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Cervical CancerPhase 3NCT05584332

A Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity, Safety of Quadrivalent HPV Recombinant Vaccine in Chinese Healthy Females

A Phase 3 study testing Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in people with Cervical Cancer and Genital Wart, run by Shanghai Bovax Biotechnology Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 4-valent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 18-45 Years . Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cervical Cancer, Genital Wart, CIN1
What is being tested?
Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,131 participants
Where
1 siteChina
Study dates
9 Dec 2022to 23 Mar 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 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • (IF Non-compliance with criterion "*" option, the visit WILL be rescheduled)
  • Chinese women aged 18-45 who can provide legal identification and had a sexual life history;
  • The subject fully understands the study procedures, understands the risks and benefits associated related this study, and voluntarily signs the informed consent;
  • Subjects are able to read, understand and fill in application forms such as diary CARDS and contact CARDS, and participate in regular follow-up visits according to the study protocol;
  • *axillary's temperature <37.3℃ on the day of enrollment;
  • Subjects have not received any form of cervical cancer screening, or have been received 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;
  • When the subjects were enrolled, the urine pregnancy test was negative (sensitivity was 25mIU/ml β-HCG), they were not in the lactation period, had no family planning from Day 0 to 30 days after receiving the third dose of the vaccine. Agree to continue to use effective contraception (including: oral contraceptives, injectable or embedded contraceptives, sustained-release topical contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (men), diaphragms, cervical caps, etc.) from the day of enrollment to 30 days after the third season of vaccination. Safe-period contraception, in vitro ejaculation, and emergency contraception are unacceptable methods of contraception.

Who cannot join

  • (IF Non-compliance with criterion "*" option, the visit WILL be rescheduled)
  • Blood pressure (BP) before the first dose of vaccination was higher than normal or increased (systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg);
  • * Subjects had fever symptoms (axillary's temperature ≥37.3℃) before the first day of vaccination (within 24 hours before vaccination);
  • History of severe side effect to previous vaccinations or History of severe allergies (e.g. Swelling of the mouth and throat, Dyspnea, Hypotension or Shock, Severe urticaria) to components of study vaccine (e.g. Histidine, Polysorbate, and Aluminium phosphate). History of severe allergies requiring medical intervention, such as anaphylactic shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc;
  • Subjects with compromised immune systemsor have been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or Autoimmune thyroid disease （e.g. Hyperthyroidism，Thyroiditis/Subacute thyroiditis，or Hypothyroidism), and other Autoimmune diseases ;
  • Previous or current have epilepsy, seizures (except febrile seizures in children) or convulsions, or mental diseases, with a family history of psychosis;
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  • Absence of spleen or functional absence of spleen, and absence of spleen or splenectomy in any case;
  • Previous or current have severe liver, kidney and cardiovascular diseases, diabetic complications or malignant tumor;
  • Patients with thrombocytopenia or any coagulation disorders that may be contraindications to intramuscular injection;
  • Immunosuppressant or immunopotentiator 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 administration (such as ointment, eye drops, inhalant or nasal spray) exceeding the recommended dosage in the directions or showing any signs of systemic exposure) or planning to receive such treatment between the day of the first dose and 30 days after the third dose of the vaccine;
  • Received any immunoglobulin or blood product within 3 months prior to the first dose of vaccination, or plans to receive such product between the day of the first dose and 30 days after the third dose of the vaccine;
  • * An acute illness or an acute episode of a chronic illness within 3 days prior to vaccination, or use antipyretic, analgesic and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
  • 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 3 months;
  • * Received inactivated/recombinant/DNA vaccines (Non-attenuated vaccines) within 14 days prior to enrollment, or attenuated live vaccines within 28 days prior to enrollment;
  • 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 vaccine and have received a vaccine/placebo vaccination;
  • Subjects 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 the scheduled visit;
  • In the opinion of the investigators, the subjects 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 of the subjects;
  • * The first dose of vaccine was in pregnancy at the time of vaccination, or the end of pregnancy had not exceeded 6 weeks;
  • * Subject is in the menstrual period;
  • Previous positive history of HPV;
  • Had 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 intraepithelial lesion (ASC - H), atypical glandular epithelial cells, or those with cervical intraepithelial neoplasia (CIN) and carcinoma in situ or abnormal cervical biopsy results such as the history;
  • Previous history of vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar cancer, vaginal cancer, cancer, etc. may be caused by HPV infection;
  • 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 had a history of condyloma;
  • 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 cancer.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Yi M

    Liuzhou, Guangxi

Other trials in China

About this study

Official title: A Multicenter,Randomized, Placebo-Controlled, and Double-blind Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity and Safety of Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Aged 18-45 Years

This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 4-valent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 18-45 Years .

