CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
rBCG-N-hRSV 1/100 +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03213405
NCT03213405Phase 1Completed
CompareCT.gov

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

Pontificia Universidad Catolica de Chile·interventional·Posted Jul 11, 2017·Updated Dec 11, 2020

In Brief

A Phase 1 clinical trial evaluating rBCG-N-hRSV 1/100, rBCG-N-hRSV 1/10, and 2 other interventions for Respiratory Syncytial Virus Infections. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Human respiratory syncytial virus (hRSV) is the main cause of lower respiratory tract infection in children under one year of age. This study will evaluate the safety, tolerability and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine that expresses the human Respiratory Syncytial Virus Nucleoprotein (N), in adult males (18 to 50 years of age).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesChile
CollaboratorsComisión Nacional de Investigación Científica y Tecnológica, Millennium Institute on Immunology and Immunotherapy

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJul 11, 2017
Enrollment StartJun 27, 2017
Primary CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.0 years ago

Interventions

rBCG-N-hRSV 1/100biological

5x10\^3 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.

rBCG-N-hRSV 1/10biological

5x10\^4 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.

rBCG-N-hRSV full dosebiological

1x10\^5 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.

Conventional BCG full dosebiological

2x10\^5 colony forming units (CFU) of conventional BCG will be administered as an intradermal injection.