An Randomized, Double-Blinded, Placebo Controlled Phase II Clinical Trial to Estimate Immunogenicity of the Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type) (E.Coli) in Healthy Adults Aged 18 to 45 Years

Xiamen University1 site in 1 country627 target enrollmentMay 13, 2019

ConditionsCondylomata Acuminata Cervical Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Condylomata Acuminata
Sponsor: Xiamen University
Enrollment: 627
Locations: 1
Primary Endpoint: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This phase II clinical study was designed to evaluate the immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter called HPV vaccine), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults aged 18-45 years old.

Registry

clinicaltrials.gov

Start Date

May 13, 2019

End Date

April 1, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Xiamen University

Responsible Party

Principal Investigator

Jun Zhang

professor

Xiamen University

Eligibility Criteria

Inclusion Criteria

•Health women aged between 18 and 45 years.
•Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
•Able to comply with the requests of the study.
•Written informed consent obtained from the participants.
•Axillary temperature not higher than 37.0°C
•Non-pregnant women 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 or plan to use within 7 months.
•Administration of any attenuated live vaccines within 21 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 , 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.

Outcomes

Primary Outcomes

Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody)

Time Frame: month 7

To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level on day 0 (before the 1st dose) and one month after dose 3

Secondary Outcomes

Unsolicited adverse events(Within 30 days (Day 0-29) after any vaccination)
Solicited local adverse reactions(During the 7-day (Day 0-6) period following each vaccination)
Serious adverse events(throughout the study period, an average of 7 months)
Solicited systematic adverse reactions(During the 7-day (Day 0-6) period following each vaccination)