The Impact of Age on Adaptive Immunity in Adults Infected With Respiratory Syncytial Virus

NCT03728413 | Completed Results DMC

• 1 other identifier: 14SM2070
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study will for the first time systematically investigate the immune responses in an elderly cohort challenged with a well-defined RSV inoculum. With a global aging population and continuing difficulties in generating vaccines that can reliably induce protective immunity in the elderly, these data will indicate the targets at which development of vaccines against RSV and other infections should be directed.

Conditions

RSV Infection

Keywords

Elderly; Human; Respiratory Syncytial Infections; RNA Virus Infections

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Challenge-related Adverse Events

  To determine the safety and tolerability of experimental challenge with RSV Memphis 37, assessed by the number of participants with challenge-related adverse events. This includes any AEs deemed at least possibly related to the study challenge intervention (RSV Memphis 37). Assessed from the time of inoculation to study completion (Day 180).

  180 days

Secondary Outcomes (2)

• Symptom Severity in RSV Infection

  Day 0 to Day 14 (14 days)

• Nasal Viral Load Measurement in RSV Infection

  Day 0 to Day 28 (28 days)

Other Outcomes (2)

• Antibody Responses to RSV Infection

  Day 0 to Day 28 (28 days)

• T Cell Responses to RSV Infection

  Day 0 to Day 28 (at 0,7,10,14 and 28 days post inoculation)

Study Arms (1)

Healthy, non-smoking or ex-smoking persons aged 60 to 75 years

OTHER

RSV A Memphis 37 will be given as intra-nasal drops.

Biological: RSV A Memphis 37

Interventions

RSV A Memphis 37 BIOLOGICAL

Subjects will be inoculated using intra-nasal drops with diluted inoculum at a given dose divided equally between the two nostrils. Dose: Good Manufacturing Practices-certified RSV Memphis 37 10(4) PFU in 1ml, 25% sucrose/Dulbecco's Modification of Eagle's Medium. Inoculations using intranasal drops will be done using a 1mL pipette with subjects supine. This will be done slowly with sufficient interval between each inoculation (2-3 minutes) to ensure maximum contact time between with the nasal and pharyngeal mucosa. Subjects will be asked not to swallow during the procedure to ensure maximal pharyngeal contact. Following inoculation, advice regarding hand hygiene will be given, subjects will be provided with alcohol hand gel and facemasks to reduce spread of virus in the environment.

Healthy, non-smoking or ex-smoking persons aged 60 to 75 years

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy persons aged 60 to 75 years, able to give informed consent
• Non smokers or ex-smokers with smokers with less than or equal to 5 pack years smoking history.
• Spirometry within the normal range for age and height (+/- 15%)
• FEV1/FVC \>70% pre-bronchodilator

You may not qualify if:

• Chronic respiratory disease (asthma, COPD, rhinitis, sinusitis) in adulthood
• Inhaled bronchodilator or steroid use within the last 12 months
• Habitual use of any medication or other product (prescription or over-the-counter) for symptoms of rhinitis or nasal congestion within the last 3 months
• Acute upper respiratory infection (URI or sinusitis) in the past 6 weeks
• Subjects with allergic symptoms present at baseline
• Clinically relevant abnormality on chest X-ray
• Those in close domestic contact (i.e. sharing a household with, caring for, or daily face to face contact) with children under 3 years, other elderly adults (\>65 years), immunosuppressed persons, or those with chronic respiratory disease
• Subjects with known or suspected immune deficiency
• Receipt of systemic glucocorticoids (in a dose ≥ 5 mg prednisone daily or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within 6 months prior to challenge
• Known IgA deficiency, immotile cilia syndrome, or Kartagener's syndrome
• History of frequent nose bleeds
• Any significant medical condition or prescribed drug deemed by the study doctor to make the participant unsuitable for the study
• Women of childbearing potential must have a negative hCG urine pregnancy test \*
• Positive urine drug screen
• Women of childbearing potential will have a pregnancy test performed prior to virus inoculation to exclude pregnancy and be required to use contraception throughout the study.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, W12 0NN, United Kingdom

Location

Related Publications (1)

• Ascough S, Dayananda P, Kalyan M, Kuong SU, Gardener Z, Bergstrom E, Paterson S, Kar S, Avadhan V, Thwaites R, Sanchez Sevilla Uruchurtu A, Ruckwardt TJ, Chen M, Nair D, Derrien-Colemyn A, Graham BS, Begg M, Hessel E, Openshaw P, Chiu C. Divergent age-related humoral correlates of protection against respiratory syncytial virus infection in older and young adults: a pilot, controlled, human infection challenge model. Lancet Healthy Longev. 2022 Jun;3(6):e405-e416. doi: 10.1016/S2666-7568(22)00103-9. Epub 2022 Jun 9.

  PMID: 36098319 DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; RNA Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Professor Christopher Chiu
• Organization: Imperial College London

c.chiu@imperial.ac.uk

02083832301

Study Officials

• Christopher Chiu

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: November 2, 2018
• Study Start: November 12, 2018
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2026-01

Locations

GB (1)