Cervical CancerPhase 3NCT04425291

Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

A Phase 3 study testing 4-valent HPV Vaccine, 9-valent HPV Vaccine and GARDASIL® in people with Cervical Cancer and Vulvar Cancer, run by Shanghai Bovax Biotechnology Co., Ltd. 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

The study will evaluate the immunogenicity and safety of 4-valent and 9-valent HPV recombinant vaccine in Chinese healthy females 20 to 45 years of age. Read more about this study

Who is it for?: Ages 20 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cervical Cancer, Vulvar Cancer, Vaginal Cancer
What is being tested?: 4-valent HPV Vaccine, 9-valent HPV Vaccine and GARDASIL®
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,680 participants
Where: 1 siteChina
Study dates: 28 May 2020to 6 Sep 2021
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 20 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Chinese women aged 20-45 who can provide legal identification;
The subject agreed to participate in the study, and voluntarily signs the informed consent;
Subjects are able to understand the study procedures and participate in follow-up according to the study requirements;
When the subjects were enrolled, the urine pregnancy test was negative, they were not in the lactation period and had no family planning within 7 months after enrollment.2 weeks before included in the study, effective contraceptive measures has been adopted and agreed to in the first seven months after the study (vaccinations after 1 months ago) continue to adopt effective contraceptive measures (effective contraceptive measures including the pill or condoms, etc );

Who cannot join

Have been vaccinated with commercially available HPV vaccine in the past or planned to be vaccinated with commercially available HPV vaccine during the study period;Or have participated in a clinical trial of the HPV vaccine;
Has a history of cervical diseases, such as cervical screening showing abnormal results including CIN or a history of hysterectomy (vaginal or total abdominal hysterectomy) or pelvic radiation therapy. Has a history of genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar cancer, vaginal cancer and anal cancer, etc.) or has a previous sexual history (including syphilis, gonorrhea, chancre, venereal lymphatic granuloma, granuloma inguinal);
A history of severe allergies requiring medical intervention, such as anaphylactic shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc;
Have an acute illness or an acute episode of a chronic illness within 3 days prior to vaccination or the use of antipyretic, analgesic and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
Subjects received inactivated or recombinant vaccines within 14 days prior to study enrollment, or attenuated live vaccines within 28 days prior to study enrollment;
Subjects present with immune impairment or have been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases. Long-term immunosuppressive therapy, e.g., long-term (more than 2 weeks) treatment with glucocorticoids (e.g., prednisone or similar drugs);

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Has been diagnosed with a severe congenital malformation or chronic disease such as Down syndrome, heart disease, liver disease, kidney disease, diabetes, etc., which may interfere with the conduct or completion of the study;
Subject receives any immunoglobulin or blood product within 3 months prior to the first dose of vaccination;
Participating in other (drug or vaccine) clinical trials prior to enrollment or planning to participate during the study;
Has been diagnosed with an infectious disease, such as tuberculosis, viral hepatitis and/or HIV infection;
A history or family history of convulsions, epilepsy, encephalopathy and mental illness;
Have contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy;
Absence of a spleen, functional absence of a spleen, and absence or removal of a spleen in any case;
Body temperature ≥37.3℃ (underarm body temperature);
Subjects may be unable to comply with the study procedure, comply with the agreement, or plan to permanently relocate from the region prior to completion of the study, or may be permanently absent from the region during the scheduled visit;
In the opinion of the investigators, the subjects had any other factors that made them unsuitable to participate in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Yangchun Center For Disease Prevention And Control
Yangchun, Guangdong

Other trials in China

About this study

Official title: A Randomized, Double-Blind and Positive-Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of the 4-valent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Hansenula Polymorpha) and 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years

The study will evaluate the immunogenicity and safety of 4-valent and 9-valent HPV recombinant vaccine in Chinese healthy females 20 to 45 years of age.

Conditions: Cervical Cancer, Vulvar Cancer, Vaginal Cancer, CIN1, CIN2, CIN3
Being tested: 4-valent HPV Vaccine, 9-valent HPV Vaccine, GARDASIL®
Medical subject headings: 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.

4-valent HPV VaccineBiological
Subjects received 3 doses of 4-valent HPV vaccine according to a 0, 2, 6-month schedule.
9-valent HPV VaccineBiological
Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
GARDASIL®Biological
Subjects received 3 doses of GARDASIL® according to a 0, 2, 6-month schedule.

Study groups in NCT04425291
Study group	Role	What they receive
4-valent HPV Vaccine	Experimental	Participants in this arm would receive 4-valent Human Papillomavirus (Types 6, 11, 16 and18) Recombinant Vaccine (Hansenula Polymorpha) Receives: Biological: 4-valent HPV Vaccine
9-valent HPV Vaccine	Experimental	Participants in this arm would receive 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) Receives: Biological: 9-valent HPV Vaccine
GARDASIL®	Active comparator	Participants in this arm would receive GARDASIL® Receives: Biological: GARDASIL®

What is being measured

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

Percentage of participants 20 to 45 Years of Age that achieve the neutralizing antibody serostatus cutoffs for seroconversion to HPV Types 6, 11, 16 and 18 at least 1 month post Dose 3.
Measured: 1 month post vaccination 3 (Month 7)

Secondary outcomes (11)

The neutralizing antibody GMTs for HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Measured: 1 month post vaccination 3 (Month 7)
Percentage of participants that achieve neutralizing antibody quadruple growth ratefor HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Measured: 1 month post vaccination 3 (Month 7)
Percentage of participants that achieve neutralizing antibody quadruple growth rate or achieve the neutralizing antibody serostatus cutoffs for HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Measured: 1 month post vaccination 3 (Month 7)
The neutralizing antibody GMTs for HPV Types 31, 33, 45 and 52 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Measured: 1 month post vaccination 3 (Month 7)
Percentage of participants that achieve neutralizing antibody quadruple growth ratefor HPV Types 31, 33, 45 and 52 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Measured: 1 month post vaccination 3 (Month 7)
Percentage of participants that achieve neutralizing antibody quadruple growth rate or achieve the neutralizing antibody serostatus cutoffs for HPV Types 31, 33, 45 and 52 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Measured: 1 month post vaccination 3 (Month 7)
Percentage of Participants Who Report at Least 1 Solicited Injection-site and Systemic Adverse Event 30 minutes post any vaccination
Measured: 30 minutes post any vaccination
Percentage of Participants Who Report at Least 1 Solicited Adverse Event 7 days post any vaccination
Measured: 7 days post any vaccination
Percentage of Participants Who Report at Least 1 Solicited and Unsolicited Adverse Event 30 days post any vaccination
Measured: 30 days post any vaccination
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) from 1st vaccination to the completion of study
Measured: Day 1 to 6 months post vaccination 3
Percentage of Participants Who Experience Pregnancy from 1st vaccination to the completion of study
Measured: Day 1 to 6 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 20206 Sep 2021

First posted11 Jun 2020
Study start28 May 2020
Primary completion6 Sep 2021
Study completion6 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cervical CancerStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,680 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04425291
Sponsor's protocol ID: 4-HPV-3001
Status last verified: Feb 2022
First submitted: 8 Jun 2020
Last updated: 25 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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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Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind and Positive-Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of the 4-valent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Hansenula Polymorpha) and 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years
ClinicalTrials.gov ID: NCT04425291
Acronym / sponsor ID: 4-HPV-3001
Conditions: Cervical Cancer, Vulvar Cancer, Vaginal Cancer, CIN1, CIN2, CIN3
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,680 participants (actual)
Lead sponsor: Shanghai Bovax Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Chongqing Bovax Biopharmaceutical Co., Ltd.
Study start: 28 May 2020 (actual)
Primary completion: 6 Sep 2021 (actual)
Study completion: 6 Sep 2021 (actual)
First posted: 11 Jun 2020 (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.

The study will evaluate the immunogenicity and safety of 4-valent and 9-valent HPV recombinant vaccine in Chinese healthy females 20 to 45 years of age.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
4-valent HPV Vaccine	Experimental	Biological: 4-valent HPV VaccineParticipants in this arm would receive 4-valent Human Papillomavirus (Types 6, 11, 16 and18) Recombinant Vaccine (Hansenula Polymorpha)
9-valent HPV Vaccine	Experimental	Biological: 9-valent HPV VaccineParticipants in this arm would receive 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)
GARDASIL®	Active comparator	Biological: GARDASIL®Participants in this arm would receive GARDASIL®

