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

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: Influenza A Vaccine: ACAM FLU-A Biological: Saline placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Flu

U.S. FDA Resources

Further study details as provided by Sanofi:

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. [ Time Frame: Day 0 through Day 60 post-vaccination ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 0 through Day 60 post-vaccination 1 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 15 through Month 10 Post-vaccination 1 ] [ Designated as safety issue: No ]
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. [ Time Frame: Month 4 through Month 10 post-vaccination 1 ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 0 and Day 60 Post-vaccination 1 ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 0 and Day 60 Post-vaccination 1 ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 0 and Day 60 Post-vaccination 1 ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 0 and Day 15 through Month 10 post-vaccination 1 ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 0 and Day 15 through Month 10 Post-vaccination 1 ] [ Designated as safety issue: No ]
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

Enrollment:	87
Study Start Date:	July 2007
Study Completion Date:	February 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 2, Intramuscular Other Name: 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, Intramuscular Other Name: ACAM FLU-A
Placebo Comparator: Study Group 4 Saline placebo	Biological: Saline placebo 0.5 mL, Intramuscular Other Name: USP Saline

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819013

Locations

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

Sponsors and Collaborators

Sanofi

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc

More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ibañez 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.

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00819013 History of Changes
Other Study ID Numbers:	H-261-001
Study First Received:	October 10, 2008
Results First Received:	November 1, 2011
Last Updated:	January 16, 2012
Health Authority:	United States: Food and Drug Administration

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 16, 2013

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