A PhaseⅡ Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Immunogenicity of the Recombinant (E.Coli) Human Papillomavirus Type 6/11 Bivalent Vaccine in Healthy Volunteers Aged 18-55 Years

Jun Zhang0 sites640 target enrollmentMarch 24, 2016

ConditionsCondylomata Acuminata

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Condylomata Acuminata
Sponsor: Jun Zhang
Enrollment: 640
Primary Endpoint: Anti-HPV 6 and anti-HPV 11 geometric mean concentrations (type specific IgG antibody)
Status: Active, Not Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This phase Ⅱ clinical study was designed to evaluate the immunogenicity and safety of the novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged 18-55 years of age at enrollment. The study volunteers would be randomized to receive the 3 different formulations of the novel HPV vaccine or placebo vaccine (recombinant hepatitis E vaccine) administered intramuscularly according to a 0-1-6 month schedule. This is a double-blind study.

Registry

clinicaltrials.gov

Start Date

March 24, 2016

End Date

December 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jun Zhang

Responsible Party

Sponsor Investigator

Principal Investigator

Jun Zhang

Professor

Xiamen University

Eligibility Criteria

Inclusion Criteria

•Participants aged between 18 and 55 years.
•Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
•Written informed consent obtained from the participants.
•Able to comply with the requests of the study.
•Axillary temperature not higher than 37.0°C
•Non-pregnancy verified by a urine pregnancy test.

Exclusion Criteria

•Pregnant or breastfeeding or plan to be pregnant within 7 months.
•Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period.
•Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.
•Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine.
•Administration of any attenuated live vaccines within 30 days preceding the first dose of the study vaccine or any subunit or inactivated vaccines within 14 days before vaccination.
•Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.
•Having the plan to participate another clinical trial during the study period.
•Received another HPV vaccine.
•Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor, .or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).
•History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy, urticaria, dyspnea, angioneurotic edema or abdominal pain.