Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) Universal Influenza Vaccine in Healthy Adults

NCT ID: NCT00921947

Last Updated: 2011-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2009-08-31

Brief Summary

1. To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population.

2. To assess the immunogenicity (anti-M2e serum antibody concentration) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked immunosorbent assay (ELISA) in a healthy adult population.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

VAX102 IM

VAX102 given as 1 µg intramuscular (i.m.)

Group Type: EXPERIMENTAL

VAX102

Intervention Type: BIOLOGICAL

Universal M2e influenza vaccine

VAX102 SC

VAX102 given as a 2 µg subcutaneous (s.c.) dose

Group Type: EXPERIMENTAL

VAX102

Intervention Type: BIOLOGICAL

Universal M2e influenza vaccine

Interventions

VAX102

Universal M2e influenza vaccine

Intervention Type: BIOLOGICAL

Other Intervention Names

STF2.4xM2e

Eligibility Criteria

Inclusion Criteria

• Adult men or women aged 18 to 49 years inclusive.
• Able and willing to provide written informed consent to participate.
• Healthy, as determined by medical history, physical examination, and vital signs.
• Willing to receive the unlicensed (VAX102) vaccine given as an i.m. or s.c. injection.
• Willing to provide multiple blood specimens collected by venipuncture.
• Females should avoid becoming pregnant during the course of the study
• Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of the first and preceding receipt of the second (booster) vaccination.
• Must exhibit comprehension of the study requirements; expressed availability for the required study period and expect to reside in the study area during the entire study period, and ability to attend scheduled visits.

Exclusion Criteria

• Persons under 18 years old or 50 years or older.
• Persons with chronic illnesses such as cancer, diabetes, liver or kidney disease.
• Person currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination.
• 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 preceding the study.
• Persons who received an influenza vaccine for the current influenza season or those who plan to receive an influenza vaccine while participating in the study.
• Persons who received any other vaccine within one week prior to enrollment (may delay enrollment).
• Persons who have had a respiratory illness or illness with fever within three days of study enrollment (may delay enrollment).
• Persons currently participating in another research study involving any study medications (medicines or vaccines).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VaxInnate Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David N Taylor, MD

Role: STUDY_DIRECTOR

VaxInnate Corporation

Locations

Jean Brown Research

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

VAX102-09

Identifier Type: -

Identifier Source: org_study_id