RSV InfectionNCT03919591
RSV Study in Adults 60 to 75 Years of Age
A study testing Challenge virus RSV-A Memphis 37b in people with RSV Infection, run by Hvivo at 1 site in United Kingdom.
Trial summary
The purpose of this study is to infect healthy volunteers aged 60-75 years old with Respiratory Syncytial Virus (RSV) to confirm how safe and well tolerated the use of an experimental RSV virus is in a population that has not previously received the virus. 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?
- Challenge virus RSV-A Memphis 37b
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Mar 2019to 11 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 subjects aged 60 to 75 years
- Able to give informed consent
- A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 33 kg/m2.
- In good health with no history of major medical conditions, or clinically significant test abnormalities that will interfere with subject safety as determined by the Investigator at screening evaluation
- Documented medical history either prior to entering the study and/or following medical history review by the Investigator at screening.
- Serum IgA result within normal range at screening.
- Subjects meeting the contraception criteria of the study.
Who cannot join
- Subjects who have smoked ≥ 10 pack years (or 20 cigarettes a day for 10 years). Of those subjects that have smoked less than 10 pack years at any time, a subject will be excluded, if in the last year, he/she has smoked any number of cigarettes in the last month and/or they have used tobacco in any form or other nicotine-containing products in any form.
- Subjects who smoked in the last month prior to the study
- Females who are breastfeeding, have been pregnant within 6 months prior to the study, or have a positive pregnancy test.
- History of clinically significant or major disease that, in the opinion of the Investigator, may interfere with a subject completing the study and necessary investigations.
- A forced expiratory volume in 1 second (FEV1) < 80% predicted.
- Twelve-lead ECG recording with clinically relevant abnormalities.
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- Positive HIV, Hep A, B or C test.
- Confirmed positive test for drugs of abuse.
- Presence of fever prior to the challenge.
- Evidence of vaccinations within the 4 weeks prior to the planned date of enrolment, or intention to receive any vaccination before the last scheduled visit of the study.
- Those employed or immediate relatives of those employed at hVIVO.
- Receipt of blood or blood products, or loss (including blood donations) of 470 mL or more of blood during the 3 months prior to the planned date of enrolment.
- Receipt of systemic glucocorticoids or systemic antiviral drugs within 6 months prior to the planned date of enrolment.
- History or currently active symptoms suggestive of upper or lower respiratory tract infection within 6 weeks prior to enrolment.
- Any clinically significant history of large nosebleeds.
- Any significant abnormality altering the anatomy of the nose.
- History of significant/severe wheeze, respiratory symptoms resulting in hospitalisation, or known bronchial hyperreactivity to viruses.
- History of anaphylaxis-and/or severe allergic reaction.
- Use or anticipated use during the conduct of the study of concomitant medications.
- Resident of nursing home and other long-term care facilities or with close or household contact with vulnerable people for approximately 2 weeks following discharge from unit.
- History or presence of alcohol addiction.
- Any other finding that, in the opinion of the Investigator, deems the subject unsuitable for the study.
- Subjects with no detectable antibody to the challenge virus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Pilot Study to Evaluate the Clinical Safety and Virologic Profile of an Experimental RSV Infection in Adults 60 to 75 Years of Age
The purpose of this study is to infect healthy volunteers aged 60-75 years old with Respiratory Syncytial Virus (RSV) to confirm how safe and well tolerated the use of an experimental RSV virus is in a population that has not previously received the virus. Additionally, this study will also look at various components of the volunteers' blood, the lining of their noses and other samples in order to measure the effects of the virus on the body, in particularly the immune system before, during and after viral infection.
Read the detailed description
RSV is a common virus that affects all human age groups. Typical RSV illness is identified by symptoms such as runny nose, stuffy nose, sneezing, sore throat, earache, malaise or tiredness, cough, shortness of breath, headache, muscle ache, joint ache or stiffness, chilliness and feverishness. RSV spreads easily from person to person through the eyes, nose or mouth when droplets containing the virus, such as those from coughing or sneezing, are inhaled or passed to others. Adults with risk factors, like another illness or disease, may experience an RSV illness that is more severe or lasts longer. RSV may also start a worsening of health in frail adults, people with weak immune systems, and those with chronic cardio-pulmonary disease.
