Warts, Genital Clinical Trial
Official title:
A Phase 3, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9vHPV Vaccine in Japanese Males, 16 to 26 Years of Age.
| Verified date | December 2023 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 (9-valent human papillomavirus [9vHPV] vaccine) in preventing HPV-related anogenital persistent infection, and to evaluate the safety/tolerability of V503, in Japanese males who are 16 to 26 years of age. It is hypothesized that administration of a 3-dose regimen of V503 reduces the combined incidence of HPV 6/11/16/18-related anogenital persistent infection, as well as the combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection, compared with placebo. The study includes a Base Study to assess efficacy and safety of V503, and an Extension Study. Participants who received placebo in the Base Study will be eligible to receive V503 vaccine on Day 1, Month 2, and Month 6 of the Extension Study. Participants who received less than 3 doses of V503 in the Base Study will be offered the opportunity to complete the 3-dose regimen in the Extension Study.
| Status | Active, not recruiting |
| Enrollment | 1050 |
| Est. completion date | January 30, 2025 |
| Est. primary completion date | January 30, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 16 Years to 26 Years |
| Eligibility | Inclusion Criteria: - Is a Japanese male 16 to 26 years of age - Has no more than 5 lifetime sexual partners Exclusion Criteria: - Has a history of known prior vaccination with an HPV vaccine or plans to receive one outside the study - Has a history of external genital warts - Has a history of severe allergic reaction that required medical intervention - Has received immune globulin or blood-derived products in the past 3 months or plan to receive any before Month 7 of the study - Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition - Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids - Has a known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections - Has ongoing alcohol or drug abuse within the past 12 months |
| Country | Name | City | State |
|---|---|---|---|
| Japan | P-One Clinic, Keikokai Medical Corp. ( Site 6419) | Hachioji | Tokyo |
| Japan | Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 6424) | Kawasaki | Kanagawa |
| Japan | Iwasa Clinic ( Site 6411) | Osaka | |
| Japan | Medical Corporation Seiwakai Hayakawa Clinic ( Site 6409) | Osaka | |
| Japan | Nomura Clinic Namba ( Site 6405) | Osaka | |
| Japan | Yamanaka Clinic ( Site 6410) | Osaka | |
| Japan | Kanno Clinic ( Site 6402) | Sakai | Osaka |
| Japan | Umeyama Clinic ( Site 6406) | Takasaki | Gunma |
| Japan | Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6404) | Tokyo | |
| Japan | Kusunoki Clinic ( Site 6412) | Tokyo | |
| Japan | Medical Corporation Iseikai My City Clinic ( Site 6414) | Tokyo | |
| Japan | Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 6418) | Tokyo | |
| Japan | Medical Corporation Sanshikai Toru Clinic ( Site 6401) | Tokyo | |
| Japan | Mildix Skin Clinic ( Site 6423) | Tokyo | |
| Japan | Naoko Dermatology Clinic ( Site 6417) | Tokyo | |
| Japan | Ogikuboekimae Clinic ( Site 6413) | Tokyo | |
| Japan | Seiyukai Medical Corporation Itoh Skin Clinic ( Site 6416) | Tokyo | |
| Japan | Shinjuku Higashiguchi Clinic ( Site 6415) | Tokyo | |
| Japan | Sugisawa Dermatology Clinic ( Site 6422) | Tokyo | |
| Japan | Taisei Clinic ( Site 6403) | Tokyo | |
| Japan | Yuge Clinic ( Site 6421) | Tokyo | |
| Japan | Ocean Clinic ( Site 6407) | Yokohama | Kanagawa |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Combined incidence of HPV 6/11/16/18-related anogenital persistent infection | This endpoint is defined to have occurred in a participant 1) who is polymerase chain reaction (PCR) positive to HPV 6, 11, 16 or 18 in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (+/- 1-month visit window) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of HPV 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The incidence of this endpoint is assessed in each treatment arm. | Up to 42 months | |
| Primary | Percentage of participants with solicited injection-site adverse events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to 5 days after injection | |
| Primary | Percentage of participants with =1 systemic AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to 15 days after injection | |
| Primary | Percentage of participants with =1 serious adverse events (SAEs) | An SAE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention, that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, results in persistent/significant disability/incapacity, is a congenital birth defect, or is an other important medical event. | Up to 6 months postdose 3 (up to 12 months) | |
| Secondary | Combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection | This endpoint is defined to have occurred in a participant 1) who is PCR positive to HPV 31, 33, 45, 52, or 58 in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (+/- 1-month visit window) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of HPV 31, 33, 45, 52, or 58 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The incidence of this endpoint is assessed in each treatment arm. | Up to 42 months | |
| Secondary | Geometric mean titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 | Serum antibody titers are measured with a competitive Luminex immunoassay (cLIA). | Month 7 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05087849 -
Intralesional HPV Vaccine for Condylomata
|
Phase 1/Phase 2 |