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Human Papillomavirus InfectionPhase 3NCT06207175

A Study to Evaluate the Immunogenicity and Safety of Nonavalent Human Papillomavirus (HPV) Vaccine

A Phase 3 study testing Nonavalent HPV study vaccine and GARDASIL® 9 in people with Human Papillomavirus Infection, run by Beijing Health Guard Biotechnology, Inc at 1 site in Indonesia.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 Study to Evaluate the Immunogenicity and Safety of Candidate Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) Administered Intramuscularly in Healthy Female Participants Aged 18 to 45 Years Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Human Papillomavirus Infection
What is being tested?
Nonavalent HPV study vaccine and GARDASIL® 9
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,260 participants
Where
1 siteIndonesia
Study dates
21 Nov 2023to 25 Jan 2026
Phase
Phase 3
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 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • *Healthy female participants, aged between 18 years and 45 years as of the 1st dose of vaccination (18 years ≤ age < 46 years).
  • Prior to enrolment, written informed consent obtained from the participants.
  • *Participants must be either of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 14 days prior to 1st vaccination, and agree to continue such precautions for 1 month after full vaccination.
  • [Effective contraception includes oral contraceptives, injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.]; Women of Childbearing Potential participants have a negative urine pregnancy test before the 1st dose.
  • Participants are able to comply with study protocol, including all scheduled visits, vaccinations, laboratory tests, and other study procedures.
  • Note: For items with an asterisk (), If the subject does not meet the criteria, the visit may be rescheduled when the criteria are met.

Who cannot join

  • * Participant has fever (axillary temperature ≥ 37.3℃) within 24 hours prior to the 1st dose of vaccination;
  • Participant has vaccinated previously or plans to vaccinate with other HPV vaccines during the study period;
  • Participant is participating or plans to participate in other clinical studies during the period of this study;
  • Participant has a history of a positive test for HPV, or a history of an abnormal Pap test result showing atypical squamous cells - undetermined significance (ASC-US), atypical squamous cells - cannot exclude HSIL (ASC-H), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), or atypical glandular cells. Participant has a history of an abnormal cervical biopsy result showing cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ or cervical cancer;
  • Participant has a history of HPV-related genital diseases (e.g., genital warts, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, vulvar cancer, vaginal cancer or anal cancer), a history of venereal disease (e.g., syphilis, gonorrhea, genital chlamydial infection, genital herpes, chancroid, lymphogranuloma venereum, inguinal granuloma, etc.);
  • Participant has a history of allergy to any component of the study vaccine or severe allergic reaction to vaccine (including but not limited to anaphylaxis, allergic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, or localized allergic necrosis (Arthus reaction), severe urticaria, dyspnea, angioneurotic edema, etc.);
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  • Immunocompromised participant or participant that has been diagnosed with 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 condition;
  • Participant who has/had epilepsy, excluding a history of febrile seizures under 2 years of age, or alcoholic epilepsy within 3 years prior to alcohol withdrawal;
  • Participant who has severe liver and kidney disease, severe cardiovascular disease, severe diabetes, malignant tumors, severe infectious diseases (e.g., tuberculosis, chronic hepatitis B/C, syphilis, etc.), is unsuitable to participate in this study based on the investigator's judgement;
  • Participant who has thrombocytopenia or any coagulopathy that is not suitable for intramuscular injection;
  • Asplenia or functional asplenia, complete or partial splenectomy from any cause;
  • Participant who is receiving or has received prolonged use (>14 days) of immunosuppressive or other immunomodulatory drugs (e.g., corticosteroids, ≥20 mg/d prednisone or equivalent; however, topical medications such as ointments, eye drops, inhalants or nasal sprays are permitted) within 6 months prior to the 1st dose of vaccination, or plans to receive them during the period from 1st dose of vaccination to 30 days after full vaccination;
  • Participant has received immunoglobulin or other blood products within 3 months prior to the 1st dose of vaccination or plans to receive them during the period from the 1st dose of vaccination to 30 days after full vaccination;
  • *Participant who has acute illness or in acute exacerbation of chronic diseases or use antipyretic, analgesic and anti-allergic drugs (e.g., paracetamol, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 3 days prior to vaccination;
  • *Participant who has vaccinated with inactivated/recombinant/nucleic acid vaccines (non-attenuated vaccines) within 14 days before enrollment or attenuated vaccines within 28 days before enrollment, or plans to administrate vaccine(s) from the 1st dose of vaccination to 30 days after the full vaccination of investigational vaccine.
  • *Participant who donated blood or lost blood ≥ 450 mL within one week before enrollment, or plans to donate blood during the period from the 1st dose of vaccination to 30 days after full vaccination of investigational vaccine;
  • Participant who cannot comply with the requirements of the study due to psychological conditions, and has a history of mental diseases or currently suffer from mental diseases;
  • Participant, who is unsuitable for participation in this study based on the investigator's judgement.
  • Note: For items with an asterisk (), if the participant meets these exclusion criteria, the visit may be rescheduled for a time when these criteria are not met. In addition to the examination items set forth in the protocol, other medical history, surgical history and medication history may be obtained in the form of inquiry.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • University of Muhammadiyah Malang Hospital

