HPV InfectioNPhase 3NCT06041061

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SCT1000 in Healthy Women Aged 18-45 Years

A Phase 3 study testing Recombinant 14-Valent Human Papillomavirus Vaccine（Insect Cell） in people with HPV InfectioN and HPV-Related Carcinoma, run by Sinocelltech Ltd. at 5 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: HPV InfectioN, HPV-Related Carcinoma
What is being tested?: Recombinant 14-Valent Human Papillomavirus Vaccine（Insect Cell）
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18,000 participants
Where: 5 sitesChina
Study dates: 13 Aug 2023to Aug 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

1. Females who are at least 18 years old and less than 46 years old (i.e., 18 to 45 years old).
2. Subjects sign a written informed consent form (ICF) to participate in the trial voluntarily, and are able to fully understand the trial procedures, the risks of participating in the trial, and the alternative interventions available to them if they do not participate in the trial.
3. Be able to read, understand and complete the diary/contact card. 4. Be in good health as judged by the history interview and physical examination.
5. Have a history of sexual behavior prior to enrollment. 6.Avoid sexual intercourse (including same-sex or opposite-sex anal, vaginal, or genital/genital contact) and avoid vaginal douching, vaginal cleansing, or the use of vaginal medications or preparations for 48 hours prior to any visit that includes sample collection.
7. Subjects who are not breastfeeding at the time of enrollment and who have used effective contraception from the time of their last menstrual period until enrollment in the study, and who understand and agree to use effective contraception from the first day of enrollment until 1 month after the last vaccination.
8. Those with axillary body temperature <37.3°C on the day of enrollment. 9. Note: Subjects who do not meet the enrollment criteria are allowed to be screened again, but the enrollment criteria still need to be confirmed again at the time of enrollment.

Who cannot join

1. *Positive urine pregnancy test or pregnancy (including ectopic pregnancy) that has ended less than 6 weeks ago.
2. Prior vaccination with a marketed HPV vaccine or already enrolled in a clinical trial of another HPV vaccine or have plans to receive a non-study HPV vaccine during the study period.
3. Have a prior history of cervical cancer screening abnormalities or lesions [including HPV DNA positivity, squamous intraepithelial lesions (SIL) or atypical squamous cells of undetermined significance (ASC-US), atypical squamous epithelial cells-without the exception of high grade squamous intraepithelial lesions (ASC-H), atypical glandular cells (AGC), or have cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS) or cervical cancer]. ) or cervical cancer, etc.].
4. Previous or current anal or genital disease (e.g. vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar, vaginal, and anal cancers) 5. Previous total hysterectomy or pelvic radiation therapy or severe developmental abnormalities of the cervix/vagina.
6. History of drug or alcohol abuse or dependence in the last year. 7. Have hypertension or diabetes mellitus that cannot be controlled and stabilized with pharmacological interventions.
8. Subjects with a history of severe allergic reactions to any vaccine or medication requiring medical intervention (e.g., anaphylaxis, anaphylactic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, localized anaphylactic necrotic reaction [Arthus reaction], etc.).

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9. Currently immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, tuberculosis, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune disease.
10. Previous splenectomy or impaired splenic function. 11. Currently receiving or have received the following immunosuppressive therapies in the last year: radiation therapy, cyclophosphamide, imidazathioprine, methotrexate, as well as chemotherapy, cyclosporine, leflunomide, tumor necrosis factor-alpha antagonists, monoclonal antibody therapies, intravenous gammaglobulin, anti-lymphocytic serums, or other therapies that are known to interfere with immunity 12. Current treatment with systemic corticosteroids or 2 or more courses of high-dose glucocorticoids lasting one week in the year prior to enrollment. The use of nasal inhaled glucocorticoids or topical short-term topical application on the skin may not be excluded.
13. Receipt of any immunoglobulin product or blood product within 3 months prior to vaccination, or planning to receive such similar products during the study period from Day 1 to Month 7.
14. Inactivated/recombinant/nucleic acid vaccine, etc. (non-attenuated) within 14 days prior to vaccination or live attenuated vaccine within 28 days prior to vaccination.
15. Contraindication to intramuscular injection such as thrombocytopenia or other coagulation disorders.
16. Blood donation within 1 week prior to vaccination or planning to donate blood between Day 1 and Month 7 of study participation.
17. Participation in other experimental clinical studies or studies with unregistered products (drugs or vaccines) or collection of cervical specimens within 3 months prior to vaccination.
18. Inability to follow trial procedures or planned relocation during the study.
19. Fever (axillary temperature ≥37.3°C) within 3 days prior to vaccination or any acute illness requiring systemic antibiotic or antiviral therapy within the past 5 days.
20. Clinical signs/symptoms suggestive of acute reproductive tract infection (e.g. acute vulvovaginitis/vaginitis/cervicitis [including purulent cervicitis], etc.) during gynecological examination.
21. Being in the menstrual period (sampling should be done 2 days after the end of menstruation).
22. Have an active neurological/psychiatric/psychological disorder that prevents compliance with the study requirements.
23. Have other abnormalities, conditions that may confound the results of the study, or conditions that are not in the best interest of the subject and may be excluded as determined by the investigator.
24. Note: Subjects who meet exclusion criteria are allowed to be re-screened, but enrollment will still require re-confirmation of inclusion criteria.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

