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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05672966




Registration number
NCT05672966
Ethics application status
Date submitted
20/12/2022
Date registered
5/01/2023
Date last updated
6/01/2023

Titles & IDs
Public title
Phase I Clinical Trial of a Candidate HPV Vaccine
Scientific title
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
Secondary ID [1] 0 0
BV-C601-202201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Papillomavirus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Human papillomavirus (HPV) Vaccine
Treatment: Other - Placebo

Experimental: 1-BV601DP(Low dose HPV vaccine with adjuvant) - Subjects received low dose of BV601DP

Experimental: 1-BV601DPP(Low dose HPV vaccine without adjuvant) - Subjects received low dose of BV601DPP

Placebo comparator: 1-Placebo - Subjects received placebo

Experimental: 2-BV601DP(High dose HPV vaccine with adjuvant) - Subjects received high dose of BV601DP

Experimental: 2-BV601DPP(High dose HPV vaccine without adjuvant) - Subjects received high dose of BV601DPP

Placebo comparator: 2-Placebo - Subjects received placebo


Treatment: Other: Human papillomavirus (HPV) Vaccine
0.5mL, Intramuscular

Treatment: Other: Placebo
0.5mL, Intramuscular
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety in terms of solicited adverse events
Timepoint [1] 0 0
within 7 days after each vaccination
Primary outcome [2] 0 0
Safety in terms of solicited systemic AEs
Timepoint [2] 0 0
within 7 days after the first vaccination
Primary outcome [3] 0 0
Safety in terms of dose-limiting toxicity (DLT)
Timepoint [3] 0 0
within 30 days after the first vaccination
Primary outcome [4] 0 0
Safety in terms of unsolicited AEs
Timepoint [4] 0 0
365 days after the first vaccination
Primary outcome [5] 0 0
Safety in terms of all solicited and unsolicited AEs
Timepoint [5] 0 0
365 days after the first vaccination
Secondary outcome [1] 0 0
Immunogencity in terms of GMT by ELISA
Timepoint [1] 0 0
Days 1, 31, 61, 91, 121, 181, 211, and 365
Secondary outcome [2] 0 0
Immunogencity in terms of Nab
Timepoint [2] 0 0
Days 1, 31, 61, 91, 121, 181, 211, and 365
Secondary outcome [3] 0 0
Immunogencity in terms of Seroconversion rate
Timepoint [3] 0 0
Days 1, 31, 61, 91, 121, 181, 211, and 365

Eligibility
Key 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
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/08/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Paratus Clinical Research Canberra - Canberra
Recruitment postcode(s) [1] 0 0
- Canberra

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Wuhan BravoVax Co., Ltd.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Shanghai BravoBio Co., Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Novotech (Australia) Pty Limited
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05672966
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Long Xu, Ph.D.
Address 0 0
Country 0 0
Phone 0 0
+86 27 8798 8585 ext. 8251
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05672966