For the treatment of acne vulgaris
Conditions
Interventions
Sentinel cohort A1-experimental group: 60µg vaccine injection on day0, day 21,day 42
Sentinel cohort A1-control group:0.25ml placebo injection on day0, day 21,day 42
Sentinel cohort B1-experimental group:120µg vaccine injection on day0, day 21,day 42
Sentinel cohort B1-control group:0.5ml placebo injection on day0, day 21,day 42
Sentinel cohort C1-experimental group:240µg vaccine injection on day0, day 21,day 42
Sentinel cohort C1-control group:1.0ml placebo injection on day0, day 21,day 42
Sentinel cohort A2-experimental group:60µg vaccine injection on day0, day 7,day 21
Sentinel cohort A2-control group:0.25ml placebo injection on day0, day 7,day 21
Sentinel cohort B2-experimental group:120µg vaccine injection on day0, day 7,day 21
Sentinel cohort B2-control group:0.5ml placebo injection on day0, day 7,day 21
Sentinel cohort C2-experimental group:240µg vaccine injection on day0, day 7,day 21
Sentinel cohort C2-control group:1.0ml placebo injection on day0, day 7,day 21
Main cohort A-experimental group:60µg vaccine injection on day0, day 21,day 42
Main cohort A-control group:0.25ml placebo injection on day0, day 21,day 42
Main cohort B-experimental group:120µg vaccine injection on day0, day 21,day 42
Main cohort B-control group:0.5ml placebo injection on day0, day 21,day 42
Main cohort C-experimental group:240µg vaccine injection on day0, day 21,day 42
Main cohort C-control group:1.0ml placebo injection on day0, day 21,day 42
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Only subjects who meet all of the following criteria will be included in this trial. 1.fully understand the purpose and requirements of this study, voluntarily participate in the clinical trial and sign the informed consent form (ICF), and be able to complete all visits according to the protocol requirements. 2.The age is 18~59 years old (including the critical value), male or female, and the subject can provide valid identity certificate. 3.Body mass index (BMI) was 18~30kg/m^2 (including cut-off values). 4.Diagnosis of mild or moderate acne vulgaris according to the Pillsbury grading method with a Baseline IGA score of 2 or 3 (Clinical trial protocol Appendix 1 Pillsbury Grading Method & Acne Vulgaris Investigator's Global Assessment Scale). 5.For female subjects of childbearing potential, the serum pregnancy test result before the trial vaccination must be negative and agree to take medically recognized effective contraceptive measures (including complete abstinence, intrauterine or implantable contraceptive device, intrauterine device, diaphragm, cervical cap, or use of condoms by their male partners, etc.) from signing the ICF to the completion of 3 doses of vaccination; In addition, female subjects must agree not to donate eggs during this period. Note: Female subjects of childbearing potential are defined as female subjects who have not achieved postmenopausal status (amenorrhea for at least 12 consecutive months with no clear cause other than menopause) after menarche and without surgery (i.e., bilateral ovarian, salpingectomy, and/or hysterectomy) or other (such as Müllerian hypoplasia) as determined by the investigator leading to permanent infertility. 6.Male subjects agree to take medically recognized effective contraceptive measures (including complete abstinence, use of condoms, and their female partners to take medically recognized effective contraceptive measures during the study period [including complete abstinence, intrauterine or implantable contraceptive devices, oral contraceptives, injectable or implanted contraceptives, topical extended-release contraceptives, intrauterine devices, diaphragms, cervical caps, etc.]; In addition, male subjects must agree not to donate sperm during this period.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the first dose of vaccination Subjects who meet any of the following criteria will not be allowed to be included in this trial. 1.Have active nodular acne, aggregate acne, acne fulminant, secondary acne (such as occupational acne [chloracne], acne caused by medications [corticosteroids, etc.]), or other forms of acne. 2.Subjects with more than 1 facial nodule/cyst (nodule/cyst defined as >=0.5cm of inflammatory lesion). 3.Facial complications of other skin diseases that may affect the evaluation of efficacy or require combined treatment, such as solar dermatitis, psoriasis, seborrheic dermatitis, rosacea, folliculitis, eczema, etc. 4.Relatively thick facial hair that, as assessed by the investigator, would preclude accurate assessment of acne vulgaris grade or lesion count. 