Human Papillomavirus InfectionPhase 3NCT05668572

A Phase III Trial Evaluates the Efficacy, Immunogenicity and Safety Profile of HPV Vaccine

A Phase 3 study testing Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) and Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)（GARDASIL®） in people with Human Papillomavirus Infection, run by Beijing Health Guard Biotechnology, Inc at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study is to demonstrate that the administration of the investigational vaccine can reduce the Combined Incidence of HPV types 6/11/16/18/31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial… Read more about this study

Who is it for?: Ages 20 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Human Papillomavirus Infection
What is being tested?: Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) and Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)（GARDASIL®）
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12,000 participants
Where: 3 sitesChina
Study dates: 5 Dec 2020to 23 Feb 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 20 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Female subjects ages ≥20 and <46 (i.e. 20-45 years of age).
Subjects who voluntarily agree to participate in the trial by giving written informed consent, fully understand of study procedures and the risks associated with participating in the study, and are aware of alternative interventions are available for those who do not participate in the trial.
Subjects who are able to read, understand, and complete the daily diary card.
Subjects who are in a good physical health as decided by the investigator based on his/her medical history and physical checkup results.
Subjects who have had sexual activity prior to enrollment.
Subjects who have refrained from sexual activity (including anal, vaginal, or genital/genital contact whether same sex or opposite sex) and agree to refrain from douching/vaginal cleansing, and using vaginal medications or preparations for 48 hours prior to any visit that includes collection of study specimens.

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Note: if a subject does not meet this inclusion criterion, the Day 0 visit (at enrollment) may be rescheduled for a time when such criterion can be met.
Subjects who are not pregnant (with negative urine pregnancy test) and breastfeeding at enrollment, and do not plan for pregnancy in the following 7 months; who have used effective contraception with no failures for 2 calendar days prior to the Day 0 visit (at enrollment), at the same time understand and agree that from Day 0 through Month 7, she shall not have sexual intercourse with males without effective contraception [Effective contraception is defined as the use of a marketed, approved contraceptive product that includes oral contraceptives, contraceptive injections, sub-dermal contraceptive implants, slow-release systems, contraception-patches, intrauterine devices (IUD), sterilization, abstinence, male condoms, contraceptive diaphragms, cervical cap].
Subjects with an axillary temperature of 37.0 ℃ or less at enrollment.

Who cannot join

Subjects who have received a marketed HPV vaccine, or have participated in an HPV vaccine clinical trial other than this one, or plan to receive an HPV vaccine other than the investigational vaccine or positive control during this study.
Subjects who have a history of cervical cancer, CIN2+, HPV infections or an abnormal cytology result.
Subjects who have a history of HPV-related external genital lesions (e.g. VIN, VaIN and genital warts), external genital cancer or vaginal cancer.
Subjects who have a history of pelvic radiotherapy.
Subjects who have had a recent history (within the last year) of drug or alcohol abuse or dependence.
Subjects who have hypertension or diabetes mellitus despite being treated by medication.

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Subjects who have a history of severe allergic reaction (e.g. anaphylactic shock, laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, Arthus reaction, etc.) to any prior vaccination or medication that required medical intervention.
Subjects who are currently immunocompromised or have been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune conditions.
Subjects who have had a splenectomy.
Subjects who are receiving or have received in the year prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), TNF-α antagonists, monocolonal antibody therapies, intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with immune responses to the interventions.
Subjects who are currently receiving systemic steroid therapy, or have received 2 or more courses of high dose systemic corticosteroids lasting at least 1 week in duration in the year prior to enrollment, with the exception of those who use inhaled, nasal, or topical corticosteroids.
Subjects who have received any immune globulin product or blood-derived product within the 3 months prior to the first vaccination, or plan to receive any such product during the Day 0 through Month 7 period of the study.
Subjects who have received inactivated vaccines within 14 days prior to the first vaccination or have received replicating (live attenuated) vaccines within 28 days prior to the first vaccination.
Subjects who have thrombocytopenia or other coagulation disorder that would contraindicate intramuscular injections.
Subject who have donated blood within 1 week prior to the first vaccination, or intend to donate during the Day 0 through Month 7 period of the study.
Subjects who are expecting to donate eggs during the Day 0 through Month 7 period of the study.
Subjects who are concurrently enrolled in clinical studies of other investigational or unregistered drug or vaccine, or studies involving collection of cervical specimens.
Subjects who are unlikely to adhere to the study procedures, keep appointments, or are planning to relocate during the study.
Subjects who have had a fever (defined as an axillary temperature ≥38.0 ˚C) within 3 days prior to the first vaccination or any acute illness that required systemic antibiotic and antiviral treatment within 5 days prior to the first vaccination.
Subjects who have acute genital infections (e.g. acute vaginitis, acute endometritis, acute salpingitis, acute oophoritis) or gross purulent cervicitis.
Subjects who are having menses (specimen collection at enrollment should be rescheduled for at least 3 days post the last day of the menstrual period).
Subjects who do not have an intact cervix uteri or have more than one cervix uteri.
Subjects who have a history or current evidence of other circumstances which might confound the results of the study, or which suggest it is not in the best interest of the subject to participate, as per the judgement of the investigator.

