HPV InfectionPhase 2NCT04436133
Immunogenicity AND Safety Study of the 11 Valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)
A Phase 2 study testing Biological/Vaccine: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) and 9-valent HPV vaccine（Gardasil 9） in people with HPV Infection and HPV-Related Cervical Carcinoma, run by National Vaccine and Serum Institute, China at 1 site in China.
Trial summary
A total of 480 Chinese women aged 18-26 years old were enrolle，experimental group and the control group were randomly assigned in a ratio of 3:1. 360 Chinese women in the experimental group and 120 in the control group. Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, HPV-Related Cervical Carcinoma
- What is being tested?
- Biological/Vaccine: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) and 9-valent HPV vaccine（Gardasil 9）
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2020to 1 Mar 2022
- Phase
- Phase 2
- 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 18 to 26 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese women aged 18-26 who can provide legal identification;
- The subject has the ability to understand the research procedure and sign an informed consent;
- Subjects have the ability to read, understand, fill out diary cards/contact cards and other research application forms and promise to participate in regular follow-up as required by the research;
- No previous history of HPV vaccination, no participation in HPV vaccine clinical trials, and no plans to receive HPV vaccine during the study period; The subject was not breastfeeding or pregnant (negative urine pregnancy test), did not have a birth plan within 7 months of enrollment; and from day 1 of the last menstrual cycle to day 0 of the study, did not have sex with men or with men Effective contraception was used during sex and no contraceptive failures occurred (examples of contraceptive failure include male condom rupture during sex). And agreed to continue to take effective contraceptive measures within the first 7 months after participating in the study (effective contraceptive measures include: oral contraceptives, hormone patches, intrauterine devices, condoms, cervical caps, etc.).
- First dose exclusion criteria:
- Previous history of cervical lesions (such as abnormal cervical cancer screening, history of CIN disease) or history of hysterectomy surgery (vaginal or total hysterectomy) or history of pelvic radiation therapy; previous history of external genital diseases (such as vulvar epithelium) Neoplasia, intraepithelial neoplasia and genital warts, etc.);
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- Previous history of severe allergic reactions requiring medical intervention for any vaccine or drug (including yeast) (eg: anaphylactic shock, allergic throat edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction) Wait);
- Immune function is impaired or has been diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile Rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases;
- Long-term treatment with immunosuppressive agents, such as: long-term (more than 2 weeks in a row) treatment with glucocorticoids (eg, prednisone or similar drugs);
- Receive any immunoglobulin or blood products within 3 months before vaccination, or plan to receive such products before the 7th month of the study;
- Received inactivated vaccine or recombinant vaccine within 14 days before vaccination, or received any live vaccine within 28 days;
- Loss of spleen or functional spleen, and removal of spleen or spleen caused by any situation;
- Has been diagnosed with a disease that may interfere with the progress or completion of the study, such as: suffering from severe cardiovascular disease (pulmonary heart disease, pulmonary edema), severe liver and kidney disease, diabetes with complications, etc.; or has been diagnosed with Infectious diseases, such as: active tuberculosis, hepatitis B, hepatitis C, etc.;
- A history of convulsions, epilepsy, encephalopathy, mental illness, family history of mental illness, etc.;
- There are thrombocytopenia or other coagulation disorders that can be contraindications to intramuscular injection; 11.3 days before the vaccination, suffering from acute disease or in the acute onset of chronic disease or using antipyretic, analgesic and anti-allergic drugs (such as: acetaminophen, ibuprofen, aspirin, loratadine, cetaxidine Tirizine, etc.);
- 12.Body temperature before inoculation≥37.3℃(armpit body temperature); 13. People who have a systolic blood pressure ≥140mmHg and/or a diastolic blood pressure ≥90mmHg before enrollment; 14. Participate or plan to participate in other clinical trials (drugs, vaccines and medical devices) during the study; 15. Plan to move out of the local area before the end of the study or leave the area for a long time during the scheduled study visit;
- Exclusion criteria for second and third doses of vaccination:
- Before vaccination (the day of vaccination), pregnant or urine pregnancy test (HCG) is positive; Note: If the subject chooses to terminate the pregnancy, at least 6 weeks after the end of pregnancy and the urine pregnancy test is negative on the day before the vaccination, or the medical certificate of termination of pregnancy issued after the end of pregnancy indicates that HCG levels have returned to normal levels, you can continue Vaccination; if you choose to continue pregnancy, you will not be vaccinated for subsequent doses.
- Newly discovered or newly occurred conditions that meet the first dose exclusion criteria (except Articles 1 and 13);
- Other serious adverse events: The researcher decides whether to terminate the test vaccination according to his treatment needs;
- The investigator assessed any other reasons why the vaccination for the trial should be terminated.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Blind, and Positive Control Design to Evaluate the Immunization Efficacy of 11 Valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 18-26 Years
A total of 480 Chinese women aged 18-26 years old were enrolle，experimental group and the control group were randomly assigned in a ratio of 3:1. 360 Chinese women in the experimental group and 120 in the control group. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or control vaccine according to the 0, 2, and 6 months immunization program.