    Malang

Other trials in Indonesia

About this study

Official title: A Phase III Trial in Healthy Indonesian Women Ages 18-45 to Evaluate the Immunogenicity and Safety of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)

This Study to Evaluate the Immunogenicity and Safety of Candidate Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) Administered Intramuscularly in Healthy Female Participants Aged 18 to 45 Years

Read the detailed description

This is a randomized, observer blinded, active controlled, multicenter clinical study.

A total of approximately 1,260 healthy female participants aged 18 to 45 years old who meet eligibility will be enrolled, and be randomly assigned into 2 groups in a 1:1 ratio.

Immunogenicity: Blood samples (5.0 mL each time) will be collected for all participants prior to the 1st dose of vaccination and on 1, 6, 12, 18 months after full vaccination for anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies and Immunoglobulin G antibodies testing.

Safety evaluation (for all participants):To assess solicited (local and systemic) Adverse Event (AEs) within 7 days after each dose of vaccination, unsolicited Adverse Event (AEs) within 30 days after each dose of vaccination, and Serious Adverse Event (SAEs) from 1st dose to 18 months after full vaccination.

Collection of pregnancy events:To assess the occurrence of pregnancy events in all participants from 1st dose to 18 months after full vaccination. The subject will be followed to determine the outcome of the pregnancy.

At the end of the pregnancy, be it a full-term or premature birth, information on the status of the newborn(s) will be followed up during the first 12 months of life.

Being tested
Nonavalent HPV study vaccine, GARDASIL® 9
Keywords
Human Papillomavirus
Medical subject headings
Papillomavirus Infections

What participants receive

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

  • Nonavalent HPV study vaccineBiological

    Also called Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli)

    A 3-dose regimen administered at months 0, 2 and 6.

  • GARDASIL® 9Biological

    A 3-dose regimen administered at months 0, 2 and 6.

Study groups in NCT06207175
Study groupRoleWhat they receive
Nonavalent HPV study vaccineExperimentalStudy vaccine: Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) (Hereinafter referred to as "Nonavalent HPV study vaccine") Provided by: Beijing Health Guard Biotechnology, Inc. Dosage: 0.5 mL per dose Appearance: White, cloudy liquid suspension Dosage form: 0.5-mL suspension for injection as a prefilled syringe Route of administration: Intramuscular injection into the lateral deltoid muscle of the upper arm Vaccination schedule in this study：3 injections on a 0, 2, 6-month schedule.
Receives: Biological: Nonavalent HPV study vaccine
GARDASIL® 9Active comparatorControl vaccine: GARDASIL® 9 Manufacturer: Merck Sharp and Dohme Corp (MSD). Dosage: 0.5 mL per dose Appearance: After thorough agitation, GARDASIL® 9 is a white cloudy liquid Dosage form: 0.5-mL suspension for injection as a prefilled syringe Route of administration: Intramuscular injection into the lateral deltoid muscle of the upper arm Vaccination schedule：3 injections on a 0, 2, 6-month schedule.
Receives: Biological: GARDASIL® 9

