Clinical trial NCT00660257: Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza(H5N1)Vaccine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pandemic Influenza Vaccine
Prevention
Pandemic Influenza
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Centers for Disease Control and Prevention, China
First posted: 2008-04-17
Enrollment: 57
Sex: ALL
Minimum age (years): 19
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: HI antibody Neutralization antibody
timeFrame: 15 and 30 days after the booster dose
Secondary outcomes:
measure: local adverse reactions systemic adverse reactions temperature
timeFrame: 3 days after booster dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References:
citation: 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.