
- Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
- Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal within 2 weeks of initial study vaccine administration unless approved by the study Principal Investigator (PI)
- Allergy treatment with antigen injections, unless on maintenance schedule
- Current anti-TB prophylaxis or therapy
- Previous H7 avian influenza investigational vaccine
- Subject has a history of any of the following clinically significant conditions:
- Contraindication to receiving an FDA-approved current seasonal influenza vaccination including hypersensitivity to eggs
- Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator
- Hereditary angioedema, acquired angioedema, or idiopathic forms of Angioedema
- Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids
- Diabetes mellitus (type I or II), with the exception of gestational diabetes
- Thyroid disease that is not well controlled
- Idiopathic urticaria within the past year
- Hypertension that is not well controlled
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study
- Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years
- Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.
- Type 1 hypersensitivity reaction to aminoglycoside antibiotics
- Guillain-Barr(SqrRoot)(Copyright) Syndrome
- Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within 5 years prior to enrollment, a history of suicide plan or attempt
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer s ability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: VRC 315: A Phase I Open-Label, Randomized Study of H7 Influenza Prime-Boost Regimens in Healthy Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or With Monovalent Influenza Subunit Virion H7N9 Vaccine (MIV) as Prime With MIV Boost Compared to MIV Prime With MIV Boost
Background:<TAB>
- Flu virus that causes disease in birds can sometimes spread to people. It can cause severe illness, even death. Vaccines are used to try to create resistance to such infections. Researchers want to test a new vaccination strategy, combining two different vaccine types, the H7 DNA Vaccine (DNA vaccine) and H7N9 Monovalent Inactivated Vaccine (MIV), to see if one of two combinations offer better protection against a certain type of bird flu in humans when compared to vaccination using two doses of MIV alone.
Read more
Objectives:
- To see if 2 vaccines for bird flu, are safe and tolerable for humans.
- To study immune responses to these vaccines.
Eligibility:
- Healthy adults 18 60 years old.
Design:
- Participants will be screened through a separate protocol.
- Participants will be randomly assigned to 1 of 3 groups. Each group will get a different combination of vaccines.
- Participants will have about 8 clinic visits. Each visit takes 2 4 hours. Blood will be drawn at some visits. Urine samples may be collected.
- Participants will receive vaccinations at 2 of the visits, 16 weeks apart.
- The H7N9 MIV will be injected in the upper arm using a needle and syringe. The DNA vaccine will be injected in the upper arm using a device that delivers the vaccine through the skin by pressure instead of a needle.
- Participants will be observed for at least 30 minutes after each vaccination.
- Soon after each vaccination, participants will get 1 2 phone calls, come to clinic for evaluation, and complete a diary at home for 1 week. They will record their temperature and symptoms and look at the injection site daily.
- Participants will have follow-up blood tests.
Read the detailed description
VRC 315 STUDY:
A Phase I Open-Label, Randomized Study of H7 Influenza Prime-Boost Regimens in Healthy Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or with Monovalent Influenza Subunit Virion H7N9 Vaccine (MIV) as Prime with MIV Boost Compared to MIV Prime with MIV Boost
STUDY DESIGN:
This is a Phase I, randomized, open-label study to evaluate the safety, tolerability, and immunogenicity of prime-boost vaccination regimens against H7N9 Influenza. A vaccination regimen with the VRC-FLUDNA071-00-VP (H7 DNA) vaccine administered alone or concurrently in different arms with A/Shanghai/2/2013(H7N9) (MIV) as prime followed by inactivated MIV boost will be compared to MIV-MIV prime-boost with a 16 week boost interval. The primary hypothesis is that all the H7 DNA prime-MIV boost, DNA+MIV prime-MIV boost, and MIV-MIV study regimens will be safe for human administration. A secondary hypothesis is that the H7 DNAMIV regimen will elicit a greater frequency and/or magnitude of antibody against H7 than the MIV-MIV regimen. The primary objective is to evaluate the safety and tolerability in healthy adults of the investigational vaccine regimens. Secondary objectives are related to the immunogenicity of the vaccination regimens.