No treatment or vaccine to treat or prevent RSV disease is available in the UK. Vaccination against RSV has the potential to be a highly beneficial and effective approach to reduce RSV disease in older adults as well as other high-risk adult and paediatric populations. The use of RSV human viral challenge model provides an important tool to evaluate the effectiveness of new RSV vaccines. Specifically, a RSV human viral challenge in 60 to 75-year-old individuals would enable measuring the effectiveness of RSV vaccines in a population that is thought to be less responsive to vaccines than the 18-45-year-old population.
The purpose of this study is to infect up to 74 healthy subjects aged 60 to 75 years old with RSV in a controlled quarantine environment to confirm how safe and well tolerated the use of an experimental RSV virus infection is in a population that has not previously received the virus. Additionally, the investigators will also look at various components of the subjects' blood, the lining of their noses and other samples in order to measure the effects of the virus on the body, in particularly the immune system before, during and after viral infection.
The study will consist of 3 phases: 1) Screening, 2) Quarantine and 3) Follow-up.
The enrolment of the subjects will be staggered with safety data reviews performed between groups. Each volunteer will be in the study for approximately 3 months from screening to their last scheduled clinic visit.
- Conditions
- RSV Infection
- Being tested
- Challenge virus RSV-A Memphis 37b
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Challenge virus RSV-A Memphis 37bOther
Each subject will receive one titre of virus, which will be up to approximately 4.5 log10 PFU.
| Study group | Role | What they receive |
|---|---|---|
| Open Label Pilot | Other | Open Label Pilot Study. All subjects will receive the viral challenge inoculum. Receives: Other: Challenge virus RSV-A Memphis 37b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of routine clinical assessment abnormalities reported as adverse events.
Multiple safety clinical parameters will be used for safety evaluation:
- Vital signs parameters (systolic blood pressure (mmHg), diastolic blood pressure (mmHg), respiratory rate (breaths per minute), heart rate (beats per minute) and SpO2 (%)
- Tympanic temperature (deg C)
- Spirometry parameters (FEV1(absolute), FEV1(% predicted), Forced vital capacity (FVC) (absolute), FVC (% predicted), FEV1/FVC ratio (absolute), FEV1/FVC ratio (% predicted)
- ECG parameters (Heart Rate (beats/min), PR interval (msec), QRS duration (msec), QT interval (msec), QTc interval (msec), QTcB interval (msec), QTcF interval (msec) and RR interval (msec))
- Physical examination (complete examination and directed examination assessments).
Measured: Safety data collected throughout the study (estimated 4 month).
Number of safety laboratory assessment abnormalities reported as adverse events.
- Haematology: platelet count, WBC count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, reticulocyte count, reticulocyte count [ each reported in 10^9/L]; RBC count (10^12/L), haemoglobin (g/L), haematocrit (%), MCV (fL), MCH (PG), MCHC (g/L), Haemoglobin A1c
- Biochemistry: sodium, potassium, glucose, chloride, bicarbonate, calcium, inorganic phosphate, urea, total cholesterol [each reported in mmol/L]; uric acid, creatinine, total bilirubin, indirect bilirubin, direct bilirubin [each reported in umol/L]; serum albumin (g/L), total protein (g/L), blood urea nitrogen (mg/dL), CRP (mg/L), GGT (IU/L), ALP (IU/L), ALT (IU/L), LDH (IU/L), AST (IU/L), urea (mmol/L), total cholesterol (mmol/L), Estimated Glomerular Filtration Rate.
- Coagulation: PT (secs), APTT (secs)
- Cardiac Enzymes: creatine kinase (IU/L), troponin T (ng/L)
- Urinalysis: colour, specific gravity, appearance, pH, blood, glucose, leukocytes, ketones, nitrite, protein, urobilinogen, bilirubin.
Measured: Safety data collected throughout the study (estimated 4 month).
Number of subjects with study related Adverse Events (AEs)
- use of concomitant medications
- frequency and severity of AEs.
Measured: Safety data collected throughout the study (estimated 4 month).
Secondary outcomes (7)
Viral loads/shedding measurement following inoculation with RSV
The AUC of RSV-A Memphis 37b viral load measured in nasopharyngeal swabs by qPCR (log10 copies/mL units) and by cell base infectivity assay (log10 copies/mL units).
Measured: Virology and clinical data collected throughout the study (estimated 4 month).
Duration of viral shedding.
The time (in hours) from first detectable viral shedding to first undetectable viral shedding.
Measured: Virology and clinical data collected throughout the study (estimated 4 month)
Measurement of the total mucus weight produced.
Total weight of nasal discharge (grams).
