A Phase-I Study of a Nanoparticle-based Peptide Vaccine Against SARS-CoV-2

NCT05113862 | Completed Phase 1 DMC

• 1 other identifier: naNO-COVID
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Coronavirus; SARS-CoV-2 Infection; COVID-19

Keywords

Coronavirus; SARS-CoV-2; COVID-19; T-cell priming; COVID vaccine; nanoparticle; T-cell vaccine

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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)

  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)

  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

  Study Days 0-180 or through termination visit, if terminated early

• Proportion of participants becoming seropositive (antibodies against SARS-CoV-2)

  Study Days 0-180 or through termination visit, if terminated early

Study Arms (4)

LD Vehicle GNP

SHAM COMPARATOR

Low dose (LD) comparator (2.5nmol) - gold nanoparticle (12.8ug) without peptides

Biological: LD Vehicle-GNP

LD PepGNP-Covid19

EXPERIMENTAL

Low dose (LD) peptide vaccine (2.5nmol) - gold nanoparticle (12.8ug) plus peptides

Biological: LD PepGNP-Covid19

HD Vehicle GNP

SHAM COMPARATOR

High dose (HD) comparator (7.5nmol) - gold nanoparticle (38.3ug) without peptides

Biological: HD Vehicle-GNP

HD PepGNP-Covid19

EXPERIMENTAL

High Dose (HD) peptide vaccine (7.5nmol) - gold nanoparticle (38.3ug) plus peptides

Biological: HD PepGNP-Covid19

Interventions

LD Vehicle-GNP BIOLOGICAL

Two intradermal injections in the upper arm spaced 21 days apart

LD Vehicle GNP

LD PepGNP-Covid19 BIOLOGICAL

Two intradermal injections in the upper arm spaced 21 days apart

LD PepGNP-Covid19

HD Vehicle-GNP BIOLOGICAL

Two intradermal injections in the upper arm spaced 21 days apart

HD Vehicle GNP

HD PepGNP-Covid19 BIOLOGICAL

Two intradermal injections in the upper arm spaced 21 days apart

HD PepGNP-Covid19

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant signed informed consent
• Residing in Switzerland

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Gylden Pharma Ltd: lead
• Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland: collaborator
• University of Lausanne Hospitals: collaborator

Study Sites (1)

Center for Primary Care and Public Health (Unisante)

Lausanne, Canton of Vaud, 1004, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 40197245 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Blaise Genton, Prof.

  Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * This trial is double-blinded (blinded to investigators and participants) * Blinding will be maintained for the duration of the study * All allocations will remain coded to all volunteers and investigators. An independent pharmacy team at CHUV will label the vaccine and comparator doses with coded participant numbers but will not have access to the identifier list linking the code to the participant identity. All vaccine and comparator doses will be prepared and labelled away from investigators and stored in identical conditions. * The appearance of the comparators and doses will be identical. The solutions of both are indistinguishable within the dosage group and thus no shielding of the solution colour is needed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 9, 2021
• Study Start: January 10, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: February 12, 2025

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 12 months of study completion
• Access Criteria: Peer-reviewed publication

Locations

CH (1)