Cervical CancerPhase 3NCT05580341
Phase III Study Comparing the Immunogenicity of 9-valent HPV Recombinant Vaccine and Gardasil-9
A Phase 3 study testing Zerun HPV-9 and GARDASIL ®9 in people with Cervical Cancer and Genital Wart, run by Shanghai Zerun Biotechnology Co.,Ltd at 1 site in China.
Trial summary
This study will evaluate the immunogenicity and safety of Zerun 9-valent HPV recombinant vaccine in healthy female 16-26 years of age by comparing with GARDASIL®9. 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
- Cervical Cancer, Genital Wart, CIN
- What is being tested?
- Zerun HPV-9 and 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
- 1 Sep 2022to Dec 2023
- 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
- Healthy female 16-26 years of age
- 16-17 years old subjects and their guardians able to provide legal identification; 18-26 years old subjects able to provide their legal identification;
- Able to understand (not illiterate) and sign the informed consent;
- Able to make a decision to participate in the clinical trial and the subject agrees to participate in the clinical trial;
- Women of child-bearing age (WOCBA): subjects must have a negative urine pregnancy test result, have used effective contraceptive measures within 2 weeks before enrollment, have no pregnancy plans, and agree to use adequate contraceptive precautions from enrollment to the 7th month (one month after full immunization).
Who cannot join
- Abnormal cervical cancer screen test results (ASC-US or worse), history of HPV infection, history of abnormal cervical biopsy results, or history of genital warts;
- Subjects with severe congenital malformations or that cause serious organ damage, developmental disorders, genetic defects, or severe malnutrition;
- Subjects have received a marketed HPV vaccine or participated in an HPV vaccine clinical trial, or participated in clinical trials of other vaccines within the past 6 months;
- Fever prior to vaccination (axillary body temperature ≥37.3℃);
- History of severe allergic reaction that required medical intervention (such as swelling of the mouth and throat, dyspnea, hypotension or shock, etc.);
- History of allergic to vaccine, or to any ingredient of vaccine (Aluminum phosphate adjuvant, sodium chloride, histidine, polysorbate 80),or history of severe adverse reaction
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- History of epilepsy, psychosis, major depression requiring medication, seizures, 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
- History of asthma, thyroidectomy, angioedema, severe liver, kidney, or cardiovascular disease, diabetes mellitus that can not be controlled by stable doses of insulin, or malignancy;
- 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 diseases or acute stage of chronic diseases or use of antipyretic, analgesic drugs (eg: acetaminophen, ibuprofen, aspirin, etc.) and anti-allergic drugs (such as: loratadine, cetirizine, etc.) within 3 days preceding the vaccination;
- Untreated/uncontrolled hypertension before vaccination (16-17 years of age > 120 mmHg and / or diastolic blood pressure > 80 mmHg; 18-26 years of age with physical examination systolic blood pressure ≥140 mmHg and / or diastolic blood pressure ≥90 mmHg);
- Subjects who received whole blood, plasma, or immunoglobulin therapy within 3 months prior to vaccination;
- Received live attenuated vaccine within 28 days prior to vaccination;
- Received subunits or inactivated vaccines within 14 days prior to vaccination;
- Breastfeeding or pregnant, or within 6 weeks after the end of pregnancy;
- According to the judgment of the investigator, subjects who have any other factors that are not suitable for participating in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Randomized, Blinded, Positive-controlled Study to Compare the Immunogenicity of Zerun 9-valent Human Papillomarivus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Pichia Pastoris) in Healthy Female Subjects Aged 16-26 Years.
This study will evaluate the immunogenicity and safety of Zerun 9-valent HPV recombinant vaccine in healthy female 16-26 years of age by comparing with GARDASIL®9.
- Conditions
- Cervical Cancer, Genital Wart, CIN, VIN, Papillomavirus Infections
- Being tested
- Zerun HPV-9, GARDASIL ®9
- Keywords
- Human Papillomavirus, Papillomavirus Vaccines, Genital Warts, Cervical Cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Condylomata Acuminata, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zerun HPV-9Biological
Zerun 9-valent Human Papillomarivus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Pichia Pastoris), 0.5mL, three doses, 0,2,6 months
GARDASIL ®9Biological
GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months
| Study group | Role | What they receive |
|---|---|---|
| Zerun HPV-9 | Experimental | Subjects receive 3 doses of Zerun HPV-9 vaccine Receives: Biological: Zerun HPV-9 |
| GARDASIL®9 | Active comparator | Subjects receive 3 doses of GARDASIL®9 Receives: Biological: GARDASIL ®9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titers (GMT) of HPV neutralizing antibodies
HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 neutralizing antibodies GMT
Measured: 30 days postdose 3 (Month 7)
Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Seroconversion is defined as a participant in PPS who was anti-HPV seronegative at Day 0 (before vaccination) and became seropositive 30days after the third dose (Month 7).
