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

NCT06465914 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 9-HPV-3004
• Study Type: interventional
• Target: 9,000
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

Genital Wart; Penile Cancer; Anal Cancer; PIN-1; PIN2; PIN3; AIN1; AIN2; AIN3; HPV-Related Carcinoma

Outcome Measures

Primary Outcomes (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.

  0-72 month

Secondary Outcomes (9)

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

  0-72 month

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

  0-72 month

• The incidence of PI 12

  0-72 month

• The incidence of PI 6

  0-72 month

• The incidence of transient infection

  0-72 month

Study Arms (2)

9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) vaccine

EXPERIMENTAL

Participants 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.

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

Placebo

PLACEBO COMPARATOR

Participants in this arm would receive Placebo. Follow-up for the study encompassed Month 7 through Month 72.

Biological: Placebo

Interventions

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).

9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) vaccine

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \[male effective contraception including abstinence, male condom, vasectomy, etc.; female valid contraception including the pill (excluding emergency contraception), injection or embedded contraception, sustained-release topical contraceptives, hormonal patch, intrauterine devices (IUD), sterilization, diaphragm, cervical caps, etc.; safe period contraception, extracorporeal ejaculation, and emergency contraception are unacceptable contraception.\]

You may not qualify if:

• \* 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；
• 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;

Sponsors & Collaborators

• Shanghai Bovax Biotechnology Co., Ltd.: lead

Study Sites (5)

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

Nanning, Guangxi, China

Location

Hunan Center for Disease Control and Prevention

Changsha, Hunan, 410153, China

Location

Shanxi Provincial Disease for Control and Prevention

Taiyuan, Shanxi, China

Location

Sichuan Center for Disease Control and Prevention

Chengdu, Sichuan, China

Location

Yunnan Center for Disease Control and Prevention

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Condylomata Acuminata; Penile Neoplasms; Anus Neoplasms

Interventions

Vaccines, Synthetic

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Penile Diseases; Male Urogenital Diseases; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; Antigens; Biological Factors

Study Officials

• Lidong Gao, Master

  Hunan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Long Sui, Doctor

  Obstetrics & Gynecology Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 20, 2024
• Study Start: July 11, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2030
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (5)