Human PapillomavirusPhase 2NCT02740790
Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 Vaccine in Healthy Females
A Phase 2 study testing HPV vaccine in people with Human Papillomavirus, run by Shanghai Zerun Biotechnology Co.,Ltd at 1 site in China.
Trial summary
Evaluate immunogenicity and safety of recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast )in different age group. And evaluate persistence of immune response in 9-17years age group. 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
- Human Papillomavirus
- What is being tested?
- HPV vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Dec 2017
- Phase
- Phase 2
- 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 female between, and including, 9 and 45 years of age at the time of the first vaccination
- Provide legal identification for for the sake of recruitment
- Be able to understand and sign informed consent prior to enrollment (For subjects below the legal age of consent, informed consent must be signed by parent(s)/legal guardian(s) in addition).
- Subject must be not pregnant at the enrollment and agree to using adequate contraceptive precautions within 7 months.
Who cannot join
- History of cervical cancer
- Previous administration of any HPV vaccine
- History of severe allergic reaction requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock)
- History of allergic to vaccine, or to any ingredient of vaccine.
- 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.
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- History of asthma, thyroidectomy, angioneurotic edema, diabetes or malignant
- Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy
- Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
- Acute disease or chronic disease acute exacerbation 7 days prior to vaccination
- Administration of immunoglobulins and/or any blood products within 3 months, or administration of any live attenuated vaccine within 28 days, or administration of any subunit or inactivated vaccines within 14 days.
- Fever or axillary temperature> 37.0 °C before vaccination
- During menstrual period, breastfeeding, pregnancy(pregnancy test positive), or planned pregnant within 7 month
- History of hypertension, physical examination systolic blood pressure> 150mmHg and/or diastolic blood pressure> 100mmHg
- Abnormal laboratory tests parameters
- Any clinical significant disease or findings during study screening that, in the opinion of the Investigator may interfere with the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of Recombinant Human Papillomavirus Bivalent(Type 16 and 18) Vaccine (Yeast) in Healthy Females
Evaluate immunogenicity and safety of recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast )in different age group. And evaluate persistence of immune response in 9-17years age group. To demonstrate that 9-17years age group was non-inferior to 18-26 years age group and 27-45 years age group in terms of immunogenicity.
Read the detailed description
This study is a multi-centre, randomized, blinded, placebo controlled study. The study vaccine is recombinant human papillomavirus bivalent (types 16 and 18) vaccine (Yeast), the placebo is aluminium phosphate diluent.
After informed and received the consent of participants/guardians, 1200 healthy females aged 9-45 will be enrolled into three age groups: 9-17, 8-26, 27-45. With the proportion of 1:1, vaccine group and placebo group will receive injection of 0.5ml of vaccine or placebo diluent.
Participants will be injected of vaccine or placebo on a three-dose schedule (0, 2, 6 months). After each inoculation, the immediate reaction will be observed for 30 minutes, and the local and systemic reaction will be systematically observed for 7 days. After the first inoculation, adverse event will be collected until one month after the final inoculation, while serious adverse event will be collected until 6 months after the final inoculation. For every participants, blood samples will be collected before the first inoculation (month 0), one month after the final inoculation (month 7), 6 months after the final inoculation (month 12) to detect the neutralizing antibody of HPV type 16 and 18, and proceed safety and immunogenicity analysis. For participants in 9-14 age group who received the vaccine, neutralizing antibody will also be detected in month 24, 36 and 48 to examine the immune persistency. Meanwhile, some participants will be chosen to study the deviation of gene expression after the vaccination and the association of that with the neutralizing antibody level.
- Conditions
- Human Papillomavirus
- Being tested
- HPV vaccine, Placebo
- Keywords
- Human papillomavirus, vaccine, cervical infection, cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV vaccineBiological
Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
PlaceboBiological
Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
| Study group | Role | What they receive |
|---|---|---|
| HPV vaccine 1 | Experimental | 300 women between 9-17 yeas of age, receiving 0,2,6 month-schedule experimental HPV vaccines Receives: Biological: HPV vaccine |
| Placebo 1 | Placebo comparator | 300 women between 9-17 yeas of age, receiving 0,2,6 month-schedule Placebo. Receives: Biological: Placebo |
| HPV vaccine 2 | Experimental | 120 women between 18-26 yeas of age, receiving 0,2,6 month-schedule experimental HPV vaccines Receives: Biological: HPV vaccine |
| HPV vaccine 3 | Experimental | 180 women between 27-45 yeas of age, receiving 0,2,6 month-schedule experimental HPV vaccines Receives: Biological: HPV vaccine |
| Placebo 2 | Placebo comparator | 120 women between 18-26 yeas of age, receiving 0,2,6 month-schedule Placebo. Receives: Biological: Placebo |
| Placebo 3 | Placebo comparator | 180 women between 27-45 yeas of age, receiving 0,2,6 month-schedule Placebo. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The neutralizing antibody responses of HPV 16/18 after vaccination by measuring Geometric Mean Titer (GMT).
Measured: 1 month after vaccination
Secondary outcomes (3)
Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions
Measured: 7 days after each vaccine dose
Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions
Measured: 6 months after finish vaccinations
The durability of neutralizing antibody responses of HPV 16/18 after vaccination.
