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InfluenzaPhase 1NCT01609998

Seasonal Influenza DNA Vaccine & Seasonal Influenza Trivalent Inactivated Vaccine (TIV) in Children & Adolescents

A Phase 1 study testing Seasonal Influenza DNA vaccine and TIV in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 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

This is a Phase I, dose escalation study in healthy adolescents and children (6-17 years) to evaluate the safety, tolerability, and immunogenicity of a prime-boost regimen of the 2012/2013 seasonal influenza DNA vaccine (HA DNA) followed by licensed 2012/2013 TIV vaccine. Read more about this study

Who is it for?
Ages 6 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Seasonal Influenza DNA vaccine and TIV
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
5 sitesUnited States
Study dates
Jun 2012to Jul 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 6 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children/adolescents aged 6 to 17 years inclusive and at least 20 kg in weight.
  • Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
  • Willing to have blood drawn 5 times over 42 weeks, including blood stored for research purposes.
  • In good general health as assessed by medical history, vital signs and targeted physical examination; stable medical conditions that, in the opinion of the investigator, will not compromise the subject's participation in the study are acceptable.
  • Capability of the legal adult representative of the minor to understand and comply with planned study procedures.
  • Capability of the legal adult representative of the minor to provide written informed consent; assent will be obtained from the child/adolescent per requirements of the site institutional review board (IRB).
  • For female adolescent of child-bearing potential (as defined by onset of menses): agrees to avoid becoming pregnant and to use effective method of contraception or practice abstinence for at least 21 day prior to the first study vaccine administration, until at least 4 weeks after the second study vaccination.
  • Within 70 days prior to enrollment, hemoglobin within institutional normal limits, creatinine less than the upper limit of normal (ULN) and ALT ≤1.5 X ULN for respective age group.

Who cannot join

  • History of Guillain-Barré syndrome.
  • Active neoplasm or history of cancer.
  • On-going immunosuppressive therapy or known to be immunosuppressed at the time of enrollment.
  • Immunoglobulin (or similar blood product) therapy within 3 months prior to enrollment.
  • Known to have HIV, hepatitis B or hepatitis C infection.
  • Acute or chronic illness that, in the opinion of the investigator, precludes participation in the study.
Show all 15Show fewer
  • Developmental delay, neurologic disorder, or seizure disorder requiring ongoing medical management (note: history of febrile seizure is not an exclusion).
  • Acute febrile and/or respiratory illness within one week prior to enrollment.
  • Idiopathic urticaria within the year 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.
  • 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.
  • Vaccination of any type within 2 weeks prior to enrollment or receipt of the 2012/2013 seasonal TIV any time prior to enrollment.
  • Participating in or planning to begin participation in another investigational study during the projected time during which the subject would be in this study.
  • Factors related to the legal representative that in the judgment of the investigator may affect the objective decision-making of the legal representative.
  • For a female adolescent of child-bearing potential: breast-feeding, known pregnancy or positive urine or serum pregnancy test on day of study enrollment.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Emory Children's Center

    Atlanta, Georgia, 30322

  • The Gamble Program for Clinical Studies, Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Saint Louis University - Doisy Research Center

    St Louis, Missouri, 63104

Other trials in United States

About this study

Official title: Open-Label, Dose-Escalation, Phase I Study of the Prime-Boost Investigational 2012/13 Seasonal Influenza DNA Vaccine, VRC-FLUDNA063-00-VP, Followed by the 2012/2013 Seasonal TIV Compared to TIV Prime-Boost in Children/Adolescents Ages 6-17

This is a Phase I, dose escalation study in healthy adolescents and children (6-17 years) to evaluate the safety, tolerability, and immunogenicity of a prime-boost regimen of the 2012/2013 seasonal influenza DNA vaccine (HA DNA) followed by licensed 2012/2013 TIV vaccine. The comparator groups will receive licensed 2012/2013 TIV as prime and boost. The hypothesis is that the 2012/2013 HA DNA prime-TIV boost regimen will be safe and result in a broader and more durable immune response than is observed in age-matched comparator TIV-TIV groups.

Read the detailed description

Vaccines are an effective way to prevent influenza infection. Each year the World Health Organization (WHO) and the U.S FDA recommend the influenza strains to include in the seasonal influenza vaccines. The licensed seasonal influenza vaccines are directed against 3 influenza virus strains: an influenza A H1N1, an influenza A H3N2, and an influenza B. The currently approved vaccines depend upon labor-intensive methods that limit manufacturing speed and capacity. Influenza vaccines that can be more rapidly produced and that induce stronger, broader and more persistent immune responses are a recognized public health need.

In this protocol we will evaluate an investigational seasonal influenza (HA DNA) vaccine in healthy adolescents and children (6-17 years). Some participants will receive HA DNA vaccine "prime" followed by licensed trivalent influenza vaccine (TIV) "boost" 18 weeks later. Other participants will receive two TIV injections 18 weeks apart. The results will be compared. The HA DNA vaccine and TIV are both directed at the 3 influenza strains selected for the 2012/2013 vaccines. Prior studies in adults of avian and seasonal influenza DNA vaccines have been completed. The DNA vaccinations were assessed as safe and well tolerated in adults. The immune response to avian influenza is augmented by DNA vaccine priming compared to two vaccinations with the inactivated avian influenza (H5N1)vaccine when the prime-boost interval is 12-24 weeks, but not when the prime-boost interval is 4 weeks.

