Cervical Intraepithelial NeoplasiaPhase 1NCT03870113
DC Vaccines Targeting HPV16/18 E6/E7 Protein to Regress CINI/CIN2
A Phase 1 study testing Vaccinated group in people with Cervical Intraepithelial Neoplasia, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
To establish therapeutic dendritic cell (DC) vaccines targeting HPV 16/18 E6/E7 protein to block the progression of CIN1/CIN2 to cervical cancer and evaluate the safety and efficacy of the vaccines. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- Vaccinated group
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 30 Dec 2022
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years ≤ 70 years at the time of informed consent
- HPV type 16/18 positive
- Pathologically confirmed CIN1/2 and no other cervical disease
- adequate organ functions.
Who cannot join
- Severe allergy to drugs
- Women of child-bearing potential who are pregnant or breast-feeding
- Any form of primary immunodeficiency
- With serious cardiac, cerebrovascular and primary diseases
- With a history of severe mental illness
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Lili Ren, Ph.D., +86-755-22942466, ren.lili@szhospital.com
Fanli Meng, Ph.D., +86-755-22942466, mengfanli2001@sina.com
About this study
Official title: Clinical Study on the Regress of Cervical Intraepithelial Neoplastic(CIN) 1/CIN2 by Highly Effective DC Vaccines Targeting HPV E6/ E7 Protein
To establish therapeutic dendritic cell (DC) vaccines targeting HPV 16/18 E6/E7 protein to block the progression of CIN1/CIN2 to cervical cancer and evaluate the safety and efficacy of the vaccines.
Read the detailed description
Cervical cancer is the second most common cause of cancer-related deaths among women worldwide with 10000 new cases each year in China. The high-risk human papillomavirus (HPV) was the major cause of cervical cancer. The oncoproteins E6 and E7 encoded by HPV16 and 18, are consistently expressed in HPV-associated Cervical cancer and are responsible for the cervical cancer malignant progression. Targeting the E6/E7 proteins could be very helpful to regress the CIN 1/2 and block the tumorigenesis.
By this research, we aim to establish the HPV16/18 E6/E7 peptide library which could induce the strong anti-virus immune response and to vaccinate the CIN 1/2 patients with dendritic cell vaccines loaded HPV 16/18 E6/E7 epitopes.
Including:
- To create an effective HPV 16/18 E6/E7 antigen peptide library using NetMHCspan software based on the MHC-I subtype of the Chinese population and screen E6/E7protein peptides with high binding affinity to MHC molecules;
- To develop HPV 16/18 E6/E7- pulsed DC vaccines and evaluate the safety and efficacy of DC vaccines;
- The patients are vaccinated with the HPV16/18 E6/E7- pulsed DC vaccines
- To evaluate the safety and efficacy of DC vaccines loaded with HPV 16/18 E6/E7.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- Vaccinated group
- Keywords
- Cervical Intraepithelial Neoplasia, Human Papillomavirus, Dentritic Vaccine, E6/E7 protein
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccinated groupBiological
Develop highly reactive DC vaccines targeting HPV 16/18 E6/ E7 protein and DC vaccine would be injected to patients once a week, six doses in total.
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated group | Experimental | Patients will be vaccinated with autologous mature dendritic cells-loaded with HPV 16/18 E6/E7, DC vaccine will be injected into the adjacent lymph-node 6 times, once a week. Receives: Biological: Vaccinated group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety]
Safety of personalized neoantigen vaccine will be measured by the number of subjects experiencing each type of adverse event. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Measured: 3 months after the last vaccination injection
Immunogenicity of neoantigen-primed DC Vaccines
Immunogenicity of the DC vaccine will be measured to detect changes of neoantigen-specific T cells by flow cytometry.
