Development of an Intranasal Proteosome Influenza Vaccine
Study to Determine if Intranasal Proteosome-Adjuvanted Trivalent Influenza Vaccine is Safe, Immunogenic and Efficacious in the Influenza Human Viral Challenge Model
Aperçu de l'étude
Statut
Les conditions
Description détaillée
A Proteosome-adjuvanted trivalent inactivated influenza vaccine (P-TIV) administered intra-nasally was shown to be effective, safe, well tolerated, immunogenic - in both systemic and mucosal compartments - and effective at preventing influenza illness.
In two separate studies using the Human Viral Challenge Model, subjects were selected for susceptibility to A/Panama/2007/1999 (H3N2) virus and then dosed with one of three regimens: (A/New Caledonia/20/1999 (H1N1), A/Panama/2007/1999 (H3N2), B/Victoria/504/2000 or B/Shangdong/7/1997) or placebo via a nasal spray. One or two doses were given, 14 days apart, before subjects were challenged with ~8.5 x 105 EID¬50 of A/Panama/2007/1999 (H3N2) virus. Immune responses to the vaccine antigens were measured, namely serum IgG (via the aemagglutination inhibition assay (HAI)) and nasal wash secretory IgA (sIgA) antibodies (via ELISA). Viral titres in nasal washes and symptoms of influenza illness were assessed after viral challenge and compared.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- La phase 1
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Young healthy adults as determined by medical history, physical examination, serology (HIV and Hepatitis B and C) and clinical laboratory tests.
- Female subjects were required to provide of a history of reliable contraceptive practice.
- Susceptibility to A/Panama/2007/1999 (H3N2) (a serum reciprocal HAI titre ≤10) was confirmed at screening. -
Exclusion Criteria:included;
- asthma,
- hypersensitivity to mercurials or chicken eggs,
- anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration, * chronic nasopharyngeal complaints,
- abnormal electrocardiogram (ECG),
- febrile illness or significant symptoms of upper respiratory infection on the day of vaccination or between admission to quarantine and administration of the challenge inoculum.
- Subjects using medication or other products for rhinitis or nasal congestion,
- Subject who had received systemic glucocorticoids within 1 month, or cytotoxic or immunosuppressive drugs within 6 months of the study start.
- Subjects agreed not to smoke during the quarantine phase.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: Placebo
|
Intranasal vaccine Protesomal Vaccine
Autres noms:
|
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Expérimental: Protesomal Vaccine 1 x 30 µg
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Experimental: Protesomal Vaccine 1 x 30 µg
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Expérimental: Protesomal Vaccine 2 x 30 µg
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Experimental: Protesomal Vaccine 2 x 30 µg
|
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Expérimental: Protesomal Vaccine 2 x 15 µg
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Experimental: Protesomal Vaccine 2 x 15 µg
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Reduction in Influenza Like Illness in those with laboratory confirmed influenza
Délai: Within the duration of infection, approx 10 days
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Within the duration of infection, approx 10 days
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Rob Lambkin-Williams, PhD, PI
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IDB 004 IDB 005
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