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A First in Human Study to Evaluate the Safety and Immune Response to a Vaccine for the Treatment of a Respiratory Virus, When Administered Into the Arm in Healthy Adult Participants

NCT04851977 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-04-21

No results posted yet for this study

Summary

Advanced Vaccine Laboratories Pty Ltd is developing a recombinant Respiratory Syncytial Virus (rRSV) vaccine for the protection of children (6 months to 5 years old) and the elderly from RSV infection. Human RSV infects nearly all children by the age of two years, and it is a leading cause of severe lower respiratory tract (LRT) disease in both paediatric and elderly populations as well as in individuals was immune system is profoundly compromised.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

Respiratory Syncytial Vaccine

BARS13 low dose (one dose of 10 μg rRSV-G protein/10 μg CsA by IM injection to the deltoid region of one arm, and one dose of placebo \[saline/mannitol\] by IM injection to the deltoid region of the other arm, given sequentially).

BIOLOGICAL

Respiratory Syncytial Vaccine

BARS13 high dose (IM injection of 10 μg rRSV-G protein/10 μg CsA administered to the deltoid region of each arm \[one injection of 10 μg rRSV-G protein/10 μg CsA per arm\], given sequentially). The high dose is twice the strength of the low dose.

BIOLOGICAL

Placebo

Placebo (IM injection of saline/mannitol administered to the deltoid region of each arm \[one injection per arm\], given sequentially).

Sponsors & Collaborators

  • Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ben Snyder, MBBS · The Alfred

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2019-04-07
Completion
2019-08-02

Countries

  • Australia

Study Locations

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Entities

Drugs

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 NCT04851977 on ClinicalTrials.gov