Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults
17. januar 2008 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)
Phase I Study of the Safety and Immunogenicity of rDEN1delta30, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 1
Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world.
The purpose of this study is to test the safety of and immune response to a new dengue virus vaccine in healthy adults.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
28
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Maryland
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Baltimore, Maryland, Forenede Stater, 21205
- Center for Immunization Research, Johns Hopkins School of Public Health
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 50 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Eksperimentel: 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.
|
Live attenuated rDEN1delta30 vaccine
|
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Placebo komparator: 3
One subcutaneous vaccination with placebo into the deltoid region of either arm.
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Placebo for rDEN1delta30
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Determine the frequency of vaccine related AEs for each dose graded by severity
Tidsramme: Throughout study
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Throughout study
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Determine the amount of dengue 1 neutralizing antibody induced by the vaccine
Tidsramme: At Day 42
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At Day 42
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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At vurdere holdbarheden af antistofresponset
Tidsramme: På dag 180
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På dag 180
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At vurdere hyppigheden, mængden og varigheden af viræmi i hver undersøgt dosiskohorte
Tidsramme: Gennem hele studiet
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Gennem hele studiet
|
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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
Tidsramme: 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
Tidsramme: At study completion
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At study completion
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At evaluere den immunopatologiske mekanisme af vaccine-associeret udslæt hos de frivillige, der er villige til at gennemgå hudbiopsi
Tidsramme: Gennem hele studiet
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Gennem hele studiet
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Anna Durbin, MD, Center for Immunization Research, John Hopkins School of Public Health
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2004
Primær færdiggørelse (Faktiske)
1. november 2005
Studieafslutning (Faktiske)
1. november 2005
Datoer for studieregistrering
Først indsendt
17. august 2004
Først indsendt, der opfyldte QC-kriterier
18. august 2004
Først opslået (Skøn)
19. august 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. januar 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. januar 2008
Sidst verificeret
1. januar 2008
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CIR 199
- H.22.04.04.23.B2
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med rDEN1delta30
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National Institute of Allergy and Infectious Diseases...Johns Hopkins Bloomberg School of Public HealthAfsluttetDengue hæmoragisk feberForenede Stater
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National Institute of Allergy and Infectious Diseases...Johns Hopkins Bloomberg School of Public HealthAfsluttetDengueForenede Stater