Trial Outcomes & Findings for Novel Mucosal Correlates Of RSV Protection In Older Adults (NCT NCT06274619)
NCT ID: NCT06274619
Last Updated: 2026-05-22
Results Overview
Number of solicited and unsolicited adverse events (AEs) from virus inoculation (Day 0) to Day 28 post-inoculation
COMPLETED
NA
20 participants
28 Days
2026-05-22
Participant Flow
Healthy, non-smoking volunteers aged 65 - 75 years
Participant milestones
| Measure |
Healthy Volunteers
Healthy volunteers aged 65-75 years undergoing controlled human infection with RSV Memphis 37
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Novel Mucosal Correlates Of RSV Protection In Older Adults
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=20 Participants
Healthy volunteers aged 65-75 years undergoing controlled human infection with RSV Memphis 37
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=2 Participants
|
|
Age, Continuous
|
69.25 years
n=2 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
White British
|
16 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Asian British
|
2 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Mixed Asian/White British
|
1 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Caribbean
|
1 Participants
n=2 Participants
|
|
Region of Enrollment
United Kingdom
|
20 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: 28 DaysNumber of solicited and unsolicited adverse events (AEs) from virus inoculation (Day 0) to Day 28 post-inoculation
Outcome measures
| Measure |
Healthy Volunteers
n=20 Participants
Healthy volunteers aged 65-75 years undergoing controlled human infection with RSV Memphis 37
RSV A Memphis 37: RSV A Memphis 37 challenge agent
|
|---|---|
|
Number of Solicited and Unsolicited Adverse Events (AEs)
|
17 adverse events
|
PRIMARY outcome
Timeframe: 10 daysInfection rate calculated by the number of infected individuals over the number of uninfected individuals expressed as a percentage, with infection defined as 2 or more quantifiable greater than lower limit of quantification (viral load ≥LLOQ) by RT-PCR from nasal wash, reported on 2 or more consecutive timepoints, starting from Day 2 post-inoculation and up to discharge from quarantine
Outcome measures
| Measure |
Healthy Volunteers
n=20 Participants
Healthy volunteers aged 65-75 years undergoing controlled human infection with RSV Memphis 37
RSV A Memphis 37: RSV A Memphis 37 challenge agent
|
|---|---|
|
Infection Rate
Infected
|
12 Participants
|
|
Infection Rate
Uninfected
|
8 Participants
|
SECONDARY outcome
Timeframe: 28 daysMean nasal viral load by reverse transcription polymerase chain reaction (RT-PCR) reported in Log10 copies/mL
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysAntibody levels in blood by serum neutralisation assay by Log2 Geometric Mean Titre
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysAntibody levels in blood by Enzyme-linked immunosorbent assay (ELISA) by Log2 Geometric Mean Titre
Outcome measures
Outcome data not reported
Adverse Events
Healthy Volunteers
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Volunteers
n=20 participants at risk
Healthy volunteers aged 65-75 years undergoing controlled human infection with RSV Memphis 37
|
|---|---|
|
Infections and infestations
Tooth and gum infection
|
5.0%
1/20 • Number of events 1 • from Day 0 to Day 180 (6 months)
|
|
Infections and infestations
Urinary Tract Infection
|
5.0%
1/20 • Number of events 1 • from Day 0 to Day 180 (6 months)
|
|
Infections and infestations
URTI
|
15.0%
3/20 • Number of events 3 • from Day 0 to Day 180 (6 months)
|
|
Gastrointestinal disorders
Consitpation
|
5.0%
1/20 • Number of events 1 • from Day 0 to Day 180 (6 months)
|
|
Infections and infestations
Body ache
|
5.0%
1/20 • Number of events 1 • from Day 0 to Day 180 (6 months)
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
5.0%
1/20 • Number of events 1 • from Day 0 to Day 180 (6 months)
|
|
Musculoskeletal and connective tissue disorders
Athroscopy
|
5.0%
1/20 • Number of events 1 • from Day 0 to Day 180 (6 months)
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • from Day 0 to Day 180 (6 months)
|
|
Infections and infestations
Fever
|
5.0%
1/20 • Number of events 1 • from Day 0 to Day 180 (6 months)
|
|
Cardiac disorders
Atrial Fibrillation
|
5.0%
1/20 • Number of events 1 • from Day 0 to Day 180 (6 months)
|
|
Musculoskeletal and connective tissue disorders
Gout
|
10.0%
2/20 • Number of events 2 • from Day 0 to Day 180 (6 months)
|
|
Infections and infestations
Sore Throat
|
10.0%
2/20 • Number of events 2 • from Day 0 to Day 180 (6 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1 • from Day 0 to Day 180 (6 months)
|
|
Infections and infestations
Runny nose and cough
|
5.0%
1/20 • Number of events 1 • from Day 0 to Day 180 (6 months)
|
|
Infections and infestations
SARS-CoV-2 positive
|
15.0%
3/20 • Number of events 3 • from Day 0 to Day 180 (6 months)
|
|
Infections and infestations
Self Reported Cold Symptoms
|
5.0%
1/20 • Number of events 1 • from Day 0 to Day 180 (6 months)
|
|
Eye disorders
Post-Operative Eye Pain
|
5.0%
1/20 • Number of events 1 • from Day 0 to Day 180 (6 months)
|
|
Infections and infestations
Fatigue
|
5.0%
1/20 • Number of events 1 • from Day 0 to Day 180 (6 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place