Influenza, HumanPhase 1NCT00776711
Vaccine for Prevention of Bird Flu
A Phase 1 study testing Monovalent Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005 and VRC-AViDNA036-00-VP in people with Influenza, Human, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Study Design: This is a Phase I, randomized, open-label study to evaluate the safety, tolerability, and immunogenicity of four vaccination regimens against the influenza virus hemagglutinin H5. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Monovalent Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005 and VRC-AViDNA036-00-VP
- Type of treatment
- Vaccines
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2008to 14 Jan 2011
- 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 clinical follow-up through Week 48.
- If enrolling from study opening (November 2008) through June 30, 2009, immunized with the current season FDA-approved influenza vaccine prior to enrollment at the specified interval [14 days to 24 weeks prior to enrollment for the inactivated influenza vaccine OR 30 days to 24 weeks prior to enrollment for the live-attenuated influenza vaccine (FluMist (Registered Trademark))]; subjects enrolling after July 1, 2009 are not required to have prior vaccination with the most recent seasonal influenza vaccine.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly.
Show all 32Show fewer
- Able and willing to complete the informed consent process.
- Willing to donate blood for sample storage to be used for future research.
- In good general health without clinically significant medical history.
- Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than 40 within the 56 days prior to enrollment.
- Laboratory Criteria within 56 days prior to nrollment:
- Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men
- White blood cells (WBC) = 3,300-12,000 cells/mm(3)
- Differential either within institutional normal range or accompanied by site physician approval
- Total lymphocyte count greater than or equal to 800 cells/mm(3)
- Platelets = 125,000 - 500,000/mm(3)
- Alanine aminotransferase (ALT) less than 1.25 times the upper limit of normal (ULN)
- Serum creatinine less than or equal to 1 times the ULN (less than or equal to 1.3 mg/dL for females; less than or equal to 1.4 mg/dL for males)
- Negative FDA-approved HIV blood test. [Note: Results of HIV enzyme-linked immunosorbent assay (ELISA) will be documented, but a negative HIV polymerase chain reaction (PCR) test result will be sufficient for eligibility screening of subjects with positive HIV ELISA that is due to prior participation in an HIV vaccine study]
- Female-Specific Criteria:
- Negative beta-HCG pregnancy test (urine or serum) for women presumed to be of reproductive potential.
- A female subject must meet one of the following criteria:
- No reproductive potential because of menopause [one year without menses] or because of a hysterectomy, bilateral oophorectomy, or tubal ligation,
- OR
- Agrees to be heterosexually inactive at least 21 days prior to enrollment and through Week 28 of the study,
- OR
- Agrees to consistently practice contraception at least 21 days prior to enrollment and through Week 28 of the study by one of the following methods:
- condoms, male or female, with or without a spermicide;
- diaphragm or cervical cap with spermicide;
- intrauterine device;
- contraceptive pills, patch, implant or any other FDA-approved contraceptive method;
- male partner has previously undergone a vasectomy.
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 during the first 28 weeks after enrollment in the study.
- Subject has received any of the following substances:
- Systemic immunosuppressive medications or cytotoxic medications, within the 12 weeks prior to enrollment. [With the exceptions that a short course (duration of 10 days or less or a single injection) of corticosteroids for a self-limited condition at least 2 weeks prior to enrollment in this study will not exclude study participation.]
- Blood products within 112 days (16 weeks) prior to HIV screening
Show all 29Show fewer
- Immunoglobulin within 56 days (8 weeks) prior to HIV screening
- Live attenuated vaccines within 28 days (4 weeks) prior to initial study vaccine administration
- Investigational research agents within 28 days (4 weeks) prior to initial study vaccine administration
- Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days (2 weeks) of initial study vaccine administration
- Current anti-TB prophylaxis or therapy
- Previous H5 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 (e.g., egg allergy)
- Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator.
- Hereditary angioedema (HAE), acquired angioedema (AAE), 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 by medication or is more than 145/95 at enrollment.
- 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.
- Allergic reaction to aminoglycoside antibiotics.
- Guillain-Barr 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: An Open-Label, Randomized Phase I Study in Healthy Adults of 4 Prime-Boost Schedules With Monovalent Influenza Subunit Virion (H5N1) Vaccine (Sanofi Pasteur, Inc), Administered Alone or Following Recombinant DNA Plasmid (H5) Vaccine (VRC, NIAID)
Study Design:
This is a Phase I, randomized, open-label study to evaluate the safety, tolerability, and immunogenicity of four vaccination regimens against the influenza virus hemagglutinin H5. One group will receive A/Indonesia/05/2005 (inactivated H5N1) vaccine as both prime and boost, two groups will receive the VRC-AVIDNA036-00-VP (DNA) vaccine as prime with inactivated H5N1 boost but with different boost intervals, and one group will receive the DNA vaccine twice as prime followed by H5N1 boost. The hypothesis is that these regimens will be safe for human administration and will elicit antibody and T cell responses against the H5 protein. The primary objectives are to evaluate the safety and tolerability of the investigational vaccine regimens, at a dose of 4 mg for the DNA vaccine and 90 microgram for the inactivated H5N1, in healthy adults. Secondary and exploratory objectives are related to the immunogenicity of the study vaccine regimens.