5.Expected skin inflammation or skin abnormalities that interfere with vaccination at and around the vaccination site. Use of any of the treatments/interventions listed below within a specific time period. 6.Use of skin care products with any anti-acne effect within 2 weeks prior to vaccination in this trial. 7.This trial is treated with any of the following systemic anti-acne drugs within 4 weeks or 5 half-lives (whichever is longer) before vaccination: 1) Corticosteroid treatment (including intramuscular injection and intralesional injection), except for inhaled and ocular drugs that do not affect the evaluation of acne efficacy. 2) Any antibiotics. 3) Immunomodulators (compound glycyrrhizin, etc.). 4) Antiandrotherapy (spironolactone, cyproterone, etc.) or immunosuppressants (cyclosporine, methotrexate, etc.). 5) Tretinoin or vitamin A of therapeutic properties in excess of 10,000 units per day (multivitamins are allowed). 8.This trial is treated with any of the following topical anti-acne drugs within 2 weeks or 5 half-lives (whichever is longer) before vaccination: 1) Benzoyl peroxide, antibiotics (such as erythromycin, lincomycin, clindamycin, metronidazole, etc.), azelaic acid, sulfonamide products, corticosteroids and salicylic acid. 2) Tretinoins, including tazarotene, adapalene, tretinoin, etc. 9.Vaccination in this trial has been performed within 3 months prior to: 1) chemical peeling treatment (AHA, salicylic acid, complex acid, etc.); 2) Photoelectric therapy (photodynamic, red and blue light, laser, intense pulsed light, radio frequency, etc.); 3) Acne surgery (needle removal, cyst incision, etc.). 10.Use of traditional Chinese medicine preparations known to have an effect on acne vulgaris within 4 weeks prior to vaccination in this trial. 11.Subjects who have used estrogen, androgen, or antiandrogen contraception for at least 6 consecutive months prior to vaccination with this trial. 12.Participation in any interventional clinical study within 3 months prior to vaccination with this trial, or current use of other investigational drugs or within 5 half-lives after the last administration of other investigational drugs. Presence of any of the following medical history or abnormalities: 13.Have a hereditary bleeding tendency or abnormal coagulation function (e.g., cytokine defects, coagulation disorders, or platelet dysregulation), or have a history of severe bleeding, or have a history of heavy bleeding or ecchymosis after intramuscular injection/venipuncture. 14.Those who may or clearly have an allergic reaction to the investigational vaccine or any of its excipients as judged by the investigator; or clinically significant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events (AEs) collected within 7 days after each dose of vaccination and non collected AEs within 28 days after completing 3 doses of vaccination from the first dose;The incidence of adverse events related to laboratory indicators on the third day after each dose of vaccination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titers (GMT) and geometric mean titers of WSK-V108E antigen-specific serum antibodies compared to baseline (GMI);The incidence of serious adverse events (SAEs) and other adverse events requiring medical care (MAAEs);Absolute and percentage changes in inflammatory skin lesion count, non inflammatory skin lesion count, and total skin lesion count of the subject's face compared to baseline. Note: Change in absolute number of lesions = number of lesions before treatment - number of lesions after treatment Percent change in lesion count = [(number of lesions before treatment - number of lesions after treatment) / number of lesions before treatment]× 100%. ;Changes in the overall assessment (IGA) score of subjects with acne compared to baseline;The proportion of subjects whose acne IGA score has improved compared to baseline (defined as a decrease of at least 1 point in IGA score from baseline);Proportion of subjects treated with WSK-V108E for mild to moderate facial acne vulgaris. Note: The criterion for effective treatment is that the patient has no or almost no skin lesions after treatment (IGA score is 0 or 1 point), or at least a 2-point decrease from the baseline IGA score. ;Changes in the Skin Disease Quality of Life Index (DLQI) score compared to baseline; | — |
Countries
China
Contacts
Public ContactXian Jiang, Ping Feng
West China Hospital of Sichuan University
Outcome results
None listed