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

January 16, 2012 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33143
        • Miami Research Associates
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Johnson County Clin-Trials
    • Washington
      • Tacoma, Washington, United States, 98418
        • Northwest Kinetics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group 1
ACAM-FLU-A low dose + Adjuvant 1
Biological: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
Other Names:
  • ACAM FLU-A
Biological: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
Other Names:
  • ACAM FLU-A
Biological: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM FLU-A low dose, Intramuscular
Other Names:
  • ACAM FLU-A
Experimental: Study Group 2
ACAM-FLU-A low dose + Adjuvant 2
Biological: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
Other Names:
  • ACAM FLU-A
Biological: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
Other Names:
  • ACAM FLU-A
Biological: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM FLU-A low dose, Intramuscular
Other Names:
  • ACAM FLU-A
Experimental: Study Group 3
ACAM-FLU-A low dose
Biological: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
Other Names:
  • ACAM FLU-A
Biological: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
Other Names:
  • ACAM FLU-A
Biological: Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM FLU-A low dose, Intramuscular
Other Names:
  • ACAM FLU-A
Placebo Comparator: Study Group 4
Saline placebo
Biological: Saline placebo
0.5 mL, Intramuscular
Other Names:
  • USP Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0 through Day 60 post-vaccination
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.
Time Frame: Day 0 through Day 7 post-vaccination
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.
Day 0 through Day 7 post-vaccination
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
Day 0 through Day 60 post-vaccination 1
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
Time Frame: Day 15 through Month 10 Post-vaccination 1
Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Day 15 through Month 10 Post-vaccination 1
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Time Frame: Day 15 through Month 10 Post-vaccination 1

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)
Day 15 through Month 10 Post-vaccination 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Time Frame: Month 4 through Month 10 post-vaccination 1
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.
Month 4 through Month 10 post-vaccination 1
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.
Time Frame: Day 0 and Day 60 Post-vaccination 1
Seroconversion was defined as an antibody Titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Day 0 and Day 60 Post-vaccination 1
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.
Time Frame: Day 0 and Day 60 Post-vaccination 1

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).
Day 0 and Day 60 Post-vaccination 1
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.
Time Frame: Day 0 and Day 60 Post-vaccination 1
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).
Day 0 and Day 60 Post-vaccination 1
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.
Time Frame: Day 0 and Day 15 through Month 10 post-vaccination 1
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Day 0 and Day 15 through Month 10 post-vaccination 1
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.
Time Frame: Day 0 and Day 15 through Month 10 Post-vaccination 1

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
Day 0 and Day 15 through Month 10 Post-vaccination 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

October 10, 2008

First Submitted That Met QC Criteria

January 6, 2009

First Posted (Estimate)

January 8, 2009

Study Record Updates

Last Update Posted (Estimate)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 16, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-261-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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