A Phase III Study of Human Papillomavirus (HPV)-16/18 Vaccine.

Shanghai Zerun Biotechnology

Status and phase

Completed

Phase 3

Conditions

Human Papilloma Virus Infection Type 18

Human Papilloma Virus Infection Type 16

Cervical Intraepithelial Neoplasia

Treatments

Biological: HPV-16/18 vaccine

Biological: HPV-16/18 placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02733068

311-HPV-1003

Details and patient eligibility

About

A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of Recombinant Human Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Healthy Females Aged 18-30 Years.

Full description

This is a multi-centre, randomized, double blinded, placebo controlled study. The study vaccine is recombinant human papillomavirus bivalent (types 16 and 18) vaccine (Yeast), the placebo is aluminium phosphate diluent.

This study planned to enrol 12000 healthy female aged 18-30 in 10 study sites. Each participants will received a three-dose schedule of vaccine or placebo randomly but with the proportion controlled as 1:1 for vaccine group and placebo group. After each inoculation, the immediate reaction will be observed for 30 minutes, and the local and systemic reaction will be systematically observed for 7 days. After the first inoculation, adverse event will be collected until one month after the final inoculation, while serious adverse event will be collected until 6 months after the final inoculation. Blood samples will be collected before the first inoculation, and one month after the final injection, blood samples will also be collected in a group of participants containing 800 people to detect antibody titer.

Follow-up visit will be conducted 14 times: month 0, month 0 + 8 days, month 2, month 2 + 8 days, month 6, month 6 + 8 days, month 7, month 12, month 18, month 24, month 30, month 36, month 48, month 60. When cervical intraepithelial neoplasia grade 2+ (CIN2+) is indicated, the participant will receive standard treatment and drop out from the study.

Enrollment

12,000 patients

Sex

Female

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

18-30 healthy female
enable to provide an legal identification
have the ability to understand and sign the Informed Consent Form
confirmed by the investigator that the participant has the ability to comply with the protocol requirements
agreed to use effective contraceptive method in 7 months or has no plan of pregnancy
can avoid vaginal sex within two days (48 hours) before every interview; don't employ a vaginal douche or any other intervention which can influence the gynecological examination and sample collection

Exclusion criteria

has received HPV vaccine previously; have received other research or unregistered product (drug or vaccine) within 30 days before the first injection
within three months before the first injection, has had received a whole-blood, plasma or immunoglobulin treatment, or planed to receive such treatments during the research period; within 28 days before the research, has had received attenuated live vaccine; or within 14 days has had received inactivated vaccine
has a history of allergic reaction which requires medical intervention; has allergic reaction for vaccine or vaccine-containing elements; has serious adverse effect history for vaccine
has a history of epilepsy, convulsion or has a family history of mental diseases
has immunodeficiency diseases including: AIDS, HIV infection, lymphoma, leukemia, Systemic Lupus Erythematosus, rheumatoid arthritis, Juvenile Rheumatoid Arthritis, inflammatory bowel disease
used immunosuppressor for treatment or corticosteroid drugs for systemic medication in 6 months
asplenia, functional asplenia, or splenectomize
liver and kidney diseases, serious cardiovascular diseases, diabetes, history of malignant tumor
coagulation disorders
in menstrual period or acute diseases
pregnant, or less than 8 weeks after delivery
has a history of sexual transmitted disease
had total hysterectomy or pelvic radiotherapy
has cervical abnormalities
abnormal screening results for cervical cancer or had CIN in two years
according to the judgement of investigator, participant has conditions that were not suitable for this trial
planning to move out of the clinical trial site during the research period
never has vaginal sexual activity