Cervical Intraepithelial NeoplasiaPhase 2NCT01356823
Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
A Phase 2 study testing 30μg HPV, 60μg HPV and 90μg HPV in people with Cervical Intraepithelial Neoplasia and Cervical Cancer, run by Xiamen University at 1 site in China.
Trial summary
This is a phase II clinical study of the novel recombinant HPV 16/18 bivalent vaccine expressed in E. coli. The primary purpose of this study is to evaluate which dosage of the HPV vaccine can induce higher antibody and at the same time caused less adverse events. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Cervical Cancer
- What is being tested?
- 30μg HPV, 60μg HPV and 90μg HPV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Oct 2013
- 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent from the subject prior to enrolment;
- Female between, and including, 18 and 25 years of age at the time of enrolment;
- Subjects must be free of obvious health problems;
- Not pregnant and having no plan for pregnancy;
Who cannot join
- Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7);
- Previous vaccination against HPV;
- Having severe allergic history or other immunodeficiency;
- Chemotherapy and other immunosuppressive agents using;
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Centre for Disease Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 25 Years
This is a phase II clinical study of the novel recombinant HPV 16/18 bivalent vaccine expressed in E. coli.
The primary purpose of this study is to evaluate which dosage of the HPV vaccine can induce higher antibody and at the same time caused less adverse events.
The secondary purpose of this study is to to evaluate the safety and immunopersistence of the study vaccine.
Read the detailed description
Totally 1600 healthy women of 18-25 years of age were enrolled. The participants were randomly stratified into 4 groups and receive different dosage of human papillomavirus (HPV) vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule. The women were actively monitored for adverse events for 1 month after each injection. Severe adverse events during the trial were followed up. Serum samples from all the subjects would be collected on day 0, 7m, 24m, 48m and 72m to evaluate the immunogenicity and immuno-persistency.
- Being tested
- 30μg HPV, 60μg HPV, 90μg HPV, Hepatitis B vaccine
- Keywords
- Human Papilloma Virus 16, Human Papilloma Virus 18, vaccine, Cervical Intraepithelial Neoplasia, cervical Cancer
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30μg HPVBiological
Participants would intramuscularly receive 30μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
60μg HPVBiological
Participants would intramuscularly receive 60μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
90μg HPVBiological
Participants would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen
Hepatitis B vaccineBiological
Participants would intramuscularly receive 10μg of hepatitis B vaccine at 0, 1, 6 month for 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| 30μg HPV | Experimental | Participants in this arm would receive 30μg HPV vaccines which contains 20μg HPV 16 antigen and 10μg HPV 18 antigen Receives: Biological: 30μg HPV |
| 60μg HPV | Experimental | Participants in this arm would receive 60μg HPV vaccines which contains 40μg HPV 16 antigen and 20μg HPV 18 antigen Receives: Biological: 60μg HPV |
| 90μg HPV | Experimental | Participants in this arm would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen Receives: Biological: 90μg HPV |
| hepatitis B vaccine | Placebo comparator | Participants in this arm would receive hepatitis B vaccine. Receives: Biological: Hepatitis B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion of anti-HPV 16 and anti-HPV 18 neutralizing antibody
To detect the anti-HPV 16 and anti-HPV 18 neutralizing antibody level on day 1 and one month after dose 3.
Measured: 7 months
Secondary outcomes (1)
Number of Participants with Adverse Events
All the adverse events in one month after each dose would be recorded in the diary card. All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial NeoplasiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen University
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
- Responsible party
- Principal investigator, Jun Zhang, Xiamen University
- Investigators
- Jun Zhang, Master, Study chair, Xiamen UniversityYuemei Hu, Bachelor, Principal investigator, Jiangsu Provincial Centre for Disease Control and PreventionTing Wu, Ph. D, Study director, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356823
- Sponsor's protocol ID
- HPV-PRO-002
- Status last verified
- Feb 2014
- First submitted
- 13 May 2011
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wu T, Hu YM, Li J, Chu K, Huang SJ, Zhao H, Wang ZZ, Yang CL, Jiang HM, Wang YJ, Lin ZJ, Pan HR, Sheng W, Wei FX, Li SW, Wang Y, Zhu FC, Li CG, Zhang J, Xia NS. Immunogenicity and safety of an E. coli-produced bivalent human papillomavirus (type 16 and 18) vaccine: A randomized controlled phase 2 clinical trial. Vaccine. 2015 Jul 31;33(32):3940-6. doi: 10.1016/j.vaccine.2015.06.052. Epub 2015 Jun 19.