China5 sites

Sichuan Center for Disease Control and Prevention
Chengdu, Sichuan
Yunan Center for Disease Control and Prevention
Kunming, Yunan
Guangxi Center for Disease Control and Prevention
Nanning, Guangxi
Shanxi Center for Disease Control and Prevention
Taiyuan, Shanxi
Henan Center for Disease Control and Prevention
Zhengzhou, Henan

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Efficacy, Safety, and Immunogenicity of a 14- Valent Recombinant Human Papillomavirus Vaccine (SCT1000) in Healthy Women Aged 18-45 Years

A total of 18000 healthy women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 36-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.

Read the detailed description

Introduction: SCT1000 is a recombinant 14-valent human papillomavirus vaccine (insect cell) that covers all 12 WHO-recognized high-risk oncogenic HPV subtypes Indications are for the prevention of cervical, vulvar, vaginal, and anal cancers, and genital warts caused by HPV6, HPV11 and HPV11 in females 9-45 years of age, as well as intraepithelial neoplasia and AIS. Intraepithelial neoplasia and AIS and genital warts due to HPV6 and HPV11.

Aim:To evaluate the protective efficacy of 3 doses of HPV vaccine (SCT1000) for the prevention of HPV type 6,11,16,18,31,33,35,39,45,51,52,56,58,59-associated lesions in healthy females aged 18-45 years compared with placebo.

Design: A Multicenter, Randomized, Double-blind, Placebo-controlled phase III Clinical trial Subject Information: a total of 18000 healthy women aged 18-45 years selected by inclusion and exclusion criteria.

Cluster situation: a ratio of 1:1 between the experimental group and the placebo group.

End point index: relative index with efficacy, safety, and immunogenicity of SCT1000

Conditions: HPV InfectioN, HPV-Related Carcinoma
Being tested: Recombinant 14-Valent Human Papillomavirus Vaccine（Insect Cell）, placebo
Keywords: HPV, Vaccine
Medical subject headings: Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant 14-Valent Human Papillomavirus Vaccine（Insect Cell）Biological
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine
placeboBiological
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo

Study groups in NCT06041061
Study group	Role	What they receive
experiment group	Experimental	According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine Receives: Biological: Recombinant 14-Valent Human Papillomavirus Vaccine（Insect Cell）
placebo	Placebo comparator	According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo Receives: Biological: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Combined Incidence of HPV Type 16/18-related CIN2/3, AIS, Invasive cervical cancer, VIN2/3, VaIN2/3, AIN1/2/3, vulvar, vaginal and anal cancer
The endpoint is defined to have occurred: (a) a HPV Pathology Panel consensus diagnosis from the results of cervical biopsy: Cervical Intraepithelial Neoplasia (CIN, including grade 2 or 3), Adenocarcinoma in Situ (AIS), Invasive cervical cancer, Vulvar Intraepithelial Neoplasia (VIN, including grade 2 or 3), Vaginal Intraepithelial Neoplasia (VaIN, including grade 2 or 3), Anal intraepithelial neoplasia (AIN, including grade 1, 2, or 3), vulvar, vaginal and anal cancer; AND (b) detection of at least 1 of Human Papillomavirus (HPV) types 16/18 by Polymerase Chain Reaction (PCR) assay for virus subtype.
Measured: 1 month after 3 doses of vaccine
Combined Incidence of HPV Type 31/33/45/52/58-related CIN2/3, AIS, Invasive cervical cancer, VIN2/3, VaIN2/3, AIN1/2/3, vulvar, vaginal and anal cancer
The endpoint is defined to have occurred: (a) a HPV Pathology Panel consensus diagnosis from the results of cervical biopsy: Cervical Intraepithelial Neoplasia (CIN, including grade 2 or 3), Adenocarcinoma in Situ (AIS), Invasive cervical cancer, Vulvar Intraepithelial Neoplasia (VIN, including grade 2 or 3), Vaginal Intraepithelial Neoplasia (VaIN, including grade 2 or 3), Anal intraepithelial neoplasia (AIN, including grade 1, 2, or 3), vulvar, vaginal and anal cancer; AND (b) detection of at least 1 of Human Papillomavirus (HPV) types 31/33/45/52/58 by Polymerase Chain Reaction (PCR) assay for virus subtype.
Measured: 1 month after 3 doses of vaccine
Combined Incidence of HPV Type 35/39/51/56/59-related CIN2/3, AIS, Invasive cervical cancer, VIN2/3, VaIN2/3, AIN1/2/3, vulvar, vaginal and anal cancer
The endpoint is defined to have occurred: (a) a HPV Pathology Panel consensus diagnosis from the results of cervical biopsy: Cervical Intraepithelial Neoplasia (CIN, including grade 2 or 3), Adenocarcinoma in Situ (AIS), Invasive cervical cancer, Vulvar Intraepithelial Neoplasia (VIN, including grade 2 or 3), Vaginal Intraepithelial Neoplasia (VaIN, including grade 2 or 3), Anal intraepithelial neoplasia (AIN, including grade 1, 2, or 3), vulvar, vaginal and anal cancer; AND (b) detection of at least 1 of Human Papillomavirus (HPV) types 35/39/51/56/59 by Polymerase Chain Reaction (PCR) assay for virus subtype.
Measured: 1 month after 3 doses of vaccine

Secondary outcomes (20)