Measured: 30 days postdose 3 (Month 7)
Secondary outcomes (4)
Percentage of subjects reporting solicited local symptoms
Solicited local symptoms assessed including pain, redness, swelling, induration and pruritus.
Measured: 0-7 days after each dose
Percentage of subjects reporting solicited general symptoms
Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction
Measured: 0-7 days after each dose
Percentage of subjects reporting unsolicited adverse events (AEs)
An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study.
Measured: 0-30 days after each dose
Percentage of subjects reporting serious adverse events (SAEs)
Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: Month 0 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Sep 2022
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Walvax Biotechnology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580341
- Sponsor's protocol ID
- 312-HPV-2002
- Status last verified
- Oct 2022
- First submitted
- 11 Oct 2022
- Last updated
- 28 Oct 2022
- 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 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Blinded, Positive-controlled Study to Compare the Immunogenicity of Zerun 9-valent Human Papillomarivus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Pichia Pastoris) in Healthy Female Subjects Aged 16-26 Years.
- ClinicalTrials.gov ID
- NCT05580341
- Acronym / sponsor ID
- 312-HPV-2002
- Conditions
- Cervical Cancer, Genital Wart, CIN, VIN, Papillomavirus Infections
- Keywords
- Human Papillomavirus, Papillomavirus Vaccines, Genital Warts, Cervical Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Walvax Biotechnology Co., Ltd.
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Oct 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.
This study will evaluate the immunogenicity and safety of Zerun 9-valent HPV recombinant vaccine in healthy female 16-26 years of age by comparing with GARDASIL®9.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zerun HPV-9 | Experimental | Biological: Zerun HPV-9Subjects receive 3 doses of Zerun HPV-9 vaccine |
| GARDASIL®9 | Active comparator | Biological: GARDASIL ®9Subjects receive 3 doses of GARDASIL®9 |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy female 16-26 years of age
- 16-17 years old subjects and their guardians able to provide legal identification; 18-26 years old subjects able to provide their legal identification;
- Able to understand (not illiterate) and sign the informed consent;
- Able to make a decision to participate in the clinical trial and the subject agrees to participate in the clinical trial;
- Women of child-bearing age (WOCBA): subjects must have a negative urine pregnancy test result, have used effective contraceptive measures within 2 weeks before enrollment, have no pregnancy plans, and agree to use adequate contraceptive precautions from enrollment to the 7th month (one month after full immunization).
Key exclusion criteria (18 listed)
- Abnormal cervical cancer screen test results (ASC-US or worse), history of HPV infection, history of abnormal cervical biopsy results, or history of genital warts;
- Subjects with severe congenital malformations or that cause serious organ damage, developmental disorders, genetic defects, or severe malnutrition;
- Subjects have received a marketed HPV vaccine or participated in an HPV vaccine clinical trial, or participated in clinical trials of other vaccines within the past 6 months;
- Fever prior to vaccination (axillary body temperature ≥37.3℃);
- History of severe allergic reaction that required medical intervention (such as swelling of the mouth and throat, dyspnea, hypotension or shock, etc.);
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 |
|---|---|---|
| Zerun HPV-9Zerun 9-valent Human Papillomarivus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Pichia Pastoris), 0.5mL, three doses, 0,2,6 months | Biological | Zerun HPV-9 |
| GARDASIL ®9GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months | Biological | GARDASIL®9 |
Primary outcome
Geometric Mean Titers (GMT) of HPV neutralizing antibodies
Time frame: 30 days postdose 3 (Month 7)
HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 neutralizing antibodies GMT
Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Time frame: 30 days postdose 3 (Month 7)
Seroconversion is defined as a participant in PPS who was anti-HPV seronegative at Day 0 (before vaccination) and became seropositive 30days after the third dose (Month 7).
4 secondary outcomes
Percentage of subjects reporting solicited local symptoms
Time frame: 0-7 days after each dose
Percentage of subjects reporting solicited general symptoms
Time frame: 0-7 days after each dose
Percentage of subjects reporting unsolicited adverse events (AEs)
Time frame: 0-30 days after each dose
Percentage of subjects reporting serious adverse events (SAEs)
Time frame: Month 0 to Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
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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 Zerun HPV-9 and GARDASIL ®9 in people with Cervical Cancer and Genital Wart, run by Shanghai Zerun 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 5 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: status not confirmed, as of the sponsor's last update on 28 Oct 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?
Results are not available in the source record.
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?
Geometric Mean Titers (GMT) of HPV neutralizing antibodies (time frame: 30 days postdose 3 (Month 7)). The study lists 2 primary outcomes in all. 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 28 Oct 2022.