Immune Reponses to RSV B Challenge in Older Adults (A Controlled Human Infection Study With RSV in Older People-02)

NCT07713628 | Not Yet Recruiting DMC

• 1 other identifier: 204808
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a human challenge sequential cohort study involving healthy, non-smoking older adults aged 65-75 years. We aim to enrol 20 participants. There will be a sentinel cohort of 6 participants at the beginning of the study (Group 1). If no pausing rules are met, the remaining 14 participants will be enrolled for a total of 20 enrolled participants (Group 2). The study will consist of three main phases: (1) screening and baseline, (2) inoculation and quarantine, and (3) follow up. All participants will attend a screening visit for a comprehensive health assessment to confirm eligibility. If eligible, participants will take part in an inpatient stay in a quarantine unit, where they will be inoculated with 105 plaque-forming units of RSV B-I54 by intranasal drops. The inoculation dose has been determined in the earlier mentioned outpatient study of the same virus strain, in healthy young adults. Due to the older age range and potentially increased risk of more severe disease, participants will remain within the quarantine unit for 10-days post inoculation and will be closely monitored by clinical review and self-completed symptom diaries. Participants will undergo daily sample collection and will remain in quarantine until the discharge criteria are met at Day 10. After discharge, participants will attend follow-up visits at Day 14, Day 28, and Day 90. Participants in Group 2 will have an additional baseline visit at Day -14 where blood, respiratory (nose and throat) and lower airway (bronchoscopy) samples will be collected. Group 2 participants will also undergo a second bronchoscopy during the inpatient period and the third and final bronchoscopy at Day 28. Clinical outcomes will be determined by symptomatology and viral detection in nasal lavage using quantitative PCR. Based on the first-in-human RSV B characterisation study and recent elderly RSV A challenge data, we anticipate approximately 74% attack rate, with a range of mild-moderate symptoms in the infected individuals. Symptoms typically commence 3 days post-inoculation and worsen to peak around days 5-9 before rapidly resolving without treatment. Timing of viral shedding is expected to correlate closely with symptoms.

Conditions

RSV

Outcome Measures

Primary Outcomes (5)

• Number, frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) Adverse Events (AEs) from the viral challenge (Day 0) up to Day 28.

  AEs may pertain to: * Solicited symptoms when they are reported as 'severe' or when they last longer than 14 days. * Unsolicited symptoms.

  28 Days

• Number, frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) Adverse Events (AEs) relating to the bronchoscopy sampling in those undergoing bronchoscopy procedures (Group 2)

  * Solicited symptoms when they are reported as 'severe' or when they last longer than 14 days. * Unsolicited symptoms.

  28 Days

• Occurrence of clinically significant abnormalities and changes from baseline in clinical laboratory tests up to and including Day

  Occurrence of clinically significant abnormalities and changes from baseline in clinical laboratory tests up to and including Day 7: * Haematology. * Biochemistry.

  7 days

• Occurrence of clinically significant abnormalities and changes from baseline in clinical measurements and assessments (physical examination, vital signs, ECG or Spirometry) from viral challenge (Day 0) up to Day 28.

  Occurrence of clinically significant abnormalities and changes from baseline in clinical measurements and assessments (physical examination, vital signs, ECG or Spirometry) from viral challenge (Day 0) up to Day 28.

  28 Days

• Infection rate in older adult participants after inoculation with a GMP wild-type RSV B

  Infection defined by: * RSV RNA detectable by qPCR in nasal swab on 2 or more consecutive measurements, the first occurring between 2-8 days (inclusive) post-inoculation. * Infection rate equalling the number of infected participants divided by the sum of all participants inoculated with the virus, expressed as a percentage.

  8 Days

Secondary Outcomes (11)

• RSV B viral dynamics in upper respiratory samples

  8 Days

• RSV B viral dynamics in upper respiratory samples

  8 Days

• RSV B viral dynamics in upper respiratory samples

  8 Days

• RSV B viral dynamics in upper respiratory samples

  8 Days

• RSV B viral dynamics in upper respiratory samples

  8 Days

Study Arms (2)

Group 1 - Sentinel

EXPERIMENTAL

A sentinel group of n=6 will be enrolled and will not undergo bronchoscopies

Biological: RSV B

Group 2 - Bronchoscopy

EXPERIMENTAL

14 participants will be enrolled and be given the same intervention and undergo the same sampling and assessement but with additional bronchoscopy sampling at 3 timepoints

Biological: RSV B

Interventions

RSV B BIOLOGICAL

RSV B challenge virus

Group 1 - Sentinel; Group 2 - Bronchoscopy

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged between 65 to 75years (inclusive) at Day 0.
• Willing and able to commit to participation in the study.
• Adequate understanding of the study, the procedures involved, and able to provide written informed consent prior to any study procedures.

You may not qualify if:

• Any significant medical condition or prescribed drug deemed by the Investigator to deem the participant unsuitable for the study.
• History or evidence of any clinically significant or currently active:
• Cardiovascular, thromboembolic or cerebrovascular disease.
• Chronic respiratory disease (e.g. asthma, COPD, rhinitis, sinusitis, reactive airway disease, pulmonary hypertension or a chronic lung condition) in adulthood (a history of childhood asthma without respiratory disease in adulthood may be accepted at the PIs discretion).
• Significant or severe wheeze, or respiratory symptoms (including wheeze) which has ever resulted in hospitalisation.
• Known bronchial hyperactivity to viruses.
• Diabetes mellitus.
• Migraine with associated neurological symptoms such as hemiplegia or vision loss. Cluster headache/migraine or prophylactic treatment for migraine.
• History or evidence of autoimmune disease or known/suspected immunodeficiency of any cause, including asplenia or history of recurrent severe infections.
• Immunosuppression of any type.
• Known IgA deficiency, immotile cilia syndrome, or Kartagener's syndrome.
• Known coagulation disorder or anticoagulant therapy.
• Other major disease that, in the opinion of the Investigator, could interfere with a participant completing the study and necessary investigations.
• Concurrent serious illness including history of malignancy that could interfere with the aims of the study or a participant completing the study.
• Any significant abnormality altering the anatomy or function of the nose or nasopharynx in a substantial way, including nasopharyngeal malignancy, arterio-venous malformation, or undiagnosed nasopharyngeal mass.

Sponsors & Collaborators

• Imperial College London: lead

Study Officials

• Christopher Chiu, BMBCh FRCP FRCPath PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Polly Fox-Sheehan, BSc, MSc

CONTACT

02033131282; polly.fox@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1 (Sentinel) Group 2 (Bronchoscopy)

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 20, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-04