deltatrials
Completed PHASE1 INTERVENTIONAL 4-arm NCT03213405

A Study to Assess Safety, Tolerability and Immunogenicity of the Live Attenuated hRSV Vaccine rBCG-N-hRSV (EVA-VRS01)

A Double Blind, Controlled by Conventional BCG, Dose-escalation Phase I Study, to Evaluate Safety, Tolerability and Immunogenicity of a Mycobacterium Bovis BCG (Bacillus Calmette-Guérin) Vaccine, 1331 Danish Strain, Live Attenuated and Recombinant for the Expression of Human Respiratory Syncytial Virus Nucleoprotein (N) in Healthy Males Within 18 and 50 Years of Age

Sponsor: Comisión Nacional de Investigación Científica y Tecnológica

Conditions Respiratory Syncytial Virus Infections
Interventions Conventional BCG full dose rBCG-N-hRSV 1/10 rBCG-N-hRSV 1/100 rBCG-N-hRSV full dose
Updated 8 times since 2017 Last updated: Nov 18, 2020 Started: Jun 27, 2017 Primary completion: Jun 1, 2018 Completion: Jun 1, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Respiratory Syncytial Virus Infections and is currently completed. Comisión Nacional de Investigación Científica y Tecnológica leads this study, which shows 8 recorded versions since 2017 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

~Aug 2017 – ~Jun 2018 · 10 months · monthly snapshotEnrolling By Invitation~Jun 2018 – ~Aug 2019 · 14 months · monthly snapshotEnrolling By Invitation~Aug 2019 – ~Jan 2021 · 17 months · monthly snapshotUnknown Status~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

8 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE1

  4. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE1

  5. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE1

    Status: Unknown Status → Completed

▶ Show 3 earlier versions

  1. Aug 2019 — Jan 2021 [monthly]

    Unknown Status PHASE1

    Status: Enrolling By Invitation → Unknown Status

  2. Jun 2018 — Aug 2019 [monthly]

    Enrolling By Invitation PHASE1

  3. Aug 2017 — Jun 2018 [monthly]

    Enrolling By Invitation PHASE1

    First recorded

Jun 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Comisión Nacional de Investigación Científica y Tecnológica
  • Millennium Institute on Immunology and Immunotherapy
  • Pontificia Universidad Catolica de Chile
Data source: Pontificia Universidad Catolica de Chile

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations