HPV InfectionsPhase 3NCT05372016
Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
A Phase 3 study testing Experimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) and Active Comparator: GARDASIL ®9 in people with HPV Infections and Cervical Cancer, run by Shanghai Bovax Biotechnology Co., Ltd. at 1 site in China.
Trial summary
The study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese healthy females16 to 26 years of age. Read more about this study
- Who is it for?
- Ages 16 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infections, Cervical Cancer, Vulvar Cancer
- What is being tested?
- Experimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) and Active Comparator: GARDASIL ®9
- 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
- 19 Sep 2020to 17 Jun 2022
- 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 16 to 26 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- (If the "" option is not met during screening, the visit can be rescheduled)
- Chinese women aged 16-26 who can provide legal identification(If the subject is under 18 years old, proof of legal guardian's identity is also required);
- The subject agreed to participate in the study, and voluntarily signs the informed consent;for subjects aged 16-18 years, they and their legal guardian(s) are supposed to understand and sign informed consent form together； supposed to understand and sign informed consent form together
- 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 ); 5.4. 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.);
- *body temperature <37.3# (underarm body temperature)
Who cannot join
- First dose exclusion criteria(If the "" option is met during screening, the visit can be rescheduled)
- 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;
- 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);
- 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;
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- 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;
- *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;
- Subject receives any immunoglobulin or blood product within 3 months prior to the first dose of vaccination;
- * after questioning, subjects had fever symptoms (subaxillary body temperature ≥37.3#) before the first day of vaccination (within 24 hours before vaccination);
- Blood pressure on physical examination before the first dose of vaccination was higher than normal or increased (for subjects aged 16-17 year，systolic blood pressure ≥120mmHgand/or diastolic blood pressure ≥80mmHg，for subjects aged 18 year and above，systolic blood pressure ≥140mmHgand/or diastolic blood pressure ≥90mmHg);
- 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
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Guangxi
About this study
Official title: A Randomized, Double-Blind and Positive-Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged16-26 Years
The study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese healthy females16 to 26 years of age.
- Conditions
- HPV Infections, Cervical Cancer, Vulvar Cancer, Vaginal Cancer, CIN1, CIN2
- Being tested
- Experimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58), Active Comparator: GARDASIL ®9
- 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.
Experimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58)Biological
9vHPV vaccine ,0.5mL, three doses, 0,2,6 months
Active Comparator: GARDASIL ®9Biological
GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) | Experimental | 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha),0.5mL, three doses, 0,2,6 months Receives: Biological: Experimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) |
| GARDASIL ®9 | Active comparator | GARDASIL®9 (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) ,0.5mL, three doses, 0,2,6 months Receives: Biological: Active Comparator: GARDASIL ®9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The seroconversion rate of neutralizing antibodies
The seroconversion rate of neutralizing antibodies dected after immunization in pre-immune negative subjects from 30 days after the last dose HPV vaccine to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58.
Measured: 30 days after the last dose
Secondary outcomes (8)
Number of subjects with postive antibodies after the whole schedule vaccination from the former negative subjects
To evaluate the vaccine immunogenicity is the geometric mean titer from 30 days after the last dose to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58.
Measured: 30 days after the last dose
The level of neutralizing antibody elicited by the vaccine among the subjects with pre-immune positive after the whole schedule vaccination
The growth rate of GMTs of anti-HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58 neutralizing antibodies in pre-immune positive subjects from 30 days after immunization
Measured: 30 days after the last dose
Number of subjects with seroconversion rate (4-fold increase) after the whole schedule vaccination
The seroconversion rate (4-fold increase) of anti-HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58 neutralizing antibodies in subjects aged 16-26-year-old from 30 days after immunization
Measured: 30 days after the last dose
Number of AE within 30 minutes after each dose
Adverse events reported within 30 minutes after each dose
Measured: 30 mins after each dose
Number of SAE within 7days after each dose
Solicited adverse events reported between day 0 to day 7 after each dose
Measured: day 0 to day 7 after each dose
Number of unsolicited adverse events within 30days after each dose
Unsolicited adverse events reported between day 0 to day 30 after each dose
Measured: day 0 to day 30 after each dose
Number of all SAE during the study period
Serious adverse events reported during the study periodfrom 1st vaccination to the completion of study
Measured: Day 0 to 6 months post vaccination 3
Number and rate of pregnancy events
Pregnant event and pregnant outcome reported during the study period
Measured: Day 0 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.
- First posted12 May 2022
- Study start19 Sep 2020
- Primary completion17 Jun 2022
- Study completion17 Jun 2022
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Bovax Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chongqing Bovax Biopharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372016
- Sponsor's protocol ID
- 9-HPV-3002
- Status last verified
- Nov 2023
- First submitted
- 27 Dec 2020
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. 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 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged16-26 Years
- ClinicalTrials.gov ID
- NCT05372016
- Acronym / sponsor ID
- 9-HPV-3002
- Conditions
- HPV Infections, Cervical Cancer, Vulvar Cancer, Vaginal Cancer, CIN1, CIN2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Shanghai Bovax Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chongqing Bovax Biopharmaceutical Co., Ltd.
- Study start
- 19 Sep 2020 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 12 May 2022 (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 9-valent HPV recombinant vaccine in Chinese healthy females16 to 26 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) | Experimental | Biological: Experimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58)9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha),0.5mL, three doses, 0,2,6 months |
| GARDASIL ®9 | Active comparator | Biological: Active Comparator: GARDASIL ®9GARDASIL®9 (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) ,0.5mL, three doses, 0,2,6 months |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- (If the "" option is not met during screening, the visit can be rescheduled)
- Chinese women aged 16-26 who can provide legal identification(If the subject is under 18 years old, proof of legal guardian's identity is also required);
- The subject agreed to participate in the study, and voluntarily signs the informed consent;for subjects aged 16-18 years, they and their legal guardian(s) are supposed to understand and sign informed consent form together； supposed to understand and sign informed consent form together
- 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 ); 5.4. 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.);
Key exclusion criteria (18 listed)
- First dose exclusion criteria(If the "" option is met during screening, the visit can be rescheduled)
- 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;
- 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);
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 |
|---|---|---|
| Experimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58)9vHPV vaccine ,0.5mL, three doses, 0,2,6 months | Biological | Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) |
| Active Comparator: GARDASIL ®9GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months | Biological | GARDASIL ®9 |
Primary outcome
The seroconversion rate of neutralizing antibodies
Time frame: 30 days after the last dose
The seroconversion rate of neutralizing antibodies dected after immunization in pre-immune negative subjects from 30 days after the last dose HPV vaccine to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58.
8 secondary outcomes
Number of subjects with postive antibodies after the whole schedule vaccination from the former negative subjects
Time frame: 30 days after the last dose
The level of neutralizing antibody elicited by the vaccine among the subjects with pre-immune positive after the whole schedule vaccination
Time frame: 30 days after the last dose
Number of subjects with seroconversion rate (4-fold increase) after the whole schedule vaccination
Time frame: 30 days after the last dose
Number of AE within 30 minutes after each dose
Time frame: 30 mins after each dose
Number of SAE within 7days after each dose
Time frame: day 0 to day 7 after each dose
Number of unsolicited adverse events within 30days after each dose
Time frame: day 0 to day 30 after each dose
Number of all SAE during the study period
Time frame: Day 0 to 6 months post vaccination 3
Number and rate of pregnancy events
Time frame: Day 0 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 24 Nov 2023.
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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 Experimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) and Active Comparator: GARDASIL ®9 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 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 24 Nov 2023. 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?
The seroconversion rate of neutralizing antibodies (time frame: 30 days after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2023.