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Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults (FLU-A)

Primary Purpose

Influenza

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Influenza A Vaccine: ACAM FLU-A
Influenza A Vaccine: ACAM FLU-A
Influenza A Vaccine: ACAM FLU-A
Saline placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult males or females 18 - 40 years of age in good general health

Exclusion Criteria:

  • Known allergies or severe reactions to any of the vaccine components including those to adjuvants
  • History of severe allergic reactions, including angioedema;
  • History of asthma or recurrent wheezing; (current or within past 2 years);
  • History of neurological symptoms or signs following administration of any vaccine;

Sites / Locations

  • Miami Research Associates
  • Johnson County Clin-Trials
  • Northwest Kinetics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Study Group 1

Study Group 2

Study Group 3

Study Group 4

Arm Description

ACAM-FLU-A low dose + Adjuvant 1

ACAM-FLU-A low dose + Adjuvant 2

ACAM-FLU-A low dose

Saline placebo

Outcomes

Primary Outcome Measures

Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine
Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)

Secondary Outcome Measures

Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Participants who reported signs and symptoms of influenza were tested using nasal pharyngeal swabs, with secretions cultured using susceptible tissue culture cell lines. Positive cultures were confirmed as influenza using immunofluorescence techniques with influenza strain specific antibodies.
Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Seroconversion was defined as an antibody Titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ).
Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).
Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Seropositivity with ELISA was defined as a Pre- or post-vaccination antibody titer ≥ 100. Seropositivity with the Commercial Kit method was defined as a positive pre- or post-vaccination response. Seropositivity were assessed by means of enzyme linked immunosorbent assay (ELISA) and the Commercial Kit methods

Full Information

First Posted
October 10, 2008
Last Updated
January 16, 2012
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00819013
Brief Title
Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults
Acronym
FLU-A
Official Title
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Safety, Reactogenicity, and Immunogenicity of Recombinant M2e Influenza-A Vaccine Candidate ACAM FLU-A) in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered. Subjects will be randomized according to a randomization scheme.
Detailed Description
All subjects will be followed up for 60 days post-randomization and through the influenza season. Following the influenza season, a subset of the subjects will receive a booster vaccine at the 12 month time point. The subjects will further be assessed at 2 days, 7 days, 15 days, 30 days and 6 months following the booster vaccination.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group 1
Arm Type
Experimental
Arm Description
ACAM-FLU-A low dose + Adjuvant 1
Arm Title
Study Group 2
Arm Type
Experimental
Arm Description
ACAM-FLU-A low dose + Adjuvant 2
Arm Title
Study Group 3
Arm Type
Experimental
Arm Description
ACAM-FLU-A low dose
Arm Title
Study Group 4
Arm Type
Placebo Comparator
Arm Description
Saline placebo
Intervention Type
Biological
Intervention Name(s)
Influenza A Vaccine: ACAM FLU-A
Other Intervention Name(s)
ACAM FLU-A
Intervention Description
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Influenza A Vaccine: ACAM FLU-A
Other Intervention Name(s)
ACAM FLU-A
Intervention Description
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Influenza A Vaccine: ACAM FLU-A
Other Intervention Name(s)
ACAM FLU-A
Intervention Description
0.5 mL ACAM FLU-A low dose, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Saline placebo
Other Intervention Name(s)
USP Saline
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Time Frame
Day 0 through Day 60 post-vaccination
Title
Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Description
Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.
Time Frame
Day 0 through Day 7 post-vaccination
Title
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Time Frame
Day 0 through Day 60 post-vaccination 1
Title
Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine
Description
Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Time Frame
Day 15 through Month 10 Post-vaccination 1
Title
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Description
Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)
Time Frame
Day 15 through Month 10 Post-vaccination 1
Secondary Outcome Measure Information:
Title
Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Description
Participants who reported signs and symptoms of influenza were tested using nasal pharyngeal swabs, with secretions cultured using susceptible tissue culture cell lines. Positive cultures were confirmed as influenza using immunofluorescence techniques with influenza strain specific antibodies.
Time Frame
Month 4 through Month 10 post-vaccination 1
Title
Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Description
Seroconversion was defined as an antibody Titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Time Frame
Day 0 and Day 60 Post-vaccination 1
Title
Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Description
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ).
Time Frame
Day 0 and Day 60 Post-vaccination 1
Title
Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Description
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).
Time Frame
Day 0 and Day 60 Post-vaccination 1
Title
Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Description
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Time Frame
Day 0 and Day 15 through Month 10 post-vaccination 1
Title
Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Description
Seropositivity with ELISA was defined as a Pre- or post-vaccination antibody titer ≥ 100. Seropositivity with the Commercial Kit method was defined as a positive pre- or post-vaccination response. Seropositivity were assessed by means of enzyme linked immunosorbent assay (ELISA) and the Commercial Kit methods
Time Frame
Day 0 and Day 15 through Month 10 Post-vaccination 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult males or females 18 - 40 years of age in good general health Exclusion Criteria: Known allergies or severe reactions to any of the vaccine components including those to adjuvants History of severe allergic reactions, including angioedema; History of asthma or recurrent wheezing; (current or within past 2 years); History of neurological symptoms or signs following administration of any vaccine;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc
Official's Role
Study Director
Facility Information:
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Johnson County Clin-Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Northwest Kinetics
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98418
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23527091
Citation
Ibanez LI, Roose K, De Filette M, Schotsaert M, De Sloovere J, Roels S, Pollard C, Schepens B, Grooten J, Fiers W, Saelens X. M2e-displaying virus-like particles with associated RNA promote T helper 1 type adaptive immunity against influenza A. PLoS One. 2013;8(3):e59081. doi: 10.1371/journal.pone.0059081. Epub 2013 Mar 18.
Results Reference
derived

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Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults

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