PRODUCT DESCRIPTION:
The investigational VRC-FLUDNA071-00-VP vaccine was developed by VRC, NIAID and is composed of a single closed-circular DNA plasmid that encodes the H7 hemagglutinin (HA) protein of A/Anhui/1/2013 (H7N9) influenza, and is supplied in single dose vials at a concentration of 4 mg/mL. H7 DNA vaccinations will be 4 mg administered as a 1 mL intramuscularly (IM) using the Biojector o 2000 Needle-Free Injection Management System (Biojector). The inactivated H7N9 vaccine is monovalent subunit virion vaccine, A/Shanghai/2/2013(H7N9) MIV, manufactured by Sanofi Pasteur, Inc (Swiftwater, PA), and supplied at 30 mcg/0.5 mL per vial. The H7N9 MIV vaccinations will be 45 mcg administered as a 0.75 mL IM injection using needle and syringe. All injections will be in the deltoid muscle.
SUBJECTS:
A total of up to 36 healthy adults, ages 18-60 years will be enrolled.
STUDY PLAN:
Subjects will be randomized equally into the three study groups and will receive two vaccinations as shown in the schema. The protocol requires 7 clinic visits and a telephone follow-up contact after each study injection. Durability of immune response will be followed through Study Week 28.
STUDY DURATION:
Subjects will be evaluated for safety and immune responses throughout the study for 12 weeks following the boost. Duration of time on study will be 28 weeks.
- Conditions
- Influenza
- Being tested
- A/Shanghai/02/2013 (H7N9) MIV, VRC-FLUDNA071-00-VP
- Keywords
- A/Anhui/1/2013 (H7N9), Antibody Response, Avian Influenza, A/Shanghai/2/2013 (H7N9), Immunogenicity
- Medical subject headings
- Influenza, Human, Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A/Shanghai/02/2013 (H7N9) MIVBiological
Monovalent Influenza Subvirion Vaccine for H7N9 avian influenza (H7N9 MIV)
VRC-FLUDNA071-00-VPBiological
H7 DNA Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | H7 DNA vaccine on Day 0 and H7N9 MIV at StudyWeek 16 Receives: Biological: A/Shanghai/02/2013 (H7N9) MIV; Biological: VRC-FLUDNA071-00-VP |
| Group 2 | Experimental | H7 DNA and H7N9 MIV administered on Day 0 and H7N9 MIV boost at Study Week 16 Receives: Biological: A/Shanghai/02/2013 (H7N9) MIV; Biological: VRC-FLUDNA071-00-VP |
| Group 3 | Experimental | H7N9 MIV on Day 0 and H7N9 MIV at Study Week 16 Receives: Biological: A/Shanghai/02/2013 (H7N9) MIV; Biological: VRC-FLUDNA071-00-VP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited adverse events (reactogenicity).
Measured: Daily for 7 days following each vaccination.
Adverse events of all severities.
Measured: Through 28 days after each injection.
Serious adverse events, new chronic medical conditions and influenza-like illnesses
Measured: From first vaccination to last study visit
Secondary outcomes (1)
H7-specific antibody response as measured by HAI assay
Measured: Day 0 (baseline) and 2 weeks after the boost vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study start29 Jul 2014
- Primary completion7 Jan 2016
- Study completion7 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Julie E Ledgerwood, D.O., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206464
- Sponsor's protocol ID
- 140160
- Other IDs
- 14-I-0160
- Status last verified
- 7 Jan 2016
- First submitted
- 31 Jul 2014
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Ledgerwood JE, Graham BS. DNA vaccines: a safe and efficient platform technology for responding to emerging infectious diseases. Hum Vaccin. 2009 Sep;5(9):623-6. doi: 10.4161/hv.8627. No abstract available.
PubMed 19779298Ledgerwood JE, Wei CJ, Hu Z, Gordon IJ, Enama ME, Hendel CS, McTamney PM, Pearce MB, Yassine HM, Boyington JC, Bailer R, Tumpey TM, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 306 Study Team. DNA priming and influenza vaccine immunogenicity: two phase 1 open label randomised clinical trials. Lancet Infect Dis. 2011 Dec;11(12):916-24. doi: 10.1016/S1473-3099(11)70240-7. Epub 2011 Oct 3.
PubMed 21975270Ledgerwood JE, Zephir K, Hu Z, Wei CJ, Chang L, Enama ME, Hendel CS, Sitar S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 310 Study Team. Prime-boost interval matters: a randomized phase 1 study to identify the minimum interval necessary to observe the H5 DNA influenza vaccine priming effect. J Infect Dis. 2013 Aug 1;208(3):418-22. doi: 10.1093/infdis/jit180. Epub 2013 Apr 30.
