Cervical Intraepithelial NeoplasiaPhase 3NCT02562508

A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls

A Phase 3 study testing 3 doses of HPV 16/18 bivalent vaccine and 2 doses of HPV 16/18 bivalent vaccine in people with Cervical Intraepithelial Neoplasia and Cervical Cancer, run by Jun Zhang at 1 site in China.

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

Who is it for?: Ages 9 to 26 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cervical Intraepithelial Neoplasia, Cervical Cancer, Vaginal Intraepithelial Neoplasia
What is being tested?: 3 doses of HPV 16/18 bivalent vaccine and 2 doses of HPV 16/18 bivalent vaccine
Type of treatment: Vaccines, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 979 participants
Where: 1 siteChina
Study dates: 5 Dec 2015to 12 Aug 2016
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 9 to 26 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

Females aged between 9 and 26 years when they receive the first vaccination (9≤age<27);
Participants aged 9-17 years whose legal guardian can provide identity certificate, or representative can provide authorization;
Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations;
Participants aged 9-17 years, able to sign or whose legal guardian agree to sign the written informed consent; or participants aged 18-26 years and agree to sign the written informed consent;
Able to comply with the requests of the study;
Axillary temperature not higher than 37.0°C;
Nonpregnancy verified by a urine pregnancy test;

Who cannot join

Pregnant or lactating woman and any woman who are willing or intend to become pregnant in next 7 months;
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first vaccination, or plan to use during the study period;
Participants who received an immunosuppressive agent or other immunomodulator agent for a long term (for 14 days or more) within 6 months of the first vaccination, or systematic corticosteroid (however, a topical corticosteroid is allowed, such as ointment, eye drops, inhalant, or nasal spray);
Participants who received immunoglobulin and/or blood product 3 months prior to the first vaccination, or planned to receive during the study period;
Use of any inactivated vaccine 14 days preceding dosing of study vaccine or attenuated vaccine 21 days before the enrollment;
Participants had fever (auxiliary temperature ≥38.0 °C) within 3 days prior to vaccination, or any acute disease requiring systematic antibiotics or antiviral therapy within the past 5 days;

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Concurrently participating another clinical trial;
Participants who have received HPV vaccines;
Participants with immunodeficiency disease (such as HIV positive), primary disease in vital organs, cancer (or precancerous lesion), or chronic history of immunological disease requiring treatment (including systemic lupus erythematosus), rheumatoid arthritis, asplenia or splenectomy due to any conditions, and other immunological diseases that may impact immune response as considered by investigator), etc.;
Participants with a history of allergy, including severe adverse reactions due to the past vaccination, such as hypersensitivity, urticaria, dyspnea, angioneurotic edema, or abdominal pain;
Participants with asthma, which is unstable in the past 2 years, requiring emergency treatment, hospitalization, or oral or intravenous corticosteroid;
Participants with concurrent severe medical disorders, such as hypertension, heart disease, diabetes mellitus, or hyperthyroidism, etc.;
Participants with coagulation dysfunction (such as coagulation factor deficiency, blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed by a physician;
Participants with epilepsy, excluding febrile epilepsy in patients under 2 years old, alcoholic epilepsy 3 years prior to alcohol abstinence, or pure epilepsy requiring no treatment within the past 3 years;
Participants who are not compliant to the study's requirements due to psychological conditions, or those with prior or existing mental disease or bipolar psychosis which are not well controlled within the past 2 years and require taking drugs, or those with suicidal tendency within the past 5 years;
According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;

Trial locations and contacts

1 site in 1 country.

China1 site

Jiangsu Provincial Centre for Disease Control and Prevention
Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: Immunogenicity and Safety Study of a Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Female Subjects Aged 9 to 17 Years

This is a bridging trial of the recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD.The primary objective of this study is to evaluate the immunogenicity (type specific IgG antibody) and safety of the tested vaccine administered in girls aged 9-17 years is non-inferior to young healthy adults of 18-26 years according to the standard 3-dose schedule (0,1,6 months). Meanwhile, this study tries to compare the difference of safety and immunogenicity among different schedules (0-6m vs 0-1-6m).

Read the detailed description

Totally 750 healthy girls of 9-17 years and 225 healthy young women of 18-26 years were enrolled. The subjects of 9-14 years will be stratified into 2 subset. Subjects in each subsets will be randomly assigned into the standard 0-1-6m schedule group or an alternative 0-6m group. All subjects of 15-26 years of age will receive the standard 0-1-6m schedule. Participants 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, 6m, 7m to evaluate the immunogenicity.

