High Grade Cervical Intraepithelial NeoplasiaPhase 1/2NCT02529930
An Exploratory Safety and Immunogenicity Study of HPV16+ Immunotherapy VB10.16 in Women With HSIL; CIN 2/3)
A Phase 1/2 study testing VB10.16 Immunotherapy (DNA vaccine) in people with High Grade Cervical Intraepithelial Neoplasia, run by Nykode Therapeutics ASA at 4 sites in Germany.
Trial summary
This is an exploratory, open, prospective multi-centre study of VB10.16 immunotherapy in patients with high grade HPV16+ Cervical Intraepithelial Neoplasia (HSIL; CIN2/3). This study will recruit approximately 27-40 female patients with high grade cervical intraepithelial neoplasia (HSIL, CIN 2/3) at multiple sites in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Grade Cervical Intraepithelial Neoplasia
- What is being tested?
- VB10.16 Immunotherapy (DNA vaccine)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 4 sitesGermany
- Study dates
- Aug 2015to 31 Jan 2019
- Phase
- Phase 1/2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥18 years
- Women with ectocervical HPV16+ associated High Grade Cervical Intraepithelial Neoplasia (HSIL) as verified by local pathology:
- (Dosing Phase: Women with histologically confirmed HPV16+ associated CIN 2; Expansion Phase: Women with histologically confirmed HPV16+ associated CIN 2/3)
- Satisfactory colposcopic examination.
Who cannot join
- More than 2 cervical quadrants of CIN 3 as visualised by colposcopy.
- Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology, malignant cells on cytology or histology or other suspicion of either micro-invasive or invasive disease.
- Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per colposcopy and clinical examination.
- Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV).
- Administration of any blood product within 3 months of enrolment.
- Concomitant or prior malignant disease.
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- Clinically significant autoimmune disease.
- Known allergy to Kanamycin or other aminoglycosides
- Known immunodeficiency and or immunosuppression.
- History of toxic shock syndrome.
- Evidence or history of clinically significant cardiac disease
- Active infection requiring parenteral antibiotics.
- Tattoos, scars, or active lesions/rashes within 2 cm of the site of vaccination or any implantable leads.
- Immunosuppression
- Major surgery within 3 months of trial entry.
- Current or recent (within 30 days of first study treatment) participation in a clinical trial.
- Previous vaccination (either therapeutic and/or prophylactic) against HPV.
- Administration of any live vaccine within 90 days of trial entry.
- Concomitant anticancer therapies.
- Inadequate bone marrow function
- Inadequate liver function
- Clinical significant electrolyte abnormalities
- Women of childbearing age not willing to use an effective form of contraception
- Pregnancy or intention to become pregnant
- Nursing women
- Evidence of any other medical condition that may interfere with study participation, patient compliance or place the patient at high risk from treatment-related complications
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Lower Saxony, 20246
IZD Institut für Zytologie und Dysplasie
Hanover, Lower Saxony, 30159
Medical School Hanover
Hanover, Lower Saxony, 30625
Klinikum Wolfsburg
Wolfsburg, Lower Saxony, 38440
About this study
Official title: An Exploratory Safety and Immunogenicity Study of Human Papillomavirus (HPV16+) Immunotherapy VB10.16 in Women With High Grade Cervical Intraepithelial Neoplasia (HSIL; CIN 2/3)
This is an exploratory, open, prospective multi-centre study of VB10.16 immunotherapy in patients with high grade HPV16+ Cervical Intraepithelial Neoplasia (HSIL; CIN2/3). This study will recruit approximately 27-40 female patients with high grade cervical intraepithelial neoplasia (HSIL, CIN 2/3) at multiple sites in Europe.
Read the detailed description
The study will be divided into two phases, a dosing and expansion phase.
During the dosing phase the safety, tolerability and immunogenicity of 2 different vaccination schedules of 3 mg VB10.16 immunotherapy will be established in a minimum of 12 patients with histology confirmed CIN 2.
During the expansion phase the safety, tolerability and immunogenicity of the selected vaccination schedule will be evaluated in approximately 15 to 20 patients with histology confirmed HPV16+ CIN 2/3.
- Being tested
- VB10.16 Immunotherapy (DNA vaccine)
- Keywords
- HSIL, CIN 2/3, Therapeutic DNA vaccine, Human Papillomavirus, Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB10.16 Immunotherapy (DNA vaccine)Biological
Also called Biological/Vaccine
Patients will receive 3 vaccinations of 3 mg VB10.16 at the pre-specified time points. VB10.16 will be administered intramuscularly in the area over the lateral deltoid muscle.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 3mg VB10.16 Vaccine | Experimental | VB10.16 Immunotherapy (DNA vaccine): Biological/Vaccine Vaccination time points: Week 0, Week 3, Week 6, 3mgs per vaccination Receives: Biological: VB10.16 Immunotherapy (DNA vaccine) |
| Cohort 2: 3mg VB10.16 Vaccine | Experimental | VB10.16 Immunotherapy (DNA vaccine): Biological/Vaccine Vaccination time points: Week 0, Week 4, Week 8, 3mgs per vaccination Receives: Biological: VB10.16 Immunotherapy (DNA vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/tolerability
- The percentage of patients with adverse events (AEs), including any dose-limiting toxicities (DLT), laboratory assessments and physical findings.
Measured: 6 months (extended follow up for additional 6 months)
Secondary outcomes (2)
Immunogenicity
- The percentage of patients with E6/E7 specific cellular immune response in the blood.
- The percentage of patients with cellular immune response in the target lesions.
- The percentage of patients with humoral response against the E6/E7 viral antigen.
