Safety, Reactogenicity and Immunogenicity of an H5N1 VLP

NCT00519389 | Completed Phase 1 DMC

• 1 other identifier: H5N1 VLP-1
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pandemic Influenza

Outcome Measures

Primary Outcomes (1)

• Safety and reactogenicity of H5N1 VLP Vaccine

  6 months

Secondary Outcomes (1)

• Immunogenicity of H5N1 VLP Influenza vaccine

  6 months

Study Arms (4)

Low dose H5N1 VLP Vaccine

EXPERIMENTAL

Biological: H5N1 VLP Vaccine

Mid dose H5N1 VLP Vaccine

EXPERIMENTAL

Biological: H5N1 VLP Vaccine

High dose H5N1 VLP Vaccine

EXPERIMENTAL

Biological: H5N1 VLP Vaccine

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

H5N1 VLP Vaccine BIOLOGICAL

Two doses - Day 0 \& Day 28

High dose H5N1 VLP Vaccine; Low dose H5N1 VLP Vaccine; Mid dose H5N1 VLP Vaccine

Placebo BIOLOGICAL

Two doses - Day 0 \& Day 28

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female 18 to 40 years of age at the time of the vaccination.
• 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).
• Available by telephone.
• Free of obvious health problems as established by medical history and clinical examination before entering the study.
• 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.
• Must provide written, informed consent.

You may not qualify if:

• 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.
• Has received any other licensed vaccines within 4 weeks prior to enrollment in this study.
• Has received any influenza vaccine within the prior 12 month period.
• Has received any investigational vaccine designed for protection against avian influenza.
• 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.
• Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
• 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.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures, with the exception of febrile seizures during childhood.

Sponsors & Collaborators

• Novavax: lead

Study Sites (1)

Healthcare Discoveries, Inc.

San Antonio, Texas, 78209, United States

Location

Study Officials

• George Atiee, M.D.

  Healthcare Discoveries, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2007
• First Posted: August 22, 2007
• Study Start: July 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: June 21, 2013

Record last verified: 2012-03

Locations

US (1)