- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07919210
A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of a Preventative Vaccine for Marburg Virus (mRNA-1519) in Healthy Adult Participants
A Phase 1, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety, Reactogenicity, and Immunogenicity of a Preventative Vaccine for Marburg Virus (mRNA-1519) in Healthy Adult Participants 18 to 55 Years of Age
The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1519
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Moderna WeCareTeam
- Numéro de téléphone: +1-866-663-3762
- E-mail: WeCareClinicalTrials@modernatx.com
Lieux d'étude
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Oxford, Royaume-Uni, OX3 7LE
- University of Oxford
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Key Inclusion Criteria:
- In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- Body mass index within the range 18 to 39 kg/m2 (inclusive).
- Female participants of childbearing potential may be enrolled in the study if not pregnant or breastfeeding, subject to other criteria specified in the study protocol.
Key Exclusion Criteria:
- History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic, or any components of an mRNA vaccine or therapeutic.
- History of participation in a prior filovirus (Ebola Zaire, Sudan, Bundibugyo, and Marburg) vaccine study.
- History of confirmed or suspected filovirus infection.
- Other conditions that in the Investigator's opinion could interfere with interpretation of study results or limit the participant's participation in the study.
- Acutely ill or febrile (temperature ≥38.0℃ [100.4°F]) within 72 hours prior to or at the Screening Visit or Day 1.
- Abnormal screening clinical laboratory values >Grade 1 for total white blood cell count, hemoglobin, alanine aminotransferase, aspartate aminotransferase, creatinine, alkaline phosphatase, total bilirubin, or platelets.
- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, the assessment of study endpoints, the assessment of immune response, or adherence to study procedures.
Note: Other inclusion and exclusion criteria may apply.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: mRNA-1519 Dose Level 1 Single Dose
Participants will receive 1 injection of mRNA-1519 at Dose Level 1 on Day 1 |
Sterile liquid for injection |
|
Comparateur placebo: Placebo Matching Dose Level 1 Single Dose
Participants will receive 1 injection of Placebo matching Dose Level 1 on Day 1 |
Sterile liquid for injection |
|
Expérimental: mRNA-1519 Dose Level 1 Two-Dose
Participants will receive 2 injections of mRNA-1519 at Dose Level 1, on Day 1 and Day 57 |
Sterile liquid for injection |
|
Comparateur placebo: Placebo Matching Dose Level 1 Two-Dose
Participants will receive 2 injections of Placebo matching Dose Level 1, on Day 1 and Day 57 |
Sterile liquid for injection |
|
Expérimental: mRNA-1519 Dose Level 2
Participants will receive 1 injection of mRNA-1519 at Dose Level 2 on Day 1 |
Sterile liquid for injection |
|
Comparateur placebo: Placebo Matching Dose Level 2
Participants will receive 1 injection of Placebo matching Dose Level 2 on Day 1 |
Sterile liquid for injection |
|
Expérimental: mRNA-1519 Dose Level 3
Participants will receive 1 injection of mRNA-1519 at Dose Level 3 on Day 1 |
Sterile liquid for injection |
|
Comparateur placebo: Placebo Matching Dose Level 3
Participants will receive 1 injection of Placebo matching Dose Level 3 on Day 1 |
Sterile liquid for injection |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Number of Participants with Serious Adverse Events (SAEs), Any AEs Leading to Discontinuation From Study Participation and/or Study Vaccination, and AEs of Special Interest (AESIs)
Délai: Up to End of Study (EOS) (Day 337)
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Up to End of Study (EOS) (Day 337)
|
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Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Délai: Through 7 days after each study intervention
|
Through 7 days after each study intervention
|
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Number of Participants with Unsolicited Adverse Events (AEs)
Délai: Through 28 days after each study intervention
|
Through 28 days after each study intervention
|
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Number of Participants with Medically Attended Adverse Events (MAAEs)
Délai: From Day 1 to 6 months after the last study intervention
|
From Day 1 to 6 months after the last study intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Geometric Mean Titer of Marburg Virus (MARV)-Specific Binding Antibodies (bAbs)
Délai: At Day 29 (Single Dose), at Day 85 (Two-Dose), and Up to EOS (Day 337)
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At Day 29 (Single Dose), at Day 85 (Two-Dose), and Up to EOS (Day 337)
|
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Geometric Mean Titer of Marburg Virus (MARV)-Specific Neutralizing Antibodies (nAbs)
Délai: Throughout the study (Up to EOS/Day 337)
|
Throughout the study (Up to EOS/Day 337)
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- mRNA-1519-P101
Informations sur les médicaments et les dispositifs, documents d'étude
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