Trial locations and contacts

3 sites in 1 country.

China3 sites

CDC, Guangdong Provinc
Guangzhou, Guangdong, 510440
CDC, Jiangsu Province
Nanjing, Jiangsu, 210009
CDC, Shanxi Province
Taiyuan, Shanxi, 030012

Other trials in China

About this study

Official title: A Multi-centre, Blinded, Randomized and Gardasil-controlled Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety Profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)

Read the detailed description

This is a multi-center, blinded, randomized and Gardasil-controlled (quadrivalent HPV vaccine GARDASIL®) Phase III clinical study. The study will recruit a total of approximately 12,000 healthy Chinese women ages 20-45 years with permanent residence, who will be randomized at a 1: 1 ratio to receive the investigational vaccine or the positive control (quadrivalent HPV vaccine GARDASIL®), respectively.

Healthy women ages 20-45 eligible for the study will be stratified at a 2: 2: 1 ratio into three age subgroups (i.e. 20-26 years of age, 27-35 years of age and 36-45 years of age), and each subgroup will be randomized at a 1: 1 ratio to receive the investigational vaccine or the positive control (quadrivalent HPV vaccine GARDASIL®), respectively. A total of 1,000 subjects will be allocated to an Immunogenicity Cohort, who will also be randomized at a 1: 1 ratio to receive the investigational vaccine or the positive control. The Immunogenicity Cohort is set up to evaluate the immune responses induced by the investigational vaccine and their persistence.

For the Sample allocation plan, twelve thousand (12,000) subjects from the chosen clinical trial sites are stratified at a 2: 2: 1 ratio into 3 age subgroups, i.e. 4,800 in the subgroup of ages 20-26 years, 4,800 in the subgroup of ages 27-35 years, and 2,400 in the subgroup 36-45 years of age.

Immunogenicity evaluation will be conducted at a clinical trial site in 1,000 subjects, selected randomly in the order of enrollment.

The Primary study objectives also involve:

-To demonstrate that administration of the investigational vaccine reduces the Combined Incidence of HPV types 6/11/16/18/31/33/45/52/58-related persistent infections, and cervical, vulvar, vaginal and anal lesions detected in samples from three or more consecutive visits (+/-1 month visit window) 12 months or longer apart.

The Secondary study objectives involve:

To evaluate the safety profile of the investigational vaccine in healthy women ages 20-45;
To demonstrate that geometric mean titers of antibody responses specific to HPV types 6/11/16/18 induced by the investigational vaccine are non-inferior to those generated by GARDASIL;
To demonstrate that the investigational vaccine produces antibody responses specific to HPV types 31/33/45/52/58;
To evaluate the levels and persistence of antibody responses against HPV types 6/11/16/18/31/33/45/52/58 generated by the investigational vaccine;
To demonstrate that the investigational vaccine reduces the Combined Incidence of HPV types 6/11/16/18/31/33/45/52/58-related persistent infections detected in samples from 2 or more consecutive visits 6 months (+/-1 month visit window) or longer apart.

