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InterventionalPhase 2NCT05060484

A Phase II Study of SCT1000 in Healthy Women Aged 18 to 45 Years

A Phase 2 study testing SCT1000, Gardasil®9 and Gardasil® in people with Interventional and Prevention, run by Sinocelltech Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Interventional, Prevention, Randomized
What is being tested?
SCT1000, Gardasil®9 and Gardasil®
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,800 participants
Where
1 siteChina
Study dates
19 Oct 2021to 31 Jul 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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；

Who cannot join

  • 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;
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  • 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;

Trial locations and contacts

1 site in 1 country.

Fengcai Zhu, Master contact

8625-83759984

jszfc@vip.sina.com

China1 site, 1 recruiting

  • Guanyun Country CDC

    Nanjing, Jiangsu, 222200

    Fengcai Zhu, Master

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
SCT1000, Gardasil®9, Gardasil®, placebo
Keywords
HPV, woman

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCT1000Biological

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

    HPV vaccine

  • Gardasil®9Biological

    HPV vaccine

  • Gardasil®Biological

    HPV vaccine

  • placeboOther

    adjuvent

Study groups in NCT05060484
Study groupRoleWhat they receive
Healthy Women Aged 18 to 26 YearsActive comparator1200 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.
Receives: Biological: SCT1000; Biological: Gardasil®9; Other: placebo
Healthy Women Aged 27 to 45 YearsActive comparator600 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.
Receives: Biological: SCT1000; Biological: Gardasil®; Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of local reaction AEs

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

    Measured: Up to 7 days following each dose

  2. Occurrence of systemic AEs

    Occurrence of systemic AEs up to 7 days following each dose

    Measured: Up to 7 days following each dose

  3. Occurrence of AEs

    Occurrence of AEs from dose1 to 30 days after each dose

    Measured: From dose1 to 30 days after each dose

  4. - Compare the geometric average titer (GMT)

    GMT

    Measured: From dose1 to 1 months after dose3

  5. serum antibody impotence 1

    serum antibody impotence rate

    Measured: From dose1 to 1 months after dose3

Secondary outcomes (1)

  1. Occurrence of SAEs

    Occurrence of SAEs from dose1 to 30 days after each dose and from dose1 to 12 months after first dose

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2021
  2. Study start19 Oct 2021
  3. Primary completion31 May 2022 (estimated)
  4. Study completion31 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05060484
Sponsor's protocol ID
SCT1000-02
Status last verified
Sep 2021
First submitted
15 Sep 2021
Last updated
28 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 21142263

  • 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.

    PubMed 16753240

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SCT1000, Gardasil®9 and Gardasil® in people with Interventional and Prevention, run by Sinocelltech Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fengcai Zhu, Master (8625-83759984, jszfc@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of local reaction AEs (time frame: Up to 7 days following each dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05060484, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.

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