Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza(H5N1)Vaccine

Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza (H5N1)Vaccine in Two-Dose Primed Healthy Adults: A Single Center, Non-Randomized Clinical Trial

A single center, non-randomized clinical trial in two-dose primed healthy adults to evaluate the safety and immunogenicity of a booster dose of an inactivated pandemic influenza (H5N1) vaccine (whole-virion, aluminium-adjuvanted).

Study Overview

• Status: Completed
• Conditions: Prevention; Pandemic Influenza; Pandemic Influenza Vaccine
• Intervention / Treatment: Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 61 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Had received two-dose priming vaccination in previous phase I trial
• Be able to show legal identity card for the sake of recruitment
• Be able to understand and sign the informed consent.

Exclusion Criteria:

• Woman： Who breast-feeding or planning to become pregnant during the study
• Any history of allergic reactions to vaccines or eggs
• Autoimmune disease or immunodeficiency
• Diabetes mellitus (type I or II), with the exception of gestational diabetes
• Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
• Hypertension that was not well controlled by medication or is more than 145/95 mmHg at enrollment
• Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study
• Guillain-Barre Syndrome
• Women subjects with positive urinary pregnancy test
• Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months
• History of any blood products administration within 3 months before the dosing
• Administration of any other investigational research agents within 30 days before the dosing
• Administration of any live attenuated vaccine within 30 days before the dosing
• Administration of subunit or inactivated vaccines, e.g. pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
• Be receiving anti-TB prophylaxis or therapy currently
• Axillary temperature >37.0 centigrade at the time of dosing
• Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
• Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No.1: 1.25 ug	Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection; Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection; Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection
Experimental: No.2: 2.5 ug	Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection; Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection; Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection
Experimental: No.3: 5.0 ug	Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection; Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection; Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection
Experimental: No. 4: 10 ug	Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection; Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection; Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HI antibody Neutralization antibody	15 and 30 days after the booster dose

Secondary Outcome Measures

Outcome Measure	Time Frame
local adverse reactions systemic adverse reactions temperature	3 days after booster dose

Collaborators and Investigators

• Sponsor: Sinovac Biotech Co., Ltd
• Collaborators: Centers for Disease Control and Prevention, China

Publications and helpful links

General Publications

• Lin JT, Li CG, Wang X, Su N, Liu Y, Qiu YZ, Yang M, Chen JT, Fang HH, Dong XP, Yin WD, Feng ZJ. Antibody persistence after 2-dose priming and booster response to a third dose of an inactivated, adjuvanted, whole-virion H5N1 vaccine. J Infect Dis. 2009 Jan 15;199(2):184-7. doi: 10.1086/595832.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: April 15, 2008
• First Submitted That Met QC Criteria: April 16, 2008
• First Posted (Estimate): April 17, 2008

Study Record Updates

• Last Update Posted (Estimate): April 17, 2008
• Last Update Submitted That Met QC Criteria: April 16, 2008
• Last Verified: April 1, 2008

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; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: PRO-PanFlu-1002