NCT04515043

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 16, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2020

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

August 12, 2020

Last Update Submit

May 27, 2021

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

INVAC-1

EXPERIMENTAL

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.

Interventions

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

Also known as: blood sampling
INVAC-1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Louis Hospital

Paris, 75010, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Luis Teixeira

    AP-HP Paris Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 17, 2020

Study Start

October 16, 2020

Primary Completion

December 19, 2020

Study Completion

December 19, 2020

Last Updated

June 1, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)