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Influenza, HumanPhase 1NCT00995982

VRC 309: A Multi-Center, Open-Label, Randomized Phase I Study of an Investigational Influenza DNA Vaccine Followed by 2009/2010 Seasonal Influenza Trivalent Inactivated Vaccine (TIV) Compared to Two Injections of TIV in Adults 45-70 Years

A Phase 1 study testing VRC-FLUDNA056-00VP in people with Influenza, Human, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Vaccines are substances used to try to create resistance or immunity to a disease and to prevent an infection. Investigators are looking into improved ways to give and test the results of different kinds of vaccines. Read more about this study

Who is it for?
Ages 45 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Influenza, Human
What is being tested?
VRC-FLUDNA056-00VP
How many people
60 participants
Where
2 sitesUnited States
Study dates
8 Oct 2009to 3 Sep 2010
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 45 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • A SUBJECT MUST MEET ALL OF THE FOLLOWING CRITERIA:
  • 45 to 70 years old.
  • Available for clinical follow-up through Week 27.
  • 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.
  • Able and willing to complete the informed consent process.
Show all 31Show fewer
  • Willing to donate blood for sample storage to be used for future research.
  • No evidence of previously undiagnosed clinically significant chronic diseases.
  • Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) < 42 within the 56 days prior to enrollment.
  • LABORATORY CRITERIA WITHIN 56 DAYS PRIOR TO ENROLLMENT:
  • 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) equal to 3,300-12,000 cells/mm(3)
  • Differential either within institutional normal range or accompanied by site physician approval as a differential that is consistent with healthy volunteer status
  • Total lymphocyte count greater than or equal to 800 cells/mm(3)
  • Platelets equal to 125,000 - 500,000/mm(3)
  • Alanine aminotransferase (ALT) less than or equal to 2.5 times upper limit of normal (ULN)
  • Serum creatinine less than or equal to 1 times 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 human chorionic gonadotropin (Beta-HCG) pregnancy test (urine or serum) for women presumed to be of reproductive potential on the day of enrollment.
  • 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 the last study visit,
  • OR
  • Agrees to consistently practice contraception at least 21 days prior to enrollment and through the last study visit 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 27 weeks after enrollment in the study.
  • Subject has received any of the following substances:
  • Seasonal influenza TIV within the 12 weeks prior to enrollment.
  • 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.]
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  • Blood products within 112 days (16 weeks) prior to HIV screening
  • 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., pneumococcal, or allergy treatment with antigen injections) within 14 days (2 weeks) of initial study vaccine administration
  • Current anti-TB prophylaxis or therapy
  • 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 investigator.
  • Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
  • Asthma that is severe, unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires 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 last 1 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.
  • Guillain-Barre 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

2 sites in 1 country.

United States2 sites

  • Clinical Alliance for Research and Education

    Annandale, Virginia

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Background:

  • Vaccines are substances used to try to create resistance or immunity to a disease and to prevent an infection. Investigators are looking into improved ways to give and test the results of different kinds of vaccines.
  • Researchers are interested in comparing the results of an experimental DNA vaccine for the prevention of seasonal influenza against a standard FDA-approved vaccine for the prevention of seasonal influenza. The experimental DNA vaccine is not yet approved by the FDA for preventing the flu.
Read more

Objectives:

  • To test the safety and immune response of an experimental DNA vaccine for seasonal influenza, compared to the standard vaccine for seasonal influenza.

Eligibility:

  • Healthy individuals between ages 45 and 70 who have not yet received the seasonal influenza vaccine.

Design:

  • Participants will have six planned clinic visits (Weeks 0, 1, 3, 4, 6, and 27) and two telephone follow-up contacts (within 2 days after each injection) during this study.
  • Participants will be divided into two groups: one group will receive two standard (TIV) flu vaccine injections given using a needle and syringe, while the other will receive the DNA flu vaccine using a needleless injection system followed by the TIV vaccine.
  • The vaccine injections for both groups will be given approximately 3 weeks apart,
  • Clinic staff will observe participants for at least 30 minutes after each vaccination. One to two days after each injection, participants must telephone the clinic staff, and for 7 days after the vaccination participants will keep a diary card to report on possible side effects.
  • During study visits, blood samples will be collected for research purposes to test for responses to vaccine.
Read the detailed description

