- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00094705
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN2/4delta30[ME]) in Healthy Adults
Phase 1 Study of the Safety and Immunogenicity of rDEN2/4delta30(ME), a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 2
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Dengue viruses cause dengue fever, as well as the more severe dengue hemorrhagic fever/shock syndrome. More than 2 billion people living in tropical and subtropical regions of the world are at risk of dengue virus infection, which 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 vaccine called rDEN2/4delta30(ME), which is derived from the DEN2 and DEN4 serotypes.
This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive rDEN2/4delta30(ME) 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 rDEN2/4delta30(ME) or placebo.
After vaccination, participants will be observed for at least 30 minutes for immediate adverse reactions. Participants will also 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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Maryland
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Baltimore, Maryland, Stati Uniti, 21205
- Johns Hopkins School of Public Health
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
- Hematologic disease
- Alcohol or drug abuse within 12 months prior to study entry
- History of severe allergic reaction or anaphylaxis
- Emergency room visit or hospitalization for severe asthma within 6 months prior to study entry
- HIV-1 infected
- Hepatitis C virus infected
- Hepatitis B surface antigen positive
- Known immunodeficiency syndrome
- Use of corticosteroids or immunosuppressive drugs within 30 days prior to study entry. Participants who have used topical or nasal corticosteroids are not excluded.
- Live vaccine within 4 weeks prior to study entry
- Killed vaccine within 2 weeks prior to study entry
- Blood products within 6 months prior to study entry
- Participation in another investigational vaccine or drug trial within 60 days of starting this study, or while this trial is ongoing
- Previously received a licensed or experimental yellow fever or dengue vaccine
- Surgical removal of spleen
- History of dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus, Japanese encephalitis virus)
- Other condition that, in the opinion of the investigator, would affect the participant's participation in the study
- Plan to travel to an area where dengue infection is common
- Pregnancy or breastfeeding
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 1
One subcutaneous vaccination with a 10^3 PFU dose of rDEN2/4delta30(ME) vaccine given in the deltoid region of either arm.
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Live attenuated rDEN2/4delta30(ME) vaccine (one of two doses)
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Sperimentale: 2
One subcutaneous vaccination with a 10^5 PFU dose of rDEN2/4delta30(ME) vaccine given in the deltoid region of either arm.
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Live attenuated rDEN2/4delta30(ME) vaccine (one of two doses)
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Comparatore placebo: 3
One subcutaneous vaccination with a placebo vaccine given in the deltoid region of either arm.
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Placebo for rDEN2/4delta30(ME) vaccine
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Frequency and severity of vaccine-related adverse effects for each dose graded by severity
Lasso di tempo: Throughout study
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Throughout study
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Amount of dengue 2 neutralizing antibody induced by the vaccine
Lasso di tempo: At Day 42
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At Day 42
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Per valutare la frequenza, la quantità e la durata della viremia in ciascuna coorte di dose studiata
Lasso di tempo: Durante lo studio
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Durante lo studio
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If both doses of vaccine are administered, to compare the infectivity rates, safety, and immunogenicity between dose groups
Lasso di tempo: At study completion
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At study completion
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Valutare il meccanismo immunopatologico del rash associato al vaccino in quei volontari che sono disposti a sottoporsi a biopsia cutanea
Lasso di tempo: Durante lo studio
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Durante lo studio
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To assess the durability of the antibody response out to Day 180
Lasso di tempo: Throughout study
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Throughout study
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To determine the number of vaccinees infected with rDEN2/4delta30(ME)
Lasso di tempo: Throughout study
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Throughout study
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To compare the T cell mediated immune response against dengue viruses of those volunteers infected with the rDEN2/4delta30(ME) vaccine virus with that of uninfected volunteers and placebo recipients
Lasso di tempo: Throughout study
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Throughout study
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Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- Edelman R. Dengue and dengue vaccines. J Infect Dis. 2005 Mar 1;191(5):650-3. doi: 10.1086/427784. Epub 2005 Jan 27. No abstract available.
- Guzman MG, Mune M, Kouri G. Dengue vaccine: priorities and progress. Expert Rev Anti Infect Ther. 2004 Dec;2(6):895-911. doi: 10.1586/14789072.2.6.895.
- Sabchareon A, Lang J, Chanthavanich P, Yoksan S, Forrat R, Attanath P, Sirivichayakul C, Pengsaa K, Pojjaroen-Anant C, Chokejindachai W, Jagsudee A, Saluzzo JF, Bhamarapravati N. Safety and immunogenicity of tetravalent live-attenuated dengue vaccines in Thai adult volunteers: role of serotype concentration, ratio, and multiple doses. Am J Trop Med Hyg. 2002 Mar;66(3):264-72. doi: 10.4269/ajtmh.2002.66.264.
- Whitehead SS, Hanley KA, Blaney JE Jr, Gilmore LE, Elkins WR, Murphy BR. Substitution of the structural genes of dengue virus type 4 with those of type 2 results in chimeric vaccine candidates which are attenuated for mosquitoes, mice, and rhesus monkeys. Vaccine. 2003 Oct 1;21(27-30):4307-16. doi: 10.1016/s0264-410x(03)00488-2.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CIR 189
- H.22.03.09.26.A2
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su rDEN2/4delta30(ME) Vaccine
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National Institute of Allergy and Infectious Diseases...Johns Hopkins Bloomberg School of Public HealthCompletato
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National Institute of Allergy and Infectious Diseases...Johns Hopkins Bloomberg School of Public HealthCompletato