Measured: Virology and clinical data collected throughout the study (estimated 4 month).
Measurement of symptoms severity by self reported symptoms diary cards.
Symptoms are recorded on a grading scale of 0 to 3.
Measured: Symptom Diary Cards data is collected throughout the quarantine period (estimated 15 days)
Measurement of the peak tympanic temperature.
Time of the highest recorded tympanic temperature.
Measured: Temperature data is collected from day 0 to day 12.
Number and percentage of subjects with confirmed RSV infection.
Confirmed infection is measured by the presence of viral shedding in nasopharyngeal swabs.
Measured: Virology data collected throughout the study (estimated 4 month)
Number and percentage of subjects with Upper and Lower Respiratory Tract Infection (URTI and LRTI)
URTI and LRTI are evaluated from Symptom Diary Cards and Physical Examination.
Measured: Clinical data collected throughout the study (estimated 4 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start12 Mar 2019
- Primary completion11 Jul 2019
- Study completion11 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Each subject will receive one titre of the Challenge Virus intranasally.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvivo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919591
- Sponsor's protocol ID
- RVL-OCS-001
- Status last verified
- Oct 2019
- First submitted
- 1 Apr 2019
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised data might be shared with hVIVO's research partners
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Pilot Study to Evaluate the Clinical Safety and Virologic Profile of an Experimental RSV Infection in Adults 60 to 75 Years of Age
- ClinicalTrials.gov ID
- NCT03919591
- Acronym / sponsor ID
- RVL-OCS-001
- Conditions
- RSV Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- HvivoIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to infect healthy volunteers aged 60-75 years old with Respiratory Syncytial Virus (RSV) to confirm how safe and well tolerated the use of an experimental RSV virus is in a population that has not previously received the virus. Additionally, this study will also look at various components of the volunteers' blood, the lining of their noses and other samples in order to measure the effects of the virus on the body, in particularly the immune system before, during and after viral infection.
Detailed description
RSV is a common virus that affects all human age groups. Typical RSV illness is identified by symptoms such as runny nose, stuffy nose, sneezing, sore throat, earache, malaise or tiredness, cough, shortness of breath, headache, muscle ache, joint ache or stiffness, chilliness and feverishness. RSV spreads easily from person to person through the eyes, nose or mouth when droplets containing the virus, such as those from coughing or sneezing, are inhaled or passed to others. Adults with risk factors, like another illness or disease, may experience an RSV illness that is more severe or lasts longer. RSV may also start a worsening of health in frail adults, people with weak immune systems, and those with chronic cardio-pulmonary disease.
No treatment or vaccine to treat or prevent RSV disease is available in the UK. Vaccination against RSV has the potential to be a highly beneficial and effective approach to reduce RSV disease in older adults as well as other high-risk adult and paediatric populations. The use of RSV human viral challenge model provides an important tool to evaluate the effectiveness of new RSV vaccines. Specifically, a RSV human viral challenge in 60 to 75-year-old individuals would enable measuring the effectiveness of RSV vaccines in a population that is thought to be less responsive to vaccines than the 18-45-year-old population.
The purpose of this study is to infect up to 74 healthy subjects aged 60 to 75 years old with RSV in a controlled quarantine environment to confirm how safe and well tolerated the use of an experimental RSV virus infection is in a population that has not previously received the virus. Additionally, the investigators will also look at various components of the subjects' blood, the lining of their noses and other samples in order to measure the effects of the virus on the body, in particularly the immune system before, during and after viral infection.
The study will consist of 3 phases: 1) Screening, 2) Quarantine and 3) Follow-up.
The enrolment of the subjects will be staggered with safety data reviews performed between groups. Each volunteer will be in the study for approximately 3 months from screening to their last scheduled clinic visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each subject will receive one titre of the Challenge Virus intranasally.
| Arm | Type | Receives |
|---|---|---|
| Open Label Pilot | Other | Other: Challenge virus RSV-A Memphis 37bOpen Label Pilot Study. All subjects will receive the viral challenge inoculum. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy subjects aged 60 to 75 years
- Able to give informed consent
- A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 33 kg/m2.
- In good health with no history of major medical conditions, or clinically significant test abnormalities that will interfere with subject safety as determined by the Investigator at screening evaluation
- Documented medical history either prior to entering the study and/or following medical history review by the Investigator at screening.
