A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine

NCT05680454 | Completed Phase 1

• 1 other identifier: KLWS-V502-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety and tolerability profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy women ages 18-45

Conditions

Human Papillomavirus Infection

Keywords

CIN; VIN; VaIN; AIN; Cervical cancer; Vaginal cancer; vulvar cancer; Anal cancer; Genital warts

Outcome Measures

Primary Outcomes (1)

• Percentage of adverse reaction(s) within 7 days post any dose of the interventions.

  Percentage of subjects with 1 or more injection-site or non-injection-site (systemic) adverse reaction(s) within 7 days post any dose of the interventions.

  0-7 months

Secondary Outcomes (20)

• Percentage of adverse event(s) within 30 days post any dose of the interventions

  The 3rd day after each injection

• Percentage of abnormal blood routine indexes, coagulation time and blood biochemical indexes

  The 3rd and 7th month after immunization

• Percentage of serious adverse event(s)

  0-7 months

• Levels of neutralization antibodies against each vaccine HPV type (6/11/16/18/31/33/45/52/58)

  The 7th month after immunization

• Percentage of subjects positive for neutralization antibodies against each vaccine HPV type (6/11/16/18/31/33/45/52/58)

  The 7th month after immunization

Study Arms (2)

The Group of Investigational Vaccine

EXPERIMENTAL

For Low-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 20μg、40μg、40μg、20μg、20μg、20μg、20μg、20μg, and 20μg respectively, totaling 220μg 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. 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.

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

Each 0.5-mL single-dose vial of GARDASIL9 contains approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type 16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type 33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV Type 58 L1 protein, totaling 270 mcg of antigens.

Biological: Recombinant nonavalent Human Papillomavirus (Types 6,11,16,18,31,33,45,52,58) Vaccine

Interventions

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

For Low-dosage group, a 3-dose regimen administered at months 0, 2 and 6. 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 nonavalent Human Papillomavirus (Types 6,11,16,18,31,33,45,52,58) Vaccine BIOLOGICAL

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

The Group of Active Control Vaccine

Eligibility Criteria

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

You may qualify if:

• Stage 1:
• Female subjects 27-45 years of age (inclusive of 27 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 understand and agree to comply with the study procedures and provide written informed consent;
• Subjects who are able to comply with protocol-specified requirements;
• Subjects with negative urine pregnancy test result at screening;
• Subjects with no childbearing potential (e.g. females who have undergone bilateral tubal ligation, hysterectomy, bilateral oophorectomy, etc.), or 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 and throughout the study;
• Subjects with axillary temperature≤37.0℃.
• Stage 2:
• Female subjects 18-26 years of age (inclusive of 18 and 26 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 understand and agree to comply with the study procedures and provide written informed consent;
• Subjects who are able to comply with protocol-specified requirements;
• Subjects with negative urine pregnancy test result at screening;
• Subjects with no childbearing potential (e.g. females who have undergone bilateral tubal ligation, hysterectomy, bilateral oophorectomy, etc), or 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 and throughout the study;

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 allergy history or who 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 two 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 mm Hg 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 a history of epilepsy other than epilepsy with febrile seizures under two years of age, 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 Pharmaceutical Technology Co., Ltd: collaborator
• School of Public Health of Southeastern University: collaborator

Study Sites (1)

CDC, Jiangsu Province

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms; Vaginal 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; Vaginal Diseases; 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 1
• 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: The trial will be conducted in two stages: Stage 1: An open-label trial will be carried out in 40 healthy women ages 27-45 in the enrolment order of mid-dosage group followed by high-dosage group. Each group of 20 subjects will be administered the mid-, and high-dosage form respectively. Stage 2: A randomized and blinded (as to intra-dosage group) trial, with Gardasil9 as the positive control will be carried out in 120 healthy women ages 18-26 in the enrolment order of low-, mid-, and high-dosage groups. Each group of 40 subjects will be enrolled and randomized at a 3: 1 ratio to receive the investigational vaccine or positive control, respectively.

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 11, 2023
• Study Start: September 1, 2019
• Primary Completion: April 6, 2020
• Study Completion: May 10, 2022
• Last Updated: January 17, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)