Hepatitis C, ChronicPhase 1/2NCT02309086
Phase I-II Vaccination of Autologous Dendritic Cells Transduced With Adenoviral Vector Encoding NS3 in Hepatitis C Encoding NS3 in Hepatitis C
A Phase 1/2 study testing Autologous dendritic cells transduced with Ad encoding NS3 in people with Hepatitis C, Chronic, run by Clinica Universidad de Navarra, Universidad de Navarra.
Trial summary
Dendritic cells (DC) play a central role in the activation of T-cell responses and have shown to be very immunogenic in preclinical in vivo and in vitro assays. The aims of this study is to assess the efficacy of therapeutic vaccination pilot clinical trial in Genotype 1 HCV patients using autologous DC transduced… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Autologous dendritic cells transduced with Ad encoding NS3
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- May 2011to May 2014
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hepatitis C (genotype 1b) that had previously failed Interferon/Ribavirin-based treatment
Who cannot join
- Liver cirrhosis HBV-coinfection Bilirubin >1.5 times ULN or ALT >7 ULN Hepatocellular carcinoma Immunodeficiency
About this study
Official title: Phase I-II Vaccination Clinical Trial in Patients With Chronic Hepatitis C by Administration of Autologous Dendritic Cells Transduced With an Adenoviral Vector Encoding NS3 Protein
Dendritic cells (DC) play a central role in the activation of T-cell responses and have shown to be very immunogenic in preclinical in vivo and in vitro assays. The aims of this study is to assess the efficacy of therapeutic vaccination pilot clinical trial in Genotype 1 HCV patients using autologous DC transduced with a recombinant adenovirus encoding NS3
- Conditions
- Hepatitis C, Chronic
- Being tested
- Autologous dendritic cells transduced with Ad encoding NS3
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous dendritic cells transduced with Ad encoding NS3Biological
Patients will receive 3 different dosis of the vaccine via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Autologous dendritic cells transduced with Ad encoding NS3 Receives: Biological: Autologous dendritic cells transduced with Ad encoding NS3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability determined by the evaluation of the number of participants with the type adverse events. Liver safety will be assessed by blood analysis and Ultrasound.
Safety assessment will be determined by the evaluation of the number of participants with the type adverse events. Liver safety will be assessed by blood analysis and Ultrasound.
Measured: 6 months
Secondary outcomes (1)
Efficacy on viral load and immune response
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Investigación Médica Aplicada (CIMA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309086
- Sponsor's protocol ID
- CD-AdNS3
- Status last verified
- Oct 2017
- First submitted
- 18 Nov 2014
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Vaccination Clinical Trial in Patients With Chronic Hepatitis C by Administration of Autologous Dendritic Cells Transduced With an Adenoviral Vector Encoding NS3 Protein
- ClinicalTrials.gov ID
- NCT02309086
- Acronym / sponsor ID
- CD-AdNS3
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Centro de Investigación Médica Aplicada (CIMA)
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 5 Dec 2014 (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.
Dendritic cells (DC) play a central role in the activation of T-cell responses and have shown to be very immunogenic in preclinical in vivo and in vitro assays. The aims of this study is to assess the efficacy of therapeutic vaccination pilot clinical trial in Genotype 1 HCV patients using autologous DC transduced with a recombinant adenovirus encoding NS3
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Biological: Autologous dendritic cells transduced with Ad encoding NS3Autologous dendritic cells transduced with Ad encoding NS3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic hepatitis C (genotype 1b) that had previously failed Interferon/Ribavirin-based treatment
Key exclusion criteria (1 listed)
- Liver cirrhosis HBV-coinfection Bilirubin >1.5 times ULN or ALT >7 ULN Hepatocellular carcinoma Immunodeficiency
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 |
|---|---|---|
| Autologous dendritic cells transduced with Ad encoding NS3Patients will receive 3 different dosis of the vaccine via subcutaneous injection | Biological | Single arm |
Primary outcome
Safety and tolerability determined by the evaluation of the number of participants with the type adverse events. Liver safety will be assessed by blood analysis and Ultrasound.
Time frame: 6 months
Safety assessment will be determined by the evaluation of the number of participants with the type adverse events. Liver safety will be assessed by blood analysis and Ultrasound.
1 secondary outcome
Efficacy on viral load and immune response
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous dendritic cells transduced with Ad encoding NS3 in people with Hepatitis C, Chronic, run by Clinica Universidad de Navarra, Universidad de Navarra.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. 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?
Safety and tolerability determined by the evaluation of the number of participants with the type adverse events. Liver safety will be assessed by blood analysis and Ultrasound. (time frame: 6 months). 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 24 Oct 2017.