Incidence of 6-month Persistent Infection associated with HPV types 16/18
The endpoint of a 6-month Persistent Infection was defined to a subject was positive for the same HPV type by the HPV PCR assay to at least 1 common gene in 2 or more consecutive cervicovaginal/external genital swab, biopsy, or definitive therapy samples obtained for over a period of at least 6 months.
Measured: 1 month after 3 doses of vaccine
Incidence of 12-month Persistent Infection associated with HPV types 16/18
The endpoint of a 12-month Persistent Infection was defined to a subject was positive for the same HPV type by the HPV PCR assay to at least 1 common gene in 3 or more consecutive cervicovaginal/external genital swab, biopsy, or definitive therapy samples obtained for over a period of at least 12 months.
Measured: 1 month after 3 doses of vaccine
Incidence of 6-month Persistent Infection associated with HPV types 31/33/45/52/58
The endpoint of a 6-month Persistent Infection was defined to a subject was positive for the same HPV type by the HPV PCR assay to at least 1 common gene in 2 or more consecutive cervicovaginal/external genital swab, biopsy, or definitive therapy samples obtained for over a period of at least 6 months.
Measured: 1 month after 3 doses of vaccine
Incidence of 12-month Persistent Infection associated with HPV types 31/33/45/52/58
The endpoint of a 12-month Persistent Infection was defined to a subject was positive for the same HPV type by the HPV PCR assay to at least 1 common gene in 3 or more consecutive cervicovaginal/external genital swab, biopsy, or definitive therapy samples obtained for over a period of at least 12 months.
Measured: 1 month after 3 doses of vaccine
Incidence of 6-month Persistent Infection associated with HPV types 35/39/51/56/59
The endpoint of a 6-month Persistent Infection was defined to a subject was positive for the same HPV type by the HPV PCR assay to at least 1 common gene in 2 or more consecutive cervicovaginal/external genital swab, biopsy, or definitive therapy samples obtained for over a period of at least 6 months.
Measured: 1 month after 3 doses of vaccine
Incidence of 12-month Persistent Infection associated with HPV types 35/39/51/56/59
The endpoint of a 12-month Persistent Infection was defined to a subject was positive for the same HPV type by the HPV PCR assay to at least 1 common gene in 3 or more consecutive cervicovaginal/external genital swab, biopsy, or definitive therapy samples obtained for over a period of at least 12 months.
Measured: 1 month after 3 doses of vaccine
Incidence of 6-month Persistent Infection associated with HPV types 6/11
The endpoint of a 6-month Persistent Infection was defined to a subject was positive for the same HPV type by the HPV PCR assay to at least 1 common gene in 2 or more consecutive cervicovaginal/external genital swab, biopsy, or definitive therapy samples obtained for over a period of at least 6 months.
Measured: 1 month after 3 doses of vaccine
Incidence of 12-month Persistent Infection associated with HPV types 6/11
The endpoint of a 12-month Persistent Infection was defined to a subject was positive for the same HPV type by the HPV PCR assay to at least 1 common gene in 3 or more consecutive cervicovaginal/external genital swab, biopsy, or definitive therapy samples obtained for over a period of at least 12 months.
Measured: 1 month after 3 doses of vaccine
Incidence of histopathologically confirmed genital warts related to HPV types 6, 11
Genital warts were diagnosed by the HPV Vaccine program pathology panel from the results of cervical biopsy.
HPV types 6/11 DNA was detected by PCR assay.
Measured: 1 month after 3 doses of vaccine
Incidence of histopathologically confirmed cervical, and/or anal, and/or vulvar, and/or vaginal lesions cases associated with HPV types 6/11/16/18 infection detected in the cervical cytology specimen
HPV types 6/11/16/18 DNA was detected by PCR assay. Cervical, anal, vulvar, and vaginal lesions were diagnosed by the HPV vaccine program pathology panel from the results of cervical biopsy.
Measured: 1 month after 3 doses of vaccine
Incidence of histopathologically confirmed cervical, and/or anal, and/or vulvar, and/or vaginal lesions cases associated with HPV types 31/33/45/52/58 infection detected in the cervical cytology specimen
HPV types 31/33/45/52/58 DNA was detected by PCR assay. Cervical, anal, vulvar, and vaginal lesions were diagnosed by the HPV vaccine program pathology panel from the results of cervical biopsy.
Measured: 1 month after 3 doses of vaccine
Incidence of histopathologically confirmed cervical, and/or anal, and/or vulvar, and/or vaginal lesions cases associated with HPV types 35/39/51/56/59 infection detected in the cervical cytology specimen
HPV types 35/39/51/56/59 DNA was detected by PCR assay. Cervical, anal, vulvar, and vaginal lesions were diagnosed by the HPV vaccine program pathology panel from the results of cervical biopsy.
Measured: 1 month after 3 doses of vaccine
Incidence of histopathologically confirmed cervical, and/or anal, and/or vulvar, and/or vaginal lesions cases associated with HPV types 6/11/16/18/31/33/45/52/58 infection detected in the cervical cytology specimen
HPV types 6/11/16/18/31/33/45/52/58 DNA was detected by PCR assay. Cervical, anal, vulvar, and vaginal lesions were diagnosed by the HPV vaccine program pathology panel from the results of cervical biopsy.
Measured: 1 month after 3 doses of vaccine
Incidence of histopathologically confirmed cervical, and/or anal, and/or vulvar, and/or vaginal lesions cases associated with HPV types 6/11/16/18/31/33/45/52/58/35/39/51/56/59 infection detected in the cervical cytology specimen
HPV types 6/11/16/18/31/33/45/52/58/35/39/51/56/59 DNA was detected by PCR assay.
Cervical, anal, vulvar, and vaginal lesions were diagnosed by the HPV vaccine program pathology panel from the results of cervical biopsy.
Measured: 1 month after 3 doses of vaccine
GMC of total anti-HPV6/11/16/18/31/33/45/52/58/35/39/51/56/59 type-associated specific IgG antibodies assessed by cLIA
GMCs was as geometric mean concertration of HPV Immunoglobulin G (IgG) antibodies and was measured using a Competitive Luminex Immunoassay (cLIA).
Measured: At least 1 month after 3 doses of immunization
Positive conversion rate of total anti-HPV6/11/16/18/31/33/45/52/58/35/39/51/56/59 type-associated specific IgG antibodies assessed by cLIA
Positive conversion rate of total HPV6/11/16/18/31/33/45/52/58/35/39/51/56/59 type-associated specific IgG antibodies using cLIA.
Measured: At least 1 month after 3 doses of immunization
GMT of HPV6/11/16/18/31/33/45/52/58/35/39/51/56/59 type-associated neutralizing antibodies.
GMTs was defined as geometric mean titers of HPV types 6/11/16/18/31/33/45/52/58/35/39/51/56/59 determined by pseudovirus-based neutralization assay.
Measured: At least 1 month after 3 doses of immunization
AEs Incidence
Adverse Events (AEs) was considered to be all adverse medical events occurring after the subject is immunized with the experimental vaccine, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but are not necessarily causal to the experimental vaccine immunization relationship
Measured: During the entire study period (From Month 0 up to Month 60)
SAEs Incidence
Serious Adverse Events (SAEs) was refered to adverse medical events, e.g., death, life-threatening, permanent or serious disability or loss of function, hospitalization or prolonged hospitalization of the subject, or congenital abnormality or birth defect after receiving the investigational vaccine. In addition, other important medical events should also be considered for SAE accelerated reporting
Measured: During the entire study period (From Month 0 up to Month 60)
Pregnancy outcomes in pregnant subjects( pregnancy event report form)
Previous pregnancy, current pregnancy mode, neonatal information.
Measured: During the entire study period (From Month 0 up to Month 60)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Aug 2023Aug 2028

