Acute Bronchiolitis Due to Respiratory Syncytial VirusPhase 1NCT04519073
Phase 1 Study to Evaluate the Safety and Immunogenicity of a Candidate Vaccine Against Respiratory Syncytial Virus
A Phase 1 study testing V-306 candidate vaccine in people with Acute Bronchiolitis Due to Respiratory Syncytial Virus, run by Virometix at 1 site in Belgium.
Trial summary
The primary and secondary objectives of this Phase 1 study are respectively to assess the safety and the immunogenicity of two administrations of the RSV vaccine candidate at three different doses. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Bronchiolitis Due to Respiratory Syncytial Virus
- What is being tested?
- V-306 candidate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Sep 2020to 2 Mar 2022
- Phase
- Phase 1
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent.
- Healthy women aged between 18-45 years.
- No evidence of disease based on medical history, physical examination, vital signs (blood pressure, heart rate, body temperature and respiratory rate), laboratory safety parameters and clinical judgement.
- Not pregnant and committed to not becoming pregnant during the whole study period. Committed to use adequate and effective contraception means in accordance with the Clinical Trial Facilitation Group (CTFG) criteria.
- The subjects must have used adequate and effective contraception means (CTFG criteria) for at least 60 days prior to the 1st administration.
- Capability to meet the requirements of the study.
Who cannot join
- Presence of serologic markers of acute or chronic Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBsAg and anti-HBc) and Hepatitis C Virus (anti-HCV) infection(s).
- As judged by the Investigator, any clinically significant disease related to the cardiovascular (CV), gastrointestinal (GI) or central nervous system (CNS).
- Any chronic disease, or history of significant disease that might interfere with the trial's conduct or completion. Some conditions may be accepted if stabilised, e.g. hypertension.
- An active respiratory disease or symptoms thereof (chronic obstructive pulmonary disease, asthma, asthmatic bronchitis, dyspnoea, wheezing, severe allergy) requiring medication, or history of such disease.
- Personal history of active or past autoimmune disease
- Administration for more than three months prior of study start of immunosuppressant or immuno-modifying drugs (including systemic corticosteroids).
Show all 18Show fewer
- Confirmed or suspected (at the discretion of the Investigator) immuno-suppressive or immuno-deficient condition.
- Current smokers (more than 10 cigarettes/day).
- Blood transfusion, blood product, immunoglobulins received during the period of 3 months prior to study start.
- Clinically significant (according to Investigator's judgement) laboratory out of range values. The abnormal lab test can be neglected if its cause is evident and of no clinical relevance
- Acute disease and/or fever (≥38°C measured by the oral route) at the time of test article administration. Vaccine administration can be postponed until the febrile episode is over.
- Recent vaccination (e.g., vaccine administration within 2 weeks or 4 weeks [live attenuated]) or evidence that a vaccine will be required during the study period (e.g., planned travel).
- Pregnant or plan to become pregnant during the study period.
- Breastfeeding.
- Women highly exposed to children less than 5 years of age will be excluded to reduce risk of RSV infection, including mothers of young children, paediatric nurses, personnel of day nursery.
- Previous participation in a RSV vaccine study.
- Any other significant finding that would increase, according to the Investigator, the risk of having an adverse outcome from participating in the study.
- History of (suspected) hypersensitivity reaction that could be triggered by any component of the vaccine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Placebo-controlled, Double-blind, Phase 1, Dose-escalating Study to Evaluate the Safety and Immunogenicity of a Synthetic Virus Like Particle (SVLP) Vaccine Against Respiratory Syncytial Virus (RSV)
The primary and secondary objectives of this Phase 1 study are respectively to assess the safety and the immunogenicity of two administrations of the RSV vaccine candidate at three different doses.
The study has a randomized, placebo-controlled, double-blind, sequential, parallel cohorts, dose-escalation (three dosages) design. Each of the three cohorts (N=20 subjects per cohort, total of 60 subjects) will receive placebo (n=5), or a low (15 µg, n=15), intermediate (50 µg, n=15) or high dosage (150 µg, n=15) of candidate vaccine, on two occasions (Day 0 and Day 56). Subjects will be healthy adult women aged between 18 and 45 years.
Read more
There will be two phases: an active treatment phase from Day 0 to Month 3, and a follow-up phase from Month 3 + 1 day to Month 12.