PubMed 26100924
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 25 Years
- ClinicalTrials.gov ID
- NCT01356823
- Acronym / sponsor ID
- HPV-PRO-002
- Keywords
- Human Papilloma Virus 16, Human Papilloma Virus 18, vaccine, Cervical Intraepithelial Neoplasia, cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Xiamen UniversityUniversity, hospital or other
- Collaborators
- Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 20 May 2011 (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 is a phase II clinical study of the novel recombinant HPV 16/18 bivalent vaccine expressed in E. coli.
The primary purpose of this study is to evaluate which dosage of the HPV vaccine can induce higher antibody and at the same time caused less adverse events.
The secondary purpose of this study is to to evaluate the safety and immunopersistence of the study vaccine.
Detailed description
Totally 1600 healthy women of 18-25 years of age were enrolled. The participants were randomly stratified into 4 groups and receive different dosage of human papillomavirus (HPV) vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule. The women were actively monitored for adverse events for 1 month after each injection. Severe adverse events during the trial were followed up. Serum samples from all the subjects would be collected on day 0, 7m, 24m, 48m and 72m to evaluate the immunogenicity and immuno-persistency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 30μg HPV | Experimental | Biological: 30μg HPVParticipants in this arm would receive 30μg HPV vaccines which contains 20μg HPV 16 antigen and 10μg HPV 18 antigen |
| 60μg HPV | Experimental | Biological: 60μg HPVParticipants in this arm would receive 60μg HPV vaccines which contains 40μg HPV 16 antigen and 20μg HPV 18 antigen |
| 90μg HPV | Experimental | Biological: 90μg HPVParticipants in this arm would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen |
| hepatitis B vaccine | Placebo comparator | Biological: Hepatitis B vaccineParticipants in this arm would receive hepatitis B vaccine. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Written informed consent from the subject prior to enrolment;
- Female between, and including, 18 and 25 years of age at the time of enrolment;
- Subjects must be free of obvious health problems;
- Not pregnant and having no plan for pregnancy;
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7);
- Previous vaccination against HPV;
- Having severe allergic history or other immunodeficiency;
- Chemotherapy and other immunosuppressive agents using;
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 |
|---|---|---|
| 30μg HPVParticipants would intramuscularly receive 30μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses. | Biological | 30μg HPV |
| 60μg HPVParticipants would intramuscularly receive 60μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses. | Biological | 60μg HPV |
| 90μg HPVParticipants would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen | Biological | 90μg HPV |
| Hepatitis B vaccineParticipants would intramuscularly receive 10μg of hepatitis B vaccine at 0, 1, 6 month for 3 doses. | Biological | hepatitis B vaccine |
Primary outcome
Seroconversion of anti-HPV 16 and anti-HPV 18 neutralizing antibody
Time frame: 7 months
To detect the anti-HPV 16 and anti-HPV 18 neutralizing antibody level on day 1 and one month after dose 3.
1 secondary outcome
Number of Participants with Adverse Events
Time frame: 7 months
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 5 Jan 2016.
- Results publication: PubMed 26100924Wu T, Hu YM, Li J, Chu K, Huang SJ, Zhao H, Wang ZZ, Yang CL, Jiang HM, Wang YJ, Lin ZJ, Pan HR, Sheng W, Wei FX, Li SW, Wang Y, Zhu FC, Li CG, Zhang J, Xia NS. Immunogenicity and safety of an E. coli-produced bivalent human papillomavirus (type 16 and 18) vaccine: A randomized controlled phase 2 clinical trial. Vaccine. 2015 Jul 31;33(32):3940-6. doi: 10.1016/j.vaccine.2015.06.052. Epub 2015 Jun 19.
Related trials for Cervical Intraepithelial Neoplasia
RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
Recruiting
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV
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.
Jun Zhang, Master study chair
Xiamen University
Yuemei Hu, Bachelor principal investigator
Jiangsu Provincial Centre for Disease Control and Prevention
Ting Wu, Ph. D study director
Xiamen University
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 30μg HPV, 60μg HPV and 90μg HPV in people with Cervical Intraepithelial Neoplasia and Cervical Cancer, run by Xiamen University 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 4 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 5 Jan 2016. 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?
Seroconversion of anti-HPV 16 and anti-HPV 18 neutralizing antibody (time frame: 7 months). 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 NCT01356823, which also lists 1 linked publication.
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 5 Jan 2016.