First posted18 Sep 2023
Study start13 Aug 2023
Primary completionMar 2024 (estimated)
Study completionAug 2028 (estimated)

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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Recombinant 14-Valent Human Papillomavirus Vaccine (Types 6,11,16,18,31,33,35,39, 45,51,52,56,58,59) （Insect Cell）
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 18,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06041061
Sponsor's protocol ID: SCT1000-03
Status last verified: Aug 2023
First submitted: 13 Aug 2023
Last updated: 18 Sep 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HPV InfectioN trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Efficacy, Safety, and Immunogenicity of a 14- Valent Recombinant Human Papillomavirus Vaccine (SCT1000) in Healthy Women Aged 18-45 Years
ClinicalTrials.gov ID: NCT06041061
Acronym / sponsor ID: SCT1000-03
Conditions: HPV InfectioN, HPV-Related Carcinoma
Keywords: HPV, Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 18,000 participants (actual)
Lead sponsor: Sinocelltech Ltd.Industry (pharma, biotech, devices)
Collaborators: Guangxi Center for Disease Control and Prevention, Henan Center for Disease Control and Prevention, Sichuan Center for Disease Control and Prevention, Centers for Disease Control and Prevention, China, Yunnan Center for Disease Control and Prevention
Study start: 13 Aug 2023 (actual)
Primary completion: Mar 2024 (estimated)
Study completion: Aug 2028 (estimated)
First posted: 18 Sep 2023 (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.

Detailed description

Cluster situation: a ratio of 1:1 between the experimental group and the placebo group.

End point index: relative index with efficacy, safety, and immunogenicity of SCT1000

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Recombinant 14-Valent Human Papillomavirus Vaccine (Types 6,11,16,18,31,33,35,39, 45,51,52,56,58,59) （Insect Cell）

Arm	Type	Receives
experiment group	Experimental	Biological: Recombinant 14-Valent Human Papillomavirus Vaccine（Insect Cell）According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine
placebo	Placebo comparator	Biological: placeboAccording to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

1. Females who are at least 18 years old and less than 46 years old (i.e., 18 to 45 years old).
2. Subjects sign a written informed consent form (ICF) to participate in the trial voluntarily, and are able to fully understand the trial procedures, the risks of participating in the trial, and the alternative interventions available to them if they do not participate in the trial.
3. Be able to read, understand and complete the diary/contact card. 4. Be in good health as judged by the history interview and physical examination.
5. Have a history of sexual behavior prior to enrollment. 6.Avoid sexual intercourse (including same-sex or opposite-sex anal, vaginal, or genital/genital contact) and avoid vaginal douching, vaginal cleansing, or the use of vaginal medications or preparations for 48 hours prior to any visit that includes sample collection.
7. Subjects who are not breastfeeding at the time of enrollment and who have used effective contraception from the time of their last menstrual period until enrollment in the study, and who understand and agree to use effective contraception from the first day of enrollment until 1 month after the last vaccination.

