CoronavirusPhase 1NCT05113862
A Phase-I Study of a Nanoparticle-based Peptide Vaccine Against SARS-CoV-2
A Phase 1 study testing LD PepGNP-Covid19 and HD PepGNP-Covid19 in people with Coronavirus and SARS-CoV-2 Infection, run by Gylden Pharma Ltd at 1 site in Switzerland.
Trial summary
This trial is Stage 2 of a 2-part adaptive trial. The study aims to investigate the safety of 2 doses of a T-cell priming specific cocktail of Coronaviruses peptides 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
- Coronavirus, SARS-CoV-2 Infection, COVID-19
- What is being tested?
- LD PepGNP-Covid19 and HD PepGNP-Covid19
- 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
- 10 Jan 2022to 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 (including vaccine against COVID) in the 4 weeks preceding the first trial vaccination (excluding influenza vaccination which may be received 2 weeks prior to the first vaccination), or planned receipt of any vaccine in the 4 weeks following each trial vaccination.
- Positive SARS-CoV2 test in the 4 weeks preceding the first trial vaccination.
- Receipt of immunoglobins, blood or blood-derived products in the past 3 months.
- Known, or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy.
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- Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B natural infection, (HBcAb positive serology) or hepatitis C.
- Known systemic hypersensitivity to any of the vaccine components (e.g gold,) or history of a life-threatening reaction to vaccines.
- 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 Unisante).
- 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 (defined as the presence of a moderate or severe illness with or without fever according to investigator's judgment. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature of ≤ 37.5°C).
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: A Phase-I, Double-blind, Randomized, Vehicle-controlled, Dose-finding, Safety Study of a Synthetic Nanoparticle-based, T Cell Priming Peptide Vaccine Against SARS-CoV-2 in Healthy Adults in Switzerland
This trial is Stage 2 of a 2-part adaptive trial. The study aims to investigate the safety of 2 doses of a T-cell priming specific cocktail of Coronaviruses peptides mounted on a gold nanoparticle.
Note: Stage 1 of the 2-part adaptive trial, testing a specifically selected mix of Dengue virus peptides, commenced Aug 2021. This is now in follow up (NCT04935801).
Read the detailed description
Despite drastic quarantine measures, SARS-CoV-2 continues to propagate and threaten global economies and healthcare systems. There is universal consensus on the need for vaccination to protect against complications, reduce viral shedding and therefore prevent severe manifestation of disease and reduce hospitalisations.
Coronavirus harbours the potential to become a seasonal disease. It is moving towards being a ''new flu'' with potential perennial circulation and continuously evolving Variants of Concern (VOCs), needing diverse vaccines to control it. The Global Vaccine Alliance, GAVI, has specifically advocated for vaccine diversity as a means to ensure equality and access as well as a means of maximising scalability.
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 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:
- The scale of the COVID-19 pandemic requires multiple vaccine candidates to ensure democratic and rapid access to protection by:
- Providing a range of vaccine choices tailored to variations in immunological profiles across demographics as well as suited to environments with various levels of resources (cold chain etc).
- Distributing and parallelizing manufacture, to speed up scale, avoid reagent stock limitations and dilute monopolies.
- The ability for SARS-CoV-2 to mutate, requires multiple vaccine candidates to ensure robust and sustainable protection. Vaccines with a range of epitopes and immune targets provide immunological diversity and reduce vulnerability to mutant escape.
- Nanotechnology fulfils the needs of a COVID vaccine by being a rapidly scalable and modular platform.
- Humoral immunity may be transient and insufficient against emerging variants of SARS-CoV-2.
- Cellular immunity against SARS-CoV-2 is lasting and associated with recovery in COVID-19.
The proposed vaccine of this trial specifically seeks to diversify the immunological target response by carefully curating an MHC-I binding antigen cocktail from the SARS viruses ligandome and loading it onto a robust nanoparticle for controlled release and coupled T-cell immunostimulation. It also specifically seeks to avoid generating a humoral response, which has the potential to be transient and even detrimental in certain cases.
For this second stage of the trial, the objectives are are follows:
Primary:
To evaluate the safety and reactogenicity of two intradermal injections of two different doses of the investigational COVID peptide T-cell inducing vaccine (PepGNP-Covid19) administered to healthy volunteers in Switzerland as a:
- candidate vaccine for the prevention of COVID-19
- proof-of-concept for a rapidly scalable modular peptide vaccine platform.
Secondary:
- To assess the evidence of a CD8 T-cell mediated immune response as a surrogate of protection against severe COVID-19 disease using a novel peptide set-point vaccine in healthy adults.
- To assess the presence of an antibody mediated response.
For naNO-COVID, a total of 26 eligible participants will be randomised into the following groups:
Group 1 (n=13) 10 low dose (LD) PepGNP-Covid19 (2.5nmol peptide +12.8ug) + 3 Comparator.
