Safety and Immunogenicity of VAX125 Influenza Vaccine in Community-living Adults >= 65 Years of Age

This study has been completed.
Sponsor:
Information provided by:
VaxInnate Corporation
ClinicalTrials.gov Identifier:
NCT00966238
First received: August 24, 2009
Last updated: July 25, 2011
Last verified: July 2011
  Purpose

A multi-center, open-label, escalating dose-ranging study to assess the safety, reactogenicity, and immunogenicity of four different VAX125 vaccine doses; 0.5 µg, 1.0 µg, 2.0 µg, or 3.0 µg, delivered i.m. as a single dose vaccination on Day 0. Hypothesis: VAX125 is safe and immunogenic at one or more of the doses tested.


Condition Intervention Phase
Influenza
Biological: VAX125
Phase 2

VaxInnate Corporation has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II, Open-label, Escalating Dose-ranging Study to Evaluate the Safety and Immunogenicity of VAX125 Influenza Vaccine in Community-living Adults ≥65 Years of Age

Resource links provided by NLM:


Further study details as provided by VaxInnate Corporation:

Primary Outcome Measures:
  • Number of Participants With Local and Systemic Immediate Reactogenicity Complaints [ Time Frame: within 4 hours following vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Geometric Mean Hemagglutinin Inhibition (HAI) Antibody Titers [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: September 2009
Study Completion Date: March 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VAX125
HA1 influenza vaccine
Biological: VAX125
STF2.HA1(SI) (VAX125), which is a recombinant fusion protein that consists of Salmonella typhimurium flagellin type 2 (STF2), a Toll-like receptor 5 (TLR5) ligand, fused at its C-terminus to the globular head domain of the hemagglutinin (HA) antigen of influenza A HA1 Solomon Islands (SI).

Detailed Description:

A total of 80 community-living adults who are ≥65 years of age will be enrolled across the four dose groups. Following vaccination, each subject will remain at the study site for at least 30 minutes to be observed for any immediate reactogenicity complaints associated with the Day 0 vaccination. Subjects will also be evaluated during clinic visits on Study Days 1, 7, 14, and 28 following vaccination. In addition, a safety follow-up telephone contact will occur on post vaccination Day 3.

There will be 20 subjects per dose group. Up to 3 study sites will enroll 6-10 subjects per dose group over a two-day enrollment period. Progression to the next higher dose group will take place only if the Safety Monitoring Committee (SMC) assessment of the 30 (+15) minutes, Day 0, and Day 1 post vaccination safety data; Day 3 telephone report: and the Day 0 and Day 1 serum C-reactive protein (CRP) results concludes that the lower dose was well tolerated.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult men or women aged 65 or older; female subjects must be post menopausal.
  • Live in the community, independently or in an assisted living environment
  • Based on the results of the Short Portable Mental Status Questionnaire (SPMSQ), be rated as normal or have no greater than mild severity dementia.
  • As defined by the Canadian Study of Health and Aging Clinical Frailty Scale (CSHA-CFS), fitness ranging from very fit to mildly frail; Classes 1 to 5 of 7.
  • Healthy volunteers, as determined by medical history, physical examination (PE), vital signs, and clinical safety laboratory examinations.
  • Able to comprehend the study requirements, agree to its provisions, have the ability to adhere to the provisions of the study, and give written informed consent prior to study entry.
  • Willing to receive the unlicensed (VAX125) vaccine given as an i.m. injection.
  • Willing to provide multiple blood specimens collected by venipuncture.

Exclusion Criteria:

  • Persons who in the opinion of the Investigator, have a psychiatric illness, a chronic illness (e.g., diabetes or liver or kidney disease), or who are taking a concomitant therapy or have any other condition that would interfere with the subject's participation in the study or interpretation of the study results.
  • Persons having cancer or have received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible.
  • Persons with impaired immune responsiveness (of any cause), including diabetes mellitus.
  • Persons presently receiving or having a recent history of receiving (within the past six months) any medication or therapeutic modality that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, radiation therapy, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable). Inhaled and topical corticosteroids are allowed.
  • Persons who have had a prior serious reaction to influenza vaccine.
  • Persons with a history of anaphylactic-type reaction to injected vaccines.
  • Persons with a history of drug or chemical abuse in the year prior to screening.
  • Persons currently participating in another research study involving study medications (drugs or vaccines) or who have participated within 30 days of vaccination.
  • Persons who have received blood or blood products within eight weeks prior to vaccination or are planning to receive blood or blood products during the study period.
  • Persons who have donated blood or blood products within eight weeks prior to vaccination or plan to donate at any time during the study.
  • Persons with 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. Vaccination can be delayed until the subject has recovered.
  • Persons with significant cardiovascular disease e.g., New York Heart Associate (NYHA) Class 3 or 4 congestive heart failure; myocardial infarction within the past six months; unstable angina, coronary angioplasty within the past six months; uncontrolled ventricular cardiac arrhythmias; resting heart rate (HR) >100 beats per minute (bpm)
  • Persons with a history of chronic obstructive pulmonary disease or history of other lung disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966238

Locations
United States, Kansas
JCCT
Lanexa, Kansas, United States, 66219
United States, New York
Univ of Rochester
Rochester, New York, United States, 14642
United States, South Carolina
Coastal Carolina Research Center
Charleston, South Carolina, United States, 29464
Sponsors and Collaborators
VaxInnate Corporation
  More Information

No publications provided by VaxInnate Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David N. Taylor, MD, VaxInnate Corporation
ClinicalTrials.gov Identifier: NCT00966238     History of Changes
Other Study ID Numbers: VAX125-02
Study First Received: August 24, 2009
Results First Received: June 13, 2011
Last Updated: July 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by VaxInnate Corporation:
influenza
vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014