bêta
IA Trial Radar
L'essai clinique NCT06919796 pour Evaluate Immune Responses Following MRNA COVID-19 Vaccine Administration Through Different Delivery Routes in Healthy Volunteers, SARS COV-2 est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
Un essai clinique correspond aux filtres sélectionnés
Vue en carte
Retour à la recherche

mRNA Covid-19 Vaccine Immune Response Comparisons Using Different Delivery Routes

Pas encore en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'essai clinique NCT06919796 est conçu pour étudier le treatment de Evaluate Immune Responses Following MRNA COVID-19 Vaccine Administration Through Different Delivery Routes in Healthy Volunteers, SARS COV-2. Il s'agit d'un essai interventionnel en Phase II. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 mai 2025, avec un objectif de 40 participants. Dirigé par PharmaJet, Inc., l'essai devrait être terminé d'ici le 25 novembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 15 avril 2025.
Résumé succinct
The purpose of this study is to determine if immune responses differ when the mRNA COVID-19 vaccine is given through different delivery methods, including a needle-free injection system, or via intramuscular injection using needle and syringe
Titre officiel

Systems Biology of a mRNA Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Given Via Intradermal (ID) Injection Using Tropis Needle-Free Injection System (NFIS) or Intramuscular (IM) Injection Using Needle and Syringe

Conditions
Evaluate Immune Responses Following MRNA COVID-19 Vaccine Administration Through Different Delivery Routes in Healthy VolunteersSARS COV-2
Autres identifiants de l'essai
  • COVID-PJ-01
Numéro NCT
NCT06919796
Date de début (réel)
2025-05-01
Dernière mise à jour publiée
2025-04-15
Date de fin (estimée)
2026-11-25
Inscription (estimée)
40
Type d'essai
Interventionnel
PHASE
Phase II
Statut
Pas encore en recrutement
Mots clés
Tropis ID
Needle-free injection
Tropis
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalmRNA vaccine administration via Tropis ID NFIS
Immunization with a single dose of mRNA Covid-19 vaccine administered intradermally using the Tropis Needle Free Injection System
COMIRNATY®
COVID-19 Vaccine, mRNA suspension
Comparateur actifIntramuscular injection of the mRNA Covid-19 vaccine via needle and syringe
Immunization with a single dose of mRNA Covid-19 vaccine administered intramuscularly using needle and syringe
COMIRNATY®
COVID-19 Vaccine, mRNA suspension
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Primary Objective
In 40 participants response rate, and magnitude of SARS-CoV-2-specific antibody neutralization titers will be measured at Day 30 and Month 6-9 after vaccination
Nine months
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Secondary Objective
1. Percentage of participants with solicited injection site and systemic AEs within 7 days after vaccination. 2. Percentage of participants with unsolicited AEs until Day 30 after vaccination. 3. Percentage of participants with SAEs, MAAEs and AEs leading to study withdrawal throughout the entire study period. 4. Percentage of participants with AESIs (Appendix A) throughout the entire study period. 5. Percentage of participants with grade 2 and above AEs within 7 days after each fine needle aspirates of draining lymph nodes and bone marrow aspirates.
Nine months
Critères d'éligibilité

Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
  1. Able to understand and give informed consent
  2. Adults aged 18 to 50 years old.
  3. Willing and able to comply with all scheduled visits, vaccination, and laboratory tests.
  4. Determined by investigator to be in good health based on medical history, targeted physical exam and laboratory testing.
  5. Participants with pre-existing stable chronic medical conditions defined as condition not requiring significant change in therapy or hospitalization for worsening disease within 4 weeks from enrollment, can be included at the discretion of the investigator.
  6. For women of childbearing potential: willing to engage in effective methods of contraception starting at least 30 days prior to enrollment and for the duration of the study.

  1. Receipt of blood products 90 days prior to study entry and for the duration of the study.
  2. Volunteers who donated blood 60 days before screening OR will donate blood on or before D30.
  3. Receipt of any experimental agents within 30 days or 5 half-lives whichever is longer prior to vaccination and for the duration of the study.
  4. Receipt of any licensed vaccine within 60 days prior to study vaccination or planned receipt of any vaccine until 60 days later as well as receipt of COVID-19 vaccine for the duration of the study.
  5. Receipt of a COVID-19 vaccine or confirmed COVID-19 in the past year or positive SARS-CoV-2 antigen test on vaccination day.
  6. Chronic medical problems including (but not limited to) autoimmune disease, severe gastrointestinal disease, and grade 4 hypertension.
  7. Any diseases or conditions that put individuals at increased risk for severe COVID-19 illness, including: type 1 or 2 diabetes, chronic lung disease (including moderate to severe asthma, bronchiectasis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease (COPD), interstitial lung disease including idiopathic pulmonary fibrosis, pulmonary embolism, or pulmonary hypertension), cystic fibrosis, dementia, Parkinson's disease, cerebrovascular disease, chronic liver disease, chronic kidney disease (any stage), heart conditions, hemoglobin blood disorders (sickle cell disease, thalassemia).
  8. BMI > 40 kg/m2
  9. Any potentially immune mediated disease (with the exception of well controlled hypothyroidism).
  10. Alcohol or drug abuse and psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data.
  11. Impaired immune function or chronic infections including (but not limited to) HIV, hepatitis B or C; organ transplant; active cancer or any history of hematologic cancer; receipt of chemotherapy, radiation therapy (past 12 months) or any other potentially immunosuppressive therapy [i.e. received oral, intramuscular or intravenous systemic immunosuppressants, or immune modifying drugs for >14 days in total within 6 months prior to any study vaccine dose (for corticosteroids ≥ 20 mg/day of prednisone equivalent). Note: Topical medications are allowed.], congenital immunodeficiency, anatomical or functional asplenia.
  12. Pregnancy or breast feeding or planned pregnancy for the duration of the study.
  13. Severe reactions to prior vaccination with Covid-19 mRNA vaccine or any of its components, including anaphylaxis.
  14. History of Guillain Barré syndrome or myopericarditis.
  15. Volunteers with any acute illness, including any fever (> 100.4 F [> 38.0C], regardless of the route) within 3 days prior to study entry.
  16. Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.
PharmaJet, Inc. logoPharmaJet, Inc.
Contact central de l'essai
Contact: Nadine Rouphael, MD, 404-712-1435, [email protected]
Contact: Sonia Wimalasena, [email protected]
1 Centres de l'essai dans 1 pays

Georgia

Hope Clinic of the Emory Vaccine Center Division of Infectious Diseases, Department of Medicine, School of Medicine, Decatur, Georgia, 30030, United States
Nadine Rouphael, MD, Contact, 404-712-1435, [email protected]