The Exploratory study objectives involve:

To evaluate the impact of a 3-dose regimen of the investigational vaccine on the incidence of HPV types 6/11/16/18/31/33/45/52/58-related cytological abnormalities (ASC-US, positive for high-risk HPV types, or worse) as determined by the Thinprep cytologic test (TCT test) among subjects, who are naïve (seronegative) to the relevant HPV type(s) (HPV 6/11/16/18/31/33/45/52/58) at baseline and remain negative to the relevant HPV type(s) as determined by HPV-DNA test and without abnormal cervical biopsy result through Month 7;
To evaluate the incidence of non-vaccine HPV type-related Cervical Intraepithelial Neoplasia (CIN), Adenocarcinoma in Situ (AIS) and Cervical Carcinoma as determined by histopathologic examination post 3 doses of the investigational vaccine;
To evaluate the incidence of non-vaccine HPV type-related persistent infections for no less than 6 months, and cervical, vulvar, vaginal and anal diseases as determined by histopathologic examination post 3 doses of the investigational vaccine;
To evaluate the incidence of non-vaccine HPV type-related cytological abnormalities (ASC-US, positive for high-risk HPV types, or worse) as determined by the TCT test post 3 doses of the investigational vaccine.

Conditions: Human Papillomavirus Infection
Being tested: Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli), Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)（GARDASIL®）
Keywords: CIN 2/3, AIS, Invasive Cervical Carcinoma, VIN 2/3, VaIN 2/3, Anal Intraepithelial Neoplas
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 Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli)Biological
0.5-mL suspension for injection, each 0.5-mL prefilled syringe dose contains L1 proteins of HPV types 6/11/16/18/31/33/45/52/58 in the amounts of 30mcg, 40mcg, 60mcg, 40mcg, 20mcg, 20mcg, 20mcg, 20mcg and 20mcg, respectively, totaling 270mcg of antigens. A 3-dose regimen administered at months 0, 2 and 6.
Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)（GARDASIL®）Biological
0.5-mL suspension for injection, each 0.5-mL single-dose syringe contains approximately 20 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 40 mcg of HPV Type 16 L1 protein, 20 mcg of HPV Type 18 L1 protein, totaling 120 mcg of antigens

Study groups in NCT05668572
Study group	Role	What they receive
The Group of Investigational Vaccine	Experimental	Not described Receives: Biological: Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli)
The Group of Active Control Vaccine	Active comparator	Not described Receives: Biological: Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)（GARDASIL®）

What is being measured

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

The combined incidence of HPV types 6/11/16/18/31/33/45/52/58-related high-grade diseases
The combined incidence of HPV types 6/11/16/18/31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), high-grade Anal Intraepithelial Neoplasia (AIN 2/3), vulvar cancer, vaginal cancer and anal cancer post 3 doses of the investigational vaccine as determined by histopathologic examination among subjects, who are naïve (seronegative) to the relevant HPV type(s) (HPV 6/11/16/18/31/33/45/52/58) at baseline and remain negative to the relevant HPV type(s) as determined by HPV-DNA test and without abnormal cervical biopsy result through Month 7 (composite end point)
Measured: Up to 60th month after full immunization
The combined incidence of specific HPV types related persistent infections for no less than 12 months and related diseases
The combined incidence of HPV types 6/11/16/18/31/33/45/52/58-related persistent infections for no less than 12 months as determined by testing samples from consecutive visits, and cervical, vulvar, vaginal and anal diseases among subjects, who are naïve (seronegative) to the relevant HPV type(s) (HPV 6/11/16/18/31/33/45/52/58) at baseline and remain negative to the relevant HPV type(s) as determined by HPV-DNA test and without abnormal cervical biopsy result through Month 7.
Measured: Up to 60th month after full immunization.

Secondary outcomes (15)

