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Human Papillomavirus InfectionPhase 1NCT05672966

Phase I Clinical Trial of a Candidate HPV Vaccine

A Phase 1 study testing Human papillomavirus (HPV) Vaccine in people with Human Papillomavirus Infection, run by Wuhan BravoVax Co., Ltd. at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Human Papillomavirus Infection
What is being tested?
Human papillomavirus (HPV) Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteAustralia
Study dates
1 Aug 2023to 31 Oct 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Long Xu, Ph.D. contact

+86 27 8798 8585 ext. 8251

ct@bravovax.com

Australia1 site

  • Paratus Clinical Research Canberra

    Canberra

    Amber Leah, Dr.

Other trials in Australia

About this study

Official 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

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.

Being tested
Human papillomavirus (HPV) Vaccine, Placebo
Keywords
HPV Vaccine, Phase I, BV601
Medical subject headings
Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human papillomavirus (HPV) VaccineBiological

    Also called BV601

    0.5mL, Intramuscular

  • PlaceboBiological

    0.5mL, Intramuscular

Study groups in NCT05672966
Study groupRoleWhat they receive
1-BV601DP(Low dose HPV vaccine with adjuvant)ExperimentalSubjects received low dose of BV601DP
Receives: Biological: Human papillomavirus (HPV) Vaccine
1-BV601DPP(Low dose HPV vaccine without adjuvant)ExperimentalSubjects received low dose of BV601DPP
Receives: Biological: Human papillomavirus (HPV) Vaccine
1-PlaceboPlacebo comparatorSubjects received placebo
Receives: Biological: Placebo
2-BV601DP(High dose HPV vaccine with adjuvant)ExperimentalSubjects received high dose of BV601DP
Receives: Biological: Human papillomavirus (HPV) Vaccine
2-BV601DPP(High dose HPV vaccine without adjuvant)ExperimentalSubjects received high dose of BV601DPP
Receives: Biological: Human papillomavirus (HPV) Vaccine
2-PlaceboPlacebo comparatorSubjects received placebo
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety in terms of solicited adverse events

    Occurrence of solicited AEs of each subject

    Measured: within 7 days after each vaccination

  2. Safety in terms of solicited systemic AEs

    Occurrence of solicited systemic AEs of each subject

    Measured: within 7 days after the first vaccination

  3. Safety in terms of dose-limiting toxicity (DLT)

    Percentage of participants with dose-limiting toxicity

    Measured: within 30 days after the first vaccination

  4. Safety in terms of unsolicited AEs

    Percentage of participants with unsolicited AEs

    Measured: 365 days after the first vaccination

  5. Safety in terms of all solicited and unsolicited AEs

    Frequency and severity of solicited and unsolicited AEs

    Measured: 365 days after the first vaccination

Secondary outcomes (3)

  1. Immunogencity in terms of GMT by ELISA

    GMT of anti-L2 immunoglobulin G (IgG) antibody responses

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

  2. Immunogencity in terms of Nab

    GMT of anti-HPV 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, and 73 type specific serum neutralizing antibody (NAb) response

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

  3. Immunogencity in terms of Seroconversion rate

    Seroconversion rate of anti-L2 IgG antibody and anti-HPV 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, and 73 type-specific serum Nab

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2023
  2. Study start1 Aug 2023 (estimated)
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion31 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05672966
Sponsor's protocol ID
BV-C601-202201
Status last verified
Dec 2022
First submitted
20 Dec 2022
Last updated
6 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38932417

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Human papillomavirus (HPV) Vaccine in people with Human Papillomavirus Infection, run by Wuhan BravoVax Co., Ltd. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Long Xu, Ph.D. (+86 27 8798 8585 ext. 8251, ct@bravovax.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety in terms of solicited adverse events (time frame: within 7 days after each vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05672966, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.

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