AzTrials
AzTrials

Human PapillomavirusPhase 2NCT02740777

Evaluating the 2-dose Immunization Schedule of Human Papillomavirus (HPV)-16/18 in Adolescent Females

A Phase 2 study testing HPV-16/18 vaccine in people with Human Papillomavirus and Cervical Intraepithelial Neoplasia, run by Shanghai Zerun Biotechnology Co.,Ltd at 2 sites in China.

Completed

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

Official record
Search all trials

Trial summary

To evaluate the immune non-inferiority, as measured by antibody responses, of a 2-dose immunization schedule (0, 6 months) of recombinant human papillomavirus virus-like particle vaccine (type 16 and 18 L1 proteins, yeast) (hereinafter referred as HPV-2 vaccine) in adolescent females aged 9 to 14 years in comparison… Read more about this study

Who is it for?
Ages 9 to 24 years, women onlyHealthy volunteers can take part
What is being tested?
HPV-16/18 vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
2 sitesChina
Study dates
Feb 2016to Jul 2019
Phase
Phase 2
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 9 to 24 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Adult group:
  • 18-26 healthy female
  • enable to provide an legal identification
  • have the ability to understand and sign the Informed Consent Form
  • aren't pregnant and do not have pregnancy plan within the 7 months after the first injection
  • used effective contraceptive method from the last menstruation, and agreed to avoid sexual activity without effective contraceptive method within the 15 days after injection
Show all 10Show fewer
  • Adolescent group:
  • 9-14 healthy female
  • enable to provide an legal identification
  • guardians have the ability to understand the Informed Consent Form, and both participant and guardian agreed to sign the Form (in case of unable to sign, the participant can use fingerprint as signature)

Who cannot join

  • History of HPV infection
  • Previous administration of any HPV vaccine
  • History of severe allergic reaction requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock)
  • History of allergic to vaccine, or to any ingredient of vaccine.
  • History of epilepsy, seizures or convulsions, or family history of mental illness
  • Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose.
Show all 16Show fewer
  • History of asthma, thyroidectomy, angioneurotic edema, diabetes or malignant
  • Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy
  • Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
  • Acute disease or chronic disease acute exacerbation 7 days prior to vaccination
  • Administration of immunoglobulins and/or any blood products within 3 months, or administration of any live attenuated vaccine within 28 days, or administration of any subunit or inactivated vaccines within 14 days.
  • Fever or axillary temperature> 37.0 °C before vaccination
  • During menstrual period, breastfeeding, pregnancy(pregnancy test positive), or planned pregnant within 7 month
  • History of hypertension, physical examination systolic blood pressure> 150mmHg and/or diastolic blood pressure> 100mmHg
  • Abnormal laboratory tests parameters
  • Any clinical significant disease or findings during study screening that, in the opinion of the Investigator may interfere with the study

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Hezhou Center for Disease Prevention and Control

    Hezhou, Guangxi, 542899

  • Zhongshan Center for Disease Prevention and Control

    Zhongshan, Guangxi, 542699

Other trials in China

About this study

Official title: Immunogenicity Study of a 2-dose Immunization Schedule of Recombinant Human Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Adolescent Females Aged 9 to 14 Years

To evaluate the immune non-inferiority, as measured by antibody responses, of a 2-dose immunization schedule (0, 6 months) of recombinant human papillomavirus virus-like particle vaccine (type 16 and 18 L1 proteins, yeast) (hereinafter referred as HPV-2 vaccine) in adolescent females aged 9 to 14 years in comparison to 3-dose immunization schedule (0, 2, 6 months) in young females aged 18 to 26 years.

Read the detailed description

The study plans to enroll 600 adolescent females aged 9 to 14 years and 300 adult females aged 18 to 26 years. The adolescents will be divided into two cohorts, 300 each, receiving either a 2-dose (0, 6 months) immunization schedule or a 3-dose (0, 2, 6 months) immunization schedule. The adult female group will receive a 3-dose (0, 2, 6 months) immunization schedule.

Each subject shall be administrated with the studied vaccine according to either 2-dose or 3-dose schedule as above. Immediate reactions occurred during 30 minutes after each inoculation, all the local and systematic reactions occurred from 0 to 7 days after each inoculation will be recorded. All the adverse events (AEs) occurred from the first dose of administration to 1 month after the final dose of administration, as well as all the serious adverse events (SAEs) occurred from the first dose of administration to 6 months after the final dose of administration will be collected. Blood samples will be collected at day 0 (prior to immunization) , month 6 (prior to the last injection) , month 7, month 12, month 24, and month 36. All the blood samples will be tested HPV 16- and HPV 18-specific antibody titers.

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

What participants receive

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

  • HPV-16/18 vaccineBiological

    HPV 16 L1 virus like particles (VLP) 40μg; HPV 18 L1 VLP 20μg; Aluminium phosphate 225μg; NaCl 0.32M; Histidine buffer 10mM; Tween-80 0.01%.

Study groups in NCT02740777
Study groupRoleWhat they receive
2-dose adolescentExperimental300 adolescent girl will receive a two-dose schedule (0 day, 6 months) immunization of HPV-16/18 vaccine.
Receives: Biological: HPV-16/18 vaccine
3-dose adolescentExperimental300 adolescent girl will receive a three-dose schedule (0 day, 2 months, 6 months) immunization of HPV-16/18 vaccine.
Receives: Biological: HPV-16/18 vaccine
3-dose adultExperimental300 adult women will receive a three-dose schedule (0 day, 2 months, 6 months) immunization of HPV-16/18 vaccine.
Receives: Biological: HPV-16/18 vaccine

What is being measured

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

  1. HPV-16 and HPV-18 antibody titers (GMT)

    Compare the HPV-16 and HPV-18 specific antibody titers (GMT) between the 2-dose immunization schedule (0, 6 months) in adolescent females aged 9 to 14 years and the 3-dose immunization schedule (0, 2, 6 months) in young females aged 18 to 26 years.

    Measured: one month after the final injection

Secondary outcomes (2)

  1. HPV-16 and HPV-18 antibody titers (GMT) and the seroconversion rate

    Compare the immunogenicity between the 2-dose (0, 6 months) and the 3-dose (0, 2, 6 months) immunization schedules in adolescent females aged 9-14 years, on the basis of: 1) antibody titers (GMT) and the seroconversion rate at one month after the final injection, 2) antibody titer persistence and 3) antibody titers at a steady status.

    Measured: 30 months after the final injection

  2. Local and systemic adverse events (AEs)

    Evaluate all local and systemic adverse events (AEs) occurred within 7 days after each inoculation, at one month and 6 month after the whole immunization

    Measured: 6 months after the final injection

Timeline

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

  1. First posted15 Apr 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionNov 2016
  4. Study completionJul 2019

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02740777
Sponsor's protocol ID
311-HPV-1004
Status last verified
Apr 2023
First submitted
5 Apr 2016
Last updated
13 Apr 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HPV-16/18 vaccine in people with Human Papillomavirus and Cervical Intraepithelial Neoplasia, run by Shanghai Zerun Biotechnology Co.,Ltd at 2 sites in China.

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 10 inclusion and 16 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 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

HPV-16 and HPV-18 antibody titers (GMT) (time frame: one month after the final injection). 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 NCT02740777.

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 13 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in