- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05060484
A Phase II Study of SCT1000 in Healthy Women Aged 18 to 45 Years
October 21, 2021 updated by: Sinocelltech Ltd.
A Randomized, Double-Blind, Controlled (Positive and Placebo) Phase II Clinical Trial to Estimate Safty and Immunogenicity of the SCT1000 in Healthy Women Aged 18 to 45 Years
A phase II random, double blind, positive and placebo control trail was conducted in 1200 healthy women in the arm A: 18-26 years old and 600 healthy women in the Arm B: 27-45 years old.
The 1800 subjects to be inoculated with middle, and high dose vaccine.
Middle dose SCT1000: hight dose SCT1000: placebo: positive control =1:1:1:1.Two arms can be recruited at the same time.
If the DSMB assessment shows that the adverse events of a certain dose group meet the criteria of suspension / termination, the dose group will be suspended / terminated.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Arm A: 18-26 years old.
Random, double blind, Gardasil®9 positive control and placebo control was conducted in 1200 healthy women.
Middle dose SCT1000: hight dose SCT1000: placebo: positive control =1:1:1:1.Arm B: 27-45 years old.
Random, double blind, Gardasil® positive control and placebo control was conducted in 600 healthy women.
Middle dose SCT1000: hight dose SCT1000: placebo: positive control =1:1:1:1.Two arms can be recruited at the same time.
If the DSMB assessment shows that the adverse events of a certain dose group meet the criteria of suspension / termination, the dose group will be suspended / terminated, and the study of other dose groups will continue.
Study Type
Interventional
Enrollment (Anticipated)
1800
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fengcai Zhu, Master
- Phone Number: 8625-83759984
- Email: jszfc@vip.sina.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 222200
- Recruiting
- Guanyun Country CDC
-
Contact:
- Fengcai Zhu, Master
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female aged between 18 and 45 years at the first vaccination;
- 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:
- Exclusion criteria of first injection - History of HPV positive;
- History of drug abuse, alcohol abuse or dependence in the last year;
- 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.
Exclusion criteria for 2nd or 3rd dose vaccination
- 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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
HPV vaccine
Other Names:
HPV vaccine
adjuvent
|
Active Comparator: 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.
|
HPV vaccine
Other Names:
adjuvent
HPV vaccine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of local reaction AEs
Time Frame: Up to 7 days following each dose
|
Occurrence of local reaction AEs up to 7 days following each dose
|
Up to 7 days following each dose
|
Occurrence of systemic AEs
Time Frame: Up to 7 days following each dose
|
Occurrence of systemic AEs up to 7 days following each dose
|
Up to 7 days following each dose
|
Occurrence of AEs
Time Frame: From dose1 to 30 days after each dose
|
Occurrence of AEs from dose1 to 30 days after each dose
|
From dose1 to 30 days after each dose
|
- Compare the geometric average titer (GMT)
Time Frame: From dose1 to 1 months after dose3
|
GMT
|
From dose1 to 1 months after dose3
|
serum antibody impotence 1
Time Frame: From dose1 to 1 months after dose3
|
serum antibody impotence rate
|
From dose1 to 1 months after dose3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of SAEs
Time Frame: From dose1 to 30 days after each dose and from dose1 to 12 months after first dose
|
Occurrence of SAEs from dose1 to 30 days after each dose and from dose1 to 12 months after first dose
|
From dose1 to 30 days after each dose and from dose1 to 12 months after first dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fengcai Zhu, Jiangsu Province CDC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 19, 2021
Primary Completion (Anticipated)
May 31, 2022
Study Completion (Anticipated)
July 31, 2022
Study Registration Dates
First Submitted
September 15, 2021
First Submitted That Met QC Criteria
September 18, 2021
First Posted (Actual)
September 29, 2021
Study Record Updates
Last Update Posted (Actual)
October 28, 2021
Last Update Submitted That Met QC Criteria
October 21, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCT1000-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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