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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04515043
Recruitment Status : Completed
First Posted : August 17, 2020
Last Update Posted : June 1, 2021
Sponsor:
Information provided by (Responsible Party):
Invectys

Study Description
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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).

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: INVAC-1 given in the previous phase 1 NCT02301754. No new injection is required in this study. Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : October 16, 2020
Actual Primary Completion Date : December 19, 2020
Actual Study Completion Date : December 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: INVAC-1
All patients have been treated by INVAC-1 vaccine during the previous phase 1 NCT02301754. No new treatment injection is required in this study.
 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
Other Name: blood sampling


Outcome Measures
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Primary Outcome Measures :
  1. long term anti telomerase specific memory responses [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04515043


Locations
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France
Saint Louis Hospital
Paris, France, 75010
Sponsors and Collaborators
Invectys
Investigators
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Principal Investigator: Luis Teixeira AP-HP Paris Hospital
More Information
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Responsible Party: Invectys
ClinicalTrials.gov Identifier: NCT04515043    
Other Study ID Numbers: INVAC1-CT-102
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No