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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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VAX102

About this trial

This is an interventional prevention trial for Influenza focused on measuring influenza vaccine, M2e, Universal influenza vaccine

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Jean Brown Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

VAX102 IM

VAX102 SC

Arm Description

VAX102 given as 1 µg intramuscular (i.m.)

VAX102 given as a 2 µg subcutaneous (s.c.) dose

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Anti-M2e Serum Antibody Concentration

Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population.

Full Information

NCT ID

NCT00921947

First Posted

June 15, 2009

Last Updated

August 22, 2011

Sponsor

VaxInnate Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00921947

Brief Title

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

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VaxInnate Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

influenza vaccine, M2e, Universal influenza vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VAX102 IM

Arm Type

Experimental

Arm Description

VAX102 given as 1 µg intramuscular (i.m.)

Arm Title

VAX102 SC

Arm Type

Experimental

Arm Description

VAX102 given as a 2 µg subcutaneous (s.c.) dose

Intervention Type

Biological

Intervention Name(s)

VAX102

Other Intervention Name(s)

STF2.4xM2e

Intervention Description

Universal M2e influenza vaccine

Primary Outcome Measure Information:

Title

Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)

Description

Solicited local and general symptoms experienced within 7 days after vaccination 1.

Time Frame

0 to 7 days after vaccination

Title

Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)

Description

Solicited local and general symptoms experienced within 14 days after vaccination 2

Time Frame

14 days after vaccination

Secondary Outcome Measure Information:

Title

Anti-M2e Serum Antibody Concentration

Description

Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population.

Time Frame

42 days (+/- 2)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David N Taylor, MD

Organizational Affiliation

VaxInnate Corporation

Official's Role

Study Director

Facility Information:

Facility Name

Jean Brown Research

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84124

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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