- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00089908
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults
Phase I Study of the Safety and Immunogenicity of rDEN1delta30, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 1
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
More than 2 billion people living in tropical and subtropical regions of the world are at risk of dengue virus infection. Dengue viruses cause dengue fever, as well as the more severe dengue hemorrhagic fever/shock syndrome, and dengue virus infection is the leading cause of hospitalization and death in children in several tropical Asian countries. This study will evaluate the safety and immunogenicity of a live, attenuated dengue virus called rDEN1delta30, which is derived from the Western Pacific DEN1 serotype.
This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive rDEN1delta30 or placebo at study entry. Cohort 2 will begin only after safety review of all participants in Cohort 1. Participants in Cohort 2 will receive a higher dose of rDEN1delta30 or placebo.
After vaccination, participants will be asked to monitor their temperature every day for 16 days. Study visits will occur every other day after vaccination until Day 16, followed by 4 additional visits at selected days through Day 180. Blood collection and a targeted physical exam will occur at each study visit. Some participants will be asked to undergo a skin biopsy or additional blood collection at selected visits.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Maryland
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Baltimore, Maryland, États-Unis, 21205
- Center for Immunization Research, Johns Hopkins School of Public Health
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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
Inclusion Criteria:
- Willing to be followed for the duration of the study
- Willing to use acceptable methods of contraception
- Good general health
Exclusion Criteria:
- Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study
- Liver, renal, or hematologic disease
- Alcohol or drug abuse within 12 months of study entry
- History of severe allergic reaction or anaphylaxis
- Emergency room visit or hospitalization for severe asthma within 6 months of study entry
- HIV-1 infected
- HCV infected
- Hepatitis B surface antigen positive
- Known immunodeficiency syndrome
- Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical or nasal corticosteroids are not excluded.
- Live vaccine within 4 weeks of study entry
- Killed vaccine within 2 weeks of study entry
- Blood products within 6 months of study entry
- Investigational drugs or vaccines within 60 days prior to study entry or while currently enrolled in this clinical trial
- Previously received a licensed or experimental yellow fever or dengue vaccine
- Surgical removal of spleen
- History of dengue virus infection or other flavivirus infection
- Other condition that, in the opinion of the investigator, would affect the participant's participation in the study
- Pregnancy or breastfeeding
- Plan to travel to an area where dengue infection is common
Plan d'étude
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 |
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Expérimental: 1
One subcutaneous vaccination with rDEN1delta30 vaccine (10^3 PFU dose) into the deltoid region of either arm.
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Live attenuated rDEN1delta30 vaccine
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Expérimental: 2
One subcutaneous vaccination with rDEN1delta30 vaccine (10^5 PFU dose) into the deltoid region of either arm.
This arm may enroll after Arm 1 depending on the effect of the vaccine on subjects in Arm 1.
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Live attenuated rDEN1delta30 vaccine
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Comparateur placebo: 3
One subcutaneous vaccination with placebo into the deltoid region of either arm.
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Placebo pour rDEN1delta30
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Determine the frequency of vaccine related AEs for each dose graded by severity
Délai: Throughout study
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Throughout study
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Determine the amount of dengue 1 neutralizing antibody induced by the vaccine
Délai: At Day 42
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At Day 42
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Pour évaluer la durabilité de la réponse anticorps
Délai: Au jour 180
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Au jour 180
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Évaluer la fréquence, la quantité et la durée de la virémie dans chaque cohorte de doses étudiée
Délai: Tout au long de l'étude
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Tout au long de l'étude
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To compare the T cell mediated immune response against dengue viruses of those volunteers infected with the rDEN1delta30 vaccine virus with that of uninfected volunteers and placebo recipients
Délai: Throughout study
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Throughout study
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If both doses of vaccine are administered, to compare the infectivity rates, safety, and immunogenicity between dose groups
Délai: At study completion
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At study completion
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Évaluer le mécanisme immunopathologique des éruptions cutanées associées au vaccin chez les volontaires qui acceptent de subir une biopsie cutanée
Délai: Tout au long de l'étude
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Tout au long de l'étude
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Anna Durbin, MD, Center for Immunization Research, John Hopkins School of Public Health
Publications et liens utiles
Publications générales
- Jacobs M, Young P. Dengue vaccines: preparing to roll back dengue. Curr Opin Investig Drugs. 2003 Feb;4(2):168-71.
- Pang T. Vaccines for the prevention of neglected diseases--dengue fever. Curr Opin Biotechnol. 2003 Jun;14(3):332-6. doi: 10.1016/s0958-1669(03)00061-2.
- Rothman AL. Dengue: defining protective versus pathologic immunity. J Clin Invest. 2004 Apr;113(7):946-51. doi: 10.1172/JCI21512.
- Sun W, Edelman R, Kanesa-Thasan N, Eckels KH, Putnak JR, King AD, Houng HS, Tang D, Scherer JM, Hoke CH Jr, Innis BL. Vaccination of human volunteers with monovalent and tetravalent live-attenuated dengue vaccine candidates. Am J Trop Med Hyg. 2003 Dec;69(6 Suppl):24-31. doi: 10.4269/ajtmh.2003.69.6_suppl.0690024.
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CIR 199
- H.22.04.04.23.B2
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Essais cliniques sur rDEN1delta30
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National Institute of Allergy and Infectious Diseases...Johns Hopkins Bloomberg School of Public HealthComplété
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National Institute of Allergy and Infectious Diseases...Johns Hopkins Bloomberg School of Public HealthComplété