Human PapillomavirusPhase 1NCT01548118
Evaluate the Safety of Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Healthy Females
A Phase 1 study testing HPV 16/18 vaccine, 0,5ml and HPV 16/18 vaccine, 1.0ml in people with Human Papillomavirus, run by Shanghai Zerun Biotechnology Co.,Ltd at 1 site in China.
Trial summary
This study will evaluate the safety of a novel recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast ) with different dose in healthy females between 9-45 years of age at enrollment. 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 16/18 vaccine, 0,5ml and HPV 16/18 vaccine, 1.0ml
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Dec 2012
- 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 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
- 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.
- History of asthma, thyroidectomy, angioneurotic edema, diabetes or malignant
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- 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: A Blind, Randomized and Placebo-controlled Clinical Trial With Recombinant HumanPapillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Health Women-Phase I
This study will evaluate the safety of a novel recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast ) with different dose in healthy females between 9-45 years of age at enrollment.
- Conditions
- Human Papillomavirus
- Being tested
- HPV 16/18 vaccine, 0,5ml, Placebo control, 0.5ml, HPV 16/18 vaccine, 1.0ml, Placebo control, 1.0ml
- 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 16/18 vaccine, 0,5mlBiological
Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
Placebo control, 0.5mlBiological
Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
HPV 16/18 vaccine, 1.0mlBiological
Subjects were planned to receive HPV vaccine 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
Placebo control, 1.0mlBiological
Subjects were planned to receive three doses of the placebo control 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
| Study group | Role | What they receive |
|---|---|---|
| Adult Group 1, HPV vaccine 0.5ml | Experimental | 20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 0.5ml experimental HPV vaccines. Receives: Biological: HPV 16/18 vaccine, 0,5ml |
| Adult Group 1, Placebo 0.5ml | Placebo comparator | 20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 0.5ml aluminum phosphate. Receives: Biological: Placebo control, 0.5ml |
| Adult Group 2, HPV vaccine 1.0ml | Experimental | 20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 1.0ml experimental HPV vaccines. Receives: Biological: HPV 16/18 vaccine, 1.0ml |
| Adult Group 2, Placebo 1.0ml | Placebo comparator | 20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 1.0ml aluminum phosphate. Receives: Biological: Placebo control, 1.0ml |
| Children Group 1, HPV vaccine 0.5ml | Experimental | 20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 0.5ml experimental HPV vaccines. Receives: Biological: HPV 16/18 vaccine, 0,5ml |
| Children Group 1, Placebo 0.5ml | Placebo comparator | 20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 0.5ml aluminum phosphate. Receives: Biological: Placebo control, 0.5ml |
| Children Group 2, HPV vaccine 1.0ml | Experimental | 20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 1.0ml experimental HPV vaccines. Receives: Biological: HPV 16/18 vaccine, 1.0ml |
| Children Group 2, Placebo 1.0ml | Placebo comparator | 20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 1.0ml aluminum phosphate. Receives: Biological: Placebo control, 1.0ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 unsolicited symptom.
Measured: 30 days after finish vaccinations
Secondary outcomes (1)
Neutralizing antibody responses of HPV 16/18 after each vaccine dose.
Measured: 30 days 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 posted8 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2012 (estimated)
- Study completionDec 2012 (estimated)
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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan-ping Li, MD, Principal investigator, Guangxi Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548118
- Sponsor's protocol ID
- 311-HPV-1001
- Status last verified
- Mar 2012
- First submitted
- 29 Feb 2012
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blind, Randomized and Placebo-controlled Clinical Trial With Recombinant HumanPapillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Health Women-Phase I
- ClinicalTrials.gov ID
- NCT01548118
- Acronym / sponsor ID
- 311-HPV-1001
- Conditions
- Human Papillomavirus
- Keywords
- Human papillomavirus, vaccine, cervical infection, cervical cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 8 Mar 2012 (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.
This study will evaluate the safety of a novel recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast ) with different dose in healthy females between 9-45 years of age at enrollment.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Adult Group 1, HPV vaccine 0.5ml | Experimental | Biological: HPV 16/18 vaccine, 0,5ml20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 0.5ml experimental HPV vaccines. |
| Adult Group 1, Placebo 0.5ml | Placebo comparator | Biological: Placebo control, 0.5ml20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 0.5ml aluminum phosphate. |
| Adult Group 2, HPV vaccine 1.0ml | Experimental | Biological: HPV 16/18 vaccine, 1.0ml20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 1.0ml experimental HPV vaccines. |
| Adult Group 2, Placebo 1.0ml | Placebo comparator | Biological: Placebo control, 1.0ml20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 1.0ml aluminum phosphate. |
| Children Group 1, HPV vaccine 0.5ml | Experimental | Biological: HPV 16/18 vaccine, 0,5ml20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 0.5ml experimental HPV vaccines. |
| Children Group 1, Placebo 0.5ml | Placebo comparator | Biological: Placebo control, 0.5ml20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 0.5ml aluminum phosphate. |
| Children Group 2, HPV vaccine 1.0ml | Experimental | Biological: HPV 16/18 vaccine, 1.0ml20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 1.0ml experimental HPV vaccines. |
| Children Group 2, Placebo 1.0ml | Placebo comparator | Biological: Placebo control, 1.0ml20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 1.0ml aluminum phosphate. |
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 (15 listed)
- History of cervical cancer
- 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.
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 16/18 vaccine, 0,5mlSubjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule | Biological | Adult Group 1, HPV vaccine 0.5ml, Children Group 1, HPV vaccine 0.5ml |
| Placebo control, 0.5mlSubjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule. | Biological | Adult Group 1, Placebo 0.5ml, Children Group 1, Placebo 0.5ml |
| HPV 16/18 vaccine, 1.0mlSubjects were planned to receive HPV vaccine 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule | Biological | Adult Group 2, HPV vaccine 1.0ml, Children Group 2, HPV vaccine 1.0ml |
| Placebo control, 1.0mlSubjects were planned to receive three doses of the placebo control 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule. | Biological | Adult Group 2, Placebo 1.0ml, Children Group 2, Placebo 1.0ml |
Primary outcome
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 unsolicited symptom.
Time frame: 30 days after finish vaccinations
1 secondary outcome
Neutralizing antibody responses of HPV 16/18 after each vaccine dose.
Time frame: 30 days after finish vaccinations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
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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.
Yan-ping 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 1 study testing HPV 16/18 vaccine, 0,5ml and HPV 16/18 vaccine, 1.0ml 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 15 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 8 Mar 2012. 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?
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?
Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions. (time frame: 7 days after each vaccine dose). 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 8 Mar 2012.