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 - Full Text View

Sponsor:	VaxInnate Corporation
Information provided by (Responsible Party):	VaxInnate Corporation
ClinicalTrials.gov Identifier:	NCT00921947

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: VAX102	Phase 1 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by VaxInnate Corporation:

Primary Outcome Measures:

Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) [ Time Frame: 0 to 7 days after vaccination ] [ Designated as safety issue: Yes ]
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) [ Time Frame: 14 days after vaccination ] [ Designated as safety issue: Yes ]
Solicited local and general symptoms experienced within 14 days after vaccination 2

Secondary Outcome Measures:

Anti-M2e Serum Antibody Concentration [ Time Frame: 42 days (+/- 2) ] [ Designated as safety issue: No ]
Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population.

Enrollment:	60
Study Start Date:	June 2009
Study Completion Date:	August 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: VAX102 IM VAX102 given as 1 µg intramuscular (i.m.)	Biological: VAX102 Universal M2e influenza vaccine Other Name: STF2.4xM2e
Experimental: VAX102 SC VAX102 given as a 2 µg subcutaneous (s.c.) dose	Biological: VAX102 Universal M2e influenza vaccine Other Name: STF2.4xM2e

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921947

Locations

United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124

Sponsors and Collaborators

VaxInnate Corporation

Investigators

Study Director:

David N Taylor, MD

VaxInnate Corporation

More Information

No publications provided

Responsible Party:	VaxInnate Corporation
ClinicalTrials.gov Identifier:	NCT00921947 History of Changes
Other Study ID Numbers:	VAX102-09
Study First Received:	June 15, 2009
Results First Received:	June 13, 2011
Last Updated:	August 22, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by VaxInnate Corporation:

influenza vaccine
M2e
Universal influenza vaccine

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2012