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NCT04515043 Clinical Trial

EXPLORATORY STUDY Addendum to INVAC1-CT-101 (NCT02301754)

Solid Tumor, Adult Clinical Trial

Official title:
AN EXPLORATORY FOLLOW-UP STUDY OF LONG TERM ANTI-TELOMERASE IMMUNE RESPONSE AFTER INVAC-1 VACCINATION IN PATIENTS WITH LONG TERM SURVIVAL. Addendum to INVAC1-CT-101 PROTOCOL - EUDRACT NUMBER : 2013-004369-15

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04515043
Other study ID # INVAC1-CT-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 16, 2020
Est. completion date December 19, 2020

Study information
Verified date May 2021
Source Invectys
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date December 19, 2020
Est. primary completion date December 19, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• INVAC-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

Locations
Country Name City State
France Saint Louis Hospital Paris

Sponsors (1)
Lead Sponsor Collaborator
Invectys

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary long term anti telomerase specific memory responses 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 1 day visit
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