Measured: 6 months
Preliminary assessment of efficacy
- The percentage of patients with HPV16+ clearance.
- The percentage of patients with lesion regression
Measured: 6 months (extended follow up for additional 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startAug 2015
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
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 High Grade 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nykode Therapeutics ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Theradex, Vaccibody AS
- Responsible party
- Sponsor
- Investigators
- Irene Skjørestad, MSc, Study director, Vaccibody AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529930
- Sponsor's protocol ID
- VB C-01
- Status last verified
- Jul 2022
- First submitted
- 19 Aug 2015
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hillemanns P, Denecke A, Woelber L, Bohmer G, Jentschke M, Schjetne KW, Bruins Slot KMH, Fredriksen AB. A Therapeutic Antigen-Presenting Cell-Targeting DNA Vaccine VB10.16 in HPV16-Positive High-Grade Cervical Intraepithelial Neoplasia: Results from a Phase I/IIa Trial. Clin Cancer Res. 2022 Nov 14;28(22):4885-4892. doi: 10.1158/1078-0432.CCR-22-1927.
PubMed 36129459
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Safety and Immunogenicity Study of Human Papillomavirus (HPV16+) Immunotherapy VB10.16 in Women With High Grade Cervical Intraepithelial Neoplasia (HSIL; CIN 2/3)
- ClinicalTrials.gov ID
- NCT02529930
- Acronym / sponsor ID
- VB C-01
- Keywords
- HSIL, CIN 2/3, Therapeutic DNA vaccine, Human Papillomavirus, Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Nykode Therapeutics ASAIndustry (pharma, biotech, devices)
- Collaborators
- Theradex, Vaccibody AS
- Study start
- Aug 2015
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 20 Aug 2015 (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 an exploratory, open, prospective multi-centre study of VB10.16 immunotherapy in patients with high grade HPV16+ Cervical Intraepithelial Neoplasia (HSIL; CIN2/3). This study will recruit approximately 27-40 female patients with high grade cervical intraepithelial neoplasia (HSIL, CIN 2/3) at multiple sites in Europe.
Detailed description
The study will be divided into two phases, a dosing and expansion phase.
During the dosing phase the safety, tolerability and immunogenicity of 2 different vaccination schedules of 3 mg VB10.16 immunotherapy will be established in a minimum of 12 patients with histology confirmed CIN 2.
During the expansion phase the safety, tolerability and immunogenicity of the selected vaccination schedule will be evaluated in approximately 15 to 20 patients with histology confirmed HPV16+ CIN 2/3.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 3mg VB10.16 Vaccine | Experimental | Biological: VB10.16 Immunotherapy (DNA vaccine)VB10.16 Immunotherapy (DNA vaccine): Biological/Vaccine Vaccination time points: Week 0, Week 3, Week 6, 3mgs per vaccination |
| Cohort 2: 3mg VB10.16 Vaccine | Experimental | Biological: VB10.16 Immunotherapy (DNA vaccine)VB10.16 Immunotherapy (DNA vaccine): Biological/Vaccine Vaccination time points: Week 0, Week 4, Week 8, 3mgs per vaccination |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women ≥18 years
- Women with ectocervical HPV16+ associated High Grade Cervical Intraepithelial Neoplasia (HSIL) as verified by local pathology:
- (Dosing Phase: Women with histologically confirmed HPV16+ associated CIN 2; Expansion Phase: Women with histologically confirmed HPV16+ associated CIN 2/3)
- Satisfactory colposcopic examination.
Key exclusion criteria (26 listed)
- More than 2 cervical quadrants of CIN 3 as visualised by colposcopy.
- Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology, malignant cells on cytology or histology or other suspicion of either micro-invasive or invasive disease.
- Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per colposcopy and clinical examination.
- Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV).
- Administration of any blood product within 3 months of enrolment.
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 |
|---|---|---|
| VB10.16 Immunotherapy (DNA vaccine)Also: Biological/VaccinePatients will receive 3 vaccinations of 3 mg VB10.16 at the pre-specified time points. VB10.16 will be administered intramuscularly in the area over the lateral deltoid muscle. | Biological | Cohort 1: 3mg VB10.16 Vaccine, Cohort 2: 3mg VB10.16 Vaccine |
Primary outcome
Safety/tolerability
Time frame: 6 months (extended follow up for additional 6 months)
- The percentage of patients with adverse events (AEs), including any dose-limiting toxicities (DLT), laboratory assessments and physical findings.
2 secondary outcomes
Immunogenicity
Time frame: 6 months
Preliminary assessment of efficacy
Time frame: 6 months (extended follow up for additional 6 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 13 Jul 2022.
- Derived from this study: PubMed 36129459Hillemanns P, Denecke A, Woelber L, Bohmer G, Jentschke M, Schjetne KW, Bruins Slot KMH, Fredriksen AB. A Therapeutic Antigen-Presenting Cell-Targeting DNA Vaccine VB10.16 in HPV16-Positive High-Grade Cervical Intraepithelial Neoplasia: Results from a Phase I/IIa Trial. Clin Cancer Res. 2022 Nov 14;28(22):4885-4892. doi: 10.1158/1078-0432.CCR-22-1927.
- 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.
Irene Skjørestad, MSc study director
Vaccibody AS
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VB10.16 Immunotherapy (DNA vaccine) in people with High Grade Cervical Intraepithelial Neoplasia, run by Nykode Therapeutics ASA at 4 sites in Germany.
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 26 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 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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 combined 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.
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?
Safety/tolerability (time frame: 6 months (extended follow up for additional 6 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 NCT02529930, 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 13 Jul 2022.