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Official title A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
ClinicalTrials.gov ID: NCT05262010
What this study is testing
What is 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)?
11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for hpv infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- \- non-gynecological related
- \ Chinese women with a history of sexual life who are 18-45 years old at the time of enrollment and can provide legal identification;
- \ Axillary body temperature \<37.3℃ on the day of enrollment;
- The people themselves have the ability to understand the clinical trial and voluntarily sign the informed consent;
- people have the ability to read, understand, and fill out research application forms such as diary cards/contact cards, and promise to follow the...
You likely can't join if
- First dose exclusion criteria: (Visits may be rescheduled if the criteria described in the "\ " option are met at screening) \- Non-gynecological...
- \ Those with abnormal blood pressure (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) on physical examination before...
- \ 3 months prior to vaccination or planned to receive any immune globulin or blood products within 7 months of enrollment;
- \ Received any vaccine within 14 days prior to vaccination, or received live vaccine within 28 days;
- \ 3 days before vaccination, suffering from acute febrile illness (body temperature ≥38.5℃) or using antipyretic, analgesic and antiallergic drugs...
- History of severe allergies/conditions requiring medical intervention (e.g. Anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura...
See the full eligibility criteria
- \- non-gynecological related
- \ Chinese women with a history of sexual life who are 18-45 years old at the time of enrollment and can provide legal identification;
- \ Axillary body temperature \<37.3℃ on the day of enrollment;
- The people themselves have the ability to understand the clinical trial and voluntarily sign the informed consent;
- people have the ability to read, understand, and fill out research application forms such as diary cards/contact cards, and promise to follow the research requirements participate in follow-up visits;
- No previous HPV vaccination history, no commercially available HPV vaccine during the study period (about 6 years after enrollment) plan of;
- The subject has a negative urine pregnancy test on the day before vaccination. \- Gynecology related
- \ Effective contraception was taken from day 1 of last menstrual cycle to day 0 of the study, and no childbearing within 7 months after enrollment plan.
- \ Before the gynecological visit and within 48 hours before any subsequent visit that includes a gynecological sample collection: asexual life (including same-sex or opposite-sex anal, vaginal or genital contact)...
- First dose exclusion criteria: (Visits may be rescheduled if the criteria described in the "\ " option are met at screening) \- Non-gynecological related
- \ Those with abnormal blood pressure (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) on physical examination before vaccination;
- \ 3 months prior to vaccination or planned to receive any immune globulin or blood products within 7 months of enrollment;
- \ Received any vaccine within 14 days prior to vaccination, or received live vaccine within 28 days;
- \ 3 days before vaccination, suffering from acute febrile illness (body temperature ≥38.5℃) or using antipyretic, analgesic and antiallergic drugs (eg: acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
- History of severe allergies/conditions requiring medical intervention (e.g. Anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis(Arthus reaction)...
- Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia Blood disease, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis...
- 1 month before vaccination or plan to receive immunosuppressive therapy within 7 months after enrollment, such as oral administration for more than 2 consecutive weeks Oral or injectable systemic corticosteroid therapy...
- Previous splenectomy or impaired spleen function;
- Those with previous or current severe liver, kidney and cardiovascular diseases, complicated diabetes, and malignant tumors;
- Have a history of epilepsy, convulsions, mental illness or a family history of mental illness;
- Suffering from thrombocytopenia or any coagulation disorder that can become a contraindication to intramuscular injection;
- Participate in other clinical studies (drugs, vaccines and medical devices) within 3 months before vaccination or during the planned study period;
- The investigator believes that the subject has any other factors that are not suitable for participating in the clinical trial (such as: poor compliance or planning Permanent relocation from the area before the study is...
- \ Pregnant, breastfeeding, or within 6 weeks of pregnancy at the time of the first dose of the vaccine;
- \ The subject is in the menstrual period;
- \ Acute lower genital tract infection (such as acute vulvitis/vaginitis/cervicitis, etc.) found by the naked eye during gynecological examination;
- Previous history of abnormal cervical cancer screening or lesions (including HPV DNA positive, squamous intraepithelial lesion (SIL)or atypical squamous cells of undetermined significance (ASC-US), atypical squamous...
- Past or current anal and genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts,vulvar cancer, vaginal cancer and anal cancer, etc.);
- Previous hysterectomy or pelvic radiation therapy or severe cervical/vaginal dysplasia. Exclusion criteria for 2nd and 3rd dose vaccination： If any of the following occurs, the investigator will terminate the subject's...
- Meet the first dose exclusion criteria 5, 6, 7, 8, 9, 12;
- Any other reasons that, in the judgment of the investigator, warrant discontinuation of the investigational vaccination.
The study team makes the final eligibility decision.
Where it's taking place
- Hechi, Guangxi, China
- Hezhou, Guangxi, China
- Lianyuan, Hunan, China
- Wuxi, Hunan, China
- Yongji, Shanxi, China
- Yuncheng, Shanxi, China
- Mianyang, Sichuan, China
- Neijiang, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hechi, Guangxi, China; Hezhou, Guangxi, China; Lianyuan, Hunan, China; Wuxi, Hunan, China; Yongji, Shanxi, China; Yuncheng, Shanxi, China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.