Group 2 (n=13) 10 high dose (HD) PepGNP-Covid19 (7.5nmol + 38.3ug) + 3 Comparator.
Thus, 20/26 vaccine and 6/26 Comparator controls. Allocations of vaccine vs bpC 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 second stage of a 2-stage study investigating the safety of 2 vaccines from a T-cell priming vaccine platform for emerging diseases. (stage 1 = naNO-Dengue, stage 2 = naNO-COVID).
- Conditions
- Coronavirus, SARS-CoV-2 Infection, COVID-19
- Being tested
- LD Vehicle-GNP, LD PepGNP-Covid19, HD Vehicle-GNP, HD PepGNP-Covid19
- Keywords
- Coronavirus, SARS-CoV-2, COVID-19, T-cell priming, COVID vaccine, nanoparticle, T-cell vaccine
- Medical subject headings
- Coronavirus Infections, COVID-19
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-Covid19Biological
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-Covid19Biological
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 (12.8ug) without peptides Receives: Biological: LD Vehicle-GNP |
| LD PepGNP-Covid19 | Experimental | Low dose (LD) peptide vaccine (2.5nmol) - gold nanoparticle (12.8ug) plus peptides Receives: Biological: LD PepGNP-Covid19 |
| HD Vehicle GNP | Sham comparator | High dose (HD) comparator (7.5nmol) - gold nanoparticle (38.3ug) without peptides Receives: Biological: HD Vehicle-GNP |
| HD PepGNP-Covid19 | Experimental | High Dose (HD) peptide vaccine (7.5nmol) - gold nanoparticle (38.3ug) plus peptides Receives: Biological: HD PepGNP-Covid19 |
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
Secondary outcomes (2)
Immunogenicity: Proportion of participants with CD8-T cell specific to PepGNP-Covid19
Frequency of CD8+ T cells specific for individual CTL peptides by flow cytometry, using ex vivo MHC I dextramer staining and activation-induced markers (AIM)
Measured: Study Days 0-180 or through termination visit, if terminated early
Proportion of participants becoming seropositive (antibodies against SARS-CoV-2)
Geometric mean titre and geometric mean fold rise of antibodies against SARS-CoV2 as determined by Enzyme-linked Immunosorbent Assay (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 posted9 Nov 2021
- Study start10 Jan 2022
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies 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
- NCT05113862
- Sponsor's protocol ID
- naNO-COVID
- Status last verified
- Nov 2022
- First submitted
- 5 Nov 2021
- Last updated
- 12 Feb 2025
- 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 the obvious flaws to conduct of the study, which may preclude data publication, safety and efficacy data will be published under the supervision and authorisation of the PI and Sponsor. Publication will include as much individual level data as possible to ensure reproducibility of results without compromising participant privacy.
Publications
Besson J, Audran R, Karlen M, Miauton A, Hajjami HM, Warpelin-Decrausaz L, Sene L, Schaufelberger S, Faivre V, Faouzi M, Hartley MA, Spertini F, Genton B. A gold nanoparticle/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland. BMC Infect Dis. 2025 Apr 7;25(1):472. doi: 10.1186/s12879-025-10844-3.
PubMed 40197245
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-I, Double-blind, Randomized, Vehicle-controlled, Dose-finding, Safety Study of a Synthetic Nanoparticle-based, T Cell Priming Peptide Vaccine Against SARS-CoV-2 in Healthy Adults in Switzerland
- ClinicalTrials.gov ID
- NCT05113862
- Acronym / sponsor ID
- naNO-COVID
- Conditions
- Coronavirus, SARS-CoV-2 Infection, COVID-19
- Keywords
- Coronavirus, SARS-CoV-2, COVID-19, T-cell priming, COVID vaccine, nanoparticle, 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
- 10 Jan 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 9 Nov 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 is Stage 2 of a 2-part adaptive trial. The study aims to investigate the safety of 2 doses of a T-cell priming specific cocktail of Coronaviruses peptides mounted on a gold nanoparticle.
Note: Stage 1 of the 2-part adaptive trial, testing a specifically selected mix of Dengue virus peptides, commenced Aug 2021. This is now in follow up (NCT04935801).
Detailed description
Despite drastic quarantine measures, SARS-CoV-2 continues to propagate and threaten global economies and healthcare systems. There is universal consensus on the need for vaccination to protect against complications, reduce viral shedding and therefore prevent severe manifestation of disease and reduce hospitalisations.
Coronavirus harbours the potential to become a seasonal disease. It is moving towards being a ''new flu'' with potential perennial circulation and continuously evolving Variants of Concern (VOCs), needing diverse vaccines to control it. The Global Vaccine Alliance, GAVI, has specifically advocated for vaccine diversity as a means to ensure equality and access as well as a means of maximising scalability.
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 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:
- The scale of the COVID-19 pandemic requires multiple vaccine candidates to ensure democratic and rapid access to protection by:
- Providing a range of vaccine choices tailored to variations in immunological profiles across demographics as well as suited to environments with various levels of resources (cold chain etc).
