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

NCT03213405 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-12-11

Study results available
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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).

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

rBCG-N-hRSV 1/100

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

BIOLOGICAL

rBCG-N-hRSV 1/10

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

BIOLOGICAL

rBCG-N-hRSV full dose

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

BIOLOGICAL

Conventional BCG full dose

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

Sponsors & Collaborators

  • Comisión Nacional de Investigación Científica y Tecnológica

    collaborator OTHER_GOV

  • Millennium Institute on Immunology and Immunotherapy

    collaborator OTHER

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Alexis M Kalergis, PhD · Pontificia Universidad Catolica de Chile

  • Katia Abarca, MD · Pontificia Universidad Catolica de Chile

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-27
Primary Completion
2018-06-01
Completion
2018-06-01

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03213405 on ClinicalTrials.gov