Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year.
25 mai 2022 mis à jour par: Novavax
A Phase II Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) Recombinant F Nanoparticle Vaccine in Healthy Older Adult Subjects Previously Treated With the Same Vaccine, or Placebo, in the Prior Year; and to Estimate the Incidence Rate of RSV Disease and Vaccine Efficacy in Subjects Based on Their RSV F Vaccine Experience Over Two Consecutive Years.
This study will enroll subjects who received the RSV F vaccine or placebo in the earlier study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a second season.
This design will permit evaluation of the safety and immunogenicity of revaccination in a second RSV season, and the safety and immunogenicity of revaccination over two years.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
1330
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
California
-
Redding, California, États-Unis, 96001
- Nothern California Clinical Research
-
-
Georgia
-
Stockbridge, Georgia, États-Unis, 30281
- Clinical Research Atlanta
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-
Kansas
-
Lenexa, Kansas, États-Unis, 66219
- Johnson County Clin-Trials
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Ohio
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Cleveland, Ohio, États-Unis, 44122
- Rapid Medical Research
-
-
Tennessee
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Nashville, Tennessee, États-Unis, 37203
- Clinical Research Associates
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-
Texas
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Dallas, Texas, États-Unis, 75234
- Research Across America
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San Antonio, Texas, États-Unis, 78229
- Clinical Trials of Texas
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-
Utah
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West Jordan, Utah, États-Unis, 84088
- Advanced Clinical Research
-
-
Washington
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Seattle, Washington, États-Unis, 98101
- Group Health Research Institute
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Wisconsin
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Wausau, Wisconsin, États-Unis, 54401
- Marshfield Clinical Research Foundation
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
60 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
Males and females ≥60 years of age who are veterans of the RSV-E-201 clinical trial and who are ambulatory and live in the community or in residential facilities which provide minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. Subjects may have one or more chronic medical diagnoses, but should be clinically stable as assessed by:
- Absence of changes in medical therapy within one month due to treatment failure or toxicity,
- Absence of medical events qualifying as SAEs within two months, and
- Absence of known, current, life-limiting diagnoses that, in the opinion of the investigator, render survival to trial completion unlikely.
- Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment.
- Able to comply with study requirements, including access to transportation for study visits. The investigator may use his/her discretion to assess potential ability and willingness to comply based on performance in the prior trial, RSV-E-201.
- Access to inbound and outbound communication by telephone with caregivers and study staff.
Exclusion Criteria:
- Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination, with the exception of participation in the preceding study RSV-E-201.
- History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization, or withdrawal from the preceding RSV-E-201 clinical trial due to an adverse event deemed test article-related or at the advice of the investigator.
- Receipt of any vaccine other than IIV in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time unless administered in the preceding study, RSV-E-201.
- Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
- Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
- Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature ≥38.0°C on the planned day of vaccine administration).
- Known disturbance of coagulation. Potential subjects receiving aspirin, clopidogrel, prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban or warfarin under good control for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or stroke in the setting of atrial fibrillation will NOT be excluded.
- Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
- Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic, cognitive, or psychiatric conditions deemed likely to impair the quality of study compliance or safety reporting).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Treatment Group A
RSV-F Vaccine ( 0.5mL Injection)
|
|
|
Comparateur placebo: Groupe de traitement B
Placebo tampon phosphate (injection de 0,5 ml)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.
Délai: Day 0 to Day 364
|
Derived/calculated endpoints based on these data will include:
|
Day 0 to Day 364
|
|
Numbers and percentages of subjects with solicited local and systemic AEs
Délai: Day 0 to Day 364
|
Solicited local and systemic AEs over the seven days post-injection; and all adverse events, solicited and unsolicited, over 56 days post-dosing (Year 2).
In addition, MAEs, SAEs, and SNMCs will be collected for 1 year (approximately 364 days) post-dosing
|
Day 0 to Day 364
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA
Délai: Day 0 to Day 182
|
Summarized by:
|
Day 0 to Day 182
|
|
Neutralizing antibody titer to at least one RSV/A and one RSV/B strain.
Délai: Day 0 to Day 182
|
Summarized by:
|
Day 0 to Day 182
|
Autres mesures de résultats
Mesure des résultats |
Délai |
|---|---|
|
Number and percentages of subjects fulfilling the definitions of RSV-associated respiratory disease and/or RSV-lower respiratory tract disease in various treatment groups.
Délai: Day 0 to Day 182
|
Day 0 to Day 182
|
|
Number and percentages of subjects with respiratory illnesses for which a non-RSV viral respiratory pathogen (with or without concurrent RSV infection) is identified by RT-PCR.
Délai: Day 0 to Day 182
|
Day 0 to Day 182
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2015
Achèvement primaire (Réel)
1 novembre 2016
Achèvement de l'étude (Réel)
1 novembre 2016
Dates d'inscription aux études
Première soumission
22 octobre 2015
Première soumission répondant aux critères de contrôle qualité
29 octobre 2015
Première publication (Estimation)
30 octobre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 mai 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 mai 2022
Dernière vérification
1 mai 2022
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- RSV-E-202
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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