InfluenzaPhase 1NCT01498718
Seasonal Influenza DNA Vaccine Prime With Trivalent Inactivated Vaccine (TIV) Boost Compared to TIV Alone
A Phase 1 study testing DNA vaccine and TIV in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
This is a Phase 1b, randomized study in healthy younger (18-50 years) and older (51-70 years) adults to evaluate the safety, tolerability, and immunogenicity of a prime-boost vaccination regimen with an investigational plasmid DNA vaccine directed towards the 2011/12 influenza vaccine strains as a prime followed 36… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- DNA vaccine and TIV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2011to Apr 2013
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 70 yrs
- Available for clinical follow-up through Study Week 60
- Able and willing to complete the informed consent process
- Willing to donate blood for sample storage to be used for future research
- Physical exam and lab results without clinically significant findings and a Body Mass Index (BMI) <40 within the 70 days prior to enrollment
- Has received the 2011/2012 licensed influenza vaccine 8 or more weeks prior to enrollment and agrees to receive the 2012/2013 TIV as part of study participation
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- Laboratory Criteria within 70 days prior to enrollment:
- Hemoglobin within institutional normal limits
- White blood cells either within institutional normal range or site physician approves as consistent with healthy adult status
- Platelets = 125,000 - 500,000/mm3
- Alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
- Serum creatinine ≤ 1 x ULN based on site institutional normal range
- Criteria applicable to women of childbearing potential:
- Negative 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 12 weeks after the first study vaccination
Who cannot join
- Women Specific:
- Breast-feeding or planning to become pregnant during the 12 weeks after enrollment in the study
- Subject has received any of the following substances:
- More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 12 weeks prior to enrollment or any within the 14 days prior to enrollment
- Blood products within 16 weeks prior to enrollment
- Immunoglobulin within 8 weeks prior to enrollment
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- Investigational research agents within 28 days (4 weeks) prior to enrollment
- Allergy treatment with antigen injections, unless on maintenance schedule and allergy shots could be staggered with the study vaccinations, within 14 days (2 weeks) prior to enrollment
- Current anti-tuberculosis prophylaxis or therapy
- History of any of the following clinically significant conditions:
- Contraindication to receiving an FDA-approved seasonal influenza vaccination
- Serious reactions to vaccines that preclude receipt of study vaccinations, as determined by the site investigator
- Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
- Asthma that is severe, unstable or required emergent care, urgent care, hospitalization or intubation during the previous two years or that is expected to require the use of oral, intravenous or high dose inhaled corticosteroids
- Diabetes mellitus type I
- Thyroid disease that is not well-controlled
- Generalized idiopathic urticaria within the 1 year prior to enrollment
- 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 intramuscular (IM) injections or blood draws, or use of blood thinners such as Coumadin or Plavix®.
- 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 for which no treatment has been required within the 3 years prior to enrollment
- Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
- Guillain-Barré Syndrome
- Psychiatric condition that precludes compliance with the protocol; past or present psychoses; disorder requiring lithium; or within 5 years prior to enrollment, a history of suicide plan or attempt
- Any medical, psychiatric, or other condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs ability to give informed consent
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, 30030
Baylor College of Medicine
Houston, Texas, 77030
St. Louis University - Doisy Research Center
St Louis, Missouri, 63104
About this study
Official title: Double-Blind, Randomized Phase 1b Study of 2011/12 Influenza Investigational DNA Vaccine, VRC-FLUDNA061-00-VP, Followed by 2012/13 Trivalent Inactivated Vaccine (TIV) Compared to 2012/13 TIV Alone in Healthy Adults
This is a Phase 1b, randomized study in healthy younger (18-50 years) and older (51-70 years) adults to evaluate the safety, tolerability, and immunogenicity of a prime-boost vaccination regimen with an investigational plasmid DNA vaccine directed towards the 2011/12 influenza vaccine strains as a prime followed 36 weeks later by the 2012/13 influenza trivalent inactivated vaccine (TIV) as the booster injection, as compared to placebo prime followed by the 2012/13 seasonal TIV. The hypothesis is that the DNA vaccine will be safe for human administration and that the DNA vaccine prime-TIV boost schedule will elicit a better immune response than the seasonal TIV alone.
