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InfluenzaPhase 1NCT00730457

Phase 1 Safety and Immunogenicity Study in Healthy Adults of VAX125, a Recombinant HA-flagellin Influenza Vaccine

A Phase 1 study testing VAX125 in people with Influenza, run by VaxInnate Corporation at 1 site 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

Is VAX125 safe at doses ranging from 0.1 to 8 ug when delivered i.m. in a single dose regimen Is VAX125 able to induce a post-vaccination serum HAI antibody response in healthy adults against the influenza A virus H1 HA. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
VAX125
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
Jul 2008to Jun 2009
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 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female aged 18 - 49 years inclusive
  • Give written informed consent to participate.
  • Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations
  • Females should willing to use another reliable form of contraception approved by the Investigator and a negative urine pregnancy test within 24 hours preceding receipt of vaccination
  • Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.

Who cannot join

  • Presence of significant uncontrolled medical or psychiatric illness (acute or chronic). This includes institution of new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed on Day 0 prior to vaccination.
  • Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies.
  • Cancer, or treatment for cancer, within 3 years. (Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible), excluding basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) which is allowed, unless at vaccination site.
  • Impaired immune responsiveness (of any cause), including diabetes mellitus.
  • Documented influenza infection with a positive culture in the 6 months prior to screening.
  • Presently receiving or history of receiving any medications or treatments that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable) in the past 6 months prior to screening. Inhaled and topical corticosteroids will be allowed.
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  • Receipt or planned administration of a nonstudy vaccine within 30 days prior to vaccination and during the study, including licensed influenza vaccines. Immunization on an emergency basis with Tetanus Toxoid Adsorbed for adult use (Td or Tdap) up to 8 days before or at least 8 days after a dose of study vaccine will be allowed. Administration of study vaccine injection can be delayed if a nonstudy vaccine has been administered and will be given as soon as acceptable, as described above, provided the vaccine is not administered within two weeks prior to study enrollment.
  • History of anaphylactic type reaction to injected vaccines.
  • History of drug or chemical abuse in the year before the study.
  • Receipt of any investigational product or nonregistered drug within the 30 days prior to vaccination or currently enrolled in any investigational drug study or intends to enroll in such a study within the ensuing study period.
  • Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the study period.
  • Donation of blood or blood products within 8 weeks prior to vaccination or at any time during the study.
  • Acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness (as determined by the investigator through medical history and physical examination; for example, those requiring an absence from work) with or without fever, or a fever >37.9ºC orally. Study vaccine can be administered to persons with a minor illness, such as diarrhea, or mild upper respiratory tract infection with or without low-grade febrile illness. Vaccination can be delayed until the subject has recovered.
  • Any condition that, in the opinion of the investigator, might interfere with study objectives

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Rochester

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: A Two Part Study to Investigate the Safety and Immunogenicity of the VAX125 Influenza Vaccine in Healthy Adults Age 18-49 Years Part I: Phase I, Open-Label, Escalating Dose-Ranging Study Part II: Phase II, Double-Blind Placebo-Controlled Study

Is VAX125 safe at doses ranging from 0.1 to 8 ug when delivered i.m. in a single dose regimen Is VAX125 able to induce a post-vaccination serum HAI antibody response in healthy adults against the influenza A virus H1 HA.

Read the detailed description

Part I: Intramuscular (i.m.) vaccination of a single dose of 0.1 µg, 0.3 µg, 1 µg, 2 µg, 3 µg, 5 µg and 8 µg of STF2.HA1 (SI) (VAX125) to be given on Day 0

Part II: Intramuscular (i.m.) vaccination of a single dose of placebo or one of two dose levels of STF2.HA1 (SI) (VAX125) (optimum dose levels to be determined from the safety and immunogenicity data from Part I of this study) to be given on Day 0

Part I Primary: To assess the safety, reactogenicity, and tolerability of the VAX125 vaccine delivered i.m. in a single dose regimen of dose levels of 0.1 µg, 0.3 µg, 1 µg, 2 µg, 3 µg, 5 µg, and 8 µg in healthy adults 18 - 49 years of age, inclusive.

Secondary: To assess the immunogenicity of the VAX125 vaccine delivered i.m. in a single dose regimen at dose levels of 0.1 µg, 0.3 µg, 1 µg, 2 µg, 3 µg, 5 µg, and 8 µg, for inducing a post-vaccination serum HAI antibody response in healthy adults against the influenza A virus H1 HA.

Part II Primary: To assess the safety, reactogenicity, and tolerability of a single dose of the VAX125 vaccine delivered i.m. in one of two dose levels as compared to placebo, (optimum dose levels to be determined from the safety and immunogenicity data from Part I of this study), in healthy adults 18- 49 years of age, inclusive.

Secondary: To assess the immunogenicity of a single dose the VAX125 vaccine delivered i.m. in one of two dose levels as compared to placebo (optimum dose levels to be determined from the safety and immunogenicity data from Part I of this study) for inducing a post-vaccination serum HAI antibody response in healthy adults against the influenza A virus H1 HA antigen.

Conditions
Influenza
Being tested
VAX125
Keywords
influenza, recombinant, hemagglutinin, vaccine
Medical subject headings
Influenza, Human

What participants receive

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

  • VAX125Biological

    Also called STF2.HA1(SI)

    Single intramuscular dose

Study groups in NCT00730457
Study groupRoleWhat they receive
AExperimentalIntramuscular (i.m.) vaccination of a single dose of 0.1 µg, 0.3 µg, 1 µg, 2 µg, 3 µg, 5 µg and 8 µg of STF2.HA1 (SI) (VAX125).
Receives: Biological: VAX125

What is being measured

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

  1. Safety (local and systemic reactogenicity, laboratory tests and AEs.

    Measured: 6 months

Secondary outcomes (1)

  1. Immunogenicity after single intramuscular dose ranging from 0.1 ug to 8 ug for inducing a post-vaccination serum HAI antibody response in healthy adults against the influenza A virus H1 HA antigen.

    Measured: 6 months

Timeline

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

  1. First posted8 Aug 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionMar 2009
  4. Study completionJun 2009

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
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00730457
Sponsor's protocol ID
VAX125-01
Status last verified
Sep 2014
First submitted
4 Aug 2008
Last updated
23 Sep 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Song L, Nakaar V, Kavita U, Price A, Huleatt J, Tang J, Jacobs A, Liu G, Huang Y, Desai P, Maksymiuk G, Takahashi V, Umlauf S, Reiserova L, Bell R, Li H, Zhang Y, McDonald WF, Powell TJ, Tussey L. Efficacious recombinant influenza vaccines produced by high yield bacterial expression: a solution to global pandemic and seasonal needs. PLoS One. 2008 May 21;3(5):e2257. doi: 10.1371/journal.pone.0002257.

    PubMed 18493310

  • Treanor JJ, Taylor DN, Tussey L, Hay C, Nolan C, Fitzgerald T, Liu G, Kavita U, Song L, Dark I, Shaw A. Safety and immunogenicity of a recombinant hemagglutinin influenza-flagellin fusion vaccine (VAX125) in healthy young adults. Vaccine. 2010 Dec 6;28(52):8268-74. doi: 10.1016/j.vaccine.2010.10.009. Epub 2010 Oct 20.

    PubMed 20969925

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VAX125 in people with Influenza, run by VaxInnate Corporation 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 5 inclusion and 14 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 23 Sep 2014. 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, laboratory tests and AEs. (time frame: 6 months). 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 NCT00730457, which also lists 2 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 23 Sep 2014.

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