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

NCT02733068 | Completed Phase 3 DMC

• 1 other identifier: 311-HPV-1003
• Study Type: interventional
• Target: 12,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Human Papilloma Virus Infection Type 16; Human Papilloma Virus Infection Type 18; Cervical Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

• Cervical intraepithelial neoplasia grade 2 or more (CIN 2+) caused by HPV type 16 and/or 18.

  Among the 14 follow-up visits which will be conducted during the study, 9 visits are gynecological follow-up visits. In these gynecological visits, cervical samples will be collected to conduct HPV DNA detection and cytological detection to evaluate whether occurred cervical intraepithelial neoplasia (CIN) and what grade of neoplasia occurred.

  five years

Secondary Outcomes (1)

• Persistent infection of HPV type 16 and/or 18.

  one year

Study Arms (2)

HPV-16/18 vaccine

EXPERIMENTAL

Including 6000 participants who received the HPV-16/18 vaccine 0.5ml.

Biological: HPV-16/18 vaccine

HPV-16/18 placebo

PLACEBO COMPARATOR

Including 6000 participants who received the HPV-16/18 placebo 0.5ml.

Biological: HPV-16/18 placebo

Interventions

HPV-16/18 vaccine BIOLOGICAL

0.5ml of recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast) on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).

HPV-16/18 vaccine

HPV-16/18 placebo BIOLOGICAL

0.5ml of placebo on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).

HPV-16/18 placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zerun Biotechnology Co.,Ltd: lead
• Guangxi Center for Disease Control and Prevention: collaborator

Related Publications (1)

• Shi L, Gao X, Huang L, Gao Z, Li J, Yu B, Fan H, Li G, Wang Y, Li Q, Yuan L, Li C, Mo Z; HPV1003 Study group. Efficacy, safety and immunogenicity of a recombinant human papillomavirus bivalent (types 16, 18) vaccine in healthy 18-30-year-old Chinese women: a phase III, double-blind, randomized, controlled trial. BMC Infect Dis. 2025 Dec 18. doi: 10.1186/s12879-025-12064-1. Online ahead of print.

  PMID: 41413453 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Zhaojun Mo

  Guangxi Center for Disease Prevention and Control(GXCDC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: April 11, 2016
• Study Start: November 2, 2014
• Primary Completion: July 30, 2019
• Study Completion: January 16, 2020
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share