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

• ClinicalTrials.gov Identifier: NCT00966238
• Recruitment Status: Completed
• First Posted: August 26, 2009
• Results First Posted: July 14, 2011
• Last Update Posted: October 2, 2014
• Sponsor: VaxInnate Corporation
• Information provided by (Responsible Party): VaxInnate Corporation

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Influenza	Biological: VAX125	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: September 2009
• Actual Primary Completion Date: April 2010
• Actual Study Completion Date: March 2011

Arms and Interventions

Arm	Intervention/treatment
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).

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Local and Systemic Immediate Reactogenicity Complaints [ Time Frame: within 4 hours following vaccination ]

Secondary Outcome Measures :

1. Geometric Mean Hemagglutinin Inhibition (HAI) Antibody Titers [ Time Frame: 28 days after vaccination ]

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• 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

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

Investigators

• Study Director: David Taylor, MD; VaxInnate Corporation

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Taylor DN, Treanor JJ, Strout C, Johnson C, Fitzgerald T, Kavita U, Ozer K, Tussey L, Shaw A. Induction of a potent immune response in the elderly using the TLR-5 agonist, flagellin, with a recombinant hemagglutinin influenza-flagellin fusion vaccine (VAX125, STF2.HA1 SI). Vaccine. 2011 Jul 12;29(31):4897-902. doi: 10.1016/j.vaccine.2011.05.001. Epub 2011 May 17.

• Responsible Party: VaxInnate Corporation
• ClinicalTrials.gov Identifier: NCT00966238
• Other Study ID Numbers: VAX125-02
• First Posted: August 26, 2009
• Results First Posted: July 14, 2011
• Last Update Posted: October 2, 2014
• Last Verified: September 2014

Keywords provided by VaxInnate Corporation:

influenza; vaccine

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases