Trial Title:
A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males
NCT ID:
NCT06465914
Condition:
Genital Wart
Penile Cancer
Anal Cancer
PIN-1
PIN2
PIN3
AIN1
AIN2
AIN3
HPV-Related Carcinoma
Conditions: Official terms:
Condylomata Acuminata
Anus Neoplasms
Penile Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Biological
Intervention name:
9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha)
Description:
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).
Arm group label:
9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) vaccine
Intervention type:
Biological
Intervention name:
Placebo
Description:
Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule (0.5 mL
intramuscular injection in the deltoid muscle).
Arm group label:
Placebo
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Chinese men aged 18-45 years who can provide legal identification and have a sexual
life history;
2. Subjects fully understands the study procedures, understands the risks and benefits
associated with participating in the study, and voluntarily signs the informed
consent;
3. 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;
4. Heterosexual men subjects must have exclusively female sexual partners and no more
than 5 before enrollment;
5. 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;
6. Subjects agree to provide effective contact information that can be used for
communication with the researchers during the study;
7. 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;
8. 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.]
Exclusion Criteria:
Initial inoculation exclusion criteria (If the "*" option is met during screening, the
enrollment can be postponed and the re-screening can be rescheduled )
1. * Subjects with axillary temperature ≥37.3℃ 24 hours before the first vaccination;
2. * Higher blood pressure on the day of the first vaccination (systolic blood pressure
≥140mmHg and/or diastolic blood pressure ≥90mmHg);
3. * 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);
4. 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;
5. Previous positive HPV test results (including types not included in the
investigational vaccine) or related cytological abnormalities；
6. Previous or current HPV-related genital warts, penile/perianal/perineal
intraepithelial neoplasia, penile/perianal/perineal cancer, anal intraepithelial
neoplasia, or anal cancer;
7. 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;
8. * 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;
9. * Received inactivated/recombinant/nucleic acid vaccine (non-attenuated vaccine)
within 7 days prior to recruitment, or attenuated vaccine within 14 days prior to
enrollment;
10. * 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;
11. * 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;
12. 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;
13. 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.);
14. Present or have a history of mental illness or the family history;
15. There are contraindications to intramuscular injection, such as having been
diagnosed with thrombocytopenia, any coagulation dysfunction, or being treated with
anticoagulants;
16. Any condition resulting in asplenia or functional asplenia；
17. 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) ;
18. 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;
19. Currently have a serious infectious disease such as active tuberculosis, active
viral hepatitis or acquired immunodeficiency syndrome (HIV infection);
20. 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;
21. A history of drug abuse prior to enrolling, or a history of drug or alcohol abuse or
dependence within the last year;
22. 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);
23. 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Address:
City:
Nanning
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Hunan Center for Disease Control and Prevention
Address:
City:
Changsha
Zip:
410153
Country:
China
Status:
Recruiting
Contact:
Last name:
Lidong Gao, Master
Phone:
13808489362
Email:
gaolidong@hncdc.com
Facility:
Name:
Shanxi Provincial Disease for Control and Prevention
Address:
City:
Taiyuan
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Sichuan Center for Disease Control and Prevention
Address:
City:
Chengdu
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Yunnan Center for Disease Control and Prevention
Address:
City:
Kunming
Country:
China
Status:
Not yet recruiting
Start date:
July 11, 2024
Completion date:
July 30, 2030
Lead sponsor:
Agency:
Shanghai Bovax Biotechnology Co., Ltd.
Agency class:
Industry
Source:
Shanghai Bovax Biotechnology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06465914