Read more
Product Description:
The inactivated H5N1 vaccine is monovalent subunit virion vaccine, A/Indonesia/05/2005 clade 2, manufactured by Sanofi Pasteur, Inc (Swiftwater, PA). Vaccine vials will be supplied at 90 microgram/0.5mL. The VRC-AVIDNA036-00-VP vaccine was developed and manufactured by VRC, NIAID and is composed of a single closed-circular DNA plasmid that encodes the H5 protein with a CMV/R promoter. Vaccine vials will be supplied at 4 mg/mL. Each vaccination will be administered intramuscularly (IM) in the deltoid muscle using needle and syringe for the H5N1 vaccine and the Biojector (Trademark) 2000 Needle-Free Injection Management System (Biojector) for the DNA vaccine.
Subjects:
A total of 60 healthy adults, ages 18-60 years will be enrolled.
Study Plan:
Subjects will be simultaneously randomized at a ratio of 1:1:1:1 into one of four groups. Subjects and clinicians will be blinded to group assignment until Day 0 following completion of the enrollment. At the point of enrollment the randomly assigned regimen will become known to subjects and clinicians. Subjects will receive either two or three injections on the schedule shown in the schema. The protocol requires five clinic visits and two telephone follow-up contacts for Groups 1, 2, and 3, and six clinic visits and three telephone follow-up contacts for Group 4.
Read the detailed description
Study Design:
This is a Phase I, randomized, open-label study to evaluate the safety, tolerability, and immunogenicity of four vaccination regimens against the influenza virus hemagglutinin H5. One group will receive A/Indonesia/05/2005 (inactivated H5N1) vaccine as both prime and boost, two groups will receive the VRC-AVIDNA036-00-VP (DNA) vaccine as prime with inactivated H5N1 boost but with different boost intervals, and one group will receive the DNA vaccine twice as prime followed by H5N1 boost. The hypothesis is that these regimens will be safe for human administration and will elicit antibody and T cell responses against the H5 protein. The primary objectives are to evaluate the safety and tolerability of the investigational vaccine regimens, at a dose of 4 mg for the DNA vaccine and 90 microgram for the inactivated H5N1, in healthy adults. Secondary and exploratory objectives are related to the immunogenicity of the study vaccine regimens.
Product Description:
The inactivated H5N1 vaccine is monovalent subunit virion vaccine, A/Indonesia/05/2005 clade 2, manufactured by Sanofi Pasteur, Inc (Swiftwater, PA). Vaccine vials will be supplied at 90 microgram/0.5mL. The VRC-AVIDNA036-00-VP vaccine was developed and manufactured by VRC, NIAID and is composed of a single closed-circular DNA plasmid that encodes the H5 protein with a CMV/R promoter. Vaccine vials will be supplied at 4 mg/mL. Each vaccination will be administered intramuscularly (IM) in the deltoid muscle using needle and syringe for the H5N1 vaccine and the Biojector (Trademark) 2000 Needle-Free Injection Management System (Biojector) for the DNA vaccine.
Subjects:
A total of 60 healthy adults, ages 18-60 years will be enrolled.
Study Plan:
Subjects will be simultaneously randomized at a ratio of 1:1:1:1 into one of four groups. Subjects and clinicians will be blinded to group assignment until Day 0 following completion of the enrollment. At the point of enrollment the randomly assigned regimen will become known to subjects and clinicians. Subjects will receive either two or three injections on the schedule shown in the schema. The protocol requires five clinic visits and two telephone follow-up contacts for Groups 1, 2, and 3, and six clinic visits and three telephone follow-up contacts for Group 4.
- Conditions
- Influenza, Human
- Being tested
- Monovalent Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005, VRC-AViDNA036-00-VP
- Keywords
- Healthy, Avian Influenza, Immunity, Preventive, Bird Flu, Healthy Volunteer, HV, Influenza
- 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.
