A Phase II Study of SCT1000 in Healthy Women Aged 18 to 45 Years
NCT ID: NCT05060484
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
1800 participants
INTERVENTIONAL
2021-10-19
2022-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Healthy Women Aged 18 to 26 Years
1200 healthy women aged18 to 26 years are in this arm. Middle dose SCT1000 : hight dose SCT1000:Gardasil®9 : placebo =1:1:1:1. SCT1000 and Gardasil®9 will be immunized at 0, 2, and 6 months, respectively.
SCT1000
HPV vaccine
Gardasil®9
HPV vaccine
placebo
adjuvent
Healthy Women Aged 27 to 45 Years
600 healthy women aged 27 to 45 years are in this arm. Middle dose SCT1000 : hight dose SCT1000:Gardasil® : placebo =1:1:1:1. SCT1000 and Gardasil®9 will be immunized at 0, 2, and 6 months, respectively.
SCT1000
HPV vaccine
Gardasil®
HPV vaccine
placebo
adjuvent
Interventions
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SCT1000
HPV vaccine
Gardasil®9
HPV vaccine
Gardasil®
HPV vaccine
placebo
adjuvent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be able to understand and comply with the request of the protocol, and sign written informed consent; - Be able to read, understand and complete diary card;
* According to the medical history and the results of physical examination and laboratory examination, the subjects were judged to be in good health
* Women who agree to use effective contraception throughout the study period；
Exclusion Criteria
* History of severe allergy (e.g., anaphylaxis and other significant reaction) to any previous vaccines, or allergy to any of the components of investigational vaccine；
* People with low immune function may be diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, tuberculosis, leukemia, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease or other autoimmune conditions；
* People whose spleen has been removed；
* People received the following immunosuppressive therapy in the past year: radiotherapy, cyclophosphamide, imidazolidine, methotrexate, chemotherapy, cyclosporine, leflunomide, tumor necrosis factor- α Antagonists, monoclonal antibody therapy, intravenous immunoglobulin, anti lymphocyte serum, or other known therapies that interfere with immunity;
* People are receiving systemic corticosteroid therapy, or received two or more courses of high-dose corticosteroids for one week one year before enrollment (nasal inhaled corticosteroids or topical corticosteroids can not be excluded);
* People receiving any immunoglobulin products or blood products within the first 3 months, or planning to receive similar products during the study period;
* Inactivated vaccine was inoculated 14 days before inoculation or attenuated vaccine was inoculated 28 days before inoculation;
* Contraindications of intramuscular injection such as thrombocytopenia or other coagulation disorders;
* Blood donation within the first week or planned during the study period;
* Egg donation was planned during the study period; - Participating in other experimental clinical studies;
* Have been vaccinated with HPV vaccine on the market or have participated in clinical trials of HPV vaccine;
* Failure to comply with the test procedures or planned relocation during the study; - Fever occurred within 24 hours before inoculation (axillary temperature \> 37 ℃); - Pregnant women (blood pregnancy test or urine pregnancy test positive) or lactating women;
* There is clinical evidence of purulent cervicitis;
* Having serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension, diabetes and drug uncontrollable; - Acute infection;
* Other abnormalities, which may confuse the results of the study, or which are not in line with the maximization of the interests of the subjects, can be excluded by the judgment of the investigators.
* having severe allergic reaction during the first or second dose of vaccination and cannot continue to be vaccinated according to the judgment of investigators;
* The serious adverse reactions with the previous vaccination were related, and the investigators judged that they could not continue to be vaccinated;
* After the first vaccination, the newly discovered or newly occurred serious medical diseases, coagulation dysfunction, etc. can not continue to be vaccinated according to the judgment of the investigators;
18 Years
45 Years
FEMALE
Yes
Sponsors
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Sinocelltech Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Fengcai Zhu
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Province CDC
Locations
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Guanyun Country CDC
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Fengcai Zhu, Master
Role: primary
References
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McCormack PL, Joura EA. Quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Gardasil(R)): a review of its use in the prevention of premalignant genital lesions, genital cancer and genital warts in women. Drugs. 2010 Dec 24;70(18):2449-74. doi: 10.2165/11204920-000000000-00000.
Villa LL, Ault KA, Giuliano AR, Costa RL, Petta CA, Andrade RP, Brown DR, Ferenczy A, Harper DM, Koutsky LA, Kurman RJ, Lehtinen M, Malm C, Olsson SE, Ronnett BM, Skjeldestad FE, Steinwall M, Stoler MH, Wheeler CM, Taddeo FJ, Yu J, Lupinacci L, Railkar R, Marchese R, Esser MT, Bryan J, Jansen KU, Sings HL, Tamms GM, Saah AJ, Barr E. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18. Vaccine. 2006 Jul 7;24(27-28):5571-83. doi: 10.1016/j.vaccine.2006.04.068. Epub 2006 May 15.
Other Identifiers
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SCT1000-02
Identifier Type: -
Identifier Source: org_study_id