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Human Papilloma Virus Infection Type 16Phase 3NCT02733068

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

A Phase 3 study testing HPV-16/18 vaccine in people with Human Papilloma Virus Infection Type 16 and Human Papilloma Virus Infection Type 18, run by Shanghai Zerun Biotechnology Co.,Ltd.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 years, women onlyHealthy volunteers can take part
What is being tested?
HPV-16/18 vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12,000 participants
Where
No sites listed yet
Study dates
2 Nov 2014to 16 Jan 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

About this study

Official title: A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of HPV-16/18 Vaccine in Healthy Females Aged 18-30 Years

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.

Read the detailed 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.

Being tested
HPV-16/18 vaccine, HPV-16/18 placebo
Medical subject headings
Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HPV-16/18 vaccineBiological

    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 placeboBiological

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

Study groups in NCT02733068
Study groupRoleWhat they receive
HPV-16/18 vaccineExperimentalIncluding 6000 participants who received the HPV-16/18 vaccine 0.5ml.
Receives: Biological: HPV-16/18 vaccine
HPV-16/18 placeboPlacebo comparatorIncluding 6000 participants who received the HPV-16/18 placebo 0.5ml.
Receives: Biological: HPV-16/18 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: five years

Secondary outcomes (1)

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

    Two continuously visits with a interval of 6 months indicate the same type of HPV infection can be regard as persistent infection.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2016 (estimated)
  2. Study start2 Nov 2014
  3. Primary completion30 Jul 2019
  4. Study completion16 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
12,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02733068
Sponsor's protocol ID
311-HPV-1003
Status last verified
Dec 2022
First submitted
19 Feb 2016
Last updated
19 Dec 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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; Li Shi; Ke Li; Min Ji; Ya-Lin Hu; Ling-Yun Zhou; Xue-Mei Yan; Jing-Jing Chen; Wei Li; Zi-Long Wang; Zhen Huang; Yu-Liang Zhao; Rong-Cheng Li; Yan-Ping Li; Nian-Min Shi; Qiang Lu; Bin He; Shi-Fang Wen; Dong-Zhang Yang; Guo-Gang Liu; Yan-Xia Cai; Wei-Jiang Cui; Jiang-Bing Zheng; Zhan-Bo Geng; Yan-Hua Xie; Yong-Biao Ren; Hai-Song Zhou. 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;26(1):248. doi: 10.1186/s12879-025-12064-1.

    PubMed 41413453

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HPV-16/18 vaccine in people with Human Papilloma Virus Infection Type 16 and Human Papilloma Virus Infection Type 18, run by Shanghai Zerun Biotechnology Co.,Ltd.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cervical intraepithelial neoplasia grade 2 or more (CIN 2+) caused by HPV type 16 and/or 18. (time frame: five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02733068, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.

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