Read the detailed description
Vaccines are an effective way of preventing influenza infection and transmission in humans. Although licensed influenza vaccines are available, ways to improve influenza vaccines continue to be studied. Annually, the World Health Organization (WHO) and the U.S FDA make recommendations on the composition of the seasonal influenza vaccine, with recommendations for the Northern Hemisphere (NH) and for the Southern Hemisphere (SH) considered at different times based on epidemiology data. The annually licensed influenza vaccines consist of 3 components: an Influenza A (H1N1) strain, an Influenza A (H3N2) strain, and an influenza B strain. The current U.S. FDA-licensed influenza vaccines depend upon labor-intensive methods that limit manufacturing capacity and which do not induce broad immune responses to various strains of influenza. The vaccine composition requires frequent adjustment for emerging influenza strains.
The need for influenza vaccines that are more immunogenic and able to induce a more universal immune response against a broad spectrum of influenza strains is well recognized. Earlier laboratory and clinical studies together suggest that an investigational DNA vaccine encoding for the influenza hemagglutinin protein(HA DNA vaccine) administered as a prime, followed by a boost with a traditional inactivated influenza vaccine, may induce a stronger immune response against various influenza strains and with improved durability. The interval of time between the prime vaccination and the boost vaccination is important for the strength of the immune response.
This clinical trial will evaluate the safety, tolerability and immune responses to the investigational HA DNA vaccine prime-TIV boost schedule compared to a placebo prime-TIV boost schedule when the time between the prime and boost is 36 weeks.
- Conditions
- Influenza
- Being tested
- DNA vaccine, TIV
- Keywords
- Influenza A (H1N1), Influenza A (H3N2), Influenza B, Trivalent Inactivated Vaccine (TIV), Healthy Adults
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA vaccineBiological
Also called VRC-FLUDNA061-00-VP, HA DNA Vaccine, Seasonal influenza trivalent DNA vaccine
VRC-FLUDNA061-00-VP is composed of 3 closed-circular DNA plasmids that encode for the hemagglutinin (HA) from the following 3 strains: A/California/04/2009 (H1N1); A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008. DNA vaccine vials will be supplied at 4 mg/mL and each dose will be 1 mL.
TIVBiological
Also called Trivalent Inactivated Vaccine
2012/13 Seasonal Influenza Trivalent Inactivated Vaccine (TIV)
| Study group | Role | What they receive |
|---|---|---|
| Group 1A (18-50 yrs): DNA vaccine + TIV | Experimental | HA DNA Vaccine (VRC-FLUDNA061-00-VP) at Day 0 and licensed TIV at Week 36 Receives: Biological: DNA vaccine; Biological: TIV |
| Group 2A (51-70 yrs): DNA vaccine + TIV | Experimental | HA DNA Vaccine (VRC-FLUDNA061-00-VP) at Day 0 and licensed TIV at Week 36 Receives: Biological: DNA vaccine; Biological: TIV |
| Group 1B (18-50 yrs): TIV only | Placebo comparator | Phosphate buffered saline (PBS) on Day 0 + TIV at Week 36 Receives: Biological: TIV |
| Group 2B (51-70 yrs): TIV only | Placebo comparator | Phosphate buffered saline (PBS) on Day 0 + TIV at Week 36 Receives: Biological: TIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of subjects per Group of serious adverse events (SAEs)
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required non-elective in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the subject or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.
Measured: Day 0 (after injection) to Week 60 (Visit 07)
Frequency of Subjects per Group of Solicited Local Reactions After First Study Injection
Frequency and severity of solicited injection site reactions following first study injection (vaccine group compared to placebo group).
Measured: Within 7 days after first vaccination
Frequency of Subjects per Group Reporting Solicited Local Reactions After TIV injection
Frequency and severity of solicited injection site reactions following the TIV booster injection by Group.
