DenguePhase 1NCT04935801
A Phase-I Study of a Nanoparticle-based Peptide Vaccine Against Dengue Virus
A Phase 1 study testing LD PepGNP-Dengue and HD PepGNP-Dengue in people with Dengue, run by Gylden Pharma Ltd at 1 site in Switzerland.
Trial summary
This trial aims to test the safety of 2 doses of a T-cell priming specific cocktail of Dengue viruses peptides representing all 4 DENV serotypes and mounted on a gold nanoparticle. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue
- What is being tested?
- LD PepGNP-Dengue and HD PepGNP-Dengue
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Aug 2021to 15 Sep 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 45 years on the day of inclusion
- Participant signed informed consent
- Residing in Switzerland
Who cannot join
- Participant is pregnant, lactating, or of childbearing potential
- Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (excepting influenza vaccination, which may be received up to 2 weeks before first study vaccine) or planned receipt of any vaccine in the 4 weeks following each trial vaccination.
- Previous vaccination against Japanese encephalitis (JE), Yellow Fever (YF), or any dengue virus vaccine (monovalent or tetravalent) at any time in the past with either a trial vaccine or another vaccine (commercial or investigational) based on medical history
- Self-reported or documented history of flavivirus (FV) infection (e.g. DENV, YF, WNV, JE, TBE), confirmed either clinically or serologically
- Receipt of immunoglobulins, blood or blood-derived products in the past 3 months
Show all 21Show fewer
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy
- Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B natural infection (HBcAb positive serology), or hepatitis C
- Previous residence for more than 12 months in, or travel in the last 30 days to FV-endemic regions (excluding TBE and WNV)
- At high risk for dengue infection during the trial
- Known systemic hypersensitivity to any of the vaccine components (e.g. gold), or history of a life-threatening reaction to vaccines, or to a vaccine containing any of the same substances
- Current alcohol abuse or drug addiction (reported or suspected)
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Thrombocytopenia or any coagulation disorder
- Identified as an Investigator or employee of the Investigator or study centre with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study (i.e. in the employment of the Tropivac clinic or DFRI unit at Unisanté).
- Refusal to be informed in the event that relevant results concerning the participant's health are revealed.
- The following events constitute contraindications to the administration of the investigational product on the day of planned vaccination.
- The participant must be followed until resolution of the event as with any medical event and may be considered for vaccination at a later date (maximum 14 days later) or withdrawn at the discretion of the Investigator. Delays due to these events do not constitute a protocol deviation.
- Temperature of >37.5°C at the time of vaccination
- Acute disease at the time of vaccination
- If there is a clinical/epidemiological suspicion of COVID-19 (according to the clinician's judgement), the participant will be asked to first take a PCR/rapid test for SARS-CoV2, and the vaccination will be delayed until the result comes back negative and the symptoms have resolved.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Center for Primary Care and Public Health, (Unisante)
Lausanne, Canton of Vaud, 1004
About this study
Official title: naNO-DENGUE: A Phase I Double-blind, Randomized, Vehicle-controlled, Dose-finding, Safety Study of a Synthetic Nanoparticle-based, T-Cell Priming Peptide Vaccine Against Dengue Virus in Healthy Adults in Switzerland
This trial aims to test the safety of 2 doses of a T-cell priming specific cocktail of Dengue viruses peptides representing all 4 DENV serotypes and mounted on a gold nanoparticle.
NOTE: This is the master protocol of a prospective 2-stage adaptive trial, which aims to add and test a Coronavirus vaccine candidate as well, in an identical trial design.
Read the detailed description
A critical limitation for Dengue vaccines is their association with antibody-dependent enhancement, where poorly formed immune responses predispose the individual to severe disease during a second infection. Thus, a more targeted vaccine (inducing / priming T cells and not producing antibodies) could be the best alternative and most successful preventive method in the fight against severe manifestations of the disease.