- Distributing and parallelizing manufacture, to speed up scale, avoid reagent stock limitations and dilute monopolies.
- The ability for SARS-CoV-2 to mutate, requires multiple vaccine candidates to ensure robust and sustainable protection. Vaccines with a range of epitopes and immune targets provide immunological diversity and reduce vulnerability to mutant escape.
- Nanotechnology fulfils the needs of a COVID vaccine by being a rapidly scalable and modular platform.
- Humoral immunity may be transient and insufficient against emerging variants of SARS-CoV-2.
- Cellular immunity against SARS-CoV-2 is lasting and associated with recovery in COVID-19.
The proposed vaccine of this trial specifically seeks to diversify the immunological target response by carefully curating an MHC-I binding antigen cocktail from the SARS viruses ligandome and loading it onto a robust nanoparticle for controlled release and coupled T-cell immunostimulation. It also specifically seeks to avoid generating a humoral response, which has the potential to be transient and even detrimental in certain cases.
For this second stage of the trial, the objectives are are follows:
Primary:
To evaluate the safety and reactogenicity of two intradermal injections of two different doses of the investigational COVID peptide T-cell inducing vaccine (PepGNP-Covid19) administered to healthy volunteers in Switzerland as a:
- candidate vaccine for the prevention of COVID-19
- proof-of-concept for a rapidly scalable modular peptide vaccine platform.
Secondary:
- To assess the evidence of a CD8 T-cell mediated immune response as a surrogate of protection against severe COVID-19 disease using a novel peptide set-point vaccine in healthy adults.
- To assess the presence of an antibody mediated response.
For naNO-COVID, a total of 26 eligible participants will be randomised into the following groups:
Group 1 (n=13) 10 low dose (LD) PepGNP-Covid19 (2.5nmol peptide +12.8ug) + 3 Comparator.
Group 2 (n=13) 10 high dose (HD) PepGNP-Covid19 (7.5nmol + 38.3ug) + 3 Comparator.
Thus, 20/26 vaccine and 6/26 Comparator controls. Allocations of vaccine vs bpC 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 second stage of a 2-stage study investigating the safety of 2 vaccines from a T-cell priming vaccine platform for emerging diseases. (stage 1 = naNO-Dengue, stage 2 = naNO-COVID).
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 (12.8ug) without peptides |
| LD PepGNP-Covid19 | Experimental | Biological: LD PepGNP-Covid19Low dose (LD) peptide vaccine (2.5nmol) - gold nanoparticle (12.8ug) plus peptides |
| HD Vehicle GNP | Sham comparator | Biological: HD Vehicle-GNPHigh dose (HD) comparator (7.5nmol) - gold nanoparticle (38.3ug) without peptides |
| HD PepGNP-Covid19 | Experimental | Biological: HD PepGNP-Covid19High Dose (HD) peptide vaccine (7.5nmol) - gold nanoparticle (38.3ug) 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 (16 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 (including vaccine against COVID) in the 4 weeks preceding the first trial vaccination (excluding influenza vaccination which may be received 2 weeks prior to the first vaccination), or planned receipt of any vaccine in the 4 weeks following each trial vaccination.
- Positive SARS-CoV2 test in the 4 weeks preceding the first trial vaccination.
- Receipt of immunoglobins, blood or blood-derived products in the past 3 months.
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-Covid19Two intradermal injections in the upper arm spaced 21 days apart | Biological | LD PepGNP-Covid19 |
| HD Vehicle-GNPTwo intradermal injections in the upper arm spaced 21 days apart | Biological | HD Vehicle GNP |
| HD PepGNP-Covid19Two intradermal injections in the upper arm spaced 21 days apart | Biological | HD PepGNP-Covid19 |
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)
2 secondary outcomes
Immunogenicity: Proportion of participants with CD8-T cell specific to PepGNP-Covid19
Time frame: Study Days 0-180 or through termination visit, if terminated early
Proportion of participants becoming seropositive (antibodies against SARS-CoV-2)
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 12 Feb 2025.
- Derived from this study: PubMed 40197245Besson J, Audran R, Karlen M, Miauton A, Hajjami HM, Warpelin-Decrausaz L, Sene L, Schaufelberger S, Faivre V, Faouzi M, Hartley MA, Spertini F, Genton B. A gold nanoparticle/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland. BMC Infect Dis. 2025 Apr 7;25(1):472. doi: 10.1186/s12879-025-10844-3.
- 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 the obvious flaws to conduct of the study, which may preclude data publication, safety and efficacy data will be published under the supervision and authorisation of the 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-Covid19 and HD PepGNP-Covid19 in people with Coronavirus and SARS-CoV-2 Infection, 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 16 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 12 Feb 2025. 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 4 primary outcomes in all. 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 NCT05113862, 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 12 Feb 2025.