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

Study Overview
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Brief Summary
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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. 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.

Official Title
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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

Conditions
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Influenza

Intervention / Treatment
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* Biological: VAX102


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VAX102 IM<br>VAX102 given as 1 µg intramuscular (i.m.) | Biological: VAX102<br>* Universal M2e influenza vaccine<br>* Other names: STF2.4xM2e;|
| Experimental: VAX102 SC<br>VAX102 given as a 2 µg subcutaneous (s.c.) dose | Biological: VAX102<br>* Universal M2e influenza vaccine<br>* Other names: STF2.4xM2e;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-M2e Serum Antibody Concentration | Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population. | 42 days (+/- 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza vaccine, M2e, Universal influenza vaccine