A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine

NCT05694728 | Completed Phase 2

• 1 other identifier: KLWS-V502-02
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

Brief Summary

This trail is to evaluate the safety profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy Chinese women ages 20-45 and determine the optimal ratio of the antigens included in the investigational vaccine. Besides, the trail is also to demonstrate that the levels of neutralizing antibodies to vaccine HPV types 31, 33, 45, 52 and 58 elicited by the investigational vaccine with the chosen optimal antigen ratio are superior to those induced by Gardasil.

Conditions

Human Papilloma Virus Infection

Keywords

CIN; VIN; VaIN; AIN; Cervical cancer; Vulvar cancer; Anal cancer; Genital warts

Outcome Measures

Primary Outcomes (2)

• Percentage of adverse reactions up to Day 7 after each dose of the interventions

  Percentage of subjects with 1 or more injection-site or non-injection-site (systemic) adverse reactions up to Day 7 after each dose of the interventions

  0-7 days after each immunization

• To determine the optimal ratio of antigens included in the investigational vaccine

  To determine the optimal ratio of antigens included in the investigational vaccine through non-inferiority analysis of the GMTs of neutralizing antibodies specific to vaccine HPV types 6, 11, 16 and 18 elicited by the investigational vaccine versus those induced by the positive control, in subjects negative for antibodies to such vaccine HPV types prior to dose 1.

  The 1st month after full immunization

Secondary Outcomes (11)

• Percentage of adverse events up to Day 30 after each dose of the interventions

  0-30 days after each immunization

• Percentage of erious adverse events for the duration of the study

  Through study completion, an average of 7 months

• To demonstrate that the levels of neutralizing antibodies

  The 1st month after full immunization

• To evaluate the levels of neutralizing antibodies

  The 7th month after first immunization

• To evaluate the levels of IgG antibodies

  The 7th month after first immunization

Study Arms (2)

The Group of Investigational Vaccine

EXPERIMENTAL

For Mid-dosage group, 0.5-mL suspension for injection, each 0.5-mL prefilled syringe dose contains L1 proteins of HPV types 6/11/16/18/31/33/45/52/58 in the amounts of 30μg#40μg#60μg#40μg#20μg#20μg#20μg#20μg and 20μg respectively, totaling 270μg of antigens. For High-dosage group, 0.5-mL suspension for injection, each 0.5-mL prefilled syringe dose contains L1 proteins of HPV types 6/11/16/18/31/33/45/52/58 in the amounts of 30μg#40μg#80μg#60μg#30μg#30μg#30μg#30μg and 30μg respectively, totaling 360μg of antigens.

Biological: Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)

The Group of Active Control Vaccine

ACTIVE COMPARATOR

0.5-mL suspension for injection, each 0.5-mL single-dose syringe contains approximately 20 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 40 mcg of HPV Type 16 L1 protein, 20 mcg of HPV Type 18 L1 protein, totaling 120 mcg of antigens.

Biological: Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)

Interventions

Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) BIOLOGICAL

For Mid-dosage group, a 3-dose regimen administered at months 0, 2 and 6. For High-dosage group, a 3-dose regimen administered at months 0, 2 and 6.

The Group of Investigational Vaccine

Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae) BIOLOGICAL

A 3-dose regimen administered at months 0, 2 and 6.

The Group of Active Control Vaccine

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects ages 20-45 (inclusive of 20 years of age and 45 years of age);
• Subjects decided to be healthy by the principal investigator in accordance with such trial subjects' medical history and physical examination results;
• Subjects who agree to participate in the trial after being fully informed of the study, and provide a written informed consent;
• Trial subjects who are able to comply with protocol-specified requirements;
• Trial subjects with negative urine pregnancy test at screening;
• Trial subjects with no childbearing potential (e.g. females who have undergone bilateral tubal ligation, hysterectomy, bilateral oophorectomy, etc), or female subjects with childbearing potential who have agreed to abstain from any sexual activity that could result in pregnancy or practice adequate contraception for at least 28 days prior to the first dose of the interventions and throughout the study.
• Subjects with axillary temperature≤37.0℃.

You may not qualify if:

• Women who are pregnant or breastfeeding, or planning for pregnancy in the following 7 months;
• Women who have received other HPV vaccine(s) prior to dose 1 of the interventions;
• Women who have received an investigational or unregistered drug or vaccine within 28 days prior to the first dose of the interventions, or plan to receive an investigational or unregistered drug or vaccine during the study;
• Women who have known anaphylaxis history or are allergic to any component of the interventions, such as penicillin and amikacin;
• Women with a history of severe adverse reactions to previous vaccinations, such as allergies, urticaria, dyspnea, angioneurotic edema, or abdominal pain;
• Women who have an autoimmune disease or immunodeficiency, are HIV positive, or have primary diseases in vital organs;
• Women who have asthma that is unstable and requires urgent care, hospitalization and the use of oral or intravenous corticosteroids during the past 2 years;
• Women who have diabetes mellitus (type I or II), with the exception of gestational diabetes;
• Women with a history of thyroidectomy or thyroid diseases that required medical care within the past 12 months;
• Women with serious angioedema episodes within the past 3 years or requiring medical care over the past 2 years
• Women who have hypertension over 145/95 at enrolment despite being treated by medication;
• Women with coagulation disorders as diagnosed by a doctor (e.g. coagulation factor deficiency, coagulopathy, or platelet disorder) or coagulation difficulty
• Women with active malignancy, or treated malignancy for which there is no reasonable assurance of sustained cure, or malignancy that is likely to recur during the study;
• Women with epilepsy other than epilepsy with febrile seizures under the age of two, epilepsy secondary to alcohol use 3 years prior to alcohol withdrawal, or a singular epileptic seizure not requiring treatment within the past 3 years;
• Women with the condition of asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen;

Sponsors & Collaborators

• Beijing Health Guard Biotechnology, Inc: lead
• Jiangsu Province Centers for Disease Control and Prevention: collaborator
• National Institutes for Food and Drug Control, China: collaborator
• Nanjing Sangruisi pharmtech Ltd.: collaborator
• Shanghai Canming pharmtech Ltd.: collaborator

Study Sites (1)

CDC, Jiangsu Province

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

• Wei M, Liu H, Yu H, Pan H, Tao H, Zhang J, Han W, Wu D, Wang W, Li J. Immunogenicity and safety of an Escherichia coli-produced 9-valent human papillomavirus vaccine (types 6/11/16/18/31/33/45/52/58) in healthy Chinese women aged 20-45 years: a single-center, randomized, observer-blinded, positive controlled phase 2 clinical trial. Front Immunol. 2025 Nov 14;16:1706662. doi: 10.3389/fimmu.2025.1706662. eCollection 2025.

  PMID: 41322412 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms; Vulvar Neoplasms; Anus Neoplasms; Condylomata Acuminata

Interventions

Papillomavirus Vaccines; Vaccines

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Vulvar Diseases; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Warts; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Biological Products; Complex Mixtures

Study Officials

• Yongjiang Liu, Bachelor

  Beijing Health Guard Biotechnology, Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The Sponsor, investigators and biostatisticians will remain blinded to subject allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Healthy women ages 20-45 eligible for the trial will be stratified at a 1: 1 ratio into 2 age subgroups (20-30 years of age and 31-45 years of age), and each subgroup will be randomized at a 1: 1: 1 ratio to receive the mid-dosage investigational vaccine, high-dosage investigational vaccine or the positive control, respectively.

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 23, 2023
• Study Start: May 23, 2020
• Primary Completion: December 11, 2020
• Study Completion: January 27, 2021
• Last Updated: January 23, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)