Solid Tumor, Adult
Conditions
Brief summary
This study will be an exploratory study of long term immunogenicity of INVAC-1 in patients who participated in the INVAC1-CT-101 phase I study (between 2014 and 2018).
Detailed description
The primary goal of the study is to analyze anti-telomerase specific memory responses in blood of long term survival patients and to correlate these immune responses to their subsequent treatment since the end of INVAC1-CT-101 phase I study. Six patients are expected to participate in this study.
Interventions
DRUGINVAC-1 given in the previous phase 1 NCT02301754. No new injection is required in this study.
blood sampling will be drawn once in order to analyse long term memory immune response to INVAC-1 vaccine
Sponsors
Invectys
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who participated in the phase I study and are still alive at the present time 2. Ability to provide written informed consent and to understand and comply with the requirements of the study.
Exclusion criteria
1. Anemia (Hgb \< 7g/dL) according to L-1121-1 annexe 2 of Code de Santé Publique 2. Systolic blood pressure below 90 mm Hg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| long term anti telomerase specific memory responses | 1 day visit | will be measured by ELISPOT on blood of patients who were treated by INVAC-1 in the phase I NCT02301754 study and are still alive at the present time |
Countries
France
Outcome results
None listed