Overall incidence of adverse events post vaccination
Overall incidence of adverse events post vaccination
Measured: 0-30 days after each immunization
Overall incidence of adverse reactions post vaccination
Overall incidence of adverse reactions post vaccination
Measured: 0-30 days after each immunization
Incidence of adverse reactions by severity post vaccination
Incidence of adverse reactions by severity post vaccination
Measured: 0-30 days after each immunization
Percentage of subjects with one or more injection-site or non-injection-site
Percentage of subjects with one or more injection-site or non-injection-site
Measured: 0-30 days after each immunization
Incidence of adverse event/adverse reaction by sign/symptom post vaccination
Incidence of adverse event/adverse reaction by sign/symptom post vaccination
Measured: 0-30 days after each immunization
Severity of adverse event/adverse reaction post vaccination
Severity of adverse event/adverse reaction post vaccination
Measured: 0-30 days after each immunization
Incidence of adverse reactions post each vaccination
Incidence of adverse reactions post each vaccination
Measured: 0-30 days after each immunization
Incidence of serious adverse events that occur during the observation period
Incidence of serious adverse events that occur during the observation period
Measured: Through study completion, an average of 5 years
Follow up the information on Pregnancy events through the interview, telephone call, and Safety follow-up Diary Card (Questionnaire).
Follow up the information on Pregnancy events through the interview, telephone call, and Safety follow-up Diary Card (Questionnaire).
Measured: Through study completion, an average of 5 years
Follow up the information on birth/infant outcomes through the interview, telephone call, and Safety follow-up Diary Card (Questionnaire).
Follow up the information on birth/infant outcomes through the interview, telephone call, and Safety follow-up Diary Card (Questionnaire).
Measured: Through study completion, an average of 5 years
Incidence of HPV types 6/11/16/18/31/33/45/52/58-related persistent infections for no less than 6 months
Incidence of HPV types 6/11/16/18/31/33/45/52/58-related persistent infections for no less than 6 months as determined by testing samples from consecutive visits among subjects, who are naïve (seronegative) to the relevant HPV type(s) (HPV 6/11/16/18/31/33/45/52/58) at baseline and remain negative to the relevant HPV type(s) as determined by HPV-DNA test and without abnormal cervical biopsy result through Month 7
Measured: Up to 60th month after the first immunization
GMTs of neutralizing antibody responses to vaccine HPV types determined among subjects who are seronegative
GMTs of neutralizing antibody responses and seroconversion rates to vaccine HPV types, as determined by Pseudovirus-based Neutralization Assay at week 4 post dose 3 in subjects who are naïve (seronegative) to the relevant HPV type(s) (HPV 6/11/16/18/31/33/45/52/58) at baseline and remain negative to the relevant HPV type(s) as determined by HPV-DNA test and without abnormal cervical biopsy result through Month 7
Measured: 7th month after the first immunization
Seroconversion rates to vaccine HPV types determined among subjects who are seronegative
Seroconversion rates to vaccine HPV types, as determined by Pseudovirus-based Neutralization Assay at week 4 post dose 3 in subjects who are naïve (seronegative) to the relevant HPV type(s) (HPV 6/11/16/18/31/33/45/52/58) at baseline and remain negative to the relevant HPV type(s) as determined by HPV-DNA test and without abnormal cervical biopsy result through Month 7
Measured: 7th month after the first immunization
The immune responses to HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58, and their persistence in terms of GMTs of vaccine HPV type-specific neutralizing antibodies among the group who are seronegative
To evaluate immune responses to HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58, and their persistence in terms of GMTs of vaccine HPV type-specific neutralizing antibodies, as determined by Pseudovirus-based Neutralization Assay , respectively among the group who are seronegative to the relevant HPV type(s) (HPV 6/11/16/18/31/33/45/52/58) at baseline and remain
Measured: Up to the 60 months after the first immunization
The immune responses to HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58, and their persistence in terms of GMTs of vaccine HPV type-specific IgG antibodies among the group who are seronegative
To evaluate immune responses to HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58, and their persistence in terms of GMTs of vaccine HPV type-specific IgG antibodies, as determined by ELISA assay, respectively among the group who are seronegative to the relevant HPV type(s) (HPV 6/11/16/18/31/33/45/52/58) at baseline and remain
Measured: Up to the 60 months after the first immunization

Timeline

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

5 Dec 202023 Feb 2023

First posted30 Dec 2022
Study start5 Dec 2020
Primary completion21 Jul 2022
Study completion23 Feb 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Human Papillomavirus 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
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 12,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05668572
Sponsor's protocol ID: KLWS-V502-03
Status last verified: Dec 2022
First submitted: 6 Dec 2022
Last updated: 4 Jan 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No informed consent was obtained to disclose the subject's data and sample test results.

