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

Influenza Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819013
• Other study ID #: H-261-001
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2008
• Last updated: January 16, 2012
• Start date: July 2007
• Est. completion date: February 2009

Study information

• Verified date: January 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
• Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
• Influenza A Vaccine: ACAM FLU-A
0.5 mL ACAM FLU-A low dose, Intramuscular
• Saline placebo
0.5 mL, Intramuscular

Locations

Country	Name	City	State
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Miami Research Associates	Miami	Florida
United States	Northwest Kinetics	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Day 0 through Day 60 post-vaccination	No
Primary	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.	Day 0 through Day 7 post-vaccination	No
Primary	Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.		Day 0 through Day 60 post-vaccination 1	No
Primary	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)	Day 15 through Month 10 Post-vaccination 1	No
Primary	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)	Day 15 through Month 10 Post-vaccination 1	No
Secondary	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.	Month 4 through Month 10 post-vaccination 1	No
Secondary	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)	Day 0 and Day 60 Post-vaccination 1	No
Secondary	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).	Day 0 and Day 60 Post-vaccination 1	No
Secondary	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).	Day 0 and Day 60 Post-vaccination 1	No
Secondary	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)	Day 0 and Day 15 through Month 10 post-vaccination 1	No
Secondary	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	Day 0 and Day 15 through Month 10 Post-vaccination 1	No