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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921947
• Other study ID #: VAX102-09
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 15, 2009
• Last updated: August 22, 2011
• Start date: June 2009
• Est. completion date: August 2009

Study information

• 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

Clinical Trial 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 information / eligibility

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• VAX102
Universal M2e influenza vaccine

Locations

Country	Name	City	State
United States	Jean Brown Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
VaxInnate Corporation

Country where clinical trial is conducted

United States, 

Outcome

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