Evidence map›Paper›PMID 40197245›Full record

Trial reportBMC infectious diseases2025

A gold nanoparticle/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland.

Juliette Besson, Régine Audran, Maxime Karlen, Alix Miauton, Hélène Maby-El Hajjami, Loane Warpelin-Decrausaz, Loredana Sene, Sylvain Schaufelberger, Vincent Faivre, Mohamed Faouzi and 3 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05113862 (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), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05113862 phase1completednot on this map

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

TypeinterventionalSponsorGylden Pharma LtdRan2022 to 2022Enrolled26ConditionsCoronavirus, SARS-CoV-2 Infection, COVID-19ArmsLD Vehicle-GNP, LD PepGNP-Covid19, HD Vehicle-GNP, HD PepGNP-Covid19
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Juliette Besson *Tropical, Travel and Vaccination Clinic, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland. Juliette.Besson@hotmail.com.
Régine Audran *Division of Immunology and Allergy, Centre Hospitalier Universitaire Vaudois (CHUV), University of Lausanne, Lausanne, Switzerland.
Maxime Karlen *Tropical, Travel and Vaccination Clinic, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.
Alix MiautonTropical, Travel and Vaccination Clinic, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.
Hélène Maby-El HajjamiClinical Trial Unit, Centre Hospitalier Universitaire Vaudois (CHUV), University of Lausanne, Lausanne, Switzerland.
Loane Warpelin-DecrausazClinical Trial Unit, Centre Hospitalier Universitaire Vaudois (CHUV), University of Lausanne, Lausanne, Switzerland.
Loredana SeneClinical Trial Unit, Centre Hospitalier Universitaire Vaudois (CHUV), University of Lausanne, Lausanne, Switzerland.
Sylvain SchaufelbergerInformation Systems and Digital Transformation, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.
Vincent FaivreInformation Systems and Digital Transformation, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.
Mohamed FaouziDivision of Biostatistics, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.
Mary-Anne HartleyTropical, Travel and Vaccination Clinic, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.
François SpertiniDivision of Immunology and Allergy, Centre Hospitalier Universitaire Vaudois (CHUV), University of Lausanne, Lausanne, Switzerland.
Blaise GentonTropical, Travel and Vaccination Clinic, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNew vaccines with broader protection against SARS-CoV-2 are needed to reduce the risk of immune escape and provide broad and long-lasting cellular immunity. The objectives of the naNO-COVID trial were to evaluate the safety and immunogenicity of a CD8 + T cell, gold nanoparticle-based, peptide COVID-19 vaccine.

methodsA randomized, double-blind, vehicle-controlled, phase 1 trial in healthy adults to receive PepGNP-Covid19 or Vehicle-GNP, followed over 180 days, using a dose-escalation strategy.

resultsTwenty participants received PepGNP-Covid19 (low dose [LD] or high dose [HD], n = 10 each) and six Vehicle-GNP (LD or HD, n = 3 each). Vaccinations were safe. No serious adverse events were reported. Most of the adverse events were mild, two adverse events of special interest related to the product (fever and fatigue). Reactogenicity was similar overall between vaccine, comparator, and doses. Virus-specific humoral responses in LD PepGNP-Covid19 and Vehicle-GNP groups coincided with SARS-CoV-2 infections. PepGNP-Covid19 vaccination induced the modulation of Covid19-specific CD137 + CD69 + CD8 + , and an increase at day 35 particularly in central and effector memory T cells in LD group, and in late effector memory cells in HD group.

conclusionsThe favourable safety profile and cellular responses observed support further development of PepGNP-Covid19.

trial registrationClinicalTrials.gov, NCT05113862, approved 09.11.2021.

Indexed as

CD8-Positive T-LymphocytesCOVID-19COVID-19 VaccinesGoldMetal NanoparticlesSARS-CoV-2AdultAntibodies, ViralDouble-Blind MethodFemaleHumansMaleMiddle AgedProtein Subunit VaccinesSwitzerlandVaccines, SubunitAntibodies, ViralCOVID-19 VaccinesGoldProtein Subunit VaccinesVaccines, SubunitCellularCOVID-19ImmunityNanoparticleSARS-CoV-2Vaccine

Identifiers

PMID40197245
PMCPMC11974014

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.