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Phase I Clinical Trial of a Candidate HPV Vaccine | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Phase I Clinical Trial of a Candidate HPV Vaccine

A Phase I, First-in-human, Randomized, Observer-blinded, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of BV601 in Healthy Adult Volunteers

NCT05672966•Wuhan BravoVax Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 35 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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

Exclusion Criteria

•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.
+9 more criteria

Locations (1)

Paratus Clinical Research Canberra

Canberra, Australia

Key Dates

Start Date

August 1, 2023

Primary Completion Date

July 31, 2024

Completion Date

October 31, 2024

Last Updated

January 6, 2023

Enrollment

ESTIMATED participants

Conditions

Human Papillomavirus Infection

Interventions

Human papillomavirus (HPV) Vaccine

BIOLOGICAL

Placebo

BIOLOGICAL

Contacts

Long Xu, Ph.D.

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase I Clinical Trial of a Candidate HPV Vaccine

Inclusion Criteria

Exclusion Criteria

Feasibility Trial of a Multi-level Media Production and Social Marketing Campaign to Reduce HPV Vaccine Hesitancy

Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus

Extended Follow-up of Women Who Received One, Two, and Three Doses of the HPV Vaccine in the Costa Rica Vaccine Trial (CVT), ESCUDDO-CVT Study

Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) Asian/Asian American Women Supplement

Prospective Evaluation of Self-Testing to Increase Screening

Transmission of Oncogenic HPV Infection Among Families