Monovalent Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005Drug
VRC-AViDNA036-00-VPDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (local and systemic reactogenicity, lab tests, AEs)
Secondary outcomes (1)
Immunogenicity (cellular and humoral immune function assays)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study start16 Oct 2008
- Primary completion14 Jan 2011
- Study completion14 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies 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
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776711
- Sponsor's protocol ID
- 090012
- Other IDs
- 09-I-0012
- Status last verified
- 14 Jan 2011
- First submitted
- 18 Oct 2008
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Subbarao K, Murphy BR, Fauci AS. Development of effective vaccines against pandemic influenza. Immunity. 2006 Jan;24(1):5-9. doi: 10.1016/j.immuni.2005.12.005.
PubMed 16413916Luke CJ, Subbarao K. Vaccines for pandemic influenza. Emerg Infect Dis. 2006 Jan;12(1):66-72. doi: 10.3201/eid1201.051147.
PubMed 16494720Taubenberger JK, Reid AH, Lourens RM, Wang R, Jin G, Fanning TG. Characterization of the 1918 influenza virus polymerase genes. Nature. 2005 Oct 6;437(7060):889-93. doi: 10.1038/nature04230.
PubMed 16208372Enama ME, Hu Z, Gordon I, Costner P, Ledgerwood JE, Grady C; VRC 306 and 307 Consent Study Teams. Randomization to standard and concise informed consent forms: development of evidence-based consent practices. Contemp Clin Trials. 2012 Sep;33(5):895-902. doi: 10.1016/j.cct.2012.04.005. Epub 2012 Apr 20.
PubMed 22542645Ledgerwood 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 21975270
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized Phase I Study in Healthy Adults of 4 Prime-Boost Schedules With Monovalent Influenza Subunit Virion (H5N1) Vaccine (Sanofi Pasteur, Inc), Administered Alone or Following Recombinant DNA Plasmid (H5) Vaccine (VRC, NIAID)
- ClinicalTrials.gov ID
- NCT00776711
- Acronym / sponsor ID
- 090012
- Conditions
- Influenza, Human
- Keywords
- Healthy, Avian Influenza, Immunity, Preventive, Bird Flu, Healthy Volunteer, HV, Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 16 Oct 2008
- Primary completion
- 14 Jan 2011 (actual)
- Study completion
- 14 Jan 2011 (actual)
- First posted
- 21 Oct 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.
Study Design:
This is a Phase I, randomized, open-label study to evaluate the safety, tolerability, and immunogenicity of four vaccination regimens against the influenza virus hemagglutinin H5. One group will receive A/Indonesia/05/2005 (inactivated H5N1) vaccine as both prime and boost, two groups will receive the VRC-AVIDNA036-00-VP (DNA) vaccine as prime with inactivated H5N1 boost but with different boost intervals, and one group will receive the DNA vaccine twice as prime followed by H5N1 boost. The hypothesis is that these regimens will be safe for human administration and will elicit antibody and T cell responses against the H5 protein. The primary objectives are to evaluate the safety and tolerability of the investigational vaccine regimens, at a dose of 4 mg for the DNA vaccine and 90 microgram for the inactivated H5N1, in healthy adults. Secondary and exploratory objectives are related to the immunogenicity of the study vaccine regimens.
Product Description:
The inactivated H5N1 vaccine is monovalent subunit virion vaccine, A/Indonesia/05/2005 clade 2, manufactured by Sanofi Pasteur, Inc (Swiftwater, PA). Vaccine vials will be supplied at 90 microgram/0.5mL. The VRC-AVIDNA036-00-VP vaccine was developed and manufactured by VRC, NIAID and is composed of a single closed-circular DNA plasmid that encodes the H5 protein with a CMV/R promoter. Vaccine vials will be supplied at 4 mg/mL. Each vaccination will be administered intramuscularly (IM) in the deltoid muscle using needle and syringe for the H5N1 vaccine and the Biojector (Trademark) 2000 Needle-Free Injection Management System (Biojector) for the DNA vaccine.
Subjects:
A total of 60 healthy adults, ages 18-60 years will be enrolled.
Study Plan:
Subjects will be simultaneously randomized at a ratio of 1:1:1:1 into one of four groups. Subjects and clinicians will be blinded to group assignment until Day 0 following completion of the enrollment. At the point of enrollment the randomly assigned regimen will become known to subjects and clinicians. Subjects will receive either two or three injections on the schedule shown in the schema. The protocol requires five clinic visits and two telephone follow-up contacts for Groups 1, 2, and 3, and six clinic visits and three telephone follow-up contacts for Group 4.