Study Design:

This is a Phase I, open-label study in healthy adults. The study will evaluate the safety, tolerability, and immunogenicity of a prime-boost vaccination regimen against the seasonal influenza virus with one dose of an investigational plasmid DNA vaccine as a prime followed 3 weeks later by the seasonal influenza trivalent inactivated vaccine (TIV) boost as compared to two injections with seasonal TIV. The hypothesis is that the DNA vaccine will be safe for administration and that the DNA vaccine prime - TIV boost schedule will elicit a greater frequency and/or magnitude of the antibody response than two injections with the seasonal TIV. The primary objective is to evaluate the safety and tolerability of the prime boost vaccine regimens. Secondary and exploratory objectives are related to evaluation of the major differences in quantity, quality and durability of humoral and cellular immune responses.

Product Description:

The VRC-FLUDNA056-00-VP vaccine was developed and manufactured by VRC, NIAID. It is composed of 3 closed-circular DNA plasmids, each with a CMV/R promoter, that encode for H1, H3, and influenza B hemagglutinin (HA) proteins from the same 2009-2010 influenza vaccine strains. DNA vaccine vials will be supplied at 4 mg/mL with each dose administered in a 1 mL volume. The TIV is the subunit inactivated vaccine for the 2009-2010 season. Each dose is composed of 45 microg hemagglutinin (HA) in 0.5 mL; with the recommended ratio of 15 microg HA of each of the following 3 strains: A/Brisbane/59/2007-like (H1N1); A/Brisbane/10/2007-like (H3N2); and B/Brisbane/60/2008-like. All injections will be administered intramuscularly (IM) in the deltoid muscle. The DNA injections will be administered by Biojector[Registered Trademark] 2000 Needle-Free Injection Management System and the TIV by needle and syringe.

Subjects:

60 healthy adults, 45-70 years old will be enrolled.

Study Plan:

There are two groups in the study randomized simultaneously at a ratio of 2:1 to the schedules shown in the schema. All subjects will receive the seasonal influenza TIV vaccine as the second injection.

The protocol requires 6 clinic visits (Weeks 0, 1, 3, 4, 6, 27) and 2 telephone follow-up contacts (within 2 days after each injection) for all groups.

Being tested
VRC-FLUDNA056-00VP
Keywords
Influenza, Healthy, Immunity, Preventive, Flu, HV, Healthy Volunteer
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VRC-FLUDNA056-00VPBiological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety (local and systemic reactogenicity, lab tests, AEs)

Secondary outcomes (1)

  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.

  1. First posted16 Oct 2009 (estimated)
  2. Study start8 Oct 2009
  3. Primary completion3 Sep 2010
  4. Study completion3 Sep 2010

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00995982
Sponsor's protocol ID
100004
Other IDs
10-I-0004
Status last verified
3 Sep 2010
First submitted
15 Oct 2009
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 16413916

  • Luke CJ, Subbarao K. Vaccines for pandemic influenza. Emerg Infect Dis. 2006 Jan;12(1):66-72. doi: 10.3201/eid1201.051147.

    PubMed 16494720

  • Fiore AE, Shay DK, Broder K, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, Cox NJ; Centers for Disease Control and Prevention. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Recomm Rep. 2009 Jul 31;58(RR-8):1-52.

    PubMed 19644442

  • Ledgerwood JE, Hu Z, Costner P, Yamshchikov G, Enama ME, Plummer S, Hendel CS, Holman L, Larkin B, Gordon I, Bailer RT, Poretz DM, Sarwar U, Kabadi A, Koup R, Mascola JR, Graham BS; VRC 307 and VRC 309 Study Teams. Phase I clinical evaluation of seasonal influenza hemagglutinin (HA) DNA vaccine prime followed by trivalent influenza inactivated vaccine (IIV3) boost. Contemp Clin Trials. 2015 Sep;44:112-118. doi: 10.1016/j.cct.2015.08.006. Epub 2015 Aug 12.

    PubMed 26275339

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VRC-FLUDNA056-00VP in people with Influenza, Human, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 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 31 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 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 2 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?

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 NCT00995982, 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 2 Jul 2017.

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