Nanoparticle antigen delivery systems have been developed to enrich specific targeting of immune receptors. These carrier systems are designed to facilitate antigen uptake and processing by antigen presenting cells (APCs), as well as to control antigen release and protect them from premature proteolytic degradation. This more targeted response also allows us to reduce the effective antigen dose (to nanomoles) and mimic a replicating infection with zero risk of developing the infectious disease.
The hypotheses are listed below:
- During the COVID-19 pandemic, Dengue virus disease is likely to cause significant diagnostic confusion and it risks further progression due to disrupted control measures.
- As the SARS-CoV-2 pandemic devastates the world, the need for highly efficient and scalable vaccines is desperately required.
- Peptide vaccines have high potential as a rapidly scalable modular platform for emerging diseases requiring targeted immunological responses.
- Dengue viruses and Coronaviruses (e.g. COVID-19 causing viruses) are particularly well suited to this approach.
For this initial naNO-DENGUE part of the trial, the objectives are as follows:
Primary:
To evaluate the safety and reactogenicity of two intradermal injections of two different doses of the investigational Dengue peptide T cell inducing vaccine (PepGNP-Dengue) administered to healthy volunteers as a:
- candidate vaccine for the prevention of Dengue
- proof-of-concept for a rapidly scalable modular peptide vaccine platform, which will be followed by a COVID-19 construct after interim analyses.
Secondary:
- To assess the evidence of a T-cell mediated immune response as a surrogate of protection against severe dengue disease using a novel peptide set-point vaccine in healthy adults.
- To check the absence of an antibody mediated response
For naNO-DENGUE, a total of 26 eligible participants will be randomized into the following groups:
- Group 1 (n=13): 10 Low Dose (LD) PepGNP-Dengue (2.5 nmol) + 3 Comparator
- Group 2 (n=13): 10 High Dose (HD) PepGNP-Dengue (7.5 nmol) + 3 Comparator, Thus, 20/26 vaccine vera and 6/26 Comparator controls. Allocations of vaccine vera vs Comparator for each group are double-blinded. Each arm will be staggered into a "Pioneer" group (3/13 participants) followed a week later after a safety review by the remaining 10/13 "Followers".
This is the master protocol for a 2-stage study investigating the safety of 2 vaccines from a T Cell priming vaccine platform for emerging diseases:
Stage 1: naNO-DENGUE A Phase-I study of a nanoparticle-based peptide vaccine against Dengue (Master protocol) Stage 2: naNO-COVID A Phase-I study of a nanoparticle-based peptide vaccine against SARS-CoV2 (Sub-protocol)
- Conditions
- Dengue
- Being tested
- LD vehicle-GNP, LD PepGNP-Dengue, HD vehicle-GNP, HD PepGNP-Dengue
- Keywords
- Dengue, peptide vaccine, T-cell, nanoparticle, Dengue vaccine, T cell vaccine
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LD vehicle-GNPBiological
Two intradermal injections in the upper arm spaced 21 days apart
LD PepGNP-DengueBiological
Two intradermal injections in the upper arm spaced 21 days apart
HD vehicle-GNPBiological
Two intradermal injections in the upper arm spaced 21 days apart
HD PepGNP-DengueBiological
Two intradermal injections in the upper arm spaced 21 days apart
| Study group | Role | What they receive |
|---|---|---|
| LD Vehicle_GNP | Sham comparator | Low dose (LD) comparator (2.5nmol) - gold nanoparticle (14.8ug) without peptides Receives: Biological: LD vehicle-GNP |
| LD PepGNP-Dengue | Experimental | Low dose (LD) peptide vaccine (2.5nmol) - gold nanoparticle (14.8ug) plus peptides Receives: Biological: LD PepGNP-Dengue |
| HD vehicle-GNP | Sham comparator | High dose (HD) comparator (7.5nmol) - gold nanoparticle (44.5ug) without peptides Receives: Biological: HD vehicle-GNP |
| HD PepGNP-Dengue | Experimental | High dose (HD) peptide vaccine (7.5nmol) - gold nanoparticle (44.5ug) plus peptides Receives: Biological: HD PepGNP-Dengue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Solicited local & Systemic AEs
Number of volunteers overall and in each dose group with local or systemic vaccine reactogenicity, based on evaluation of solicited adverse events (AEs) recorded on subject memory aids or during clinical assessments
Measured: Through 14 days after prime or boost vaccination
Safety: Unsolicited AEs
Number of volunteers overall and in each dose group with unsolicited vaccine-associated adverse events (AEs) in each dose group
Measured: Study Days 0-180 or through termination visit, if terminated early
Safety: SAEs
Number of volunteers overall and in each dose group with vaccine-associated serious adverse events (SAEs)
Measured: Study Days 0-180 or through termination visit, if terminated early
Safety: Adverse Events of Special Interest (AESI)
Number of volunteers overall and in each dose group with vaccine-associated adverse events of special interest (AESIs)
Measured: Study Days 0-180 or through termination visit, if terminated early
Safety: Haemoglobin blood levels measurement
Number of volunteers overall and in each dose group with abnormal results in blood test regarding haemoglobin (Hb) measured in g/l.