Measured: Within 7 days after TIV injection
Frequency of Subjects per Group Reporting Solicited Systemic Reactions After First Study Injection
Frequency and severity of solicited systemic reactions following first study injection (vaccine group compared to placebo group).
Measured: Within 7 days after first study injection
Frequency of Subjects per Group Reporting Solicited Systemic Reactions After TIV injection
Frequency and severity of solicited systemic reactions following TIV injection.
Measured: Within 7 days after TIV injection
Frequency by group of all unsolicited adverse events (AEs) after first study injection.
Frequency of adverse events (AEs) during 28 days after first study injection (vaccine as compared to placebo groups).
Measured: Through Day 28 after first injection
Frequency by group of all unsolicited adverse events (AEs) after TIV vaccination.
Frequency of unsolicited adverse events (AEs) during 28 days after TIV vaccination by group.
Measured: Through Day 28 after second vaccincation
Secondary outcomes (2)
Proportion of subjects per group with an Hemagglutination Inhibition (HAI) titer ≥ 1:40 or four-fold greater than baseline (Day 0) compared to those who received the seasonal influenza TIV alone.
Blood is collected from all subjects at baseline and at 4 weeks after TIV (Week 40) for testing in an HAI assay for each of the 3 strains of influenza in the vaccine. A positive response is 1:40 or greater (or a 4-fold increase over baseline if positive at baseline). Groups are compared for statistically significant differences.
Measured: Week 40 (4 weeks after TIV)
Proportion of subjects by group with a four-fold or greater rise from baseline (Day 0) and Week 40 in specific H1, H3 and B neutralizing antibodies
Blood is collected from all subjects at baseline (Day 0) and at Week 40 (4 weeks after TIV) for testing in a neutralizing antibody assay for strain-specific H1, H3 and B antigens. A positive response is a four-fold rise or greater from baseline.
Measured: Week 40 (4 weeks after TIV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- The Emmes Company, LLC
- Responsible party
- Sponsor
- Investigators
- Julie Ledgerwood, D.O., Study chair, Deputy Chief, Clinical Trials Core Vaccine Research Center, NIAID, NIHBarney S Graham, M.D., Ph.D., Study director, Chief, Clinical Trials Core Vaccine Research Center, NIAID, NIH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498718
- Sponsor's protocol ID
- VRC 701
- Other IDs
- VRC 701
- Status last verified
- Mar 2016
- First submitted
- 21 Dec 2011
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ledgerwood 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, 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 19779298Wei CJ, Boyington JC, McTamney PM, Kong WP, Pearce MB, Xu L, Andersen H, Rao S, Tumpey TM, Yang ZY, Nabel GJ. Induction of broadly neutralizing H1N1 influenza antibodies by vaccination. Science. 2010 Aug 27;329(5995):1060-4. doi: 10.1126/science.1192517. Epub 2010 Jul 15.
PubMed 20647428Ledgerwood JE, Bellamy AR, Belshe R, Bernstein DI, Edupuganti S, Patel SM, Renehan P, Zajdowicz T, Schwartz R, Koup R, Bailer RT, Yamshchikov GV, Enama ME, Sarwar U, Larkin B, Graham BS; VRC 701 study team. DNA priming for seasonal influenza vaccine: a phase 1b double-blind randomized clinical trial. PLoS One. 2015 May 7;10(5):e0125914. doi: 10.1371/journal.pone.0125914. eCollection 2015.
PubMed 25950433
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized Phase 1b Study of 2011/12 Influenza Investigational DNA Vaccine, VRC-FLUDNA061-00-VP, Followed by 2012/13 Trivalent Inactivated Vaccine (TIV) Compared to 2012/13 TIV Alone in Healthy Adults
- ClinicalTrials.gov ID
- NCT01498718
- Acronym / sponsor ID
- VRC 701
- Conditions
- Influenza
- Keywords
- Influenza A (H1N1), Influenza A (H3N2), Influenza B, Trivalent Inactivated Vaccine (TIV), Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- The Emmes Company, LLC
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 23 Dec 2011 (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 1b, randomized study in healthy younger (18-50 years) and older (51-70 years) adults to evaluate the safety, tolerability, and immunogenicity of a prime-boost vaccination regimen with an investigational plasmid DNA vaccine directed towards the 2011/12 influenza vaccine strains as a prime followed 36 weeks later by the 2012/13 influenza trivalent inactivated vaccine (TIV) as the booster injection, as compared to placebo prime followed by the 2012/13 seasonal TIV. The hypothesis is that the DNA vaccine will be safe for human administration and that the DNA vaccine prime-TIV boost schedule will elicit a better immune response than the seasonal TIV alone.