Key exclusion criteria (20 listed)

1. *Positive urine pregnancy test or pregnancy (including ectopic pregnancy) that has ended less than 6 weeks ago.
2. Prior vaccination with a marketed HPV vaccine or already enrolled in a clinical trial of another HPV vaccine or have plans to receive a non-study HPV vaccine during the study period.
3. Have a prior history of cervical cancer screening abnormalities or lesions [including HPV DNA positivity, squamous intraepithelial lesions (SIL) or atypical squamous cells of undetermined significance (ASC-US), atypical squamous epithelial cells-without the exception of high grade squamous intraepithelial lesions (ASC-H), atypical glandular cells (AGC), or have cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS) or cervical cancer]. ) or cervical cancer, etc.].
4. Previous or current anal or genital disease (e.g. vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar, vaginal, and anal cancers) 5. Previous total hysterectomy or pelvic radiation therapy or severe developmental abnormalities of the cervix/vagina.
6. History of drug or alcohol abuse or dependence in the last year. 7. Have hypertension or diabetes mellitus that cannot be controlled and stabilized with pharmacological interventions.

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
Recombinant 14-Valent Human Papillomavirus Vaccine（Insect Cell）According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine	Biological	experiment group
placeboAccording to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo	Biological	placebo

Primary outcome

Combined Incidence of HPV Type 16/18-related CIN2/3, AIS, Invasive cervical cancer, VIN2/3, VaIN2/3, AIN1/2/3, vulvar, vaginal and anal cancer
Time frame: 1 month after 3 doses of vaccine
The endpoint is defined to have occurred: (a) a HPV Pathology Panel consensus diagnosis from the results of cervical biopsy: Cervical Intraepithelial Neoplasia (CIN, including grade 2 or 3), Adenocarcinoma in Situ (AIS), Invasive cervical cancer, Vulvar Intraepithelial Neoplasia (VIN, including grade 2 or 3), Vaginal Intraepithelial Neoplasia (VaIN, including grade 2 or 3), Anal intraepithelial neoplasia (AIN, including grade 1, 2, or 3), vulvar, vaginal and anal cancer; AND (b) detection of at least 1 of Human Papillomavirus (HPV) types 16/18 by Polymerase Chain Reaction (PCR) assay for virus subtype.
Combined Incidence of HPV Type 31/33/45/52/58-related CIN2/3, AIS, Invasive cervical cancer, VIN2/3, VaIN2/3, AIN1/2/3, vulvar, vaginal and anal cancer
Time frame: 1 month after 3 doses of vaccine
The endpoint is defined to have occurred: (a) a HPV Pathology Panel consensus diagnosis from the results of cervical biopsy: Cervical Intraepithelial Neoplasia (CIN, including grade 2 or 3), Adenocarcinoma in Situ (AIS), Invasive cervical cancer, Vulvar Intraepithelial Neoplasia (VIN, including grade 2 or 3), Vaginal Intraepithelial Neoplasia (VaIN, including grade 2 or 3), Anal intraepithelial neoplasia (AIN, including grade 1, 2, or 3), vulvar, vaginal and anal cancer; AND (b) detection of at least 1 of Human Papillomavirus (HPV) types 31/33/45/52/58 by Polymerase Chain Reaction (PCR) assay for virus subtype.
Combined Incidence of HPV Type 35/39/51/56/59-related CIN2/3, AIS, Invasive cervical cancer, VIN2/3, VaIN2/3, AIN1/2/3, vulvar, vaginal and anal cancer
Time frame: 1 month after 3 doses of vaccine
The endpoint is defined to have occurred: (a) a HPV Pathology Panel consensus diagnosis from the results of cervical biopsy: Cervical Intraepithelial Neoplasia (CIN, including grade 2 or 3), Adenocarcinoma in Situ (AIS), Invasive cervical cancer, Vulvar Intraepithelial Neoplasia (VIN, including grade 2 or 3), Vaginal Intraepithelial Neoplasia (VaIN, including grade 2 or 3), Anal intraepithelial neoplasia (AIN, including grade 1, 2, or 3), vulvar, vaginal and anal cancer; AND (b) detection of at least 1 of Human Papillomavirus (HPV) types 35/39/51/56/59 by Polymerase Chain Reaction (PCR) assay for virus subtype.

