Clinical trial NCT00921947: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza
Keywords: influenza vaccine
M2e
Universal influenza vaccine
Lead sponsor: VaxInnate Corporation
Sponsor class: INDUSTRY
First posted: 2009-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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).

Primary outcomes:
measure: Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
timeFrame: 0 to 7 days after vaccination
measure: Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)
timeFrame: 14 days after vaccination
Secondary outcomes:
measure: Anti-M2e Serum Antibody Concentration
timeFrame: 42 days (+/- 2)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: VaxInnate Corporation
name: David N Taylor, MD
role: STUDY_DIRECTOR
References: