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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 - NCT00921947-84124(Clinical Trial 298025)



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City:  Salt Lake City
State:  
UT
Zip Code: 84124
Conditions: Influenza
Purpose: 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.
Study summary:
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).
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Data Source: ClinicalTrials.gov
Date Processed: February 2, 2010
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