Clinical trial NCT01356823: Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Intraepithelial Neoplasia
Cervical Cancer
Keywords: Human Papilloma Virus 16
Human Papilloma Virus 18
vaccine
Cervical Intraepithelial Neoplasia
cervical Cancer
Lead sponsor: Xiamen University
Sponsor class: OTHER
Collaborators: name: Xiamen Innovax Biotech Co., Ltd
name: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
First posted: 2011-05-20
Enrollment: 1600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Seroconversion of anti-HPV 16 and anti-HPV 18 neutralizing antibody
timeFrame: 7 months
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 7 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial Centre for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Xiamen University
name: Jun Zhang, Master
role: STUDY_CHAIR
affiliation: Jiangsu Provincial Centre for Disease Control and Prevention
name: Yuemei Hu, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiamen University
name: Ting Wu, Ph. D
role: STUDY_DIRECTOR
References:
citation: Wu T, Hu YM, Li J, Chu K, Huang SJ, Zhao H, Wang ZZ, Yang CL, Jiang HM, Wang YJ, Lin ZJ, Pan HR, Sheng W, Wei FX, Li SW, Wang Y, Zhu FC, Li CG, Zhang J, Xia NS. Immunogenicity and safety of an E. coli-produced bivalent human papillomavirus (type 16 and 18) vaccine: A randomized controlled phase 2 clinical trial. Vaccine. 2015 Jul 31;33(32):3940-6. doi: 10.1016/j.vaccine.2015.06.052. Epub 2015 Jun 19.