Influenza Clinical Trial
Official title:
A Phase II, Randomized, Open-Label Study to Evaluate the Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) in Healthy Adults
Verified date | August 2011 |
Source | VaxInnate Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 49 Years |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Jean Brown Research | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
VaxInnate Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Solicited local and general symptoms experienced within 7 days after vaccination 1. | 0 to 7 days after vaccination | Yes |
Primary | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Solicited local and general symptoms experienced within 14 days after vaccination 2 | 14 days after vaccination | Yes |
Secondary | Anti-M2e Serum Antibody Concentration | Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population. | 42 days (+/- 2) | No |
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