PubMed 23633407
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VRC 315: A Phase I Open-Label, Randomized Study of H7 Influenza Prime-Boost Regimens in Healthy Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or With Monovalent Influenza Subunit Virion H7N9 Vaccine (MIV) as Prime With MIV Boost Compared to MIV Prime With MIV Boost
- ClinicalTrials.gov ID
- NCT02206464
- Acronym / sponsor ID
- 140160
- Conditions
- Influenza
- Keywords
- A/Anhui/1/2013 (H7N9), Antibody Response, Avian Influenza, A/Shanghai/2/2013 (H7N9), Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 29 Jul 2014
- Primary completion
- 7 Jan 2016 (actual)
- Study completion
- 7 Jan 2016 (actual)
- First posted
- 1 Aug 2014 (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.
Background:<TAB>
- Flu virus that causes disease in birds can sometimes spread to people. It can cause severe illness, even death. Vaccines are used to try to create resistance to such infections. Researchers want to test a new vaccination strategy, combining two different vaccine types, the H7 DNA Vaccine (DNA vaccine) and H7N9 Monovalent Inactivated Vaccine (MIV), to see if one of two combinations offer better protection against a certain type of bird flu in humans when compared to vaccination using two doses of MIV alone.
Objectives:
- To see if 2 vaccines for bird flu, are safe and tolerable for humans.
- To study immune responses to these vaccines.
Eligibility:
- Healthy adults 18 60 years old.
Design:
- Participants will be screened through a separate protocol.
- Participants will be randomly assigned to 1 of 3 groups. Each group will get a different combination of vaccines.
- Participants will have about 8 clinic visits. Each visit takes 2 4 hours. Blood will be drawn at some visits. Urine samples may be collected.
- Participants will receive vaccinations at 2 of the visits, 16 weeks apart.
- The H7N9 MIV will be injected in the upper arm using a needle and syringe. The DNA vaccine will be injected in the upper arm using a device that delivers the vaccine through the skin by pressure instead of a needle.
- Participants will be observed for at least 30 minutes after each vaccination.
- Soon after each vaccination, participants will get 1 2 phone calls, come to clinic for evaluation, and complete a diary at home for 1 week. They will record their temperature and symptoms and look at the injection site daily.
- Participants will have follow-up blood tests.
Detailed description
VRC 315 STUDY:
A Phase I Open-Label, Randomized Study of H7 Influenza Prime-Boost Regimens in Healthy Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or with Monovalent Influenza Subunit Virion H7N9 Vaccine (MIV) as Prime with MIV Boost Compared to MIV Prime with MIV Boost
STUDY DESIGN:
This is a Phase I, randomized, open-label study to evaluate the safety, tolerability, and immunogenicity of prime-boost vaccination regimens against H7N9 Influenza. A vaccination regimen with the VRC-FLUDNA071-00-VP (H7 DNA) vaccine administered alone or concurrently in different arms with A/Shanghai/2/2013(H7N9) (MIV) as prime followed by inactivated MIV boost will be compared to MIV-MIV prime-boost with a 16 week boost interval. The primary hypothesis is that all the H7 DNA prime-MIV boost, DNA+MIV prime-MIV boost, and MIV-MIV study regimens will be safe for human administration. A secondary hypothesis is that the H7 DNAMIV regimen will elicit a greater frequency and/or magnitude of antibody against H7 than the MIV-MIV regimen. The primary objective is to evaluate the safety and tolerability in healthy adults of the investigational vaccine regimens. Secondary objectives are related to the immunogenicity of the vaccination regimens.
PRODUCT DESCRIPTION:
The investigational VRC-FLUDNA071-00-VP vaccine was developed by VRC, NIAID and is composed of a single closed-circular DNA plasmid that encodes the H7 hemagglutinin (HA) protein of A/Anhui/1/2013 (H7N9) influenza, and is supplied in single dose vials at a concentration of 4 mg/mL. H7 DNA vaccinations will be 4 mg administered as a 1 mL intramuscularly (IM) using the Biojector o 2000 Needle-Free Injection Management System (Biojector). The inactivated H7N9 vaccine is monovalent subunit virion vaccine, A/Shanghai/2/2013(H7N9) MIV, manufactured by Sanofi Pasteur, Inc (Swiftwater, PA), and supplied at 30 mcg/0.5 mL per vial. The H7N9 MIV vaccinations will be 45 mcg administered as a 0.75 mL IM injection using needle and syringe. All injections will be in the deltoid muscle.