Reference range (from "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" - https://www.fda.gov/media/73679/download):
Female 117-157 g/l / Male: 133-177 g/l)
Anaemia reported as:
GRADE 1: <117 - 100 g/l GRADE 2: <100 - 80 g/l GRADE 3: < 80 g/l
Measured: Screening, Days 7, 14, 28, 35
Safety: Alkaline Phosphate Blood levels measurement
Number of volunteers overall and in each dose group with abnormal results in blood test regarding Alkaline phosphate measured in U/L.
Reference ranges (from "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" - https://www.fda.gov/media/73679/download): 36-120 U/L
Elevation in Alkaline phosphate reported as:
GRADE 1: 121 - 300 U/L GRADE 2: >300 - 600 U/L GRADE 3: >600 U/L
Measured: Screening, Days 7, 14, 28, 35
Secondary outcomes (2)
Immunogenicity: Proportion of participants with CD8-T cell specific to PepGNP-Dengue
Frequency of CD8+ T cells specific peptides by cytometry ex vivo, using staining with dengue specific dextramers and activation-induced markers (AIM)
Measured: Study Days 0-180 or through termination visit, if terminated early
Proportion of participants becoming seropositive (antibodies against Dengue virus)
Dengue serology rapid test: Serology to detect antibodies against the four dengue serotypes by rapid test
Anti-DENV2 Ig: Serology to detect antibodies against natural DENV (lysate or inactivated viral particles), by ELISA
Measured: Study Days 0-180 or through termination visit, if terminated early
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start2 Aug 2021
- Primary completion11 Mar 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gylden Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, University of Lausanne Hospitals
- Responsible party
- Sponsor
- Investigators
- Blaise Genton, Prof, Principal investigator, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935801
- Sponsor's protocol ID
- naNO-DENGUE
- Status last verified
- Nov 2022
- First submitted
- 9 Jun 2021
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Investigators will be involved in writing and/or reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study. Apart from obvious flaws to the conduct of the study, which may preclude data publication, safety and efficacy data will be published under the supervision and authorization of PI and Sponsor. Publication will include as much individual level data as possible to ensure reproducibility of results without compromising participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- naNO-DENGUE: A Phase I Double-blind, Randomized, Vehicle-controlled, Dose-finding, Safety Study of a Synthetic Nanoparticle-based, T-Cell Priming Peptide Vaccine Against Dengue Virus in Healthy Adults in Switzerland
- ClinicalTrials.gov ID
- NCT04935801
- Acronym / sponsor ID
- naNO-DENGUE
- Conditions
- Dengue
- Keywords
- Dengue, peptide vaccine, T-cell, nanoparticle, Dengue vaccine, T cell vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Gylden Pharma LtdIndustry (pharma, biotech, devices)
- Collaborators
- Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, University of Lausanne Hospitals
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 23 Jun 2021 (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.
This trial aims to test the safety of 2 doses of a T-cell priming specific cocktail of Dengue viruses peptides representing all 4 DENV serotypes and mounted on a gold nanoparticle.
