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Tests treatment safety and results for Cervical Cancer
Official title Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
ClinicalTrials.gov ID: NCT04422366
What this study is testing
What is 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)?
9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) is an investigational medicine, being studied as a potential treatment for cervical cancer.
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
- This study is designed to evaluate the vaccine efficacy, 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 Aged 20-45 Years .
- 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 20 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- (If the "\ " option is not met during screening, the visit can be rescheduled)
- Chinese women aged 20-45 who can provide legal identification and have a sexual life history;
- The subject fully understands the study procedures, understands the risks and benefits associated with participating in the study, and voluntarily...
- people are able to read, understand and fill in application forms such as diary CARDS and contact CARDS, and participate in follow-up according to...
- people have not been screened for cervical cancer, or have been screened for cervical cancer but the results are normal;
You likely can't join if
- 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...
- Previous positive history of HPV;
- Has a history of abnormal cervical cytology, including squamous intraepithelial lesions (SIL) or not clear meaning of the atypical squamous cells...
- Past history of anal and genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar cancer...
- Received total hysterectomy or pelvic radiotherapy;
See the full eligibility criteria
Who can join
- (If the "\ " option is not met during screening, the visit can be rescheduled)
- Chinese women aged 20-45 who can provide legal identification and have a sexual life history;
- The subject fully understands the study procedures, understands the risks and benefits associated with participating in the study, and voluntarily signs the informed consent;
- people are able to read, understand and fill in application forms such as diary CARDS and contact CARDS, and participate in follow-up according to the study requirements;
- people have not been screened for cervical cancer, or have been screened for cervical cancer but the results are normal;
- \ 0 days before the gynecological visit, no sex within 48 hours, no flushing or vaginal cleaning within 72 hours, no use of vaginal drugs or preparations;Subject agrees to refrain from sexual intercourse (including...
- When the people were enrolled, the urine pregnancy test was negative (sensitivity was 25mIU/ml cox-hcg), they were not in the lactation period and had no family planning within 7 months after enrollment (1 month before...
- \ body temperature \<37.3℃ (underarm body temperature)
What rules you out
- 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...
- Previous positive history of HPV;
- Has a history of abnormal cervical cytology, including squamous intraepithelial lesions (SIL) or not clear meaning of the atypical squamous cells (ASC - US), except the atypical squamous cells - not highly squamous...
- Past history of anal and genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar cancer, vaginal cancer and anal cancer, etc.);
- Received total hysterectomy or pelvic radiotherapy;
- Cervical insufficiency or abnormal cervical structure (judged by the results of routine gynecological examination);
- Previous sexual history (including syphilis, gonorrhea, chancre, venereal lymphatic granuloma, granuloma inguinal) or have obvious condyloma;
- A history of seizures, convulsions or convulsions, or a family history of mental illness;
- Have participated in other gynecology-related clinical trials within 6 months, and have used or plan to use other investigational or unregistered products (drugs or vaccines) other than the vaccine in this study within...
- 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)...
- Subject receives any immunoglobulin or blood product within 3 months prior to the first dose of vaccination, or plans to receive such product within the next 7 months (1 month prior to the full course of vaccination);
- people present/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...
- Immunosuppressant therapy within 1 month before the first dose of vaccination, such as long-term use of systemic glucocorticoid therapy (≥2mg/kg/ day, for more than 2 weeks, such as prednisone or similar drugs;Topical...
- Absence of spleen or functional absence of spleen, and absence of spleen or splenectomy in any case;
- Patients with severe liver, kidney and cardiovascular diseases, diabetes or malignant tumor with complications;
- Patients with thrombocytopenia or any coagulation disorders that may be contraindications to intramuscular injection;
- \ people received inactivated or recombinant vaccines within 14 days prior to study enrollment, or attenuated live vaccines within 28 days prior to study enrollment;
- \ 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...
- \ the first dose of vaccine was in pregnancy at the time of vaccination, or the end of pregnancy had not exceeded 6 weeks;
- \ after questioning, people had fever symptoms (subaxillary body temperature ≥37.3℃) before the first day of vaccination (within 24 hours before vaccination);
- \ the subject is in the menstrual period;
- \ severe acute vaginitis and suppurative cervicitis found by naked eye during gynecological examination (purulent secretion visible by naked eye);
- Blood pressure on physical examination before the first dose of vaccination was higher than normal or increased (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg);
- Gynecological examination before the first dose of vaccination suspected genital warts, or on the basis of clinical symptoms and signs suspected vulva, vagina or cervical precancerous lesions and the possibility of...
- people 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...
- In the opinion of the investigators, the people had any other factors that made them unsuitable to participate in the clinical trial, so that continued participation in the study could not guarantee the maximum benefit...
- new discoveries or new occurrences that meet the first dose exclusion criteria (except for articles 2, 3, 4, 21);
- other serious adverse events: the investigator decides whether to terminate the experimental vaccination according to its treatment needs;
- the investigator assays for any other reasons that may be considered necessary to terminate the trial vaccination. Second and third doses of vaccine were delayed criteria Vaccination may be postponed if:
- fever (underarm body temperature ≥37.3℃);
- before inoculation (on the day of inoculation), the urine pregnancy test was positive (sensitivity was 25mIU/ml n-hcg);
- acute illness or acute attack of a chronic disease or use of antipyretic, analgesic and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 3 days before vaccination;
- insufficient interval between other vaccines (inactivated or recombinant vaccines received within 14 days prior to vaccination, or any live attenuated vaccine received within 28 days);
- any immunoglobulin or blood products received during vaccination should be administered at least 3 months after the vaccination;
- other circumstances that can be postponed as judged by the researcher.
The study team makes the final eligibility decision.
Where it's taking place
- Liuzhou, Guangxi, 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, 20 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 Liuzhou, Guangxi, China. 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.