SUBJECTS:
A total of up to 36 healthy adults, ages 18-60 years will be enrolled.
STUDY PLAN:
Subjects will be randomized equally into the three study groups and will receive two vaccinations as shown in the schema. The protocol requires 7 clinic visits and a telephone follow-up contact after each study injection. Durability of immune response will be followed through Study Week 28.
STUDY DURATION:
Subjects will be evaluated for safety and immune responses throughout the study for 12 weeks following the boost. Duration of time on study will be 28 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: A/Shanghai/02/2013 (H7N9) MIV, Biological: VRC-FLUDNA071-00-VPH7 DNA vaccine on Day 0 and H7N9 MIV at StudyWeek 16 |
| Group 2 | Experimental | Biological: A/Shanghai/02/2013 (H7N9) MIV, Biological: VRC-FLUDNA071-00-VPH7 DNA and H7N9 MIV administered on Day 0 and H7N9 MIV boost at Study Week 16 |
| Group 3 | Experimental | Biological: A/Shanghai/02/2013 (H7N9) MIV, Biological: VRC-FLUDNA071-00-VPH7N9 MIV on Day 0 and H7N9 MIV at Study Week 16 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 18 to 60 years old.
- Available for clinic visits for up to 28 weeks after enrollment.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Willing to donate blood for sample storage to be used for future research.
- In good general health without clinically significant medical history.
Key exclusion criteria (28 listed)
- A subject will be excluded if one or more of the following conditions apply. Women Specific:
- Breast-feeding or planning to become pregnant while participating in the study
- More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
- Blood products within 16 weeks prior to enrollment
- Live attenuated vaccines within 4 weeks prior to initial study vaccine administration
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 |
|---|---|---|
| A/Shanghai/02/2013 (H7N9) MIVMonovalent Influenza Subvirion Vaccine for H7N9 avian influenza (H7N9 MIV) | Biological | Group 1, Group 2, Group 3 |
| VRC-FLUDNA071-00-VPH7 DNA Vaccine | Biological | Group 1, Group 2, Group 3 |
Primary outcome
Solicited adverse events (reactogenicity).
Time frame: Daily for 7 days following each vaccination.
Adverse events of all severities.
Time frame: Through 28 days after each injection.
Serious adverse events, new chronic medical conditions and influenza-like illnesses
Time frame: From first vaccination to last study visit
1 secondary outcome
H7-specific antibody response as measured by HAI assay
Time frame: Day 0 (baseline) and 2 weeks after the boost vaccination.
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 17 Dec 2019.
- Background: PubMed 19779298Ledgerwood JE, Graham BS. DNA vaccines: a safe and efficient platform technology for responding to emerging infectious diseases. Hum Vaccin. 2009 Sep;5(9):623-6. doi: 10.4161/hv.8627. No abstract available.
- Background: PubMed 21975270Ledgerwood JE, Wei CJ, Hu Z, Gordon IJ, Enama ME, Hendel CS, McTamney PM, Pearce MB, Yassine HM, Boyington JC, Bailer R, Tumpey TM, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 306 Study Team. DNA priming and influenza vaccine immunogenicity: two phase 1 open label randomised clinical trials. Lancet Infect Dis. 2011 Dec;11(12):916-24. doi: 10.1016/S1473-3099(11)70240-7. Epub 2011 Oct 3.
- Background: PubMed 23633407Ledgerwood JE, Zephir K, Hu Z, Wei CJ, Chang L, Enama ME, Hendel CS, Sitar S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 310 Study Team. Prime-boost interval matters: a randomized phase 1 study to identify the minimum interval necessary to observe the H5 DNA influenza vaccine priming effect. J Infect Dis. 2013 Aug 1;208(3):418-22. doi: 10.1093/infdis/jit180. Epub 2013 Apr 30.
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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.
Julie E Ledgerwood, D.O. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A/Shanghai/02/2013 (H7N9) MIV and VRC-FLUDNA071-00-VP in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 18 inclusion and 28 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 17 Dec 2019. 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. 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?
Solicited adverse events (reactogenicity). (time frame: Daily for 7 days following each vaccination.). The study lists 3 primary outcomes in all. 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 NCT02206464, which also lists 3 linked publications.
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 17 Dec 2019.