Detailed description
Vaccines are an effective way of preventing influenza infection and transmission in humans. Although licensed influenza vaccines are available, ways to improve influenza vaccines continue to be studied. Annually, the World Health Organization (WHO) and the U.S FDA make recommendations on the composition of the seasonal influenza vaccine, with recommendations for the Northern Hemisphere (NH) and for the Southern Hemisphere (SH) considered at different times based on epidemiology data. The annually licensed influenza vaccines consist of 3 components: an Influenza A (H1N1) strain, an Influenza A (H3N2) strain, and an influenza B strain. The current U.S. FDA-licensed influenza vaccines depend upon labor-intensive methods that limit manufacturing capacity and which do not induce broad immune responses to various strains of influenza. The vaccine composition requires frequent adjustment for emerging influenza strains.
The need for influenza vaccines that are more immunogenic and able to induce a more universal immune response against a broad spectrum of influenza strains is well recognized. Earlier laboratory and clinical studies together suggest that an investigational DNA vaccine encoding for the influenza hemagglutinin protein(HA DNA vaccine) administered as a prime, followed by a boost with a traditional inactivated influenza vaccine, may induce a stronger immune response against various influenza strains and with improved durability. The interval of time between the prime vaccination and the boost vaccination is important for the strength of the immune response.
This clinical trial will evaluate the safety, tolerability and immune responses to the investigational HA DNA vaccine prime-TIV boost schedule compared to a placebo prime-TIV boost schedule when the time between the prime and boost is 36 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1A (18-50 yrs): DNA vaccine + TIV | Experimental | Biological: DNA vaccine, Biological: TIVHA DNA Vaccine (VRC-FLUDNA061-00-VP) at Day 0 and licensed TIV at Week 36 |
| Group 2A (51-70 yrs): DNA vaccine + TIV | Experimental | Biological: DNA vaccine, Biological: TIVHA DNA Vaccine (VRC-FLUDNA061-00-VP) at Day 0 and licensed TIV at Week 36 |
| Group 1B (18-50 yrs): TIV only | Placebo comparator | Biological: TIVPhosphate buffered saline (PBS) on Day 0 + TIV at Week 36 |
| Group 2B (51-70 yrs): TIV only | Placebo comparator | Biological: TIVPhosphate buffered saline (PBS) on Day 0 + TIV at Week 36 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 18 to 70 yrs
- Available for clinical follow-up through Study Week 60
- Able and willing to complete the informed consent process
- Willing to donate blood for sample storage to be used for future research
- Physical exam and lab results without clinically significant findings and a Body Mass Index (BMI) <40 within the 70 days prior to enrollment
Key exclusion criteria (25 listed)
- Breast-feeding or planning to become pregnant during the 12 weeks after enrollment in the study
- More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 12 weeks prior to enrollment or any within the 14 days prior to enrollment
- Blood products within 16 weeks prior to enrollment
- Immunoglobulin within 8 weeks prior to enrollment
- Investigational research agents within 28 days (4 weeks) prior to enrollment
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 |
|---|---|---|
| DNA vaccineAlso: VRC-FLUDNA061-00-VP, HA DNA Vaccine, Seasonal influenza trivalent DNA vaccineVRC-FLUDNA061-00-VP is composed of 3 closed-circular DNA plasmids that encode for the hemagglutinin (HA) from the following 3 strains: A/California/04/2009 (H1N1); A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008. DNA vaccine vials will be supplied at 4 mg/mL and each dose will be 1 mL. | Biological | Group 1A (18-50 yrs): DNA vaccine + TIV, Group 2A (51-70 yrs): DNA vaccine + TIV |
| TIVAlso: Trivalent Inactivated Vaccine2012/13 Seasonal Influenza Trivalent Inactivated Vaccine (TIV) | Biological | Group 1A (18-50 yrs): DNA vaccine + TIV, Group 1B (18-50 yrs): TIV only, Group 2A (51-70 yrs): DNA vaccine + TIV, Group 2B (51-70 yrs): TIV only |
Primary outcome
Frequency of subjects per Group of serious adverse events (SAEs)
Time frame: Day 0 (after injection) to Week 60 (Visit 07)
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required non-elective in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the subject or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.