During the active phase, subjects will complete diary cards to record oral temperature (daily), solicited local and general adverse events (AEs) and unsolicited AEs for 7 days after each administration. Unsolicited AEs will be recorded up to Day 28 post-each administration. Serious adverse events (SAEs) and adverse events of specific interest (AESI) will be recorded throughout the duration of the active phase. Subjects will visit the clinical site for safety monitoring on Days 1, 7 and 28 following each administration.
Blood will be drawn at a screening visit and the safety test data will be available just before 1st administration. The screening set includes markers of infection with hepatitis B virus, hepatitis C virus and human immunodeficiency virus. A serum sample will be taken for detection of pregnancy. At the next scheduled time points, pregnancy will be screened in a urine sample. Laboratory safety parameters will be examined further at Days 0, 1, 7, 28, 56, 57, 63 and 84.
During the follow-up phase, visits for safety monitoring are scheduled at Months 6, 9 and 12 post-1st administration. SAEs and AESI will be recorded at each visit.
Humoral immunity will be measured on Days 0, 28, 56, Month 3, Month 6, Month 9 and Month 12. Cellular immunity will be measured on Days 0, 7, 28, 56, 63 and 84.
The duration of the study for each subject will be approximately 13 months. The total duration of the study will be approximately 18 months.
Read the detailed description
Virometix designed and developed a candidate vaccine coded V-306 based on synthetic virus like particles (SVLP) that present the neutralizing Palivizumab epitope of the antigenic site II region of the F-protein (FsII). V-306 has been evaluated in cotton rats, mice and rabbits for safety and immunogenicity. Strong immunogenicity was demonstrated in mice and rabbits by ELISA and RSV A and B neutralization. Full protection with no vaccine-associated enhanced respiratory disease (VAERD) was demonstrated in a validated mouse challenge model. Reduction of the viral load with no VAERD was also shown in the cotton rat challenge model.
The primary objective of the first-in-human Phase 1 study is to assess the safety of two administrations of the RSV vaccine candidate at three different dosages of V-306.
The secondary objective is to assess the immunogenicity of two administrations of the RSV vaccine candidate at three different dosages of V-306.
The study has a randomized, placebo-controlled, double-blind, sequential, parallel cohorts, dose-escalation (three dosages) design. It will be conducted in one centre. Each of the three cohorts (N=20 subjects per cohort, total of 60 subjects) will receive placebo (n=5), or a low (15 µg/administration, n=15), intermediate (50 µg/administration, n=15) or high dosage (150 µg/administration, n=15) of candidate vaccine, on two occasions (Day 0 and Day 56). Subjects will be healthy adult women aged between 18 and 45 years. The enrolment schedule with sentinel dosing will be the same in each cohort. After each administration, the subject will be observed in the clinical trial centre for 120 minutes, before being discharged.
The study will be in two phases: (1) an active treatment phase from Day 0 to Month 3, i.e. one month post 2nd administration, with unblinding and primary analysis of data collected up to Month 3, and (2) a follow-up phase from Month 3 + 1 day to Month 12 post-1st administration for safety and immunogenicity. The sponsor will be unblinded at Month 3, while the clinical site and laboratory will remain blinded during the whole study.
During the active phase, subjects will complete diary cards to record oral temperature (daily), solicited local and general adverse events (AEs) and unsolicited AEs for 7 days after each administration. Unsolicited AEs will be recorded up to Day 28 post-each administration. Serious adverse events (SAEs) and adverse events of specific interest (AESI) will be recorded throughout the duration of the active phase. Subjects will visit the clinical site for safety monitoring on Days 1, 7 and 28 following each administration. A time window will be defined for each visit.
Blood will be drawn at a screening visit (up to 14 days before Day 0 for lab safety analyses and up to 2 months before Day 0 for serology analyses) and the safety test data will be available just before 1st administration. The screening set includes markers of infection with hepatitis B virus, hepatitis C virus and human immunodeficiency virus. These data will be part of the baseline health status of each subject. A serum sample will be taken for detection of pregnancy. At the next scheduled time points, pregnancy will be screened in a urine sample and if positive will be confirmed by blood analysis. Laboratory safety parameters will be examined further at Days 0, 1, 7, 28, 56, 57, 63 and 84.
During the follow-up phase, visits for safety monitoring are scheduled at Months 6, 9 and 12 post-1st administration. SAEs and AESI will be recorded at each visit.
