A Phase I Safty and Immunogenicity Study of SCT1000 in Healthy Women Aged 18 to 45 Years

NCT04921111 | Unknown Phase 1

• 1 other identifier: SCT1000-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

A phase 1 random, double blind, positive and placebo control trail was conducted in 120 healthy women in the arm A: 18-26 years old and Arm B: 27-45 years old. The 40 subjects to be inoculated with low, middle, and high dose vaccinefirst in sequence if there was no safety issue. In each dose group SCT1000 : placebo: positive =3:1:1.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 vaccination of this dose group or higher dose group will not be carried out, and the study of other dose groups will continue. If this happens at a low dose, the study will be suspended / terminated.

Conditions

HPV Infection Vaccine Safety SCT1000

Outcome Measures

Primary Outcomes (3)

• Occurrence of local reaction AEs

  Occurrence of local reaction AEs up to 7 days following each dose

  Up to 7 days following each dose

• Occurrence of systemic AEs

  Occurrence of systemic AEs up to 7 days following each dose

  Up to 7 days following each dose

• Occurrence of AEs

  Occurrence of AEs from dose1 to 30 days after each dose

  From dose1 to 30 days after each dose

Secondary Outcomes (2)

• Occurrence of SAEs

  From dose1 to 30 days after each dose and from dose1 to 12 months after first dose

• Abnormal hematology and chemistry laboratoty values 3 days after each dose

  3 days after each dose

Study Arms (2)

Healthy Women Aged 18 to 26 Years

EXPERIMENTAL

120 healthy women aged18 to 26 years are in this arm. The first group was 40 subjects to be inoculated with low dose vaccine; After the first low dose group was completed, the safety observation was conducted 7 days after the first dose was completed. If there was no need to suspend / terminate the study, 40 subjects in the group were continued to receive the medium dose vaccine; After the first dose group was completed, the safety observation was 7 days after the first dose was completed. If there was no need to suspend / terminate the test, 40 subjects in the group were inoculated with high dose group. In each dose group SCT1000 : Gardasil®9 : placebo =3:1:1.

Drug: SCT1000; Drug: Gardasil®9; Drug: placebo

Healthy Women Aged 27 to 45 Years

EXPERIMENTAL

120 healthy women aged 27 to 45 years are in this arm. The first group was 40 subjects to be inoculated with low dose vaccine; After the first low dose group was completed, the safety observation was conducted 7 days after the first dose was completed. If there was no need to suspend / terminate the study, 40 subjects in the group were continued to receive the medium dose vaccine; After the first dose group was completed, the safety observation was 7 days after the first dose was completed. If there was no need to suspend / terminate the test, 40 subjects in the group were inoculated with high dose group. In each dose group SCT1000 : Gardasil® : placebo =3:1:1.

Drug: SCT1000; Drug: placebo; Drug: Gardasil®

Interventions

SCT1000 DRUG

Recombinant 14 valent human papillomavirus vaccine (6,11,16,18,31,33,35,39,45,51,52,56,58,59) (insect cells)

Also known as: Recombinant 14 valent Human Papillomavirus Vaccine

Healthy Women Aged 18 to 26 Years; Healthy Women Aged 27 to 45 Years

Gardasil®9 DRUG

Recombinant 9 or 4 valent human papillomavirus vaccine

Also known as: Recombinant 9 valent human papillomavirus vaccine

Healthy Women Aged 18 to 26 Years

placebo DRUG

aluminium phosphate

Also known as: aluminium phosphate

Healthy Women Aged 18 to 26 Years; Healthy Women Aged 27 to 45 Years

Gardasil® DRUG

Recombinant 4 valent human papillomavirus vaccine

Also known as: Recombinant 4 valent human papillomavirus vaccine

Healthy Women Aged 27 to 45 Years

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Healthy Women Aged 18 to 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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；

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Guanyun Country CDC

Nanjing, Jiangsu, 222200, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 21142263 RESULT

• 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.

  PMID: 16753240 RESULT

• Palmieri B, Poddighe D, Vadala M, Laurino C, Carnovale C, Clementi E. Severe somatoform and dysautonomic syndromes after HPV vaccination: case series and review of literature. Immunol Res. 2017 Feb;65(1):106-116. doi: 10.1007/s12026-016-8820-z.

  PMID: 27503625 RESULT

MeSH Terms

Interventions

aluminum phosphate; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Central Study Contacts

Fengcai Zhu, Master

CONTACT

8625-83759984; jszfc@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 10, 2021
• Study Start: July 2, 2021
• Primary Completion: July 31, 2022
• Study Completion: October 31, 2022
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)