- Conditions
- HPV Infection, HPV-Related Cervical Carcinoma
- Being tested
- Biological/Vaccine: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha), 9-valent HPV vaccine（Gardasil 9）
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological/Vaccine: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)Biological
Inject vaccine produced by ChinaVaccineSerum, containing HPV antigen protein, 270μg/1ml per bottle
9-valent HPV vaccine（Gardasil 9）Biological
Inject Gardasil 9 , containing HPV antigen protein, 270μg/0.5ml per bottle
| Study group | Role | What they receive |
|---|---|---|
| vaccine group | Experimental | Not described Receives: Biological: Biological/Vaccine: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) |
| Positive control group | Active comparator | Not described Receives: Biological: 9-valent HPV vaccine（Gardasil 9） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HPV neutralizing antibodies GMT
Measured: 30 days after full immunization
Anti-HPV neutralizing antibody positive conversion rate（after full immunization 30 days）
Measured: 30 days after full immunization
Collect all SAEs
Vaccine-related and unrelated
Measured: through study completion, an average of 13 months
Collect AEs incidence
Vaccine-related and unrelated
Measured: Within 30 minutes of injection
Collect AEs incidence
All AEs: incidence of AEs related to vaccines and unrelated
The rate of Solicited for AE
Non-collective AEs: incidence of AEs related to vaccines and unrelated
AE level 3 and above: incidence of vaccine-related and unrelated AEs
Measured: Within 30 days after inoculation
collect AEs leading subject to withdrawal
Incidence of vaccine-related and unrelated AEs
Measured: through study completion, an average of 13months
collect All pregnancy conditions and pregnancy outcomes
collect pregnant woman Anti-HPV neutralizing antibody positive conversion rate and Anti-HPV neutralizing antibodies GMT
Measured: through study completion, an average of 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start20 Jun 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Vaccine and Serum Institute, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chengdu Institute of Biological Products Co.,Ltd., Simoon Record Pharma Information Consulting Co., Ltd., Guangxi Center for Disease Control and Prevention, Beijing Kantorico Statistical Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436133
- Sponsor's protocol ID
- GXIRB2020-0036
- Status last verified
- May 2022
- First submitted
- 11 Jun 2020
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blind, and Positive Control Design to Evaluate the Immunization Efficacy of 11 Valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 18-26 Years
- ClinicalTrials.gov ID
- NCT04436133
- Acronym / sponsor ID
- GXIRB2020-0036
- Conditions
- HPV Infection, HPV-Related Cervical Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- National Vaccine and Serum Institute, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- Chengdu Institute of Biological Products Co.,Ltd., Simoon Record Pharma Information Consulting Co., Ltd., Guangxi Center for Disease Control and Prevention, Beijing Kantorico Statistical Technology Co., Ltd.
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 17 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.
A total of 480 Chinese women aged 18-26 years old were enrolle，experimental group and the control group were randomly assigned in a ratio of 3:1. 360 Chinese women in the experimental group and 120 in the control group. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or control vaccine according to the 0, 2, and 6 months immunization program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaccine group | Experimental | Biological: Biological/Vaccine: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) |
| Positive control group | Active comparator | Biological: 9-valent HPV vaccine（Gardasil 9） |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Chinese women aged 18-26 who can provide legal identification;
- The subject has the ability to understand the research procedure and sign an informed consent;
- Subjects have the ability to read, understand, fill out diary cards/contact cards and other research application forms and promise to participate in regular follow-up as required by the research;
- No previous history of HPV vaccination, no participation in HPV vaccine clinical trials, and no plans to receive HPV vaccine during the study period; The subject was not breastfeeding or pregnant (negative urine pregnancy test), did not have a birth plan within 7 months of enrollment; and from day 1 of the last menstrual cycle to day 0 of the study, did not have sex with men or with men Effective contraception was used during sex and no contraceptive failures occurred (examples of contraceptive failure include male condom rupture during sex). And agreed to continue to take effective contraceptive measures within the first 7 months after participating in the study (effective contraceptive measures include: oral contraceptives, hormone patches, intrauterine devices, condoms, cervical caps, etc.).
- Previous history of cervical lesions (such as abnormal cervical cancer screening, history of CIN disease) or history of hysterectomy surgery (vaginal or total hysterectomy) or history of pelvic radiation therapy; previous history of external genital diseases (such as vulvar epithelium) Neoplasia, intraepithelial neoplasia and genital warts, etc.);
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Biological/Vaccine: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)Inject vaccine produced by ChinaVaccineSerum, containing HPV antigen protein, 270μg/1ml per bottle | Biological | vaccine group |
| 9-valent HPV vaccine（Gardasil 9）Inject Gardasil 9 , containing HPV antigen protein, 270μg/0.5ml per bottle | Biological | Positive control group |
Primary outcome
Anti-HPV neutralizing antibodies GMT
Time frame: 30 days after full immunization
Anti-HPV neutralizing antibody positive conversion rate（after full immunization 30 days）
Time frame: 30 days after full immunization
Collect all SAEs
Time frame: through study completion, an average of 13 months
Vaccine-related and unrelated
Collect AEs incidence
Time frame: Within 30 minutes of injection
Vaccine-related and unrelated
Collect AEs incidence
Time frame: Within 30 days after inoculation
All AEs: incidence of AEs related to vaccines and unrelated The rate of Solicited for AE Non-collective AEs: incidence of AEs related to vaccines and unrelated AE level 3 and above: incidence of vaccine-related and unrelated AEs
collect AEs leading subject to withdrawal
Time frame: through study completion, an average of 13months
Incidence of vaccine-related and unrelated AEs
collect All pregnancy conditions and pregnancy outcomes
Time frame: through study completion, an average of 13 months
collect pregnant woman Anti-HPV neutralizing antibody positive conversion rate and Anti-HPV neutralizing antibodies GMT
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 6 May 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 2 study testing Biological/Vaccine: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) and 9-valent HPV vaccine（Gardasil 9） in people with HPV Infection and HPV-Related Cervical Carcinoma, run by National Vaccine and Serum Institute, China 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 21 inclusion and 0 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 6 May 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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-HPV neutralizing antibodies GMT (time frame: 30 days after full immunization). The study lists 7 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 6 May 2022.