Measured: once per three month
Secondary outcomes (1)
Objective Response Rate
Objective Response Rate will be measured by detection of protein expression of HPV E6 / E7and evaluation of CIN phase
Measured: once per three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Qi, M.D., Study director, Shen Zhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870113
- Sponsor's protocol ID
- ShenzhenPH BTR-002
- Status last verified
- Mar 2019
- First submitted
- 8 Mar 2019
- Last updated
- 14 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Regress of Cervical Intraepithelial Neoplastic(CIN) 1/CIN2 by Highly Effective DC Vaccines Targeting HPV E6/ E7 Protein
- ClinicalTrials.gov ID
- NCT03870113
- Acronym / sponsor ID
- ShenzhenPH BTR-002
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- Cervical Intraepithelial Neoplasia, Human Papillomavirus, Dentritic Vaccine, E6/E7 protein
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 11 Mar 2019 (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 establish therapeutic dendritic cell (DC) vaccines targeting HPV 16/18 E6/E7 protein to block the progression of CIN1/CIN2 to cervical cancer and evaluate the safety and efficacy of the vaccines.
Detailed description
Cervical cancer is the second most common cause of cancer-related deaths among women worldwide with 10000 new cases each year in China. The high-risk human papillomavirus (HPV) was the major cause of cervical cancer. The oncoproteins E6 and E7 encoded by HPV16 and 18, are consistently expressed in HPV-associated Cervical cancer and are responsible for the cervical cancer malignant progression. Targeting the E6/E7 proteins could be very helpful to regress the CIN 1/2 and block the tumorigenesis.
By this research, we aim to establish the HPV16/18 E6/E7 peptide library which could induce the strong anti-virus immune response and to vaccinate the CIN 1/2 patients with dendritic cell vaccines loaded HPV 16/18 E6/E7 epitopes.
Including:
- To create an effective HPV 16/18 E6/E7 antigen peptide library using NetMHCspan software based on the MHC-I subtype of the Chinese population and screen E6/E7protein peptides with high binding affinity to MHC molecules;
- To develop HPV 16/18 E6/E7- pulsed DC vaccines and evaluate the safety and efficacy of DC vaccines;
- The patients are vaccinated with the HPV16/18 E6/E7- pulsed DC vaccines
- To evaluate the safety and efficacy of DC vaccines loaded with HPV 16/18 E6/E7.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccinated group | Experimental | Biological: Vaccinated groupPatients will be vaccinated with autologous mature dendritic cells-loaded with HPV 16/18 E6/E7, DC vaccine will be injected into the adjacent lymph-node 6 times, once a week. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years ≤ 70 years at the time of informed consent
- HPV type 16/18 positive
- Pathologically confirmed CIN1/2 and no other cervical disease
- adequate organ functions.
Key exclusion criteria (5 listed)
- Severe allergy to drugs
- Women of child-bearing potential who are pregnant or breast-feeding
- Any form of primary immunodeficiency
- With serious cardiac, cerebrovascular and primary diseases
- With a history of severe 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 |
|---|---|---|
| Vaccinated groupDevelop highly reactive DC vaccines targeting HPV 16/18 E6/ E7 protein and DC vaccine would be injected to patients once a week, six doses in total. | Biological | Vaccinated group |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: 3 months after the last vaccination injection
Safety of personalized neoantigen vaccine will be measured by the number of subjects experiencing each type of adverse event. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Immunogenicity of neoantigen-primed DC Vaccines
Time frame: once per three month
Immunogenicity of the DC vaccine will be measured to detect changes of neoantigen-specific T cells by flow cytometry.
1 secondary outcome
Objective Response Rate
Time frame: once per three month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- 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.
Hui Qi, M.D. study director
Shen Zhen People's Hospital
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 Vaccinated group in people with Cervical Intraepithelial Neoplasia, run by Shenzhen People's Hospital 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 5 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 14 Mar 2019. 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 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?
Contact Lili Ren, Ph.D. (+86-755-22942466, ren.lili@szhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety] (time frame: 3 months after the last vaccination injection). 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 14 Mar 2019.