NOTE: This is the master protocol of a prospective 2-stage adaptive trial, which aims to add and test a Coronavirus vaccine candidate as well, in an identical trial design.
Detailed description
A critical limitation for Dengue vaccines is their association with antibody-dependent enhancement, where poorly formed immune responses predispose the individual to severe disease during a second infection. Thus, a more targeted vaccine (inducing / priming T cells and not producing antibodies) could be the best alternative and most successful preventive method in the fight against severe manifestations of the disease.
Nanoparticle antigen delivery systems have been developed to enrich specific targeting of immune receptors. These carrier systems are designed to facilitate antigen uptake and processing by antigen presenting cells (APCs), as well as to control antigen release and protect them from premature proteolytic degradation. This more targeted response also allows us to reduce the effective antigen dose (to nanomoles) and mimic a replicating infection with zero risk of developing the infectious disease.
The hypotheses are listed below:
- During the COVID-19 pandemic, Dengue virus disease is likely to cause significant diagnostic confusion and it risks further progression due to disrupted control measures.
- As the SARS-CoV-2 pandemic devastates the world, the need for highly efficient and scalable vaccines is desperately required.
- Peptide vaccines have high potential as a rapidly scalable modular platform for emerging diseases requiring targeted immunological responses.
- Dengue viruses and Coronaviruses (e.g. COVID-19 causing viruses) are particularly well suited to this approach.
For this initial naNO-DENGUE part of the trial, the objectives are as follows:
Primary:
To evaluate the safety and reactogenicity of two intradermal injections of two different doses of the investigational Dengue peptide T cell inducing vaccine (PepGNP-Dengue) administered to healthy volunteers as a:
- candidate vaccine for the prevention of Dengue
- proof-of-concept for a rapidly scalable modular peptide vaccine platform, which will be followed by a COVID-19 construct after interim analyses.
Secondary:
- To assess the evidence of a T-cell mediated immune response as a surrogate of protection against severe dengue disease using a novel peptide set-point vaccine in healthy adults.
- To check the absence of an antibody mediated response
For naNO-DENGUE, a total of 26 eligible participants will be randomized into the following groups:
- Group 1 (n=13): 10 Low Dose (LD) PepGNP-Dengue (2.5 nmol) + 3 Comparator
- Group 2 (n=13): 10 High Dose (HD) PepGNP-Dengue (7.5 nmol) + 3 Comparator, Thus, 20/26 vaccine vera and 6/26 Comparator controls. Allocations of vaccine vera vs Comparator for each group are double-blinded. Each arm will be staggered into a "Pioneer" group (3/13 participants) followed a week later after a safety review by the remaining 10/13 "Followers".
This is the master protocol for a 2-stage study investigating the safety of 2 vaccines from a T Cell priming vaccine platform for emerging diseases:
Stage 1: naNO-DENGUE A Phase-I study of a nanoparticle-based peptide vaccine against Dengue (Master protocol) Stage 2: naNO-COVID A Phase-I study of a nanoparticle-based peptide vaccine against SARS-CoV2 (Sub-protocol)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LD Vehicle_GNP | Sham comparator | Biological: LD vehicle-GNPLow dose (LD) comparator (2.5nmol) - gold nanoparticle (14.8ug) without peptides |
| LD PepGNP-Dengue | Experimental | Biological: LD PepGNP-DengueLow dose (LD) peptide vaccine (2.5nmol) - gold nanoparticle (14.8ug) plus peptides |
| HD vehicle-GNP | Sham comparator | Biological: HD vehicle-GNPHigh dose (HD) comparator (7.5nmol) - gold nanoparticle (44.5ug) without peptides |
| HD PepGNP-Dengue | Experimental | Biological: HD PepGNP-DengueHigh dose (HD) peptide vaccine (7.5nmol) - gold nanoparticle (44.5ug) plus peptides |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18 to 45 years on the day of inclusion
- Participant signed informed consent
- Residing in Switzerland
Key exclusion criteria (21 listed)
- Participant is pregnant, lactating, or of childbearing potential
- Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (excepting influenza vaccination, which may be received up to 2 weeks before first study vaccine) or planned receipt of any vaccine in the 4 weeks following each trial vaccination.
