InfluenzaPhase 2NCT03883113
Efficacy of MVA-NP+M1 in the Influenza H3N2 Human Challenge Model
A Phase 2 study testing MVA-NP+M1, Saline and H3N2 (A/Belgium/2417/2015) in people with Influenza, run by Barinthus Biotherapeutics at 1 site in Belgium.
Trial summary
A Phase 2, single center, randomized, double blind study evaluating the safety, efficacy, and immunogenicity of MVA NP+M1 in the H3N2 human influenza challenge model; on healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- MVA-NP+M1, Saline and H3N2 (A/Belgium/2417/2015)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Jun 2019to 17 Apr 2020
- Phase
- Phase 2
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females aged ≥18 and ≤55 years of age at the point of enrolment.
- Non-smokers or those who stopped smoking ≥ 3 months prior to screening 1 visit.
- Willingness to remain in isolation for the duration of the study.
- A female participant is eligible for this study if she is not pregnant or breast feeding and 1 of the following:
- Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year).
- Of childbearing potential but has been and agrees to continue practicing highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 6 months prior to vaccination to 6 months after administration of the influenza challenge virus. Highly effective methods of contraception include 1 or more of the following:
- male partner who is sterile (vasectomised) prior to the female participants entry into the study and is the sole sexual partner for the female participant; ii. hormonal (oral, intravaginal, transdermal, implantable or injectable); iii. an intrauterine hormone-releasing system (IUS); iv. an intrauterine device (IUD) with a documented failure rate of < 1%; v. bilateral tubal occlusion.
- Pre-challenge serum microneutralization test (MNT) against A/Belgium/4217/2015 (H3N2) challenge strain < 20.
Who cannot join
- BMI < 19 and > 32.
- Presence of any significant acute or chronic, uncontrolled medical (or psychiatric) illness including a history of chronic respiratory illness.
- History of seasonal hay fever or a clinically significant seasonal allergic rhinitis (SAR), including the use of symptomatic prescription only medication and non-prescription medication.
- History or evidence of autoimmune disease or known immunodeficiency of any cause - with the exception of atopic dermatitis/eczema and atopic rhinitis.
- Any history of anaphylaxis in reaction to vaccination or history of allergic reactions likely to be exacerbated by any component of the vaccine.
- History of lung disease (Asthma, COPD).
Show all 28Show fewer
- Current smokers or those who stopped smoking < 3months prior to screening 1 visit.
- Positive diagnostic tests for HIV, Hepatitis B or Hepatitis C indicating active infection.
- Evidence of drug abuse or a positive urine drug screen or alcohol breath test.
- Chronic use of any medication or other product (prescription or over-the-counter), for symptoms of rhinitis or nasal congestion or for any chronic nasopharyngeal complaint, or chronic use of any intranasal medication for any indication that has not ceased within 30 days prior to screening 1.
- Receipt of any investigational drug within 3 months prior to vaccination, or prior participation in a clinical trial of any influenza vaccine, or any investigational vaccine or experimental influenza viral challenge delivered directly to the respiratory tract within 1 year prior to challenge.
- Receipt of the 2018/2019 seasonal flu vaccine.
- Receipt of any live vaccines within the 4 weeks prior to vaccination.
- Any laboratory test which is abnormal and which is deemed by the Investigator(s) to be clinically significant.
- Receipt of any systemic chemotherapy agent at any time.
- Physician reported influenza or a syndrome consistent with influenza (as judged by the investigator) in the previous 6 months.
- Known allergy to treatments for influenza (including but not limited to oseltamivir).
- History of frequent epistaxis (nose bleeds).
- Any nasal or sinus surgery within 6 months of Viral Challenge or any significant abnormality, either of which results in alteration of the anatomy of the nose or nasopharynx (including significant nasal polyps).
- Volunteers with household contacts who are at risk for serious or severe complications of influenza disease including, but not limited to: persons ≥ 65 years; presence of significant chronic cardiopulmonary, metabolic, renal, or neurological conditions; immunosuppression due to any condition or therapies; BMI >40.
- Participants that are an employee or family member of the Investigator or study site personnel may not be enrolled.
- Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study.
- Abnormal spirometry assessed to be clinically significant.
- Known close contact with anyone known to have influenza in the past 7 days at the time of quarantine.
- Influenza-like illness (ILI) symptoms as assessed at the admission to clinic on Day -2 prior to challenge.
- Presence of fever, defined as participant presenting with a temperature reading of > 38.0°C on admission to quarantine.
- Qualitative Polymerase chain reaction (PCR) results positive for viral infection. However, participants may be included into later challenge cohort.
- Acute use of any medication or other product, prescription or over-the-counter, for symptoms of rhinitis or nasal congestion within 7 days prior to challenge. This includes any oral corticosteroid or beta agonist containing nasal spray.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
SGS Life Sciences, Clinical Pharmacology Unit (CPU)
Antwerp, 2060
About this study
A Phase 2, single center, randomized, double blind study evaluating the safety, efficacy, and immunogenicity of MVA NP+M1 in the H3N2 human influenza challenge model; on healthy adult volunteers.
Read the detailed description
The study consists of an outpatient vaccination phase (155 participants), and at least 2 months later an inpatient challenge phase (134 participants). Participants are randomized 93:62 to receive either MVA-NP+M1 or Placebo. Up to 20 participants will be challenged over several 3-week blocks, and the remainder at the final 3-week block for a total of 80 MVA-NP+M1 and 54 Placebo recipients challenged.
- Conditions
- Influenza
- Being tested
- MVA-NP+M1, Saline, H3N2 (A/Belgium/2417/2015)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA-NP+M1Biological
Trial Vaccine
SalineBiological
Sodium Chloride Placebo
H3N2 (A/Belgium/2417/2015)Biological
Challenge Agent
| Study group | Role | What they receive |
|---|---|---|
| MVA-NP+M1 & H3N2 Challenge Virus | Experimental | Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu.); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10^6 TCID50/ml) Receives: Biological: MVA-NP+M1; Biological: H3N2 (A/Belgium/2417/2015) |
| Saline Placebo & H3N2 Challenge Virus | Placebo comparator | Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10^6 TCID50/ml) Receives: Biological: Saline; Biological: H3N2 (A/Belgium/2417/2015) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Nasopharyngeal Viral Shedding as Determined by Quantitative Polymerase Chain Reaction qPCR
Measure of nasopharyngeal viral shedding during challenge; recorded as viral area under curve (vAUC) as determined by quantitative real time polymerase chain reaction (qRT-PCR). vAUC is calculated by plotting the log viral particles number/ml for each time point against time and is using the trapezoidal rule.
Measured: Throughout 9 days (Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day9, Day10) after viral Inoculation (Day1) of the challenge phase. Nasal swabs taken twice a day (b.i.d) at least 8 hours apart.
Secondary outcomes (17)
Number and Percentage of Virologically Confirmed Influenza-Like Illness
Incidence (frequency tabulation) of laboratory-confirmed influenza-like illness compared between vaccine and placebo arms Virologically confirmed influenza-like illness (ILI) is defined as having respiratory or flu-like symptom occurring on two consecutive days, along with a positive qPCR or qCulture result.
Measured: 9 days from day 2 to day 10
Percentage of Participants With Attack Rate of Challenge Agent (qRT-PCR)
The attack rate is defined as the percentage of inoculated participants with at least two consecutive positive swabs as determined by qRT-PCR within the timespan of two consecutive days
Measured: 9 days from day 2 to day 10
Percentage of Participants With Quantitative Culture Attack Rate of Challenge Agent (qCulture)
The attack rate is defined as the percentage of inoculated participants with at least two consecutive positive swabs as determined by qCulture within the timespan of two consecutive days
Measured: 9 days from day 2 to day 10
Time to Start of Viral Shedding (qPCR) From Virus Inoculation
The Time to Start of Viral Shedding (qPCR) is calculated as (datetime of first of two positive swabs (qPCR) within 2 consecutive days - challenge datetime)/(60*60)
Measured: 9 days from day 2 to day 10
Time to Start of Viral Shedding (qCulture) From Virus Inoculation
Time to Start of Viral Shedding (qCulture) is calculated as (datetime of first of two positive swabs (qCulture) within 2 consecutive days - challenge datetime)/(60*60)
Measured: 9 days from day 2 to day 10
Peak Viral Shedding (qPCR) After the Virus Inoculation
This is measured by the highest viral load concentration by qPCR
Measured: 9 days from Day 2 to Day 10
Peak Viral Shedding (qCulture) After Virus Inoculation
This is measured by the highest viral load concentration by qCulture.
