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Genital WartPhase 3NCT06465914

A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males

A Phase 3 study testing 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in people with Genital Wart and Penile Cancer, run by Shanghai Bovax Biotechnology Co., 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

This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Human Papillomavirus (HPV) Recombinant Vaccine (Hansenula Polymorpha) in Chinese male subjects aged 18-45 years. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Genital Wart, Penile Cancer, Anal Cancer
What is being tested?
9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9,000 participants
Where
5 sitesChina
Study dates
11 Jul 2024to 30 Jul 2030
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Chinese men aged 18-45 years who can provide legal identification and have a sexual life history;
  • Subjects fully understands the study procedures, understands the risks and benefits associated with participating in the study, and voluntarily signs the informed consent;
  • Subjects are able to read, understand and fill in the research application forms such as diary CARDS and contact CARDS, and promise to participate in regular follow-up according to the study requirements;
  • Heterosexual men subjects must have exclusively female sexual partners and no more than 5 before enrollment;
  • MSM subject must have had sex with men within the past year (either insertive or receptive anal intercourse); and the cumulative number of sexual partners (including male and female sexual partners) does not exceed 5 before enrollment;
  • Subjects agree to provide effective contact information that can be used for communication with the researchers during the study;
  • Subjects consent to external anogenital lesion inspection and sample collection (including but not limited to wet swab collection and necessary biopsy) during the study period;
  • Subjects agree to take effective contraceptive measures from the first dose to 1 month after the last dose [male effective contraception including abstinence, male condom, vasectomy, etc.; female valid contraception including the pill (excluding emergency contraception), injection or embedded contraception, sustained-release topical contraceptives, hormonal patch, intrauterine devices (IUD), sterilization, diaphragm, cervical caps, etc.; safe period contraception, extracorporeal ejaculation, and emergency contraception are unacceptable contraception.]

Who cannot join

  • Initial inoculation exclusion criteria (If the "" option is met during screening, the enrollment can be postponed and the re-screening can be rescheduled )
  • * Subjects with axillary temperature ≥37.3℃ 24 hours before the first vaccination;
  • * Higher blood pressure on the day of the first vaccination (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg);
  • * Sexual activity (including anal, vaginal/genital contact of the same or opposite sex) within 48 hours prior to the sampling visit; Self-shave hair from genital area within 24 hours prior to the genital examination visit (and/or using any post-shaving lotions or lubricants);
  • Have been or planned to be vaccinated with commercially available HPV vaccine; Have participated in or plan to participate in other HPV vaccine clinical trials;
  • Previous positive HPV test results (including types not included in the investigational vaccine) or related cytological abnormalities；
Show all 24Show fewer
  • Previous or current HPV-related genital warts, penile/perianal/perineal intraepithelial neoplasia, penile/perianal/perineal cancer, anal intraepithelial neoplasia, or anal cancer;
  • Significant clinical evidence of external genital lesions and anal diseases (only MSM) suggesting the HPV infection during the external anogenital inspection before the first vaccination;
  • * Acute illness or acute episode of chronic disease, or use of antipyretic, analgesic and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 3 days prior to vaccination;
  • * Received inactivated/recombinant/nucleic acid vaccine (non-attenuated vaccine) within 7 days prior to recruitment, or attenuated vaccine within 14 days prior to enrollment;
  • * Received any immune globulin or blood derived products within 3 months prior to enrollment, or plan to use any between the first vaccination and 1 month after full immunization;
  • * Received immunosuppressive therapy within 1 month prior to vaccination, such as immunosuppressive doses of glucocorticoids (dose reference: equivalent to prednisone 20mg/day for more than 7 days), or monoclonal antibodies, thymosin, interferon, etc., or plan to receive such treatment during the first dose until 1 month after full immunization, but topical administration (such as ointment, eye drops, inhalants or nasal sprays) is allowed;
  • Other investigational or unregistered products (drug or vaccine) that have been used within 3 months prior to the first dose or are planned to be used during the study period;
  • Present or have a history of convulsions (except febrile convulsions in childhood (0-14 years)), epilepsy, other serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.);
  • Present or have a history of mental illness or the family history;
  • There are contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation dysfunction, or being treated with anticoagulants;
  • Any condition resulting in asplenia or functional asplenia；
  • A history of severe allergic reactions requiring medical intervention (such as anaphylactic shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction), etc.); A history of severe adverse reactions to previous vaccination or a history of severe allergies (e.g. mouth and throat swelling, dyspnea, hypotension or shock, severe urticaria, etc.) to any vaccine component (histidine, sodium chloride, polysorbate 80, aluminum phosphate adjuvant and water for injection) ;
  • Subjects have been diagnosed with congenital or acquired immunodeficiency disease, such as: AIDS, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease or other immune disorders;
  • Currently have a serious infectious disease such as active tuberculosis, active viral hepatitis or acquired immunodeficiency syndrome (HIV infection);
  • Diagnosed with a serious congenital malformation or chronic disease that may interfere with the conduct or completion of the study, such as Down syndrome, heart disease, liver disease, kidney disease, diabetes with complications, or malignant tumors;
  • A history of drug abuse prior to enrolling, or a history of drug or alcohol abuse or dependence within the last year;
  • Subjects plan to permanently relocate from the region before the completion of the study or leave the region for a long period of time during the scheduled visit (affecting the scheduled visit time);
  • Investigators consider that the subjects have any condition that may interfere with the evaluation of the objectives of the study, or that participation in the study does not guarantee the maximum benefit of the subjects.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Hunan Center for Disease Control and Prevention

    Changsha, Hunan, 410153

  • Sichuan Center for Disease Control and Prevention

    Chengdu, Sichuan

  • Yunnan Center for Disease Control and Prevention

    Kunming, Yunnan

  • Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

    Nanning, Guangxi

  • Shanxi Provincial Disease for Control and Prevention

    Taiyuan, Shanxi

Other trials in China

About this study

Official title: A Randomized, Double-blinded, Multicenter and Placebo-controlled Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Recombinant Vaccine (Hansenula Polymorpha) in Chinese Males Aged 18-45 Years

This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Human Papillomavirus (HPV) Recombinant Vaccine (Hansenula Polymorpha) in Chinese male subjects aged 18-45 years. The primary hypothesis in the study is the 9-valent HPV recombinant vaccine reduces the incidence of vaccine HPV types-related genital warts compared with placebo in Chinese men.

Read the detailed description

The primary aim of this clinical trial is to evaluate the efficacy of the 9-valent HPV vaccine in men aged 18-45 years old. It will also learn about the safety and immunogenicity of the 9-valent HPV vaccine.

Participants will inoculate the 9-valent HPV vaccine or a placebo according to the 0, 2, 6 month immunization program.

Visit the clinic on the 8th and 31st day after each dose of vaccination for the collection of safety information, keeping a diary of their symptoms and medications.

Being tested
9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha), Placebo
Medical subject headings
Condylomata Acuminata, Penile Neoplasms, Anus Neoplasms

What participants receive

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

  • 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha)Biological

    Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle).

  • PlaceboBiological

    Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle).

Study groups in NCT06465914
Study groupRoleWhat they receive
9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) vaccineExperimentalParticipants in this arm would receive 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha). Follow-up for the study encompassed Month 7 through Month 72.
Receives: Biological: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha)
PlaceboPlacebo comparatorParticipants in this arm would receive Placebo. Follow-up for the study encompassed Month 7 through Month 72.
Receives: Biological: Placebo

What is being measured

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

  1. The incidence of genital wart

    The incidence of histopathologic confirmed HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, 58-related genital wart in male subjects who are neutralizing antibody seronegative at day 0 and HPV-DNA negative from day 0 through 30-day after full immunization.

    Measured: 0-72 month

Secondary outcomes (9)

  1. The combined incidence of AIN1/2/3 and anal cancer in MSM

    The combined incidence of histopathologic confirmed HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, 58-related AIN1/2/3 and anal cancer in MSM subjects who are neutralizing antibody seronegative at day 0 and HPV-DNA negative from day 0 through 30-day after full immunization.

    Measured: 0-72 month

  2. The combined incidence of PIN1/2/3 and Penile/perianal/perineal cancer

    The composite incidence of histopathologic confirmed HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, 58-related PIN1/2/3 and Penile/perianal/perineal cancer in male subjects who are neutralizing antibody seronegative at day 0 and HPV-DNA negative from day 0 through 30-day after full immunization.

    Measured: 0-72 month

  3. The incidence of PI 12

    The incidence of 12-month persistent HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, 58-related infection detected from anogenital swabs, anal cells, or tissue samples which are successive sampled post Dose 3 immunization in subjects who are neutralizing antibody seronegative at day 0 and HPV-DNA negative from day 0 through 30-day after full immunization.

    Measured: 0-72 month

  4. The incidence of PI 6

    The incidence of 6-month persistent HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, 58-related infection detected from anogenital swabs, anal cells, or tissue samples which are successive sampled post Dose 3 immunization in subjects who are neutralizing antibody seronegative at day 0 and HPV-DNA negative from day 0 through 30-day after full immunization.

    Measured: 0-72 month

  5. The incidence of transient infection

    The incidence of transient HPV 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52-, 58-related infection detected from anogenital swabs, anal cells, or tissue samples which are successive sampled post Dose 3 immunization in subjects who are neutralizing antibody seronegative at day 0 and HPV-DNA negative from day 0 through 30-day after full immunization.

    Measured: 0-72 month

  6. Immunogenicity

    Immunogenicity: Geometric mean titer (GMTs) of HPV vaccine type-related neutralizing antibodies (pseudoviral neutralizing antibody assay) and lgG antibodies (ELISA assay) of subjects at day 0, 30-day after full immunization, 12, 36, and 72 months, and serological conversion rate (SCR) was calculated.

    Measured: 0-72 month

  7. The incidence of solicited adverse events

    The incidence of solicited adverse events within 30 minutes and 0-7 days after each dose of vaccine for all subjects;

    Measured: 0-7 days after each dose of vaccine

  8. The incidence of unsolicited adverse events

    The incidence of unsolicited adverse events within 0-30 days after each dose of vaccine for all subjects;

    Measured: 0-30 days after each dose of vaccine

  9. The incidence of serious adverse events

    The incidence of all serious adverse events that occurred between the first dose and the last follow-up in all subjects.

    Measured: 0-72 month

Timeline

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

  1. First posted20 Jun 2024
  2. Study start11 Jul 2024
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion30 Jul 2030 (estimated)

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
9,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06465914
Sponsor's protocol ID
9-HPV-3004
Status last verified
Dec 2024
First submitted
14 Jun 2024
Last updated
12 Dec 2024
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 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in people with Genital Wart and Penile Cancer, run by Shanghai Bovax Biotechnology Co., 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 8 inclusion and 24 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 12 Dec 2024. 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?

The incidence of genital wart (time frame: 0-72 month). 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 NCT06465914.

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 12 Dec 2024.

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