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RSV InfectionINFLAMMAGENCT03728413

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

A study testing RSV A Memphis 37 in people with RSV Infection, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 75 yearsHealthy volunteers can take part
Conditions the study is for
RSV Infection
What is being tested?
RSV A Memphis 37
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited Kingdom
Study dates
12 Nov 2018to 4 May 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Imperial College London

    London, W12 0NN

Other trials in United Kingdom

About this study

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.

Read the detailed description

Respiratory syncytial virus (RSV) is one of the most common causes of chest infection worldwide, with 64 million episodes and 160,000 deaths each year. Despite this, it remains an underappreciated health problem and there are currently no specific treatments or vaccines against it. Although RSV infection is most frequent in young children, the majority of deaths occur in older adults, particularly in those with underlying heart and lung disease. This is believed to be due in part to the ageing immune system's reduced ability to protect against infection and symptomatic disease. However, little is known about the way human immune responses to RSV infection in older individuals differ from those of younger people. Further understanding of the mechanisms underlying immunity and potential impairments in these higher-risk people are therefore necessary. This project aims to study the role of T cells (which destroy virus-infected cells and are likely to be essential for recovery from infection) in healthy older volunteers after they have been given an RSV-induced common cold. Samples will be taken from the blood and respiratory tract in order to identify the differences in T cell responses that occur in older adults compared with their younger counterparts. Participants will be carefully screened to ensure they do not have any underlying health problems that might make them more at risk of severe disease and will be monitored closely throughout the course of infection. The investigators anticipate that T cell function even in healthy older individuals will be impaired compared to young adults, thus contributing in those with additional health problems to more severe disease. By analysing the networks of genes that are switched on and off, the investigators aim to identify the particular defects underlying these functional defects in order to ultimately define targets for novel treatments and T cell-stimulating vaccines.

Conditions
RSV Infection
Being tested
RSV A Memphis 37
Keywords
Elderly, Human, Respiratory Syncytial Infections, RNA Virus Infections
Medical subject headings
Respiratory Syncytial Virus Infections, RNA Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RSV A Memphis 37Biological

    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.

Study groups in NCT03728413
Study groupRoleWhat they receive
Healthy, non-smoking or ex-smoking persons aged 60 to 75 yearsOtherRSV A Memphis 37 will be given as intra-nasal drops.
Receives: Biological: RSV A Memphis 37

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 180 days

Secondary outcomes (2)

  1. Symptom Severity in RSV Infection

    This is the total symptom score for the whole 14 day period and is therefore the sum of all the scores from Day 0 to Day 14.

    Self-reported upper and lower respiratory and systemic symptoms by diary card. A self-completed diary card of upper respiratory tract clinical symptoms was completed on Day 0 and daily for 14 days after inoculation.

    A total 'upper respiratory clinical symptom score' will be derived using a four-point scale (0-3 for absent, mild, moderate and severe) for each of the following four respiratory symptoms: sneezing, nasal discharge, nasal obstruction, and sore throat, giving a maximum clinical severity score of 12 per day.

    Measured: Day 0 to Day 14 (14 days)

  2. Nasal Viral Load Measurement in RSV Infection

    Change from baseline in viral load by qPCR of 28 days post inoculation.

    Measured: Day 0 to Day 28 (28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2018
  2. Study start12 Nov 2018
  3. Primary completion4 May 2023
  4. Study completion4 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03728413
Sponsor's protocol ID
14SM2070
Acronym
INFLAMMAGE
Status last verified
Jan 2026
First submitted
16 Oct 2018
Last updated
26 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data may be shared, all data will be anonymised.

Publications

  • 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.

    PubMed 36098319

Questions about this trial

What is this clinical trial studying?

A study testing RSV A Memphis 37 in people with RSV Infection, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Challenge-related Adverse Events (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03728413, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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