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Completed

NCT Number: NCT04515043

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

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).

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Key information

Conditions

Solid Tumor, Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Saint Louis Hospital

Paris, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who participated in the phase I study and are still alive at the present time
  • Ability to provide written informed consent and to understand and comply with the requirements of the study.

Exclusion criteria

  • Anemia (Hgb < 7g/dL) according to L-1121-1 annexe 2 of Code de Santé Publique
  • Systolic blood pressure below 90 mm Hg

Treatment and study plan

INVAC-1 given in the previous phase 1 NCT02301754. No new injection is required in this study.

Drug

blood sampling will be drawn once in order to analyse long term memory immune response to INVAC-1 vaccine

Other names: blood sampling

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Invectys

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2020
Registry last updated
Jun 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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