Frequency of Subjects per Group of Solicited Local Reactions After First Study Injection
Time frame: Within 7 days after first vaccination
Frequency and severity of solicited injection site reactions following first study injection (vaccine group compared to placebo group).
Frequency of Subjects per Group Reporting Solicited Local Reactions After TIV injection
Time frame: Within 7 days after TIV injection
Frequency and severity of solicited injection site reactions following the TIV booster injection by Group.
Frequency of Subjects per Group Reporting Solicited Systemic Reactions After First Study Injection
Time frame: Within 7 days after first study injection
Frequency and severity of solicited systemic reactions following first study injection (vaccine group compared to placebo group).
Frequency of Subjects per Group Reporting Solicited Systemic Reactions After TIV injection
Time frame: Within 7 days after TIV injection
Frequency and severity of solicited systemic reactions following TIV injection.
Frequency by group of all unsolicited adverse events (AEs) after first study injection.
Time frame: Through Day 28 after first injection
Frequency of adverse events (AEs) during 28 days after first study injection (vaccine as compared to placebo groups).
Frequency by group of all unsolicited adverse events (AEs) after TIV vaccination.
Time frame: Through Day 28 after second vaccincation
Frequency of unsolicited adverse events (AEs) during 28 days after TIV vaccination by group.
2 secondary outcomes
Proportion of subjects per group with an Hemagglutination Inhibition (HAI) titer ≥ 1:40 or four-fold greater than baseline (Day 0) compared to those who received the seasonal influenza TIV alone.
Time frame: Week 40 (4 weeks after TIV)
Proportion of subjects by group with a four-fold or greater rise from baseline (Day 0) and Week 40 in specific H1, H3 and B neutralizing antibodies
Time frame: Week 40 (4 weeks after TIV)
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 24 Mar 2016.
- 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 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 20647428Wei CJ, Boyington JC, McTamney PM, Kong WP, Pearce MB, Xu L, Andersen H, Rao S, Tumpey TM, Yang ZY, Nabel GJ. Induction of broadly neutralizing H1N1 influenza antibodies by vaccination. Science. 2010 Aug 27;329(5995):1060-4. doi: 10.1126/science.1192517. Epub 2010 Jul 15.
- Derived from this study: PubMed 25950433Ledgerwood JE, Bellamy AR, Belshe R, Bernstein DI, Edupuganti S, Patel SM, Renehan P, Zajdowicz T, Schwartz R, Koup R, Bailer RT, Yamshchikov GV, Enama ME, Sarwar U, Larkin B, Graham BS; VRC 701 study team. DNA priming for seasonal influenza vaccine: a phase 1b double-blind randomized clinical trial. PLoS One. 2015 May 7;10(5):e0125914. doi: 10.1371/journal.pone.0125914. eCollection 2015.
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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 Ledgerwood, D.O. study chair
Deputy Chief, Clinical Trials Core Vaccine Research Center, NIAID, NIH
Barney S Graham, M.D., Ph.D. study director
Chief, Clinical Trials Core Vaccine Research Center, NIAID, NIH
4 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 DNA vaccine and TIV in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 25 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 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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?
Frequency of subjects per Group of serious adverse events (SAEs) (time frame: Day 0 (after injection) to Week 60 (Visit 07)). The study lists 7 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 NCT01498718, which also lists 4 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 24 Mar 2016.