Evaluate the Safety and Immunogenicity of a Seasonal Influenza VLP Vaccine (Recombinant) in Healthy Adults

Influenza Clinical Trial

Official title: A Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant) in Healthy Adults

Status Completed

Clinical Trial Summary

A Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine (recombinant) in Healthy Adults.

Study Objectives:

Primary:

• To assess the tolerability and safety of Influenza VLP Vaccine

• To assess the immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers to each of the three component viral strains

Secondary:

• To evaluate the cross-strain immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers against drifted strains

• To quantify antibody against neuraminidase and hemagglutinin following administration of Influenza VLP Vaccine

• To assess cell-mediated immune (CMI) responses to Influenza VLP Vaccine as quantified by interferon-gamma (IFNg) and Granzyme-B produced by peripheral blood mononuclear cells (PBMCs).

Clinical Trial Description

Study Design:

This is a Phase 2a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of three dose levels (low, middle or high) of Influenza VLP Vaccine or placebo in healthy adults(18 to 49 years of age).

Eligible subjects will provide a blood sample for baseline evaluation of immunological measures followed by a single intramuscular (IM) injection of Influenza VLP Vaccine or placebo (Day 1).

Subjects will be monitored in the clinic for a period of at least 30 minutes following vaccination for the occurrence of adverse events including local injection site reactions and systemic responses. For 7 days following vaccination and beginning the day of vaccination, subjects will maintain a symptom diary for daily recording of injection-site reactions as well as generalized systemic reactions including measurement of body temperature. Clinic staff will contact the subjects by telephone 2 days post vaccination (Day 3) to check for adverse events and to answer any questions related to collection of symptom diary information. Subjects will return to the clinic 7 days following vaccination (Day 8) for safety evaluation that will include a review of diary card information. A subset of subjects will additionally return to the clinic 10-14 days following vaccination (Days 11-15) to provide a blood sample for evaluation of cell-mediated immune (CMI) responses. All subjects will return to the clinic 21 days following injection (Day 22) for a safety evaluation and to provide a blood sample for measurement of humoral immunological parameters. A final safety evaluation (telephone contact) will occur at approximately 6 months following vaccination (Day 181).

The study will be conducted as a parallel group design with a total of approximately 300 subjects (18 to 49 years of age) randomly assigned to one of 4 treatment arms (high, middle, low and placebo) in a 2:2:1:1 ratio. The following is a summary of subject allocation to treatment:

Subject Allocation Treatment Condition Number of Subjects High dose vaccine/ 0.5 mL - 100 Middle dose vaccine/ 0.5 mL - 100 Low dose vaccine/ 0.5 mL - 50 Placebo (0.5 mL) - 50 ;

Study Design

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

• NCT number: NCT00754455
• Study type: Interventional
• Source: Novavax
• Status: Completed
• Phase: Phase 2
• Start date: September 2008
• Completion date: March 2009