Trial Title:
Phase I Clinical Trial of a Candidate HPV Vaccine
NCT ID:
NCT05672966
Condition:
Human Papillomavirus Infection
Conditions: Official terms:
Papillomavirus Infections
Conditions: Keywords:
HPV Vaccine
Phase I
BV601
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
Human papillomavirus (HPV) Vaccine
Description:
0.5mL, Intramuscular
Arm group label:
1-BV601DP(Low dose HPV vaccine with adjuvant)
Arm group label:
1-BV601DPP(Low dose HPV vaccine without adjuvant)
Arm group label:
2-BV601DP(High dose HPV vaccine with adjuvant)
Arm group label:
2-BV601DPP(High dose HPV vaccine without adjuvant)
Other name:
BV601
Intervention type:
Biological
Intervention name:
Placebo
Description:
0.5mL, Intramuscular
Arm group label:
1-Placebo
Arm group label:
2-Placebo
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.
Criteria for eligibility:
Criteria:
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.
- 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).
- Positive toxicology panel (urine test including qualitative identification of
barbiturates, THC, amphetamines, benzodiazepines, opiates, and cocaine).
- Positive results of hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg),
HIV antibody, HPV, SARS-CoV-2, and pregnancy test.
- Pregnancy or breast feeding or plan to get pregnant or breastfeed during the study.
- Anything that the Investigator(s) considers that may jeopardise the safety of the
participant, prevent complete participation in the study, or compromise
interpretation of study data.
Gender:
All
Minimum age:
18 Years
Maximum age:
35 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Paratus Clinical Research Canberra
Address:
City:
Canberra
Country:
Australia
Investigator:
Last name:
Amber Leah, Dr.
Email:
Principal Investigator
Start date:
August 1, 2023
Completion date:
October 31, 2024
Lead sponsor:
Agency:
Wuhan BravoVax Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Shanghai BravoBio Co., Ltd.
Agency class:
Other
Collaborator:
Agency:
Novotech (Australia) Pty Limited
Agency class:
Industry
Source:
Wuhan BravoVax Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05672966