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 Human Papillomavirus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre, Blinded, Randomized and Gardasil-controlled Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety Profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)
ClinicalTrials.gov ID: NCT05668572
Acronym / sponsor ID: KLWS-V502-03
Conditions: Human Papillomavirus Infection
Keywords: CIN 2/3, AIS, Invasive Cervical Carcinoma, VIN 2/3, VaIN 2/3, Anal Intraepithelial Neoplas
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 12,000 participants (actual)
Lead sponsor: Beijing Health Guard Biotechnology, IncIndustry (pharma, biotech, devices)
Study start: 5 Dec 2020 (actual)
Primary completion: 21 Jul 2022 (actual)
Study completion: 23 Feb 2023 (estimated)
First posted: 30 Dec 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.

Detailed description

Immunogenicity evaluation will be conducted at a clinical trial site in 1,000 subjects, selected randomly in the order of enrollment.

The Primary study objectives also involve:

The Secondary study objectives involve:

To evaluate the safety profile of the investigational vaccine in healthy women ages 20-45;
To demonstrate that geometric mean titers of antibody responses specific to HPV types 6/11/16/18 induced by the investigational vaccine are non-inferior to those generated by GARDASIL;
To demonstrate that the investigational vaccine produces antibody responses specific to HPV types 31/33/45/52/58;
To evaluate the levels and persistence of antibody responses against HPV types 6/11/16/18/31/33/45/52/58 generated by the investigational vaccine;
To demonstrate that the investigational vaccine reduces the Combined Incidence of HPV types 6/11/16/18/31/33/45/52/58-related persistent infections detected in samples from 2 or more consecutive visits 6 months (+/-1 month visit window) or longer apart.

The Exploratory study objectives involve:

To evaluate the impact of a 3-dose regimen of the investigational vaccine on the incidence of HPV types 6/11/16/18/31/33/45/52/58-related cytological abnormalities (ASC-US, positive for high-risk HPV types, or worse) as determined by the Thinprep cytologic test (TCT test) among subjects, who are naïve (seronegative) to the relevant HPV type(s) (HPV 6/11/16/18/31/33/45/52/58) at baseline and remain negative to the relevant HPV type(s) as determined by HPV-DNA test and without abnormal cervical biopsy result through Month 7;
To evaluate the incidence of non-vaccine HPV type-related Cervical Intraepithelial Neoplasia (CIN), Adenocarcinoma in Situ (AIS) and Cervical Carcinoma as determined by histopathologic examination post 3 doses of the investigational vaccine;
To evaluate the incidence of non-vaccine HPV type-related persistent infections for no less than 6 months, and cervical, vulvar, vaginal and anal diseases as determined by histopathologic examination post 3 doses of the investigational vaccine;
To evaluate the incidence of non-vaccine HPV type-related cytological abnormalities (ASC-US, positive for high-risk HPV types, or worse) as determined by the TCT test post 3 doses of the investigational vaccine.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
The Group of Investigational Vaccine	Experimental	Biological: Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli)
The Group of Active Control Vaccine	Active comparator	Biological: Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)（GARDASIL®）

Who may qualify

Ages: 20 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Female subjects ages ≥20 and <46 (i.e. 20-45 years of age).
Subjects who voluntarily agree to participate in the trial by giving written informed consent, fully understand of study procedures and the risks associated with participating in the study, and are aware of alternative interventions are available for those who do not participate in the trial.
Subjects who are able to read, understand, and complete the daily diary card.
Subjects who are in a good physical health as decided by the investigator based on his/her medical history and physical checkup results.
Subjects who have had sexual activity prior to enrollment.

Key exclusion criteria (23 listed)

Subjects who have received a marketed HPV vaccine, or have participated in an HPV vaccine clinical trial other than this one, or plan to receive an HPV vaccine other than the investigational vaccine or positive control during this study.
Subjects who have a history of cervical cancer, CIN2+, HPV infections or an abnormal cytology result.
Subjects who have a history of HPV-related external genital lesions (e.g. VIN, VaIN and genital warts), external genital cancer or vaginal cancer.
Subjects who have a history of pelvic radiotherapy.
Subjects who have had a recent history (within the last year) of drug or alcohol abuse or dependence.