Being tested
Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha), Placebo
Medical subject headings
Uterine Cervical Neoplasms, Condylomata Acuminata

What participants receive

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

  • Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha)Biological

    0.5 ml injection in 3 dosing regimen

  • PlaceboBiological

    0.5 ml injection in 3 dosing regimen

Study groups in NCT05584332
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo
4vHPV VaccineExperimentalNot described
Receives: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha)

What is being measured

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

  1. The person-year incidence of HPV 16 and 18-related CIN 2+ observed in Chinese women aged 18-45 years after receiving 3 doses of quadrivalent HPV vaccine at least 30 days ago.

    Measured: Over 30 months

Secondary outcomes (14)

  1. The person-year incidence of HPV 6-, 11-, 16-, and 18-related 6-month Persistent Infection at least 30 days post Dose 3

    Measured: from Month 7 up to Month 60

  2. The person-year incidence of HPV 6-, 11-, 16-, and 18-related 12-month Persistent Infection at least 30 days post Dose 3

    Measured: from Month 7 up to Month 60

  3. The person-year incidence of HPV 6-, 11-, 16-, and 18-related disease (e.g., VIN1+ orAIN1+ or VAIN1+ and genital warts)

    Measured: from Month 7 up to Month 60

  4. Percentage of Participants Who Report at any Injection-site and Systemic Adverse Event 30 minutes post any vaccination

    Measured: 30 minutes after any dose of vaccination

  5. Number of subjects with Adverse Events (AEs)

    Subjects with solicited and unsolicited AEs

    Measured: From Day 0 to Month 30

  6. Number of subjects with Severe adverse events (SAE)

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

    Measured: Through study completion，expected 60 months

  7. Number of subjects with pregnancy events

    Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA) , Live infant, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth, Lost to follow up and Pregnancy ongoing.

    Measured: Through study completion，expected 60 months

  8. Number of subjects receiving the whole schedule vaccination with antibody responses as assessed by SCR

    Measured: Month7

  9. The neutralizing antibody level among the subjects receiving the whole schedule vaccination

    Measured: Month7

  10. The person-year incidence of non-vaccine-realted HPV types related CIN2+ observed in Chinese women aged 18-45 years at least 30 days post Dose 3

    Measured: Through study completion，expected 60 months

  11. The person-year incidence of non-vaccine-realted HPV types related disease (e.g., VIN1+ or AIN1+ or VAIN1+ and genital warts) observed in Chinese women aged 18-45 years at least 30 days post Dose 3

    Measured: Through study completion，expected 60 months

  12. The person-year incidence of HPV 6-, 11-, 16-, and 18-related 6-month and 12-month Persistent Infection at least 30 days post Dose 1

    Measured: From Month 1 up to Month 60

  13. The person-year incidence of HPV 16- and 18-related CIN2+ at least 30 days post Dose 1

    Measured: From Month 1 up to Month 60

  14. The person-year incidence of HPV 6-, 11-, 16- and 18-related diseases (e.g., VIN1+ or AIN1+ or VAIN1+ and genital warts) at least 30 days post Dose 1

    Measured: From Month 1 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.

  1. First posted18 Oct 2022
  2. Study start9 Dec 2022
  3. Primary completion23 Mar 2023
  4. Study completion23 Mar 2023

Why it stopped: Strategic adjustment

Resources

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
3,131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05584332
Sponsor's protocol ID
4-HPV-3004
Status last verified
Oct 2022
First submitted
12 Oct 2022
Last updated
21 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in people with Cervical Cancer and Genital Wart, run by Shanghai Bovax Biotechnology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 26 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: stopped early, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

The study was stopped early (reason given: Strategic adjustment). 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 person-year incidence of HPV 16 and 18-related CIN 2+ observed in Chinese women aged 18-45 years after receiving 3 doses of quadrivalent HPV vaccine at least 30 days ago. (time frame: Over 30 months). 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 NCT05584332.

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 21 Jul 2023.

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