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

Assessment of the safety, tolerance, and immunogenicity of EG-HPV (human papillomavirus vaccine) in healthy male adult volunteers: A double-blinded, randomized, adjuvant vehicle-controlled trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000604

Enrollment

Registered

2012-12-12

Start date

2012-12-14

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : Study Drug 1: EG-HPV-10 inj. [HPV16/18 L1 VLP 20? each plus alum 500? and CIA05 10?] per 0.5 ml Study Drug 2: EG-HPV-50 inj. (high adjuvant dose) [HPV16/18 L1 VLP

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
ASSESSMENT OF SEVERITY & RELATIONSHIP TO STUDY DRUG(ELECTROCARDIOGRAPHY,VITAL SIGNS,CLINICAL LABORATORY TESTS)	—

Secondary

Measure	Time frame
ASSESSMENT OF SEVERITY & RELATIONSHIP TO STUDY DRUG(ASSESSMENT OF SERUM ANTIBODY TITERS,ASSESSMENT OF NEUTRALIZING ANTIBODY TITERS)	—

Countries

Korea, Republic of

Contacts

Public ContactShin Dong-Seong

Seoul National University Hospital

Outcome results