Measured: 9 days from day 2 to day 10
Time to Peak of Viral Shedding (qPCR) From the Viral Inoculation
This is calculated as (datetime of highest viral load concentration (qPCR) - challenge datetime)/(60*60)
Measured: 9 days from day 2 to day 10
Time to Peak of Viral Shedding (qCulture) From the Viral Inoculation
This is calculated as (datetime of highest viral load concentration (qCulture) - challenge datetime)/(60*60)
Measured: 9 days from day 2 to day 10
Duration of Viral Shedding (qPCR) After the Virus Inoculation
It is calculated as (datetime of first negative swab (qPCR) following the last positive swab (qPCR) - datetime of first positive of two positive swabs (qPCR) within 2 consecutive days)/(60*60)
Measured: 9 days from day2 to day10
Duration of Viral Shedding (qCulture) After the Virus Inoculation
It is calculated as (datetime of first negative swab (qCulture) following the last positive swab (qCulture) - datetime of first positive of two positive swabs (qCulture) within 2 consecutive days)/(60*60)
Measured: 9 days from day 2 to day 10
Total Area Under the Curve (AUC) of Self-reported Influenza Total Symptom Score (SSC AUC)
Total symptom scores were compared for MVA-NP+M1 vs. Placebo from Day1 to Day11 post-challenge as AUC of composite score.
Symptoms were collected twice a day (lymphadenopathy once a day) on a Symptom Score Card(SSC).
SSC recorded scores for each 16 general (gastrointestinal/body systemic) and 12 local (upper/lower respiratory tract) symptoms, on the scale per timepoint (for example Day2,AM).
Participants rated the severity of symptoms, higher scores indicating a more severe symptom.
The scores ranged from 0 to 3 (0:symptom free, 1:mild, 2:moderate, 3:severe).The SSC also contained the question whether the subject felt well to go to work "today" (yes/no). The Overall SSC score was calculated, as the Arithmetic Mean of the Scores collected across all 28 items on the card per Timepoint and ranged from 0 to maximum 3.
The SSC AUC [0-11 days] was derived based on the Overall SSC score against time (*hour), using the linear trapezoidal rule and it ranged from 0 to 110 Score*hour.
Measured: 11 days from Day 1 to Day 11
Total Days of Fever
Total days of fever for MVA-NP+M1 vs. Placebo
Measured: 11 days from Day 1 to Day 11
Average Total Mucus Production
Total mucus weight of used tissue (regardless of take rate) for MVA-NP+M1 vs. Placebo.
Total mucus production was only be calculated in case all tissues were returned (sum of clean and used tissues returned should be 20 tissues for each bag).
Measured: 11 days from Day 1 to Day 11
T Cell Responses as Defined by ELISpot Assay in Relation to the Primary Endpoint, Symptom Scores and Influenza Incidence
T Cell Response was assessed for IFN gamma and granzyme B, on the peripheral blood mononuclear cell using a double-colour enzymatic ELISpot assay.
For each of them, three stimulation antigens were assessed: nucleoprotein NP, matrix1 M1 and a negative control, dimethyl sulfoxide (DMSO).
The number of spot-forming T cell colonies per well (i.e. 200,000 cells) +/- standard deviation for the total response to NP+M1 is reported.
The endpoint was recorded as the mean spot-forming units per million peripheral blood mononuclear cells in the peptide-stimulated wells minus the mean DMSO control wells for the sample. T cell responses over time (sampling timepoints) were then assessed in relation to the primary endpoint, symptom scores, and influenza incidence.
Measured: 3 months (day 0, day 8 and day 28 of the vaccination period and day -1 and day 28 of the challenge period)
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Occurrence of solicited local and systemic reactogenicity signs and symptoms for 7 days following vaccination; self-reported symptoms recorded using paper diaries
Measured: 7 days following vaccination
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Occurrence of solicited local and systemic reactogenicity signs and symptoms; self-reported symptoms recorded using questionnaires and adverse event monitoring
Measured: 17 days following vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start3 Jun 2019
- Primary completion16 Dec 2019
- Study completion17 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barinthus Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robin Rogiers, MD, Principal investigator, SGS S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883113
- Sponsor's protocol ID
- FLU010
- Status last verified
- Mar 2021
- First submitted
- 21 Feb 2019
- Last updated
- 18 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Evans TG, Castellino F, Kowalik Dobczyk M, Tucker G, Walley AM, Van Leuven K, Klein J, Rutkowski K, Ellis C, Eagling-Vose E, Treanor J, van Baalen C, Filkov E, Laurent C, Thacker J, Asher J, Donabedian A. Assessment of CD8+ T-cell mediated immunity in an influenza A(H3N2) human challenge model in Belgium: a single centre, randomised, double-blind phase 2 study. Lancet Microbe. 2024 Jul;5(7):645-654. doi: 10.1016/S2666-5247(24)00024-7. Epub 2024 May 7.
PubMed 38729196
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of MVA-NP+M1 in the Influenza H3N2 Human Challenge Model
- ClinicalTrials.gov ID
- NCT03883113
- Acronym / sponsor ID
- FLU010
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Barinthus BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 17 Apr 2020 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Posted 18 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2, single center, randomized, double blind study evaluating the safety, efficacy, and immunogenicity of MVA NP+M1 in the H3N2 human influenza challenge model; on healthy adult volunteers.
Detailed description
The study consists of an outpatient vaccination phase (155 participants), and at least 2 months later an inpatient challenge phase (134 participants). Participants are randomized 93:62 to receive either MVA-NP+M1 or Placebo. Up to 20 participants will be challenged over several 3-week blocks, and the remainder at the final 3-week block for a total of 80 MVA-NP+M1 and 54 Placebo recipients challenged.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MVA-NP+M1 & H3N2 Challenge Virus | Experimental | Biological: MVA-NP+M1, Biological: H3N2 (A/Belgium/2417/2015)Vaccination administered: MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu.); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10^6 TCID50/ml) |
| Saline Placebo & H3N2 Challenge Virus | Placebo comparator | Biological: Saline, Biological: H3N2 (A/Belgium/2417/2015)Vaccination administered: Sodium Chloride (IM injection, 0.5 ml, 0.9%); Challenge Virus administered: H3N2 (nasal spray, 0.5 ml, 1.0x10^6 TCID50/ml) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy males and females aged ≥18 and ≤55 years of age at the point of enrolment.
- Non-smokers or those who stopped smoking ≥ 3 months prior to screening 1 visit.
- Willingness to remain in isolation for the duration of the study.
- A female participant is eligible for this study if she is not pregnant or breast feeding and 1 of the following:
- Pre-challenge serum microneutralization test (MNT) against A/Belgium/4217/2015 (H3N2) challenge strain < 20.
Key exclusion criteria (28 listed)
- BMI < 19 and > 32.
- Presence of any significant acute or chronic, uncontrolled medical (or psychiatric) illness including a history of chronic respiratory illness.
- History of seasonal hay fever or a clinically significant seasonal allergic rhinitis (SAR), including the use of symptomatic prescription only medication and non-prescription medication.
- History or evidence of autoimmune disease or known immunodeficiency of any cause - with the exception of atopic dermatitis/eczema and atopic rhinitis.
- Any history of anaphylaxis in reaction to vaccination or history of allergic reactions likely to be exacerbated by any component of the vaccine.
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 |
|---|---|---|
| MVA-NP+M1Trial Vaccine | Biological | MVA-NP+M1 & H3N2 Challenge Virus |
| SalineSodium Chloride Placebo | Biological | Saline Placebo & H3N2 Challenge Virus |
| H3N2 (A/Belgium/2417/2015)Challenge Agent | Biological | MVA-NP+M1 & H3N2 Challenge Virus, Saline Placebo & H3N2 Challenge Virus |
Primary outcome
Degree of Nasopharyngeal Viral Shedding as Determined by Quantitative Polymerase Chain Reaction qPCR
Time frame: Throughout 9 days (Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day9, Day10) after viral Inoculation (Day1) of the challenge phase. Nasal swabs taken twice a day (b.i.d) at least 8 hours apart.
