Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

Xiamen University1,600 enrolled

Overview

This is a phase II clinical study of the novel recombinant HPV 16/18 bivalent vaccine expressed in E. coli. The primary purpose of this study is to evaluate which dosage of the HPV vaccine can induce higher antibody and at the same time caused less adverse events. The secondary purpose of this study is to to evaluate the safety and immunopersistence of the study vaccine.

Totally 1600 healthy women of 18-25 years of age were enrolled. The participants were randomly stratified into 4 groups and receive different dosage of human papillomavirus (HPV) vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule. The women were actively monitored for adverse events for 1 month after each injection. Severe adverse events during the trial were followed up. Serum samples from all the subjects would be collected on day 0, 7m, 24m, 48m and 72m to evaluate the immunogenicity and immuno-persistency.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

1,600

Conditions

Cervical Intraepithelial Neoplasia Cervical Cancer

Interventions

30μg HPVBIOLOGICAL

Participants would intramuscularly receive 30μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.

60μg HPVBIOLOGICAL

Participants would intramuscularly receive 60μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.

90μg HPVBIOLOGICAL

Participants would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent from the subject prior to enrolment; * Female between, and including, 18 and 25 years of age at the time of enrolment; * Subjects must be free of obvious health problems; * Not pregnant and having no plan for pregnancy; Exclusion Criteria: * Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7); * Previous vaccination against HPV; * Having severe allergic history or other immunodeficiency; * Chemotherapy and other immunosuppressive agents using;

Locations (1)

Jiangsu Provincial Centre for Disease Control and Prevention

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Seroconversion of anti-HPV 16 and anti-HPV 18 neutralizing antibody

To detect the anti-HPV 16 and anti-HPV 18 neutralizing antibody level on day 1 and one month after dose 3.

Time frame: 7 months

Secondary Outcomes

Number of Participants with Adverse Events

All the adverse events in one month after each dose would be recorded in the diary card. All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded.

Time frame: 7 months

Data from ClinicalTrials.gov

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