20 secondary outcomes

Incidence of 6-month Persistent Infection associated with HPV types 16/18
Time frame: 1 month after 3 doses of vaccine
Incidence of 12-month Persistent Infection associated with HPV types 16/18
Time frame: 1 month after 3 doses of vaccine
Incidence of 6-month Persistent Infection associated with HPV types 31/33/45/52/58
Time frame: 1 month after 3 doses of vaccine
Incidence of 12-month Persistent Infection associated with HPV types 31/33/45/52/58
Time frame: 1 month after 3 doses of vaccine
Incidence of 6-month Persistent Infection associated with HPV types 35/39/51/56/59
Time frame: 1 month after 3 doses of vaccine
Incidence of 12-month Persistent Infection associated with HPV types 35/39/51/56/59
Time frame: 1 month after 3 doses of vaccine
Incidence of 6-month Persistent Infection associated with HPV types 6/11
Time frame: 1 month after 3 doses of vaccine
Incidence of 12-month Persistent Infection associated with HPV types 6/11
Time frame: 1 month after 3 doses of vaccine
Incidence of histopathologically confirmed genital warts related to HPV types 6, 11
Time frame: 1 month after 3 doses of vaccine
Incidence of histopathologically confirmed cervical, and/or anal, and/or vulvar, and/or vaginal lesions cases associated with HPV types 6/11/16/18 infection detected in the cervical cytology specimen
Time frame: 1 month after 3 doses of vaccine
Incidence of histopathologically confirmed cervical, and/or anal, and/or vulvar, and/or vaginal lesions cases associated with HPV types 31/33/45/52/58 infection detected in the cervical cytology specimen
Time frame: 1 month after 3 doses of vaccine
Incidence of histopathologically confirmed cervical, and/or anal, and/or vulvar, and/or vaginal lesions cases associated with HPV types 35/39/51/56/59 infection detected in the cervical cytology specimen
Time frame: 1 month after 3 doses of vaccine
Incidence of histopathologically confirmed cervical, and/or anal, and/or vulvar, and/or vaginal lesions cases associated with HPV types 6/11/16/18/31/33/45/52/58 infection detected in the cervical cytology specimen
Time frame: 1 month after 3 doses of vaccine
Incidence of histopathologically confirmed cervical, and/or anal, and/or vulvar, and/or vaginal lesions cases associated with HPV types 6/11/16/18/31/33/45/52/58/35/39/51/56/59 infection detected in the cervical cytology specimen
Time frame: 1 month after 3 doses of vaccine
GMC of total anti-HPV6/11/16/18/31/33/45/52/58/35/39/51/56/59 type-associated specific IgG antibodies assessed by cLIA
Time frame: At least 1 month after 3 doses of immunization
Positive conversion rate of total anti-HPV6/11/16/18/31/33/45/52/58/35/39/51/56/59 type-associated specific IgG antibodies assessed by cLIA
Time frame: At least 1 month after 3 doses of immunization
GMT of HPV6/11/16/18/31/33/45/52/58/35/39/51/56/59 type-associated neutralizing antibodies.
Time frame: At least 1 month after 3 doses of immunization
AEs Incidence
Time frame: During the entire study period (From Month 0 up to Month 60)
SAEs Incidence
Time frame: During the entire study period (From Month 0 up to Month 60)
Pregnancy outcomes in pregnant subjects( pregnancy event report form)
Time frame: During the entire study period (From Month 0 up to Month 60)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
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.

Yi Mo principal investigator

Guangxi Center for Disease Control and Prevention

Yan Zheng principal investigator

Yunnan Center for Disease Control and Prevention

Guohua Li principal investigator

Centers for Disease Control and Prevention, China

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant 14-Valent Human Papillomavirus Vaccine（Insect Cell） in people with HPV InfectioN and HPV-Related Carcinoma, run by Sinocelltech Ltd. at 5 sites 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 20 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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?

Combined Incidence of HPV Type 16/18-related CIN2/3, AIS, Invasive cervical cancer, VIN2/3, VaIN2/3, AIN1/2/3, vulvar, vaginal and anal cancer (time frame: 1 month after 3 doses of vaccine). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06041061.

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 18 Sep 2023.