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

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 16, 2018

Primary Completion Date

April 7, 2019

Study Completion Date

August 2, 2019

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).

Trial Locations (1)

3181

Advanced Vaccine Laboratories Pty Ltd, Melbourne

All Listed Sponsors
lead

Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.

INDUSTRY

NCT04851977 - 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 | Biotech Hunter | Biotech Hunter