Key exclusion criteria (23 listed)
- Subjects who have smoked ≥ 10 pack years (or 20 cigarettes a day for 10 years). Of those subjects that have smoked less than 10 pack years at any time, a subject will be excluded, if in the last year, he/she has smoked any number of cigarettes in the last month and/or they have used tobacco in any form or other nicotine-containing products in any form.
- Subjects who smoked in the last month prior to the study
- Females who are breastfeeding, have been pregnant within 6 months prior to the study, or have a positive pregnancy test.
- History of clinically significant or major disease that, in the opinion of the Investigator, may interfere with a subject completing the study and necessary investigations.
- A forced expiratory volume in 1 second (FEV1) < 80% predicted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Challenge virus RSV-A Memphis 37bEach subject will receive one titre of virus, which will be up to approximately 4.5 log10 PFU. | Other | Open Label Pilot |
Primary outcome
Number of routine clinical assessment abnormalities reported as adverse events.
Time frame: Safety data collected throughout the study (estimated 4 month).
Multiple safety clinical parameters will be used for safety evaluation: * Vital signs parameters (systolic blood pressure (mmHg), diastolic blood pressure (mmHg), respiratory rate (breaths per minute), heart rate (beats per minute) and SpO2 (%) * Tympanic temperature (deg C) * Spirometry parameters (FEV1(absolute), FEV1(% predicted), Forced vital capacity (FVC) (absolute), FVC (% predicted), FEV1/FVC ratio (absolute), FEV1/FVC ratio (% predicted) * ECG parameters (Heart Rate (beats/min), PR interval (msec), QRS duration (msec), QT interval (msec), QTc interval (msec), QTcB interval (msec), QTcF interval (msec) and RR interval (msec)) * Physical examination (complete examination and directed examination assessments).
Number of safety laboratory assessment abnormalities reported as adverse events.
Time frame: Safety data collected throughout the study (estimated 4 month).
* Haematology: platelet count, WBC count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, reticulocyte count, reticulocyte count [ each reported in 10^9/L]; RBC count (10^12/L), haemoglobin (g/L), haematocrit (%), MCV (fL), MCH (PG), MCHC (g/L), Haemoglobin A1c * Biochemistry: sodium, potassium, glucose, chloride, bicarbonate, calcium, inorganic phosphate, urea, total cholesterol [each reported in mmol/L]; uric acid, creatinine, total bilirubin, indirect bilirubin, direct bilirubin [each reported in umol/L]; serum albumin (g/L), total protein (g/L), blood urea nitrogen (mg/dL), CRP (mg/L), GGT (IU/L), ALP (IU/L), ALT (IU/L), LDH (IU/L), AST (IU/L), urea (mmol/L), total cholesterol (mmol/L), Estimated Glomerular Filtration Rate. * Coagulation: PT (secs), APTT (secs) * Cardiac Enzymes: creatine kinase (IU/L), troponin T (ng/L) * Urinalysis: colour, specific gravity, appearance, pH, blood, glucose, leukocytes, ketones, nitrite, protein, urobilinogen, bilirubin.
Number of subjects with study related Adverse Events (AEs)
Time frame: Safety data collected throughout the study (estimated 4 month).
* use of concomitant medications * frequency and severity of AEs.
7 secondary outcomes
Viral loads/shedding measurement following inoculation with RSV
Time frame: Virology and clinical data collected throughout the study (estimated 4 month).
Duration of viral shedding.
Time frame: Virology and clinical data collected throughout the study (estimated 4 month)
Measurement of the total mucus weight produced.
Time frame: Virology and clinical data collected throughout the study (estimated 4 month).
Measurement of symptoms severity by self reported symptoms diary cards.
Time frame: Symptom Diary Cards data is collected throughout the quarantine period (estimated 15 days)
Measurement of the peak tympanic temperature.
Time frame: Temperature data is collected from day 0 to day 12.
Number and percentage of subjects with confirmed RSV infection.
Time frame: Virology data collected throughout the study (estimated 4 month)
Number and percentage of subjects with Upper and Lower Respiratory Tract Infection (URTI and LRTI)
Time frame: Clinical data collected throughout the study (estimated 4 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Individual participant dataSharing planned: No. Anonymised data might be shared with hVIVO's research partners
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RSV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Challenge virus RSV-A Memphis 37b in people with RSV Infection, run by Hvivo 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 7 inclusion and 23 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 14 Oct 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 routine clinical assessment abnormalities reported as adverse events. (time frame: Safety data collected throughout the study (estimated 4 month).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2019.