NCT05580341

Brief Summary

This study will evaluate the immunogenicity and safety of Zerun 9-valent HPV recombinant vaccine in healthy female 16-26 years of age by comparing with GARDASIL®9.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

October 11, 2022

Last Update Submit

October 26, 2022

Conditions

Cervical CancerGenital WartCINVINPapillomavirus Infections

Keywords

Human PapillomavirusPapillomavirus VaccinesGenital WartsCervical Cancer

Outcome Measures

Primary Outcomes (2)

  • Geometric Mean Titers (GMT) of HPV neutralizing antibodies

    HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 neutralizing antibodies GMT

    30 days postdose 3 (Month 7)

  • Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

    Seroconversion is defined as a participant in PPS who was anti-HPV seronegative at Day 0 (before vaccination) and became seropositive 30days after the third dose (Month 7).

    30 days postdose 3 (Month 7)

Secondary Outcomes (4)

  • Percentage of subjects reporting solicited local symptoms

    0-7 days after each dose

  • Percentage of subjects reporting solicited general symptoms

    0-7 days after each dose

  • Percentage of subjects reporting unsolicited adverse events (AEs)

    0-30 days after each dose

  • Percentage of subjects reporting serious adverse events (SAEs)

    Month 0 to Month 12

Study Arms (2)

Zerun HPV-9

EXPERIMENTAL

Subjects receive 3 doses of Zerun HPV-9 vaccine

Biological: Zerun HPV-9

GARDASIL®9

ACTIVE COMPARATOR

Subjects receive 3 doses of GARDASIL®9

Biological: GARDASIL ®9

Interventions

Zerun HPV-9BIOLOGICAL

Zerun 9-valent Human Papillomarivus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Pichia Pastoris), 0.5mL, three doses, 0,2,6 months

Zerun HPV-9
GARDASIL ®9BIOLOGICAL

GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months

GARDASIL®9

Eligibility Criteria

Age16 Years - 26 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy female 16-26 years of age
  • years old subjects and their guardians able to provide legal identification; 18-26 years old subjects able to provide their legal identification;
  • Able to understand (not illiterate) and sign the informed consent;
  • Able to make a decision to participate in the clinical trial and the subject agrees to participate in the clinical trial;
  • Women of child-bearing age (WOCBA): subjects must have a negative urine pregnancy test result, have used effective contraceptive measures within 2 weeks before enrollment, have no pregnancy plans, and agree to use adequate contraceptive precautions from enrollment to the 7th month (one month after full immunization).

You may not qualify if:

  • Abnormal cervical cancer screen test results (ASC-US or worse), history of HPV infection, history of abnormal cervical biopsy results, or history of genital warts;
  • Subjects with severe congenital malformations or that cause serious organ damage, developmental disorders, genetic defects, or severe malnutrition;
  • Subjects have received a marketed HPV vaccine or participated in an HPV vaccine clinical trial, or participated in clinical trials of other vaccines within the past 6 months;
  • Fever prior to vaccination (axillary body temperature ≥37.3℃);
  • History of severe allergic reaction that required medical intervention (such as swelling of the mouth and throat, dyspnea, hypotension or shock, etc.);
  • History of allergic to vaccine, or to any ingredient of vaccine (Aluminum phosphate adjuvant, sodium chloride, histidine, polysorbate 80),or history of severe adverse reaction
  • History of epilepsy, psychosis, major depression requiring medication, seizures, convulsions, or family history of mental illness
  • Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose
  • History of asthma, thyroidectomy, angioedema, severe liver, kidney, or cardiovascular disease, diabetes mellitus that can not be controlled by stable doses of insulin, or malignancy;
  • Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy;
  • Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
  • Acute diseases or acute stage of chronic diseases or use of antipyretic, analgesic drugs (eg: acetaminophen, ibuprofen, aspirin, etc.) and anti-allergic drugs (such as: loratadine, cetirizine, etc.) within 3 days preceding the vaccination;
  • Untreated/uncontrolled hypertension before vaccination (16-17 years of age \> 120 mmHg and / or diastolic blood pressure \> 80 mmHg; 18-26 years of age with physical examination systolic blood pressure ≥140 mmHg and / or diastolic blood pressure ≥90 mmHg);
  • Subjects who received whole blood, plasma, or immunoglobulin therapy within 3 months prior to vaccination;
  • Received live attenuated vaccine within 28 days prior to vaccination;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GuangXi Center for Diseases Control and Prevention

Nanning, Guangxi, China

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsCondylomata AcuminataPapillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 14, 2022

Study Start

September 1, 2022

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

October 28, 2022

Record last verified: 2022-10

Locations

CN(1)