Humoral immunity will be measured on Days 0, 28, 56, Month 3, Month 6, Month 9 and Month 12. Months 6, 9 and 12 aim to evaluate the persistence of the humoral response.
Cellular immunity will be measured on Days 0, 7, 28, 56, 63 and 84. Data collection will use an electronic Case Report Form (eCRF). The duration of the study for each subject will be approximately 13 months. The total duration of the study will be approximately 18 months.
- Being tested
- V-306 candidate vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-306 candidate vaccineBiological
Each V-306 monomer consists of the following elements:
- A Lipopeptide Building Block that contains an optimized, artificially designed coiled-coil domain, which self-assembles into highly stable trimers.
- A 'universal' T-helper epitope fused at the C-terminus of the coiled-coil domain.
- A lipid component di-palmitoyl-S-glyceryl cysteine (Pam2C), fused at the N-terminus.
- A mimetic of the Palivizumab epitope, referred to RSV F-protein site II antigen mimetic (FsIIm), which is coupled near the C-terminus of the Lipopeptide Building Block via a short maleimide-PEG-oxime linker.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0.5 mL of diluent (phosphate buffer) Receives: Biological: V-306 candidate vaccine |
| V-306 low dose | Experimental | V-306 at 15 µg Receives: Biological: V-306 candidate vaccine |
| V-306 intermediate dose | Experimental | V-306 at 50 µg Receives: Biological: V-306 candidate vaccine |
| V-306 high dose | Experimental | V-306 at 150 µg Receives: Biological: V-306 candidate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited local and general adverse events
Number and percentage of subjects reporting solicited local and general AEs reported on diary card during 7 days post-each administration in the placebo group and in the three vaccine cohorts. Local solicited symptoms are pain, induration, erythema, and swelling at administration site. General solicited symptoms are headache, fatigue, body temperature (measured orally) and generalized myalgia.
Measured: During 7 days post-each administration
Adverse events of special interest (AESI)
Number and percentage of subjects reporting AESI in the placebo group and in the three vaccine cohorts. Monitoring of AESI will include lower respiratory tract infection (LRTI) and respiratory events such as dyspnoea, wheezing, cough, other asthmatic symptoms and increased sputum production.
Measured: Day 0 to Month 12
Serious adverse events
Number and percentage of subjects reporting serious adverse events in the placebo group and in the three vaccine cohorts.
Measured: Day 0 to Month 12
Secondary outcomes (1)
Humoral immune response
RSV micro-neutralization titers against RSV A and B.
Measured: Day 0 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start7 Sep 2020
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Bronchiolitis Due to Respiratory Syncytial VirusStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized, placebo-controlled, double-blind, sequential, parallel cohorts, dose-escalation (three dosages) study in one centre.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virometix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Center of Vaccinology, Ghent, Belgium (CEVAC), Expert Clinical Services Organization, Brussels, Belgium (ECSOR)
- Responsible party
- Sponsor
- Investigators
- Anna Sumeray, MD, Study director, Virometix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519073
- Sponsor's protocol ID
- VMXRSV306-001
- Status last verified
- Mar 2022
- First submitted
- 15 Aug 2020
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Double-blind, Phase 1, Dose-escalating Study to Evaluate the Safety and Immunogenicity of a Synthetic Virus Like Particle (SVLP) Vaccine Against Respiratory Syncytial Virus (RSV)
- ClinicalTrials.gov ID
- NCT04519073
- Acronym / sponsor ID
- VMXRSV306-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- VirometixIndustry (pharma, biotech, devices)
- Collaborators
- Center of Vaccinology, Ghent, Belgium (CEVAC), Expert Clinical Services Organization, Brussels, Belgium (ECSOR)
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 19 Aug 2020 (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 primary and secondary objectives of this Phase 1 study are respectively to assess the safety and the immunogenicity of two administrations of the RSV vaccine candidate at three different doses.
The study has a randomized, placebo-controlled, double-blind, sequential, parallel cohorts, dose-escalation (three dosages) design. Each of the three cohorts (N=20 subjects per cohort, total of 60 subjects) will receive placebo (n=5), or a low (15 µg, n=15), intermediate (50 µg, n=15) or high dosage (150 µg, n=15) of candidate vaccine, on two occasions (Day 0 and Day 56). Subjects will be healthy adult women aged between 18 and 45 years.
There will be two phases: an active treatment phase from Day 0 to Month 3, and a follow-up phase from Month 3 + 1 day to Month 12.
During the active phase, subjects will complete diary cards to record oral temperature (daily), solicited local and general adverse events (AEs) and unsolicited AEs for 7 days after each administration. Unsolicited AEs will be recorded up to Day 28 post-each administration. Serious adverse events (SAEs) and adverse events of specific interest (AESI) will be recorded throughout the duration of the active phase. Subjects will visit the clinical site for safety monitoring on Days 1, 7 and 28 following each administration.
Blood will be drawn at a screening visit and the safety test data will be available just before 1st administration. The screening set includes markers of infection with hepatitis B virus, hepatitis C virus and human immunodeficiency virus. A serum sample will be taken for detection of pregnancy. At the next scheduled time points, pregnancy will be screened in a urine sample. Laboratory safety parameters will be examined further at Days 0, 1, 7, 28, 56, 57, 63 and 84.
During the follow-up phase, visits for safety monitoring are scheduled at Months 6, 9 and 12 post-1st administration. SAEs and AESI will be recorded at each visit.
Humoral immunity will be measured on Days 0, 28, 56, Month 3, Month 6, Month 9 and Month 12. Cellular immunity will be measured on Days 0, 7, 28, 56, 63 and 84.
The duration of the study for each subject will be approximately 13 months. The total duration of the study will be approximately 18 months.
Detailed description
Virometix designed and developed a candidate vaccine coded V-306 based on synthetic virus like particles (SVLP) that present the neutralizing Palivizumab epitope of the antigenic site II region of the F-protein (FsII). V-306 has been evaluated in cotton rats, mice and rabbits for safety and immunogenicity. Strong immunogenicity was demonstrated in mice and rabbits by ELISA and RSV A and B neutralization. Full protection with no vaccine-associated enhanced respiratory disease (VAERD) was demonstrated in a validated mouse challenge model. Reduction of the viral load with no VAERD was also shown in the cotton rat challenge model.
The primary objective of the first-in-human Phase 1 study is to assess the safety of two administrations of the RSV vaccine candidate at three different dosages of V-306.
The secondary objective is to assess the immunogenicity of two administrations of the RSV vaccine candidate at three different dosages of V-306.
The study has a randomized, placebo-controlled, double-blind, sequential, parallel cohorts, dose-escalation (three dosages) design. It will be conducted in one centre. Each of the three cohorts (N=20 subjects per cohort, total of 60 subjects) will receive placebo (n=5), or a low (15 µg/administration, n=15), intermediate (50 µg/administration, n=15) or high dosage (150 µg/administration, n=15) of candidate vaccine, on two occasions (Day 0 and Day 56). Subjects will be healthy adult women aged between 18 and 45 years. The enrolment schedule with sentinel dosing will be the same in each cohort. After each administration, the subject will be observed in the clinical trial centre for 120 minutes, before being discharged.
The study will be in two phases: (1) an active treatment phase from Day 0 to Month 3, i.e. one month post 2nd administration, with unblinding and primary analysis of data collected up to Month 3, and (2) a follow-up phase from Month 3 + 1 day to Month 12 post-1st administration for safety and immunogenicity. The sponsor will be unblinded at Month 3, while the clinical site and laboratory will remain blinded during the whole study.
During the active phase, subjects will complete diary cards to record oral temperature (daily), solicited local and general adverse events (AEs) and unsolicited AEs for 7 days after each administration. Unsolicited AEs will be recorded up to Day 28 post-each administration. Serious adverse events (SAEs) and adverse events of specific interest (AESI) will be recorded throughout the duration of the active phase. Subjects will visit the clinical site for safety monitoring on Days 1, 7 and 28 following each administration. A time window will be defined for each visit.
Blood will be drawn at a screening visit (up to 14 days before Day 0 for lab safety analyses and up to 2 months before Day 0 for serology analyses) and the safety test data will be available just before 1st administration. The screening set includes markers of infection with hepatitis B virus, hepatitis C virus and human immunodeficiency virus. These data will be part of the baseline health status of each subject. A serum sample will be taken for detection of pregnancy. At the next scheduled time points, pregnancy will be screened in a urine sample and if positive will be confirmed by blood analysis. Laboratory safety parameters will be examined further at Days 0, 1, 7, 28, 56, 57, 63 and 84.
