HPV InfectionsPhase 3NCT04895020

Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years

A Phase 3 study testing 9-valent HPV vaccine in people with HPV Infections and Cervical Cancer, run by Shanghai Bovax Biotechnology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This phase 3 study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese females aged 9 to 45 years Read more about this study

Who is it for?: Ages 9 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: HPV Infections, Cervical Cancer, Vulvar Cancer
What is being tested?: 9-valent HPV vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,200 participants
Where: 1 siteChina
Study dates: 28 May 2021to May 2026
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 45 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

Healthy Chinese females aged 9 to 45 years; Provide legal identification;
The subject voluntarily agrees to enroll in this study. If the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form;
Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements;
Had a negative urine pregnancy test on the day of enrollment, among the subjects of childbearing age; Not in the duration of breast-feeding and no birth plan within 7 months; According to the investigator's judgment that there is no possibility of pregnancy at that time: subjects have taken effective contraception, or asexual life after the last menstrual period, or use IUD, or had undergone ligation; subjects agree to continue take effective contraception such as taking OCS and condom use;
No fever symptoms on the day of enrollment (aged> 14 years old, axillary temperature<37.3°C; aged ≤ 14 years old, axillary temperature<37.5°C );
Received all 3 doses of trial vaccination;
Subjects aged 9 to 19 years at the first stage.

Who cannot join

Received marketed HPV vaccine or plan to receive marketed HPV vaccine during this study period or have enrolled in HPV vaccine clinical trials;
History of positive test to HPV, history of cervical cancer (e.g. abnormal screening test results, abnormal cervical biopsy results, including CIN, AIS, and cervical cancer) or history of hysterectomy (vaginal or abdominal radical hysterectomy), or history of pelvic radiotherapy; History of genital diseases related to HPV infection (e.g. uterine peristalsis, VIN, VAIN, AIN, and related cancers); History of STDs, including syphilis, gonorrhea, genital herpes, Mycoplasma genitalium, Lymphgranuloma Venereum, granuloma inguinale, etc.;
Known allergy to any vaccine components or history of severe allergic diseases requiring treatment, including shock, laryngeal edema, urticarial, Henoch-Schonlein purpura, Arthus reaction, etc.;
Had primary or acquired immunodeficiency such as HIV, SLE, JRA, etc. or received immunosuppressive treatment within one month before study such as long-term glucocorticoid use(≥2mg per kg per day, lasted more than two wks), or plan to receive such treatment from day 0 to month 7 after the last dose;
Had chronic diseases or congenital malformations, which might interfere with the process and completion of this study, such as Down Syndrome, heart diseases, liver diseases, chronic diabetes complications, and malignant tumor;
Enrolling or plan to enroll in other clinical trials (drug or vaccine);

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Had infectious diseases such as TB, viral hepatitis, and/or HIV infection;
Had convulsions, epilepsy, encephalopathy, and mental illness or family history;
With prohibitive contraindications such as Thrombocytopenia or coagulopathy;
Asplenic, functionally asplenic, or splenectomy caused by any condition;
Within 3 days prior to vaccination, have an acute disease or are in the acute attack of a chronic disease or have used antipyretic, analgesic and anti-allergic drugs (such as: acetaminophen, ibuprofen, aspirin, loratadine, ceti Rizine, etc.);
Receipt of inactivated or recombinant vaccines within 14 days, live vaccines within 28 days;
Receipt of immune globulin or blood-related products within 3 months; or plan to receive such products during this study period;
Had fever symptoms within 24 hours on the first day (aged> 14 years old, axillary temperature ≥ 37.3°C; aged ≤ 14 years old, axillary temperature ≥37.5°C );
Untreated/uncontrolled hypertension before vaccination (aged 9 to 17 years: systolic BP>120mmHg and/or diastolic BP>80mmHg; aged more than 18 years: Systolic BP≥140mmHg and/or diastolic BP ≥90mmHg);
Plan to permanently relocate from the area before the end of the study or leave the local area for a long time during the study visit (affecting the scheduled visit time);
According to the investigator's judgment, the subject has any condition may interfere with process of evaluation or participating in this study cannot guarantee the object's maximum benefit.

Trial locations and contacts

1 site in 1 country.

