The purpose of this study is to evaluate the safety, infectivity and replication, and immunogenicity of a recombinant respiratory syncytial virus (rRSV A/Maryland/001/11) challenge virus administered intranasally to healthy adults.
This study will evaluate the safety, infectivity and replication, and immunogenicity of a recombinant respiratory syncytial virus (rRSV A/Maryland/001/11) challenge virus administered intranasally to healthy adults. Participants will be admitted to the inpatient isolation unit and will receive a single dose of 10\^5 plaque forming units (PFUs) of rRSV A/Maryland/001/11, delivered intranasally on Day 0. Participants will be enrolled outside of the RSV season between April 1 and October 31. Participants will remain in the inpatient isolation unit for a minimum of 8 days after the challenge and will be discharged after two RSV reverse transcription polymerase chain reaction (RT-PCR) results lower than 3 Log10 genome equivalents per mL of nasal wash. Upon discharge from the inpatient unit, participants will attend outpatient visits on Days 10 (if previously discharged), 28, and 56. These study visits may include physical examinations, blood collection, and nasal washes. At 6 months, there will be a follow-up phone contact to assess for any new chronic conditions or serious health events/hospitalizations. Volunteers in Cohort 1 received a dose of 10\^5 PFU, consistent with similar RSV challenge studies done previously. Cohort 2 will be conducted as an extension of Cohort 1 to extend the safety and infectivity evaluation, and will also receive a single dose of 10\^5 PFU rRSV A/Maryland/001/11 challenge.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
10\^5 PFU; delivered intranasally
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States
Frequency of challenge virus-related solicited signs and symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Time frame: Measured through Day 56
Severity of challenge virus-related solicited signs and symptoms
Graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Time frame: Measured through Day 56
Frequency of adverse events (AEs)
Graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Time frame: Measured through Day 56
Severity of AEs
Graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Time frame: Measured through Day 56
Number of participants infected with rRSV A/Maryland/001/11 challenge virus
Defined as recovery of challenge virus from nasal wash, and/or detection of virus in nasal wash by real-time reverse transcription polymerase chain reaction (rRT-PCR), and/or a greater than or equal to 2.5-fold rise in serum neutralizing antibody titer to RSV
Time frame: Measured through Day 56
Nasal wash virus titers of challenge virus shed
Measured by plaque titration and rRT-PCR
Time frame: Measured through Day 56
Number of days challenge virus was shed
Measured by plaque titration and rRT-PCR
Time frame: Measured through Day 56
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Titer of serum immunoglobulin G (IgG) antibodies to the RSV F protein
Measured by enzyme-linked immunosorbent assay (ELISA)
Time frame: Measured through Day 56
Change in serum neutralizing antibody titer to RSV
Measured by plaque reduction assay
Time frame: Measured through Day 56