During the follow-up phase, visits for safety monitoring are scheduled at Months 6, 9 and 12 post-1st administration. SAEs and AESI will be recorded at each visit.
Humoral immunity will be measured on Days 0, 28, 56, Month 3, Month 6, Month 9 and Month 12. Months 6, 9 and 12 aim to evaluate the persistence of the humoral response.
Cellular immunity will be measured on Days 0, 7, 28, 56, 63 and 84. Data collection will use an electronic Case Report Form (eCRF). The duration of the study for each subject will be approximately 13 months. The total duration of the study will be approximately 18 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized, placebo-controlled, double-blind, sequential, parallel cohorts, dose-escalation (three dosages) study in one centre.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: V-306 candidate vaccine0.5 mL of diluent (phosphate buffer) |
| V-306 low dose | Experimental | Biological: V-306 candidate vaccineV-306 at 15 µg |
| V-306 intermediate dose | Experimental | Biological: V-306 candidate vaccineV-306 at 50 µg |
| V-306 high dose | Experimental | Biological: V-306 candidate vaccineV-306 at 150 µg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent.
- Healthy women aged between 18-45 years.
- No evidence of disease based on medical history, physical examination, vital signs (blood pressure, heart rate, body temperature and respiratory rate), laboratory safety parameters and clinical judgement.
- Not pregnant and committed to not becoming pregnant during the whole study period. Committed to use adequate and effective contraception means in accordance with the Clinical Trial Facilitation Group (CTFG) criteria.
- The subjects must have used adequate and effective contraception means (CTFG criteria) for at least 60 days prior to the 1st administration.
Key exclusion criteria (18 listed)
- Presence of serologic markers of acute or chronic Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBsAg and anti-HBc) and Hepatitis C Virus (anti-HCV) infection(s).
- As judged by the Investigator, any clinically significant disease related to the cardiovascular (CV), gastrointestinal (GI) or central nervous system (CNS).
- Any chronic disease, or history of significant disease that might interfere with the trial's conduct or completion. Some conditions may be accepted if stabilised, e.g. hypertension.
- An active respiratory disease or symptoms thereof (chronic obstructive pulmonary disease, asthma, asthmatic bronchitis, dyspnoea, wheezing, severe allergy) requiring medication, or history of such disease.
- Personal history of active or past autoimmune disease
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 |
|---|---|---|
| V-306 candidate vaccineEach V-306 monomer consists of the following elements: 1. A Lipopeptide Building Block that contains an optimized, artificially designed coiled-coil domain, which self-assembles into highly stable trimers. 2. A 'universal' T-helper epitope fused at the C-terminus of the coiled-coil domain. 3. A lipid component di-palmitoyl-S-glyceryl cysteine (Pam2C), fused at the N-terminus. 4. A mimetic of the Palivizumab epitope, referred to RSV F-protein site II antigen mimetic (FsIIm), which is coupled near the C-terminus of the Lipopeptide Building Block via a short maleimide-PEG-oxime linker. | Biological | Placebo, V-306 high dose, V-306 intermediate dose, V-306 low dose |
Primary outcome
Solicited local and general adverse events
Time frame: During 7 days post-each administration
Number and percentage of subjects reporting solicited local and general AEs reported on diary card during 7 days post-each administration in the placebo group and in the three vaccine cohorts. Local solicited symptoms are pain, induration, erythema, and swelling at administration site. General solicited symptoms are headache, fatigue, body temperature (measured orally) and generalized myalgia.
Adverse events of special interest (AESI)
Time frame: Day 0 to Month 12
Number and percentage of subjects reporting AESI in the placebo group and in the three vaccine cohorts. Monitoring of AESI will include lower respiratory tract infection (LRTI) and respiratory events such as dyspnoea, wheezing, cough, other asthmatic symptoms and increased sputum production.
Serious adverse events
Time frame: Day 0 to Month 12
Number and percentage of subjects reporting serious adverse events in the placebo group and in the three vaccine cohorts.
1 secondary outcome
Humoral immune response
Time frame: Day 0 to Month 12
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 7 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Anna Sumeray, MD study director
Virometix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing V-306 candidate vaccine in people with Acute Bronchiolitis Due to Respiratory Syncytial Virus, run by Virometix 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 6 inclusion and 18 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 7 Mar 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Solicited local and general adverse events (time frame: During 7 days post-each administration). 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 7 Mar 2022.