HPV InfectionPhase 3NCT04965350
Lot Consistency Clinical Trial of Bivalent HPV Vaccine in 9 to 30 Years Old Healthy Females
A Phase 3 study testing Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris) in people with HPV Infection, run by Shanghai Zerun Biotechnology Co.,Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of bivalent HPV (Type 16,18) vaccine (Pichia pastoris) in healthy female subjects aged 9 - 30 years, and demonstrate the non-inferiority of the candidate HPV vaccine manufactured at commercial scale compared with a pilot… Read more about this study
- Who is it for?
- Ages 9 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection
- What is being tested?
- Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2021to 16 May 2022
- 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 9 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 9-30 healthy female able to provide legal identification.
- Written informed consent had to be obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent had to be obtained from a parent or legal guardian of the subject and, in addition, the subject had to sign and personally date a written informed assent).
- Women of child-bearing age(WOCBA): Subject had to have a negative urine pregnancy test, no plan to be pregnant in 7 months, and agree to use adequate contraceptive precautions during study period.
Who cannot join
- Subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial.
- History of abnormal cervical screen test result (ASC-US or worse) or history of genital warts.
- History of severe allergic reaction that required medical intervention.
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines.
- Pregnant or breastfeeding, or within 6 weeks after the end of pregnancy.
- Fever prior to vaccination (auxiliary temperature ≥37.3 °C).
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- Hypertension (physical examination systolic blood pressure 140mmHg and or diastolic blood pressure 90mmHg.
- Received live attenuated vaccine within 15 days before vaccination or subunit or inactivated vaccine within 7 days.
- Received immunoglobulin and/or blood product 3 months prior to the first vaccination.
- Acute diseases or acute stage of the chronic diseases within 3 days preceding the vaccination.
- According to the judgment of the investigator, subject has or had any other symptoms, medical history and other factors that are not suitable for participating in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Mianyang Center for Disease Control and Prevention
Mianyang, Sichuan
About this study
Official title: A Phase III, Randomized, Double-blind Study to Assess the Consistency of the Immunogenicity of Three Consecutive Production Lots of Bivalent HPV Vaccine in Healthy Female Subjects Aged 9 - 30 Years and to Demonstrate Non-inferiority of the Candidate HPV Vaccine Manufactured at Commercial Scale Compared With a Pilot Scale
The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of bivalent HPV (Type 16,18) vaccine (Pichia pastoris) in healthy female subjects aged 9 - 30 years, and demonstrate the non-inferiority of the candidate HPV vaccine manufactured at commercial scale compared with a pilot scale.
- Conditions
- HPV Infection
- Being tested
- Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)Biological
sterile solution for intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 2vHPV Consistency Lot 1 | Experimental | Not described Receives: Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris) |
| 2vHPV Consistency Lot 2 | Experimental | Not described Receives: Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris) |
| 2vHPV Consistency Lot 3 | Experimental | Not described Receives: Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris) |
| 2vHPV Pilot Scale Lot | Active comparator | Not described Receives: Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titers (GMTs) for HPV-16 and/or HPV-18 at one month post 3rd dose
Measured: At Month 7
Percentage of participants who seroconvert to HPV-16 and/or HPV-18 at one month post 3rd dose
Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:40 prior to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:40 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
Measured: At Month 7
Secondary outcomes (4)
Incidence of Treatment-Emergent Adverse Events (TEAE) during 30 days after each dose
Measured: 0~30 days after each vaccination
Incidence of solicited adverse events (AEs) after vaccination
Measured: 0~7 days after each vaccination
Incidence of unsolicited AEs after vaccination
Measured: 0~30 days after each vaccination
Incidence of serious adverse events (SAEs)
Measured: Month 0 to Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start20 Apr 2021
- Primary completion27 Apr 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yuxi Zerun Biotechnology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Ting Huang, Principal investigator, Sichuan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965350
- Sponsor's protocol ID
- 311-HPV-1005
- Status last verified
- Apr 2023
- First submitted
- 21 Jun 2021
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blind Study to Assess the Consistency of the Immunogenicity of Three Consecutive Production Lots of Bivalent HPV Vaccine in Healthy Female Subjects Aged 9 - 30 Years and to Demonstrate Non-inferiority of the Candidate HPV Vaccine Manufactured at Commercial Scale Compared With a Pilot Scale
- ClinicalTrials.gov ID
- NCT04965350
- Acronym / sponsor ID
- 311-HPV-1005
- Conditions
- HPV Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Yuxi Zerun Biotechnology Co., Ltd.
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of bivalent HPV (Type 16,18) vaccine (Pichia pastoris) in healthy female subjects aged 9 - 30 years, and demonstrate the non-inferiority of the candidate HPV vaccine manufactured at commercial scale compared with a pilot scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2vHPV Consistency Lot 1 | Experimental | Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris) |
| 2vHPV Consistency Lot 2 | Experimental | Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris) |
| 2vHPV Consistency Lot 3 | Experimental | Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris) |
| 2vHPV Pilot Scale Lot | Active comparator | Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris) |
Who may qualify
- Ages
- 9 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 9-30 healthy female able to provide legal identification.
- Written informed consent had to be obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent had to be obtained from a parent or legal guardian of the subject and, in addition, the subject had to sign and personally date a written informed assent).
- Women of child-bearing age(WOCBA): Subject had to have a negative urine pregnancy test, no plan to be pregnant in 7 months, and agree to use adequate contraceptive precautions during study period.
Key exclusion criteria (11 listed)
- Subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial.
- History of abnormal cervical screen test result (ASC-US or worse) or history of genital warts.
- History of severe allergic reaction that required medical intervention.
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines.
- Pregnant or breastfeeding, or within 6 weeks after the end of pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)sterile solution for intramuscular injection | Biological | 2vHPV Consistency Lot 1, 2vHPV Consistency Lot 2, 2vHPV Consistency Lot 3, 2vHPV Pilot Scale Lot |
Primary outcome
Geometric Mean Titers (GMTs) for HPV-16 and/or HPV-18 at one month post 3rd dose
Time frame: At Month 7
Percentage of participants who seroconvert to HPV-16 and/or HPV-18 at one month post 3rd dose
Time frame: At Month 7
Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:40 prior to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:40 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
4 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (TEAE) during 30 days after each dose
Time frame: 0~30 days after each vaccination
Incidence of solicited adverse events (AEs) after vaccination
Time frame: 0~7 days after each vaccination
Incidence of unsolicited AEs after vaccination
Time frame: 0~30 days after each vaccination
Incidence of serious adverse events (SAEs)
Time frame: Month 0 to Month 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Huang principal investigator
Sichuan Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris) in people with HPV Infection, run by Shanghai Zerun Biotechnology Co.,Ltd at 1 site in China.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 13 Apr 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Titers (GMTs) for HPV-16 and/or HPV-18 at one month post 3rd dose (time frame: At Month 7). 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?
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 13 Apr 2023.