Cervical CancersPhase 1NCT03676101
Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
A Phase 1 study testing 9-valent HPV Recombinant Vaccine in people with Cervical Cancers and Vulvar Cancer, run by Shanghai Bovax Biotechnology Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years. Read more about this study
- Who is it for?
- Ages 9 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancers, Vulvar Cancer, Vaginal Cancer
- What is being tested?
- 9-valent HPV Recombinant Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2018to 10 Jan 2020
- 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 9 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy females between, and including, 9 and 45 years of age at the time of enrolment
- Be able to provide legal identification for the sake of recruitment
- Be able to understand and sign informed consent form prior to enrollment and for subjects aged 9-17 years, they and their legal guardian(s) are supposed to understand and sign informed consent form together
- Subjects who the investigator believes that they can and will comply with the protocol requirements
- Subject must be not pregnant at the enrollment and agree to use adequate contraceptive precautions within 7 months or don't have pregnancy plan
Who cannot join
- Fever or axillary temperature> 37.0℃ before vaccination
- Previous vaccination against HPV
- Planned administration/administration of investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding first dose of vaccine
- Planned to take part in other clinical research within 7 months after participating this study or have taken part in other clinical research within 3 months before participating this study
- Abnormal laboratory tests parameters(except the part the clinician diagnosed as non clinical significance)
- Administration of any whole blood, plasma or immunoglobulins products within 3 months preceding first vaccination
Show all 19Show fewer
- Interval between administration of the study vaccination and any attenuated live vaccine less than 14 days, and other vaccines less than 10 days
- History of serious allergic disease requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock)
- History of to adverse event to vaccine, or allergic to some food or drug
- History of epilepsy, seizures or convulsions, or family history of mental illness
- Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose.
- Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy
- Subject to severe hepatorenal disease, cardiovascular disease, hypertension, diabetes, malignant tumor, all kinds of infectious diseases and acute illness, or during chronic disease acute attack period
- Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
- Breastfeeding, pregnancy (including pregnancy test positive), or planned to be pregnant within 7 months
- During acute disease (including infectious and non-infectious disease) and chronic diease period of onset
- Abnormal cervical cancer screening or subject to CIN or acuteness wet wart that relevant to HPV infection in the past two years
- Planned to move out of local before the end of the study or leave the local for a long time during the study period
- Other unsuitable factors for the study judged by investigators
Trial locations and contacts
1 site in 1 country.
China1 site
Zhejiang Provincial Center for Disease Control and Prevention
Hanzhou
About this study
Official title: A Randomized, Double-Blind and Placebo-Controlled Phase I Study to Evaluate the Safety and Primary Immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years
To evaluate the safety and immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years.
- Conditions
- Cervical Cancers, Vulvar Cancer, Vaginal Cancer, CIN1, CIN2, CIN 3
- Being tested
- 9-valent HPV Recombinant Vaccine, Placebo
- Medical subject headings
- Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9-valent HPV Recombinant VaccineBiological
Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
PlaceboBiological
Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule.
| Study group | Role | What they receive |
|---|---|---|
| 9-valent HPV Recombinant Vaccine | Experimental | Not described Receives: Biological: 9-valent HPV Recombinant Vaccine |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Solicited Adverse Events
Measured: 7 days after each vaccination
Number of Subjects Reporting Unsolicited Adverse Events
Measured: 30 days after each vaccination
Number of Subjects Reporting Serious Adverse Events
Measured: 30 days after third dose of vaccination
Secondary outcomes (1)
Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58
Measured: 30 days after third dose of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start10 Oct 2018
- Primary completion20 Aug 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancersStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Bovax Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chongqing Bovax Biopharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676101
- Sponsor's protocol ID
- 9-HPV-1001
- Status last verified
- Jan 2020
- First submitted
- 12 Sep 2018
- Last updated
- 22 Jan 2020
- 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 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind and Placebo-Controlled Phase I Study to Evaluate the Safety and Primary Immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years
- ClinicalTrials.gov ID
- NCT03676101
- Acronym / sponsor ID
- 9-HPV-1001
- Conditions
- Cervical Cancers, Vulvar Cancer, Vaginal Cancer, CIN1, CIN2, CIN 3
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Shanghai Bovax Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chongqing Bovax Biopharmaceutical Co., Ltd.
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 18 Sep 2018 (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.
To evaluate the safety and immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 9-valent HPV Recombinant Vaccine | Experimental | Biological: 9-valent HPV Recombinant Vaccine |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 9 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy females between, and including, 9 and 45 years of age at the time of enrolment
- Be able to provide legal identification for the sake of recruitment
- Be able to understand and sign informed consent form prior to enrollment and for subjects aged 9-17 years, they and their legal guardian(s) are supposed to understand and sign informed consent form together
- Subjects who the investigator believes that they can and will comply with the protocol requirements
- Subject must be not pregnant at the enrollment and agree to use adequate contraceptive precautions within 7 months or don't have pregnancy plan
Key exclusion criteria (19 listed)
- Fever or axillary temperature> 37.0℃ before vaccination
- Previous vaccination against HPV
- Planned administration/administration of investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding first dose of vaccine
- Planned to take part in other clinical research within 7 months after participating this study or have taken part in other clinical research within 3 months before participating this study
- Abnormal laboratory tests parameters(except the part the clinician diagnosed as non clinical significance)
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 |
|---|---|---|
| 9-valent HPV Recombinant VaccineSubjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule. | Biological | 9-valent HPV Recombinant Vaccine |
| PlaceboSubjects received 3 doses of Placebo according to a 0, 2, 6-month schedule. | Biological | Placebo |
Primary outcome
Number of Subjects Reporting Solicited Adverse Events
Time frame: 7 days after each vaccination
Number of Subjects Reporting Unsolicited Adverse Events
Time frame: 30 days after each vaccination
Number of Subjects Reporting Serious Adverse Events
Time frame: 30 days after third dose of vaccination
1 secondary outcome
Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58
Time frame: 30 days after third dose of vaccination
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 22 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 9-valent HPV Recombinant Vaccine in people with Cervical Cancers and Vulvar Cancer, run by Shanghai Bovax 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 5 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: finished, as of the sponsor's last update on 22 Jan 2020. 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. 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?
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?
Number of Subjects Reporting Solicited Adverse Events (time frame: 7 days after each vaccination). The study lists 3 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 22 Jan 2020.