Detailed description
Study Design:
This is a Phase I, randomized, open-label study to evaluate the safety, tolerability, and immunogenicity of four vaccination regimens against the influenza virus hemagglutinin H5. One group will receive A/Indonesia/05/2005 (inactivated H5N1) vaccine as both prime and boost, two groups will receive the VRC-AVIDNA036-00-VP (DNA) vaccine as prime with inactivated H5N1 boost but with different boost intervals, and one group will receive the DNA vaccine twice as prime followed by H5N1 boost. The hypothesis is that these regimens will be safe for human administration and will elicit antibody and T cell responses against the H5 protein. The primary objectives are to evaluate the safety and tolerability of the investigational vaccine regimens, at a dose of 4 mg for the DNA vaccine and 90 microgram for the inactivated H5N1, in healthy adults. Secondary and exploratory objectives are related to the immunogenicity of the study vaccine regimens.
Product Description:
The inactivated H5N1 vaccine is monovalent subunit virion vaccine, A/Indonesia/05/2005 clade 2, manufactured by Sanofi Pasteur, Inc (Swiftwater, PA). Vaccine vials will be supplied at 90 microgram/0.5mL. The VRC-AVIDNA036-00-VP vaccine was developed and manufactured by VRC, NIAID and is composed of a single closed-circular DNA plasmid that encodes the H5 protein with a CMV/R promoter. Vaccine vials will be supplied at 4 mg/mL. Each vaccination will be administered intramuscularly (IM) in the deltoid muscle using needle and syringe for the H5N1 vaccine and the Biojector (Trademark) 2000 Needle-Free Injection Management System (Biojector) for the DNA vaccine.
Subjects:
A total of 60 healthy adults, ages 18-60 years will be enrolled.
Study Plan:
Subjects will be simultaneously randomized at a ratio of 1:1:1:1 into one of four groups. Subjects and clinicians will be blinded to group assignment until Day 0 following completion of the enrollment. At the point of enrollment the randomly assigned regimen will become known to subjects and clinicians. Subjects will receive either two or three injections on the schedule shown in the schema. The protocol requires five clinic visits and two telephone follow-up contacts for Groups 1, 2, and 3, and six clinic visits and three telephone follow-up contacts for Group 4.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (32 listed)
- 18 to 60 years old.
- Available for clinical follow-up through Week 48.
- If enrolling from study opening (November 2008) through June 30, 2009, immunized with the current season FDA-approved influenza vaccine prior to enrollment at the specified interval [14 days to 24 weeks prior to enrollment for the inactivated influenza vaccine OR 30 days to 24 weeks prior to enrollment for the live-attenuated influenza vaccine (FluMist (Registered Trademark))]; subjects enrolling after July 1, 2009 are not required to have prior vaccination with the most recent seasonal influenza vaccine.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly.
Key exclusion criteria (29 listed)
- A subject will be excluded if one or more of the following conditions apply.
- Breast-feeding or planning to become pregnant during the first 28 weeks after enrollment in the study.
- Systemic immunosuppressive medications or cytotoxic medications, within the 12 weeks prior to enrollment. [With the exceptions that a short course (duration of 10 days or less or a single injection) of corticosteroids for a self-limited condition at least 2 weeks prior to enrollment in this study will not exclude study participation.]
- Blood products within 112 days (16 weeks) prior to HIV screening
- Immunoglobulin within 56 days (8 weeks) prior to HIV screening
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 Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005 | Drug | – |
| VRC-AViDNA036-00-VP | Drug | – |
Primary outcome
Safety (local and systemic reactogenicity, lab tests, AEs)
1 secondary outcome
Immunogenicity (cellular and humoral immune function assays)
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 2 Jul 2017.
- Background: PubMed 16413916Subbarao K, Murphy BR, Fauci AS. Development of effective vaccines against pandemic influenza. Immunity. 2006 Jan;24(1):5-9. doi: 10.1016/j.immuni.2005.12.005.
- Background: PubMed 16494720Luke CJ, Subbarao K. Vaccines for pandemic influenza. Emerg Infect Dis. 2006 Jan;12(1):66-72. doi: 10.3201/eid1201.051147.
- Background: PubMed 16208372Taubenberger JK, Reid AH, Lourens RM, Wang R, Jin G, Fanning TG. Characterization of the 1918 influenza virus polymerase genes. Nature. 2005 Oct 6;437(7060):889-93. doi: 10.1038/nature04230.
- Derived from this study: PubMed 22542645Enama ME, Hu Z, Gordon I, Costner P, Ledgerwood JE, Grady C; VRC 306 and 307 Consent Study Teams. Randomization to standard and concise informed consent forms: development of evidence-based consent practices. Contemp Clin Trials. 2012 Sep;33(5):895-902. doi: 10.1016/j.cct.2012.04.005. Epub 2012 Apr 20.
- Derived from this study: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Monovalent Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005 and VRC-AViDNA036-00-VP in people with Influenza, Human, 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 32 inclusion and 29 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 2 Jul 2017. 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?
Safety (local and systemic reactogenicity, lab tests, AEs). 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 NCT00776711, which also lists 5 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 2 Jul 2017.