Conditions
Influenza
Being tested
Seasonal Influenza DNA vaccine, TIV
Keywords
Influenza A (H1), Influenza A (H3), Influenza B, DNA Vaccine, Trivalent Inactivated Vaccine (TIV), Healthy Adolescents, Healthy Children
Medical subject headings
Influenza, Human

What participants receive

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

  • Seasonal Influenza DNA vaccineBiological

    Also called VRC-FLUDNA063-00-VP, HA DNA Vaccine, Seasonal influenza trivalent DNA vaccine

    VRC-FLUDNA063-00-VP is composed of 3 closed-circular DNA plasmids that encode for the hemagglutinin (HA) from the following 3 strains: A/California/04/2009 (H1); A/Victoria/361/2011 (H3), and B/Wisconsin/2010. DNA vaccine vials will be supplied at 4 mg/mL in single use vials. The 1 mg dosage is administered as 0.25 mL volume and the 4 mg dosage as a 1 mL volume.

  • TIVBiological

    Also called 2012/13 Seasonal Influenza Trivalent Inactivated Vaccine

    2012/13 Seasonal Influenza Trivalent Inactivated Vaccine (TIV)

Study groups in NCT01609998
Study groupRoleWhat they receive
Group 1A (12-17yrs):1 mg DNA vaccine+TIVExperimental2012/13 seasonal influenza DNA Vaccine (VRC-FLUDNA063-00-VP) at Day 0 and licensed 2012/13 TIV at Week 18±2 wks
Receives: Biological: Seasonal Influenza DNA vaccine; Biological: TIV
Group 1B (6-11yrs):1 mg DNA vaccine+TIVExperimental2012/13 seasonal influenza DNA Vaccine (VRC-FLUDNA063-00-VP) at Day 0 and licensed 2012/13 TIV at Week 18±2 wks
Receives: Biological: Seasonal Influenza DNA vaccine; Biological: TIV
Group 2A (12-17yrs):4 mg DNA vaccine+TIVExperimental2012/13 seasonal influenza DNA Vaccine (VRC-FLUDNA063-00-VP) at Day 0 and licensed 2012/13 TIV at Week 18±2 wks
Receives: Biological: Seasonal Influenza DNA vaccine; Biological: TIV
Group 2B (6-11yrs):4 mg DNA vaccine+TIVExperimental2012/13 seasonal influenza DNA Vaccine (VRC-FLUDNA063-00-VP) at Day 0 and licensed 2012/13 TIV at Week 18±2 wks
Receives: Biological: Seasonal Influenza DNA vaccine; Biological: TIV
Group 3A: (12-17yrs): TIV+TIVActive comparatorLicensed 2012/13 TIV at Day 0 and Week 18±2 wks
Receives: Biological: TIV
Group 3B: (6-11yrs): TIV+TIVActive comparatorLicensed 2012/13 TIV at Day 0 and Week 18±2 wks
Receives: Biological: TIV

What is being measured

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

  1. Incidence of solicited and unsolicited adverse events

    Incidence is reported for solicited events for 7 days after each injection, for unsolicited adverse event (AE) of any severity for 28 days after each injection, and for serious adverse events or new chronic medical conditions through 24 weeks after the 2nd injection.

    Measured: 7 days after injection for solicited events; from 1st injection to study completion for unsolicited events

  2. Mean change from baseline in safety laboratory measures

    At day 28 (+/- 7 days) blood will be drawn prior to receiving the second injection to measure hemoglobin, creatinine, and alanine transaminase (ALT).

    Measured: Day 28

  3. Number of subjects with influenza or influenza-like illnesses

    Participants who experience at least one influenza or influenza-like illness will be counted.

    Measured: Day 0 through 24 weeks post TIV boost (Day 294)

Secondary outcomes (2)

  1. Proportion of subjects with either a baseline hemagglutination inhibition (HAI) titer <1:10 and post-vaccination HAI titer ≥1:40 or baseline HAI titer ≥1:10 and a minimum 4-fold rise in HAI titer for each of the 3 strains in the 2012/13 TIV at Week 22.

    Blood is collected from all subjects at baseline and at 4 weeks after TIV boost(Week 22 +/- 7 days) for testing in an HAI assay for each of the 3 strains of influenza in the 2012/2013 TIV.

    Measured: Week 22 (4 weeks after TIV boost)

  2. Proportion of subjects with a four-fold or greater rise from baseline (Day 0) and Week 22 in 2012/13 TIV specific H1, H3 and B neutralizing antibodies

    Blood is collected from all subjects at baseline (Day 0) and 4 weeks after TIV boost (Week 22 +/- 7 days) for testing in a neutralizing antibody assays for 2012/13 strain-specific H1, H3 and B antigens.

    Measured: Week 22 (4 weeks after TIV boost)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionJul 2013
  4. Study completionJul 2013

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
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01609998
Sponsor's protocol ID
VRC 702
Other IDs
VRC 702
Status last verified
Dec 2018
First submitted
30 May 2012
Last updated
6 Dec 2018
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 21975270

  • 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 19779298

  • Houser KV, Yamshchikov GV, Bellamy AR, May J, Enama ME, Sarwar U, Larkin B, Bailer RT, Koup R, Paskel M, Subbarao K, Anderson E, Bernstein DI, Creech B, Keyserling H, Spearman P, Wright PF, Graham BS, Ledgerwood JE; VRC 702 study team. DNA vaccine priming for seasonal influenza vaccine in children and adolescents 6 to 17 years of age: A phase 1 randomized clinical trial. PLoS One. 2018 Nov 2;13(11):e0206837. doi: 10.1371/journal.pone.0206837. eCollection 2018.

    PubMed 30388160

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Seasonal Influenza DNA vaccine and TIV in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 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 8 inclusion and 15 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 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Incidence of solicited and unsolicited adverse events (time frame: 7 days after injection for solicited events; from 1st injection to study completion for unsolicited events). 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 NCT01609998, 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 6 Dec 2018.

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