Huakun Lv contact

13588458021

hklv@cdc.zj.cn

China1 site, 1 recruiting

Huakun Lv
Hangzhou
Huakun Lv, 13588458021, hklv@cdc.zj.cn
Recruiting

Other trials in China

About this study

Official title: Evaluating the Immunogenicity and Safety of 9-valent Human Papillomavirus(Type6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine in Chinese Females Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomised Clinical Trial

This phase 3 study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese females aged 9 to 45 years

Read the detailed description

This study (protocol 9-HPV-3003) is an immunogenicity and safety study in the subjects (9-19 years of age) who received the 9-valent HPV recombinant vaccine compared with the subjects (20-45 years of age). In this study, we will assess whether the immunogenicity of the 9-valent HPV vaccine given 3-dose schedule in the subjects (9-19 years of age) in noninferior to that in the subjects (20-45 years of age) receiving 3 doses, while assessing the safety of this vaccine.

Conditions: HPV Infections, Cervical Cancer, Vulvar Cancer, Vaginal Cancer, CIN1, CIN2
Being tested: 9-valent HPV vaccine
Medical subject headings: Papillomavirus Infections, Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Condylomata Acuminata

What participants receive

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

9-valent HPV vaccineBiological
9-valent HPV recombinant vaccine (Hansenula Polymorpha) All subjects aged 9 to 45 years received 3 doses of 9v HPV vaccine at 0,2,6 month scehdule

Study groups in NCT04895020
Study group	Role	What they receive
9-valent HPV vaccine	Experimental	9-valent HPV recombinant vaccine (Hansenula Polymorpha) All subjects aged 9 to 45 years received 3 doses of 9v HPV vaccine at 0,2,6 month scehdule Receives: Biological: 9-valent HPV vaccine

What is being measured

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

The primary immunogenicity objective
The primary outcome measure for assessing vaccine immunogenicity, among subjects aged between 9 and 45, is the results of seroconversion rate of neutralizing antibodies after immunization in pre-immune negative subjects from 30 days after the last dose (3 doses schedule, Month 7) to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58.
Measured: 30 days after the last dose(3 doses schedule)

Secondary outcomes (3)

Number of patients with postive antibodies after the whole schedule vaccination from the former negative subjects
The secondary outcome measure for assessing vaccine immunogenicity, among subjects aged between 9 and 45, is the geometric mean titer (GMT) from 30 days after the last dose (3 doses schedule, Month 7) to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58.
Measured: 30 days after the last dose(3 doses schedule)
Rate of seroconversion among the patient aged 9-26 after the whole schedule vaccination
To assess vaccine immunogenicity among the subjects aged between 9 and 26, is the seroconversion rate of neutralizing antibodies and the GMT from 30 days after the last dose (3 doses schedule, Month 7) to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58.
Measured: 30 days after the last dose(3 doses schedule)
GMT and seropositive rate of HPV in the 9-19 age group after 60-month follow-up
After receiving all 3 doses vaccinations, the subjects aged 9 to 19 years will be followed for 60 month (Month 12/24/36/48/60) after first vaccination to assess the GMT and seropositive rate (4-fold-increase) to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Measured: Day 1 to 60 months post vaccination 3

Timeline

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

28 May 2021May 2026

First posted20 May 2021
Study start28 May 2021
Primary completion13 Jan 2023
Study completionMay 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HPV InfectionsStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04895020
Sponsor's protocol ID: 9-HPV-3003
Status last verified: Apr 2024
First submitted: 17 May 2021
Last updated: 17 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Huakun Lv

13588458021

hklv@cdc.zj.cn

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 HPV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Immunogenicity and Safety of 9-valent Human Papillomavirus(Type6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine in Chinese Females Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomised Clinical Trial
ClinicalTrials.gov ID: NCT04895020
Acronym / sponsor ID: 9-HPV-3003
Conditions: HPV Infections, Cervical Cancer, Vulvar Cancer, Vaginal Cancer, CIN1, CIN2
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 1,200 participants (estimated)
Lead sponsor: Shanghai Bovax Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Chongqing Bovax Biopharmaceutical Co., Ltd.
Study start: 28 May 2021 (actual)
Primary completion: 13 Jan 2023 (actual)
Study completion: May 2026 (estimated)
First posted: 20 May 2021 (actual)
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.