- Previous vaccination against Japanese encephalitis (JE), Yellow Fever (YF), or any dengue virus vaccine (monovalent or tetravalent) at any time in the past with either a trial vaccine or another vaccine (commercial or investigational) based on medical history
- Self-reported or documented history of flavivirus (FV) infection (e.g. DENV, YF, WNV, JE, TBE), confirmed either clinically or serologically
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 |
|---|---|---|
| LD vehicle-GNPTwo intradermal injections in the upper arm spaced 21 days apart | Biological | LD Vehicle_GNP |
| LD PepGNP-DengueTwo intradermal injections in the upper arm spaced 21 days apart | Biological | LD PepGNP-Dengue |
| HD vehicle-GNPTwo intradermal injections in the upper arm spaced 21 days apart | Biological | HD vehicle-GNP |
| HD PepGNP-DengueTwo intradermal injections in the upper arm spaced 21 days apart | Biological | HD PepGNP-Dengue |
Primary outcome
Safety: Solicited local & Systemic AEs
Time frame: Through 14 days after prime or boost vaccination
Number of volunteers overall and in each dose group with local or systemic vaccine reactogenicity, based on evaluation of solicited adverse events (AEs) recorded on subject memory aids or during clinical assessments
Safety: Unsolicited AEs
Time frame: Study Days 0-180 or through termination visit, if terminated early
Number of volunteers overall and in each dose group with unsolicited vaccine-associated adverse events (AEs) in each dose group
Safety: SAEs
Time frame: Study Days 0-180 or through termination visit, if terminated early
Number of volunteers overall and in each dose group with vaccine-associated serious adverse events (SAEs)
Safety: Adverse Events of Special Interest (AESI)
Time frame: Study Days 0-180 or through termination visit, if terminated early
Number of volunteers overall and in each dose group with vaccine-associated adverse events of special interest (AESIs)
Safety: Haemoglobin blood levels measurement
Time frame: Screening, Days 7, 14, 28, 35
Number of volunteers overall and in each dose group with abnormal results in blood test regarding haemoglobin (Hb) measured in g/l. Reference range (from "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" - https://www.fda.gov/media/73679/download): Female 117-157 g/l / Male: 133-177 g/l) Anaemia reported as: GRADE 1: <117 - 100 g/l GRADE 2: <100 - 80 g/l GRADE 3: < 80 g/l
Safety: Alkaline Phosphate Blood levels measurement
Time frame: Screening, Days 7, 14, 28, 35
Number of volunteers overall and in each dose group with abnormal results in blood test regarding Alkaline phosphate measured in U/L. Reference ranges (from "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" - https://www.fda.gov/media/73679/download): 36-120 U/L Elevation in Alkaline phosphate reported as: GRADE 1: 121 - 300 U/L GRADE 2: >300 - 600 U/L GRADE 3: >600 U/L
2 secondary outcomes
Immunogenicity: Proportion of participants with CD8-T cell specific to PepGNP-Dengue
Time frame: Study Days 0-180 or through termination visit, if terminated early
Proportion of participants becoming seropositive (antibodies against Dengue virus)
Time frame: Study Days 0-180 or through termination visit, if terminated early
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 5 Dec 2022.
- Individual participant dataSharing planned: Yes. The Investigators will be involved in writing and/or reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study. Apart from obvious flaws to the conduct of the study, which may preclude data publication, safety and efficacy data will be published under the supervision and authorization of PI and Sponsor. Publication will include as much individual level data as possible to ensure reproducibility of results without compromising participant privacy.
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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.
Blaise Genton, Prof principal investigator
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
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 LD PepGNP-Dengue and HD PepGNP-Dengue in people with Dengue, run by Gylden Pharma Ltd at 1 site in Switzerland.
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 3 inclusion and 21 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 5 Dec 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 Switzerland. 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?
Safety: Solicited local & Systemic AEs (time frame: Through 14 days after prime or boost vaccination). The study lists 6 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 5 Dec 2022.