Trial Outcomes & Findings for The Development of a Human Model of Respiratory Syncytial Virus Infection (NCT NCT01349543)

NCT ID: NCT01349543

Last Updated: 2024-09-19

Results Overview

The host response to RSV challenge has been assessed at baseline, daily for 14 days and at study conclusion (28 days) using methods such as symptom diaries, volume of nasal secretions, numbers of inflammatory cells in nasal mucus, and levels of chemical mediators in nasal fluids.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: Prior to and 0-28 days post challenge
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	Viral Challenge RSV A Memphis 37: Intranasal administration
Overall Study STARTED	58
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sex was not used as a baseline measure.

Baseline characteristics by cohort

Measure	Viral Challenge n=58 Participants RSV A Memphis 37: Intranasal administration
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants • Sex was not used as a baseline measure.
Sex: Female, Male Male	37 Participants n=5 Participants • Sex was not used as a baseline measure.
Region of Enrollment United Kingdom	58 participants n=5 Participants
Assessed as healthy with no pre-existing disease	58 Participants n=5 Participants

PRIMARY outcome

Timeframe: Prior to and 0-28 days post challenge

The host response to RSV challenge has been assessed at baseline, daily for 14 days and at study conclusion (28 days) using methods such as symptom diaries, volume of nasal secretions, numbers of inflammatory cells in nasal mucus, and levels of chemical mediators in nasal fluids.

Outcome measures

Measure	Viral Challenge; Resulting in Common Cold Symptoms n=58 Participants RSV A Memphis 37: Intranasal administration resulting in a cold
Host Response to RSV Challenge Measured as Change From Baseline of Chemical Mediators in Nasal Fluid	23 Participants

Adverse Events

Viral Challenge; Common Cold Symptoms

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof Peter JM Openshaw

Imperial College London

Phone: 07973820801

Email: p.openshaw@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place