Measured: 48 months after finish vaccinations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human PapillomavirusStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rong-cheng Li, MD, Principal investigator, Guangxi Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740790
- Sponsor's protocol ID
- 311-HPV-1002
- Status last verified
- Apr 2023
- First submitted
- 18 Feb 2016
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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
- Immunogenicity and Safety of Recombinant Human Papillomavirus Bivalent(Type 16 and 18) Vaccine (Yeast) in Healthy Females
- ClinicalTrials.gov ID
- NCT02740790
- Acronym / sponsor ID
- 311-HPV-1002
- Conditions
- Human Papillomavirus
- Keywords
- Human papillomavirus, vaccine, cervical infection, cervical cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2013 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Apr 2016 (estimated)
- 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.
Evaluate immunogenicity and safety of recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast )in different age group. And evaluate persistence of immune response in 9-17years age group. To demonstrate that 9-17years age group was non-inferior to 18-26 years age group and 27-45 years age group in terms of immunogenicity.
Detailed description
This study is a multi-centre, randomized, blinded, placebo controlled study. The study vaccine is recombinant human papillomavirus bivalent (types 16 and 18) vaccine (Yeast), the placebo is aluminium phosphate diluent.
After informed and received the consent of participants/guardians, 1200 healthy females aged 9-45 will be enrolled into three age groups: 9-17, 8-26, 27-45. With the proportion of 1:1, vaccine group and placebo group will receive injection of 0.5ml of vaccine or placebo diluent.
Participants will be injected of vaccine or placebo on a three-dose schedule (0, 2, 6 months). After each inoculation, the immediate reaction will be observed for 30 minutes, and the local and systemic reaction will be systematically observed for 7 days. After the first inoculation, adverse event will be collected until one month after the final inoculation, while serious adverse event will be collected until 6 months after the final inoculation. For every participants, blood samples will be collected before the first inoculation (month 0), one month after the final inoculation (month 7), 6 months after the final inoculation (month 12) to detect the neutralizing antibody of HPV type 16 and 18, and proceed safety and immunogenicity analysis. For participants in 9-14 age group who received the vaccine, neutralizing antibody will also be detected in month 24, 36 and 48 to examine the immune persistency. Meanwhile, some participants will be chosen to study the deviation of gene expression after the vaccination and the association of that with the neutralizing antibody level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| HPV vaccine 1 | Experimental | Biological: HPV vaccine300 women between 9-17 yeas of age, receiving 0,2,6 month-schedule experimental HPV vaccines |
| Placebo 1 | Placebo comparator | Biological: Placebo300 women between 9-17 yeas of age, receiving 0,2,6 month-schedule Placebo. |
| HPV vaccine 2 | Experimental | Biological: HPV vaccine120 women between 18-26 yeas of age, receiving 0,2,6 month-schedule experimental HPV vaccines |
| HPV vaccine 3 | Experimental | Biological: HPV vaccine180 women between 27-45 yeas of age, receiving 0,2,6 month-schedule experimental HPV vaccines |
| Placebo 2 | Placebo comparator | Biological: Placebo120 women between 18-26 yeas of age, receiving 0,2,6 month-schedule Placebo. |
| Placebo 3 | Placebo comparator | Biological: Placebo180 women between 27-45 yeas of age, receiving 0,2,6 month-schedule Placebo. |
Who may qualify
- Ages
- 9 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Healthy female between, and including, 9 and 45 years of age at the time of the first vaccination
- Provide legal identification for for the sake of recruitment
- Be able to understand and sign informed consent prior to enrollment (For subjects below the legal age of consent, informed consent must be signed by parent(s)/legal guardian(s) in addition).
- Subject must be not pregnant at the enrollment and agree to using adequate contraceptive precautions within 7 months.
Key exclusion criteria (16 listed)
- History of cervical cancer
- Previous administration of any HPV vaccine
- History of severe allergic reaction requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock)
- History of allergic to vaccine, or to any ingredient of vaccine.
- History of epilepsy, seizures or convulsions, or family history of mental illness
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 |
|---|---|---|
| HPV vaccineSubjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule | Biological | HPV vaccine 1, HPV vaccine 2, HPV vaccine 3 |
| PlaceboSubjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule | Biological | Placebo 1, Placebo 2, Placebo 3 |
Primary outcome
The neutralizing antibody responses of HPV 16/18 after vaccination by measuring Geometric Mean Titer (GMT).
Time frame: 1 month after vaccination
3 secondary outcomes
Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions
Time frame: 7 days after each vaccine dose
Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions
Time frame: 6 months after finish vaccinations
The durability of neutralizing antibody responses of HPV 16/18 after vaccination.
Time frame: 48 months after finish vaccinations
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.
- Individual participant dataSharing planned: No
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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.
Rong-cheng Li, MD principal investigator
Guangxi Centers 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 2 study testing HPV vaccine in people with Human Papillomavirus, 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 4 inclusion and 16 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The neutralizing antibody responses of HPV 16/18 after vaccination by measuring Geometric Mean Titer (GMT). (time frame: 1 month after vaccination). 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.