Assessment of the safety, tolerance, and immunogenicity of EG-HPV (human papillomavirus vaccine) in healthy male adult volunteers:

Not Applicable

Recruiting

• Conditions: Not Applicable

• Registration Number: KCT0000604
• Lead Sponsor: Eyegene

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

1. Healthy male adults aged 20 years or older
2. Weighed 45 kg or over, and in the range of ideal body weight* ± 20 %
*Ideal Body Weight = [height (in cm)-100]?0.9
3. No deviation from normal range in vital signs, physical examination, haematology, blood coagulation test, biochemistry, urinalysis, or 12-lead ECG performed within 4 weeks prior to the study as determined by the investigator
4. Willingness to participate in the study
5. Written informed consent

Exclusion Criteria

1.Prior receipt of a HPV vaccine
2.Any history of anaphylaxis in reaction to vaccination
3.Seropositive for HPV 16 or HPV 18 (> 7 unit)
4.History of fever or infectious disease within 2 weeks prior to the study
5.History of a whole blood donation within 2 months or a component donation within one month prior to the study, or planned donation during the study period
6.Any vaccination within 2 months prior to the study
7.Any immunological disorder or administration of immunological therapy including cyclophosphamide, azathiprine, leflunomide, TNF-a antagonist, therapeutic monoclonal antibody, intravenous gamma immunoglobulin, high dose of systemic corticosteroid hormone therapy
8.Thrombocytopenia or any other coagulation disorder
9.History of fever (oral temperature =100? or =37.8?) within 24 hours prior to the vaccination
10.Chronic drug abuse or alcohol abuse (an alcohol intake of greater than 28 units every week)
11.Use of any investigational drug within 2 months prior to the study
12.Receipt of any ETC drug within two weeks, or receipt of any OTC drug within one week prior to the study
13.Any other finding which in the opinion of the investigator would significantly increase the risk of having an adverse outcome from participating in this protocol

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ASSESSMENT OF SEVERITY & RELATIONSHIP TO STUDY DRUG(ELECTROCARDIOGRAPHY,VITAL SIGNS,CLINICAL LABORATORY TESTS)

Secondary Outcome Measures

Name	Time	Method
ASSESSMENT OF SEVERITY & RELATIONSHIP TO STUDY DRUG(ASSESSMENT OF SERUM ANTIBODY TITERS,ASSESSMENT OF NEUTRALIZING ANTIBODY TITERS)