Safety, Reactogenicity and Immunogenicity of an H5N1 VLP

A Phase I/IIa Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of an H5N1 Virus-Like Particle (VLP) Influenza Vaccine (Recombinant)

This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.

Study Overview

• Status: Completed
• Conditions: Pandemic Influenza
• Intervention / Treatment: Biological: H5N1 VLP Vaccine; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • Healthcare Discoveries, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female 18 to 40 years of age at the time of the vaccination.
2. Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visits and completion of the data collection tool).
3. Available by telephone.
4. Free of obvious health problems as established by medical history and clinical examination before entering the study.
5. If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception) for 30 days prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for two months after completion of vaccination.
6. Must provide written, informed consent.

Exclusion Criteria:

1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
2. Has received any other licensed vaccines within 4 weeks prior to enrollment in this study.
3. Has received any influenza vaccine within the prior 12 month period.
4. Has received any investigational vaccine designed for protection against avian influenza.
5. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. The use of inhaled and nasal steroids will be permitted.
6. Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
7. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
8. Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever ≥ 100.5º F.
9. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
10. Major congenital defects or serious chronic illness.
11. History of any neurological disorders or seizures, with the exception of febrile seizures during childhood.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Two doses - Day 0 & Day 28
Experimental: Low dose H5N1 VLP Vaccine	Biological: H5N1 VLP Vaccine; Two doses - Day 0 & Day 28
Experimental: Mid dose H5N1 VLP Vaccine	Biological: H5N1 VLP Vaccine; Two doses - Day 0 & Day 28
Experimental: High dose H5N1 VLP Vaccine	Biological: H5N1 VLP Vaccine; Two doses - Day 0 & Day 28

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and reactogenicity of H5N1 VLP Vaccine	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity of H5N1 VLP Influenza vaccine	6 months

Collaborators and Investigators

• Sponsor: Novavax
• Investigators: Principal Investigator: George Atiee, M.D., Healthcare Discoveries, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: August 20, 2007
• First Submitted That Met QC Criteria: August 20, 2007
• First Posted (Estimate): August 22, 2007

Study Record Updates

• Last Update Posted (Estimate): June 21, 2013
• Last Update Submitted That Met QC Criteria: June 12, 2013
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: H5N1 VLP-1