Who may qualify

Ages: 20 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Chinese women aged 20-45 who can provide legal identification;
The subject agreed to participate in the study, and voluntarily signs the informed consent;
Subjects are able to understand the study procedures and participate in follow-up according to the study requirements;
When the subjects were enrolled, the urine pregnancy test was negative, they were not in the lactation period and had no family planning within 7 months after enrollment.2 weeks before included in the study, effective contraceptive measures has been adopted and agreed to in the first seven months after the study (vaccinations after 1 months ago) continue to adopt effective contraceptive measures (effective contraceptive measures including the pill or condoms, etc );

Key exclusion criteria (16 listed)

Have been vaccinated with commercially available HPV vaccine in the past or planned to be vaccinated with commercially available HPV vaccine during the study period;Or have participated in a clinical trial of the HPV vaccine;
Has a history of cervical diseases, such as cervical screening showing abnormal results including CIN or a history of hysterectomy (vaginal or total abdominal hysterectomy) or pelvic radiation therapy. Has a history of genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar cancer, vaginal cancer and anal cancer, etc.) or has a previous sexual history (including syphilis, gonorrhea, chancre, venereal lymphatic granuloma, granuloma inguinal);
A history of severe allergies requiring medical intervention, such as anaphylactic shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc;
Have an acute illness or an acute episode of a chronic illness within 3 days prior to vaccination or the use of antipyretic, analgesic and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
Subjects received inactivated or recombinant vaccines within 14 days prior to study enrollment, or attenuated live vaccines within 28 days prior to study 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
4-valent HPV VaccineSubjects received 3 doses of 4-valent HPV vaccine according to a 0, 2, 6-month schedule.	Biological	4-valent HPV Vaccine
9-valent HPV VaccineSubjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.	Biological	9-valent HPV Vaccine
GARDASIL®Subjects received 3 doses of GARDASIL® according to a 0, 2, 6-month schedule.	Biological	GARDASIL®

Primary outcome

Percentage of participants 20 to 45 Years of Age that achieve the neutralizing antibody serostatus cutoffs for seroconversion to HPV Types 6, 11, 16 and 18 at least 1 month post Dose 3.
Time frame: 1 month post vaccination 3 (Month 7)

11 secondary outcomes

The neutralizing antibody GMTs for HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Time frame: 1 month post vaccination 3 (Month 7)
Percentage of participants that achieve neutralizing antibody quadruple growth ratefor HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Time frame: 1 month post vaccination 3 (Month 7)
Percentage of participants that achieve neutralizing antibody quadruple growth rate or achieve the neutralizing antibody serostatus cutoffs for HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Time frame: 1 month post vaccination 3 (Month 7)
The neutralizing antibody GMTs for HPV Types 31, 33, 45 and 52 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Time frame: 1 month post vaccination 3 (Month 7)
Percentage of participants that achieve neutralizing antibody quadruple growth ratefor HPV Types 31, 33, 45 and 52 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Time frame: 1 month post vaccination 3 (Month 7)
Percentage of participants that achieve neutralizing antibody quadruple growth rate or achieve the neutralizing antibody serostatus cutoffs for HPV Types 31, 33, 45 and 52 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Time frame: 1 month post vaccination 3 (Month 7)
Percentage of Participants Who Report at Least 1 Solicited Injection-site and Systemic Adverse Event 30 minutes post any vaccination
Time frame: 30 minutes post any vaccination
Percentage of Participants Who Report at Least 1 Solicited Adverse Event 7 days post any vaccination
Time frame: 7 days post any vaccination
Percentage of Participants Who Report at Least 1 Solicited and Unsolicited Adverse Event 30 days post any vaccination
Time frame: 30 days post any vaccination
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) from 1st vaccination to the completion of study
Time frame: Day 1 to 6 months post vaccination 3
Percentage of Participants Who Experience Pregnancy from 1st vaccination to the completion of study
Time frame: Day 1 to 6 months post vaccination 3

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 25 Feb 2022.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 4-valent HPV Vaccine, 9-valent HPV Vaccine and GARDASIL® in people with Cervical Cancer and Vulvar 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 4 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 25 Feb 2022. 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?

Percentage of participants 20 to 45 Years of Age that achieve the neutralizing antibody serostatus cutoffs for seroconversion to HPV Types 6, 11, 16 and 18 at least 1 month post Dose 3. (time frame: 1 month post vaccination 3 (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 NCT04425291.

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 25 Feb 2022.