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 Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli)0.5-mL suspension for injection, each 0.5-mL prefilled syringe dose contains L1 proteins of HPV types 6/11/16/18/31/33/45/52/58 in the amounts of 30mcg, 40mcg, 60mcg, 40mcg, 20mcg, 20mcg, 20mcg, 20mcg and 20mcg, respectively, totaling 270mcg of antigens. A 3-dose regimen administered at months 0, 2 and 6.	Biological	The Group of Investigational Vaccine
Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)（GARDASIL®）0.5-mL suspension for injection, each 0.5-mL single-dose syringe contains approximately 20 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 40 mcg of HPV Type 16 L1 protein, 20 mcg of HPV Type 18 L1 protein, totaling 120 mcg of antigens	Biological	The Group of Active Control Vaccine

Primary outcome

The combined incidence of HPV types 6/11/16/18/31/33/45/52/58-related high-grade diseases
Time frame: Up to 60th month after full immunization
The combined incidence of HPV types 6/11/16/18/31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), high-grade Anal Intraepithelial Neoplasia (AIN 2/3), vulvar cancer, vaginal cancer and anal cancer post 3 doses of the investigational vaccine as determined by histopathologic examination among subjects, who are naïve (seronegative) to the relevant HPV type(s) (HPV 6/11/16/18/31/33/45/52/58) at baseline and remain negative to the relevant HPV type(s) as determined by HPV-DNA test and without abnormal cervical biopsy result through Month 7 (composite end point)
The combined incidence of specific HPV types related persistent infections for no less than 12 months and related diseases
Time frame: Up to 60th month after full immunization.
The combined incidence of HPV types 6/11/16/18/31/33/45/52/58-related persistent infections for no less than 12 months as determined by testing samples from consecutive visits, and cervical, vulvar, vaginal and anal diseases among subjects, who are naïve (seronegative) to the relevant HPV type(s) (HPV 6/11/16/18/31/33/45/52/58) at baseline and remain negative to the relevant HPV type(s) as determined by HPV-DNA test and without abnormal cervical biopsy result through Month 7.

15 secondary outcomes

Overall incidence of adverse events post vaccination
Time frame: 0-30 days after each immunization
Overall incidence of adverse reactions post vaccination
Time frame: 0-30 days after each immunization
Incidence of adverse reactions by severity post vaccination
Time frame: 0-30 days after each immunization
Percentage of subjects with one or more injection-site or non-injection-site
Time frame: 0-30 days after each immunization
Incidence of adverse event/adverse reaction by sign/symptom post vaccination
Time frame: 0-30 days after each immunization
Severity of adverse event/adverse reaction post vaccination
Time frame: 0-30 days after each immunization
Incidence of adverse reactions post each vaccination
Time frame: 0-30 days after each immunization
Incidence of serious adverse events that occur during the observation period
Time frame: Through study completion, an average of 5 years
Follow up the information on Pregnancy events through the interview, telephone call, and Safety follow-up Diary Card (Questionnaire).
Time frame: Through study completion, an average of 5 years
Follow up the information on birth/infant outcomes through the interview, telephone call, and Safety follow-up Diary Card (Questionnaire).
Time frame: Through study completion, an average of 5 years
Incidence of HPV types 6/11/16/18/31/33/45/52/58-related persistent infections for no less than 6 months
Time frame: Up to 60th month after the first immunization
GMTs of neutralizing antibody responses to vaccine HPV types determined among subjects who are seronegative
Time frame: 7th month after the first immunization
Seroconversion rates to vaccine HPV types determined among subjects who are seronegative
Time frame: 7th month after the first immunization
The immune responses to HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58, and their persistence in terms of GMTs of vaccine HPV type-specific neutralizing antibodies among the group who are seronegative
Time frame: Up to the 60 months after the first immunization
The immune responses to HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58, and their persistence in terms of GMTs of vaccine HPV type-specific IgG antibodies among the group who are seronegative
Time frame: Up to the 60 months after the first immunization

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
Individual participant dataSharing planned: No. No informed consent was obtained to disclose the subject's data and sample test results.

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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.

Yongjiang Liu, Bachelor study chair

Beijing Health Guard Biotechnology, Inc

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

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 23 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 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. 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?

The combined incidence of HPV types 6/11/16/18/31/33/45/52/58-related high-grade diseases (time frame: Up to 60th month after full immunization). 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?

On the ClinicalTrials.gov record for NCT05668572.

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 4 Jan 2023.