Measure of nasopharyngeal viral shedding during challenge; recorded as viral area under curve (vAUC) as determined by quantitative real time polymerase chain reaction (qRT-PCR). vAUC is calculated by plotting the log viral particles number/ml for each time point against time and is using the trapezoidal rule.
17 secondary outcomes
Number and Percentage of Virologically Confirmed Influenza-Like Illness
Time frame: 9 days from day 2 to day 10
Percentage of Participants With Attack Rate of Challenge Agent (qRT-PCR)
Time frame: 9 days from day 2 to day 10
Percentage of Participants With Quantitative Culture Attack Rate of Challenge Agent (qCulture)
Time frame: 9 days from day 2 to day 10
Time to Start of Viral Shedding (qPCR) From Virus Inoculation
Time frame: 9 days from day 2 to day 10
Time to Start of Viral Shedding (qCulture) From Virus Inoculation
Time frame: 9 days from day 2 to day 10
Peak Viral Shedding (qPCR) After the Virus Inoculation
Time frame: 9 days from Day 2 to Day 10
Peak Viral Shedding (qCulture) After Virus Inoculation
Time frame: 9 days from day 2 to day 10
Time to Peak of Viral Shedding (qPCR) From the Viral Inoculation
Time frame: 9 days from day 2 to day 10
Time to Peak of Viral Shedding (qCulture) From the Viral Inoculation
Time frame: 9 days from day 2 to day 10
Duration of Viral Shedding (qPCR) After the Virus Inoculation
Time frame: 9 days from day2 to day10
Duration of Viral Shedding (qCulture) After the Virus Inoculation
Time frame: 9 days from day 2 to day 10
Total Area Under the Curve (AUC) of Self-reported Influenza Total Symptom Score (SSC AUC)
Time frame: 11 days from Day 1 to Day 11
Total Days of Fever
Time frame: 11 days from Day 1 to Day 11
Average Total Mucus Production
Time frame: 11 days from Day 1 to Day 11
T Cell Responses as Defined by ELISpot Assay in Relation to the Primary Endpoint, Symptom Scores and Influenza Incidence
Time frame: 3 months (day 0, day 8 and day 28 of the vaccination period and day -1 and day 28 of the challenge period)
Number of Participants With MVA-NP+M1 Vaccination Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Time frame: 7 days following vaccination
Number of Participants With H3N2 Challenge Related Adverse Events and Symptoms, Measured by Self-reported Symptoms
Time frame: 17 days following vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38729196Evans TG, Castellino F, Kowalik Dobczyk M, Tucker G, Walley AM, Van Leuven K, Klein J, Rutkowski K, Ellis C, Eagling-Vose E, Treanor J, van Baalen C, Filkov E, Laurent C, Thacker J, Asher J, Donabedian A. Assessment of CD8+ T-cell mediated immunity in an influenza A(H3N2) human challenge model in Belgium: a single centre, randomised, double-blind phase 2 study. Lancet Microbe. 2024 Jul;5(7):645-654. doi: 10.1016/S2666-5247(24)00024-7. Epub 2024 May 7.
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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.
Robin Rogiers, MD principal investigator
SGS S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MVA-NP+M1, Saline and H3N2 (A/Belgium/2417/2015) in people with Influenza, run by Barinthus Biotherapeutics at 1 site in Belgium.
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 8 inclusion and 28 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 18 Mar 2021. 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 Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2021). 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?
Degree of Nasopharyngeal Viral Shedding as Determined by Quantitative Polymerase Chain Reaction qPCR (time frame: Throughout 9 days (Day2, Day3, Day4, Day5, Day6, Day7, Day8, Day9, Day10) after viral Inoculation (Day1) of the challenge phase. Nasal swabs taken twice a day (b.i.d) at least 8 hours apart.). 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 NCT03883113, 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 18 Mar 2021.