Conditions: Cervical Intraepithelial Neoplasia, Cervical Cancer, Vaginal Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Persistent Infection
Being tested: 3 doses of HPV 16/18 bivalent vaccine, 2 doses of HPV 16/18 bivalent vaccine
Keywords: Human Papilloma Virus 16, Human Papilloma Virus 18, vaccine, adolescent girl, bridging trial, non-inferiority
Medical subject headings: Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Persistent Infection

What participants receive

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

3 doses of HPV 16/18 bivalent vaccineProcedure or surgery
Participants would receive 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)
2 doses of HPV 16/18 bivalent vaccineProcedure or surgery
Participants would receive 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)

Study groups in NCT02562508
Study group	Role	What they receive
9-17y (0,1,6m)	Experimental	Participants in this arm would receive 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine Receives: Procedure: 3 doses of HPV 16/18 bivalent vaccine
9-14y (0,6m)	Experimental	Participants in this arm would receive 60μg of HPV 16/18 bivalent vaccine according to 2 doses of HPV 16/18 bivalent vaccine Receives: Procedure: 2 doses of HPV 16/18 bivalent vaccine
18-26y (0,1,6m)	Experimental	Participants in this arm would receive 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine Receives: Procedure: 3 doses of HPV 16/18 bivalent vaccine

What is being measured

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

Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 (type specific IgG antibody)
To detect the anti-HPV 16 and anti-HPV 18 type specific IgG antibody level on day 0 (before the 1st dose) ,six month after the dose 1 (before the 3rd dose) and one month after dose 3
Measured: Month 7

Secondary outcomes (1)

Number of Participants with Adverse Events
All the adverse events in one month after each dose would be recorded in the diary card. All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded.
Measured: Month 7

Timeline

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

5 Dec 201512 Aug 2016

First posted29 Sep 2015 (estimated)
Study start5 Dec 2015
Primary completion12 Aug 2016
Study completion12 Aug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Single blind
Who is masked: Outcomes assessor
Enrolment: 979 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02562508
Sponsor's protocol ID: HPV-PRO-006
Status last verified: Aug 2018
First submitted: 14 Sep 2015
Last updated: 16 Aug 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cervical Intraepithelial Neoplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Study of a Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Female Subjects Aged 9 to 17 Years
ClinicalTrials.gov ID: NCT02562508
Acronym / sponsor ID: HPV-PRO-006
Conditions: Cervical Intraepithelial Neoplasia, Cervical Cancer, Vaginal Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Persistent Infection
Keywords: Human Papilloma Virus 16, Human Papilloma Virus 18, vaccine, adolescent girl, bridging trial, non-inferiority
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 979 participants (actual)
Lead sponsor: Jun ZhangUniversity, hospital or other
Collaborators: Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Study start: 5 Dec 2015 (actual)
Primary completion: 12 Aug 2016 (actual)
Study completion: 12 Aug 2016 (actual)
First posted: 29 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
9-17y (0,1,6m)	Experimental	Procedure: 3 doses of HPV 16/18 bivalent vaccineParticipants in this arm would receive 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine
9-14y (0,6m)	Experimental	Procedure: 2 doses of HPV 16/18 bivalent vaccineParticipants in this arm would receive 60μg of HPV 16/18 bivalent vaccine according to 2 doses of HPV 16/18 bivalent vaccine
18-26y (0,1,6m)	Experimental	Procedure: 3 doses of HPV 16/18 bivalent vaccineParticipants in this arm would receive 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine

Who may qualify

Ages: 9 to 26 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

Females aged between 9 and 26 years when they receive the first vaccination (9≤age<27);
Participants aged 9-17 years whose legal guardian can provide identity certificate, or representative can provide authorization;
Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations;
Participants aged 9-17 years, able to sign or whose legal guardian agree to sign the written informed consent; or participants aged 18-26 years and agree to sign the written informed consent;
Able to comply with the requests of the study;

Key exclusion criteria (16 listed)

Pregnant or lactating woman and any woman who are willing or intend to become pregnant in next 7 months;
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first vaccination, or plan to use during the study period;
Participants who received an immunosuppressive agent or other immunomodulator agent for a long term (for 14 days or more) within 6 months of the first vaccination, or systematic corticosteroid (however, a topical corticosteroid is allowed, such as ointment, eye drops, inhalant, or nasal spray);
Participants who received immunoglobulin and/or blood product 3 months prior to the first vaccination, or planned to receive during the study period;
Use of any inactivated vaccine 14 days preceding dosing of study vaccine or attenuated vaccine 21 days before the enrollment;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
3 doses of HPV 16/18 bivalent vaccineParticipants would receive 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)	Procedure or surgery	18-26y (0,1,6m), 9-17y (0,1,6m)
2 doses of HPV 16/18 bivalent vaccineParticipants would receive 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)	Procedure or surgery	9-14y (0,6m)

Primary outcome

Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 (type specific IgG antibody)
Time frame: Month 7
To detect the anti-HPV 16 and anti-HPV 18 type specific IgG antibody level on day 0 (before the 1st dose) ,six month after the dose 1 (before the 3rd dose) and one month after dose 3

1 secondary outcome

Number of Participants with Adverse Events
Time frame: Month 7

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ting Wu, Ph. D. study chair

Xiamen University

Yuemei Hu, Bachelor principal investigator

Jiangsu Provincial Centre for Disease Control and Prevention

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 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 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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?

Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 (type specific IgG antibody) (time frame: Month 7). 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 NCT02562508.

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 16 Aug 2018.