This phase 3 study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese females aged 9 to 45 years

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
9-valent HPV vaccine	Experimental	Biological: 9-valent HPV vaccine9-valent HPV recombinant vaccine (Hansenula Polymorpha) All subjects aged 9 to 45 years received 3 doses of 9v HPV vaccine at 0,2,6 month scehdule

Who may qualify

Ages: 9 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

Healthy Chinese females aged 9 to 45 years; Provide legal identification;
The subject voluntarily agrees to enroll in this study. If the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form;
Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements;
Had a negative urine pregnancy test on the day of enrollment, among the subjects of childbearing age; Not in the duration of breast-feeding and no birth plan within 7 months; According to the investigator's judgment that there is no possibility of pregnancy at that time: subjects have taken effective contraception, or asexual life after the last menstrual period, or use IUD, or had undergone ligation; subjects agree to continue take effective contraception such as taking OCS and condom use;
No fever symptoms on the day of enrollment (aged> 14 years old, axillary temperature<37.3°C; aged ≤ 14 years old, axillary temperature<37.5°C );

Key exclusion criteria (17 listed)

Received marketed HPV vaccine or plan to receive marketed HPV vaccine during this study period or have enrolled in HPV vaccine clinical trials;
History of positive test to HPV, history of cervical cancer (e.g. abnormal screening test results, abnormal cervical biopsy results, including CIN, AIS, and cervical cancer) or history of hysterectomy (vaginal or abdominal radical hysterectomy), or history of pelvic radiotherapy; History of genital diseases related to HPV infection (e.g. uterine peristalsis, VIN, VAIN, AIN, and related cancers); History of STDs, including syphilis, gonorrhea, genital herpes, Mycoplasma genitalium, Lymphgranuloma Venereum, granuloma inguinale, etc.;
Known allergy to any vaccine components or history of severe allergic diseases requiring treatment, including shock, laryngeal edema, urticarial, Henoch-Schonlein purpura, Arthus reaction, etc.;
Had primary or acquired immunodeficiency such as HIV, SLE, JRA, etc. or received immunosuppressive treatment within one month before study such as long-term glucocorticoid use(≥2mg per kg per day, lasted more than two wks), or plan to receive such treatment from day 0 to month 7 after the last dose;
Had chronic diseases or congenital malformations, which might interfere with the process and completion of this study, such as Down Syndrome, heart diseases, liver diseases, chronic diabetes complications, and malignant tumor;

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
9-valent HPV vaccine9-valent HPV recombinant vaccine (Hansenula Polymorpha) All subjects aged 9 to 45 years received 3 doses of 9v HPV vaccine at 0,2,6 month scehdule	Biological	9-valent HPV vaccine

Primary outcome

The primary immunogenicity objective
Time frame: 30 days after the last dose(3 doses schedule)
The primary outcome measure for assessing vaccine immunogenicity, among subjects aged between 9 and 45, is the results of seroconversion rate of neutralizing antibodies after immunization in pre-immune negative subjects from 30 days after the last dose (3 doses schedule, Month 7) to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58.

3 secondary outcomes

Number of patients with postive antibodies after the whole schedule vaccination from the former negative subjects
Time frame: 30 days after the last dose(3 doses schedule)
Rate of seroconversion among the patient aged 9-26 after the whole schedule vaccination
Time frame: 30 days after the last dose(3 doses schedule)
GMT and seropositive rate of HPV in the 9-19 age group after 60-month follow-up
Time frame: Day 1 to 60 months post vaccination 3

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.

Related trials for HPV Infections

Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer

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.

Huakun Lv contact

13588458021

hklv@cdc.zj.cn

Person(s) responsible for the overall scientific leadership of Lv study director

Zhejiang Provincial Center 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?

A Phase 3 study testing 9-valent HPV vaccine in people with HPV Infections and Cervical Cancer, run by Shanghai Bovax Biotechnology Co., Ltd. at 1 site 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 7 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. 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?

Results are not available in the source record.

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

Contact Huakun Lv (13588458021, hklv@cdc.zj.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary immunogenicity objective (time frame: 30 days after the last dose(3 doses schedule)). 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 NCT04895020.

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 17 Apr 2024.