Phase I Clinical Trial of a Candidate HPV Vaccine

NCT05672966 | Unknown Phase 1

• 1 other identifier: BV-C601-202201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, first-in-human, randomized, observer-blinded, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and immunogenicity of BV601 (a HPV Vaccine) in healthy adult volunteers.

Conditions

Human Papillomavirus Infection

Keywords

HPV Vaccine; Phase I; BV601

Outcome Measures

Primary Outcomes (5)

• Safety in terms of solicited adverse events

  Occurrence of solicited AEs of each subject

  within 7 days after each vaccination

• Safety in terms of solicited systemic AEs

  Occurrence of solicited systemic AEs of each subject

  within 7 days after the first vaccination

• Safety in terms of dose-limiting toxicity (DLT)

  Percentage of participants with dose-limiting toxicity

  within 30 days after the first vaccination

• Safety in terms of unsolicited AEs

  Percentage of participants with unsolicited AEs

  365 days after the first vaccination

• Safety in terms of all solicited and unsolicited AEs

  Frequency and severity of solicited and unsolicited AEs

  365 days after the first vaccination

Secondary Outcomes (3)

• Immunogencity in terms of GMT by ELISA

  Days 1, 31, 61, 91, 121, 181, 211, and 365

• Immunogencity in terms of Nab

  Days 1, 31, 61, 91, 121, 181, 211, and 365

• Immunogencity in terms of Seroconversion rate

  Days 1, 31, 61, 91, 121, 181, 211, and 365

Study Arms (6)

1-BV601DP(Low dose HPV vaccine with adjuvant)

EXPERIMENTAL

Subjects received low dose of BV601DP

Biological: Human papillomavirus (HPV) Vaccine

1-BV601DPP(Low dose HPV vaccine without adjuvant)

EXPERIMENTAL

Subjects received low dose of BV601DPP

Biological: Human papillomavirus (HPV) Vaccine

1-Placebo

PLACEBO COMPARATOR

Subjects received placebo

Biological: Placebo

2-BV601DP(High dose HPV vaccine with adjuvant)

EXPERIMENTAL

Subjects received high dose of BV601DP

Biological: Human papillomavirus (HPV) Vaccine

2-BV601DPP(High dose HPV vaccine without adjuvant)

EXPERIMENTAL

Subjects received high dose of BV601DPP

Biological: Human papillomavirus (HPV) Vaccine

2-Placebo

PLACEBO COMPARATOR

Subjects received placebo

Biological: Placebo

Interventions

Human papillomavirus (HPV) Vaccine BIOLOGICAL

0.5mL, Intramuscular

Also known as: BV601

1-BV601DP(Low dose HPV vaccine with adjuvant); 1-BV601DPP(Low dose HPV vaccine without adjuvant); 2-BV601DP(High dose HPV vaccine with adjuvant); 2-BV601DPP(High dose HPV vaccine without adjuvant)

Placebo BIOLOGICAL

0.5mL, Intramuscular

1-Placebo; 2-Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged between 18 and 35 years (inclusive) at the time of Screening Visit.
• In good general health, with no significant medical history, and have no clinically significant abnormalities on vital signs, physical examination, laboratory tests, and ECG at Screening Visit and before the first vaccination of IP at the discretion of the Investigator(s) or designee.
• Body Mass Index (BMI) of ≥ 18.0 and ≤ 32.0 (BMI will be calculated by weight in kilograms \[kg\]/square of height in meters \[m2\]) and weigh at least 50 kg at Screening Visit.
• Able and willing to comply with all study requirements and study procedures.
• Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
• Male and female of childbearing age should agree to take effective contraception measures

You may not qualify if:

• Physical or psychological medical histories (within 3 months prior to Screening Visit) or ongoing conditions of any clinically significant hepatic (eg, active liver disease, hepatic impairment), renal/genitourinary (eg, renal impairment), gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological, hematological disease, and/or any other medical conditions which, at the discretion of the Investigator(s), may jeopardize the safety of the participants and/or effect the results of the study.
• Histories or on-going conditions of immune function impaired, congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases.
• Histories or on-going conditions of malignancy, except for non-melanoma skin cancer, excised more than 2 years ago.
• History of abnormal cervical biopsy results (showing cervical intraepithelial neoplasia or worse) or cervical disease (ie, surgical treatment for cervical lesions) within 5 years prior to Screening Visit.
• History of a positive test for HPV infection.
• Histories of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents.
• Loss of spleen or functional spleen, and/or removal of spleen caused by any situation
• Body temperature before vaccination ≥ 38℃ for ear or temporal artery temperature or ≥ 37.2 ℃ for armpit temperature before vaccination.
• Systolic blood pressure ≥ 140 mmHg and/or a diastolic blood pressure ≥ 90 mmHg before vaccination.
• Receipt of systemic immunosuppressants or immune-modifying drugs for \> 14 days in total within 6 months prior to Screening Visit (for corticosteroids ≥ 20 mg/day of prednisone equivalent). Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
• Receipt of immunoglobulins and/or any blood products within the 3 months prior to the first vaccination or planned administration during the study period.
• Receipt of any HPV vaccination within 3 months prior to the first vaccination. Receipt of any vaccination other than HPV vaccination within 30 days prior to first vaccination. Plan to receive any vaccination within 7 days prior to the secondary or third IP vaccination. Plan to receive any vaccination within 30 days after the first, secondary, or third IP vaccination.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first vaccination of IP.
• Use of (or anticipated use of) any prescription drugs (other than hormonal contraception; oral contraceptive pills \[OCPs\], long-acting implantable hormones, injectable hormones, a vaginal ring, or an IUD), over the counter (OTC) medication, or herbal remedies 2 weeks prior to dosing and during course of study, unless the medication will not affect the safety and efficacy evaluations in the study at the discretion of the Investigator(s).
• Regular alcohol consumption defined as \> 21 alcohol units per week (where 1 unit = 284 mL of beer, 25 mL of 40% spirit or a 125 mL glass of wine).

Sponsors & Collaborators

• Wuhan BravoVax Co., Ltd.: lead
• Shanghai BravoBio Co., Ltd.: collaborator
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

Paratus Clinical Research Canberra

Canberra, Australia

Location

Related Publications (1)

• Han Z, Wang S, Mu T, Zhao P, Song L, Zhang Y, Zhao J, Yin W, Wu Y, Wang H, Gong B, Ji M, Roden RBS, Yang Y, Klein M, Wu K. Vaccination with a Human Papillomavirus L2 Multimer Provides Broad Protection against 17 Human Papillomavirus Types in the Mouse Cervicovaginal Challenge Model. Vaccines (Basel). 2024 Jun 20;12(6):689. doi: 10.3390/vaccines12060689.

  PMID: 38932417 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Long Xu, Ph.D.

CONTACT

+86 27 8798 8585 ext. 8251; ct@bravovax.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 5, 2023
• Study Start: August 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: October 31, 2024
• Last Updated: January 6, 2023

Record last verified: 2022-12

Locations

AU (1)