What is being measured

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

  1. Geometric mean titer (GMT) for anti-HPV neutralizing antibodies 30 days after full vaccination

    Geometric mean titer (GMT) for anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination in participants who are seronegative to the relevant HPV type prior to 1st vaccination.

    Measured: 30 days after full vaccination

  2. Seroconversion Rate (SCR) for anti-HPV neutralizing antibodies 30 days after full vaccination

    Seroconversion Rate (SCR) for anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination in participants who are seronegative to the relevant HPV type prior to 1st vaccination.

    Measured: 30 days after full vaccination

Secondary outcomes (7)

  1. Geometric mean titer (GMT) of anti-HPV immunoglobulin G antibodies 30 days after full vaccination

    Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 immunoglobulin G antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) 30 days after full vaccination in participants who are seronegative to the relevant HPV type prior to 1st vaccination.

    Measured: 30 days after full vaccination

  2. Seroconversion Rate (SCR) of anti-HPV immunoglobulin G antibodies 30 days after full vaccination

    Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 immunoglobulin G antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) 30 days after full vaccination in participants who are seronegative to the relevant HPV type prior to 1st vaccination.

    Measured: 30 days after full vaccination

  3. Geometric mean titer (GMT) of anti-HPV neutralizing antibodies and immunoglobulin G antibodies 6,12,18 months after full vaccination

    Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies and immunoglobulin G antibodies 6 months, 12 months and 18 months after full vaccination in participants.

    Measured: 6 months, 12 months and 18 months after full vaccination

  4. Seroconversion Rate (SCR) of anti-HPV neutralizing antibodies and immunoglobulin G antibodies 6,12,18 months after full vaccination

    Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies and immunoglobulin G antibodies 6 months, 12 months and 18 months after full vaccination in participants.

    Measured: 6 months, 12 months and 18 months after full vaccination

  5. Incidenct, severity and duration of each solicited (local and systemic) AE within 7 days after each dose of vaccination

    Incidenct, severity and duration of each solicited (local and systemic) AE within 7 days after each dose of vaccination.

    Measured: 0-7 days after each dose of vaccination

  6. Incidenct, severity and duration of each unsolicited AE within 30 days after each dose of vaccination

    Incidenct, severity and duration of each unsolicited AE within 30 days after each dose of vaccination.

    Measured: 0-30 days after each dose of vaccination

  7. Incidence, severity and causality of SAE and incidence of pregnancy events from 1st dose to 18 months after full vaccination

    Incidence, severity and causality of SAE and incidence of pregnancy events from 1st dose to 18 months after full vaccination.

    Measured: from 1st dose to 18 months after full vaccination

Timeline

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

  1. First posted16 Jan 2024
  2. Study start21 Nov 2023
  3. Primary completion17 Nov 2024 (estimated)
  4. Study completion25 Jan 2026 (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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06207175
Sponsor's protocol ID
KLWS-V502-05
Status last verified
Jan 2024
First submitted
2 Jan 2024
Last updated
23 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No informed consent was obtained to disclose the subject's data and sample test results

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nonavalent HPV study vaccine and GARDASIL® 9 in people with Human Papillomavirus Infection, run by Beijing Health Guard Biotechnology, Inc at 1 site in Indonesia.

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 23 Jan 2024. 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 Indonesia. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric mean titer (GMT) for anti-HPV neutralizing antibodies 30 days after full vaccination (time frame: 30 days after full vaccination). The study lists 2 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 NCT06207175.

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 23 Jan 2024.

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