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

A Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 25 Years

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01356823

Enrollment

1600

Registered

2011-05-20

Start date

2011-03-31

Completion date

2013-10-31

Last updated

2016-01-05

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

Conditions

Cervical Cancer, Cervical Intraepithelial Neoplasia

Keywords

Human Papilloma Virus 16, Human Papilloma Virus 18, vaccine, Cervical Intraepithelial Neoplasia, cervical Cancer

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICAL30μg HPV

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

BIOLOGICAL60μg HPV

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

BIOLOGICAL90μg HPV

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

BIOLOGICALHepatitis B vaccine

Participants would intramuscularly receive 10μg of hepatitis B vaccine at 0, 1, 6 month for 3 doses.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 25 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

Measure	Time frame	Description
Seroconversion of anti-HPV 16 and anti-HPV 18 neutralizing antibody	7 months	To detect the anti-HPV 16 and anti-HPV 18 neutralizing antibody level on day 1 and one month after dose 3.

Secondary

Measure	Time frame	Description
Number of Participants with Adverse Events	7 months	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026