AzTrials
AzTrials

Cervical CancerPhase 3NCT04782895

Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) Versus Gardasil®9 in Healthy Females 18-26 Years of Age

A Phase 3 study testing Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli) and Gardasil®9 in people with Cervical Cancer and Condylomata Acuminata, run by Xiamen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to compare the immunogenicity of a novel recombinant human papillomavirus vaccine (types 6,11,16,18,31,33,45,52,58 )(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., with Gardasil®9 in females 18-26 Years of Age. Read more about this study

Who is it for?
Ages 18 to 26 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cervical Cancer, Condylomata Acuminata
What is being tested?
Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli) and Gardasil®9
Could I receive a placebo?
No, everyone receives an active treatment
How many people
488 participants
Where
1 siteChina
Study dates
14 Mar 2021to 25 Jul 2022
Phase
Phase 3
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 26 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subject is female, between and including 18-26 years of age at the first vaccination;
  • Subject is able to understand and comply with the requirements of the protocol(e.g. biological specimen collection, completion of the diary cards, return for follow-up visits), and written informed consent must be obtained from the subject prior to enrollment;
  • Subject who agrees to practice effective contraception within 8 months after the first vaccination or has undergone tubal ligation,subtotal hysterectomy for benign lesion, ovarian benign tumor resection;
  • No previous history of sexually transmitted diseases (including syphilis, gonorrhea, chancroid, venereal lymphogranuloma, groin granuloma, etc.);
  • No previous history of abnormal cervical screening results or cervical intraepithelial neoplasia (CIN);

Who cannot join

  • Axillary temperature > 37.0℃;
  • Subject who has a positive urine pregnancy test, or is pregnant or breastfeeding;
  • Subject has used of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine or plans to use during the study period , or has participated in another clinical research in the past two years, or plans to participate in another research during the study period;
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs or systemic corticosteroids (Except intranasal steroid, the use of low dose topical, ophthalmic and inhaled steroid preparations will be permitted.) within 6 months prior to vaccination.
  • Administration of immunoglobulin and/or blood products within 3 months prior to vaccination or planned to use them within 7 months after the first dose.
  • Administration of inactivated vaccine within 14 days prior to vaccination or live vaccine within 21 days;
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  • Fever (Axillary temperature ≥38.0℃) 3 days prior to vaccination or system administration of antibiotics or antiviral agents within 5 days prior to vaccination;
  • Subject has received other HPV vaccines or participated in clinical research related to HPV or cervical cancer previously;
  • Subject has immunodeficiency disease, primary disease of important viscera, cancer and autoimmune disease (including systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy due to any condition, and other immunological diseases that investigators believe may influence the immune response).
  • History of severe allergy (e.g., anaphylaxis, generalized urticaria, dyspnea, angioedema, and other significant reaction) to any previous vaccination, or be allergic to any of the components of the study vaccines.
  • Asthma, which has been unstable for the past two years and requires emergency treatment, hospitalization, oral or intravenous corticosteroids;
  • Subject has Serious medical disorders;
  • Self-report coagulation disorders or abnormal coagulation function;
  • Epilepsy, excluding febrile epilepsy under 2 years of age, alcoholic epilepsy 3 years prior to abstinence or simple epilepsy that does not require treatment in the past 3 years;
  • Medical, psychological, social conditions, occupation or other factors, which considered by the investigator that may influence the conduct of the clinical study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jiangsu Provincial Centre for Disease Control and Prevention

    Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: A Randomized, Single-blind Study to Compare Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) (Xiamen Innovax Biotech Co.,Ltd.) Versus Gardasil®9 (Merck & Co., Inc.) in Healthy Females 18-26 Years of Age

This study is designed to compare the immunogenicity of a novel recombinant human papillomavirus vaccine (types 6,11,16,18,31,33,45,52,58 )(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., with Gardasil®9 in females 18-26 Years of Age.

Being tested
Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli), Gardasil®9
Keywords
human papillomavirus vaccine, immunogenicity
Medical subject headings
Uterine Cervical Neoplasms, Condylomata Acuminata

What participants receive

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

  • Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)Biological

    Three doses administered intramuscularly at 0, 45 day and 6 month.

  • Gardasil®9Biological

    Three doses administered intramuscularly at 0, 45 day and 6 month.

Study groups in NCT04782895
Study groupRoleWhat they receive
Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) groupExperimentalSubjects would receive 3 doses of 270μg/0.5ml Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli) .
Receives: Biological: Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)
Gardasil®9 groupActive comparatorSubjects would receive 3 doses of 270μg/0.5ml Gardasil®9 .
Receives: Biological: Gardasil®9

What is being measured

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

  1. Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level

    Anti-HPV 6,11,16,18,31,33,45,52 and 58 seroconversion rates and geometric mean concentrations at months 7

    Measured: 7 months after the first dose

Secondary outcomes (4)

  1. safety1:Local and systematic adverse events/reactions occurred within 7 days after each vaccination.

    Local and systematic adverse events/reactions occurred within 7 days after each vaccination.

    Measured: During the 7-day period following each vaccination

  2. safety2:Adverse events/reactions occurred within 30 days after each vaccination.

    Adverse events/reactions occurred within 30 days after each vaccination.

    Measured: Within 30 days (Day 0-30) after any vaccination

  3. safety3:Severe adverse events occurred throughout the study. To evaluate number of SAEs compared with the control vaccine.

    Severe adverse events occurred throughout the study. To evaluate number of SAEs compared with the control vaccine.

    Measured: Up to 8 month

  4. safety4:Pregnancy and pregnancy outcome. To evaluate number of births and terminations compared with the control vaccine.

    Pregnancy and pregnancy outcome. To evaluate number of births and terminations compared with the control vaccine.

    Measured: Up to 8 month

Timeline

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

  1. First posted4 Mar 2021
  2. Study start14 Mar 2021
  3. Primary completion30 May 2022
  4. Study completion25 Jul 2022

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
488 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04782895
Sponsor's protocol ID
HPV-PRO-011
Status last verified
Jun 2023
First submitted
25 Feb 2021
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhu FC, Zhong GH, Huang WJ, Chu K, Zhang L, Bi ZF, Zhu KX, Chen Q, Zheng TQ, Zhang ML, Liu S, Xu JB, Pan HX, Sun G, Zheng FZ, Zhang QF, Yi XM, Zhuang SJ, Huang SJ, Pan HR, Su YY, Wu T, Zhang J, Xia NS. Head-to-head immunogenicity comparison of an Escherichia coli-produced 9-valent human papillomavirus vaccine and Gardasil 9 in women aged 18-26 years in China: a randomised blinded clinical trial. Lancet Infect Dis. 2023 Nov;23(11):1313-1322. doi: 10.1016/S1473-3099(23)00275-X. Epub 2023 Jul 17.

    PubMed 37475116

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli) and Gardasil®9 in people with Cervical Cancer and Condylomata Acuminata, run by Xiamen University 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 5 inclusion and 15 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: finished, as of the sponsor's last update on 15 Jun 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level (time frame: 7 months after the first dose). 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 NCT04782895, which also lists 1 linked publication.

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 15 Jun 2023.

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