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

Phase 1

Completed

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.

Recruitment & 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).

Arm && Interventions

Group	Intervention	Description
VAX102 IM	VAX102	VAX102 given as 1 µg intramuscular (i.m.)
VAX102 SC	VAX102	VAX102 given as a 2 µg subcutaneous (s.c.) dose

Primary Outcome Measures

Name	Time	Method
Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)	0 to 7 days after vaccination	Solicited local and general symptoms experienced within 7 days after vaccination 1.
Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)	14 days after vaccination	Solicited local and general symptoms experienced within 14 days after vaccination 2

Secondary Outcome Measures

Name	Time	Method
Anti-M2e Serum Antibody Concentration	42 days (+/- 2)	Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population.