- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21205
- Johns Hopkins School of Public Health
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
One subcutaneous vaccination with a 10^3 PFU dose of rDEN2/4delta30(ME) vaccine given in the deltoid region of either arm.
|
Live attenuated rDEN2/4delta30(ME) vaccine (one of two doses)
|
Eksperimentel: 2
One subcutaneous vaccination with a 10^5 PFU dose of rDEN2/4delta30(ME) vaccine given in the deltoid region of either arm.
|
Live attenuated rDEN2/4delta30(ME) vaccine (one of two doses)
|
Placebo komparator: 3
One subcutaneous vaccination with a placebo vaccine given in the deltoid region of either arm.
|
Placebo for rDEN2/4delta30(ME) vaccine
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Frequency and severity of vaccine-related adverse effects for each dose graded by severity
Tidsramme: Throughout study
|
Throughout study
|
Amount of dengue 2 neutralizing antibody induced by the vaccine
Tidsramme: At Day 42
|
At Day 42
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
At vurdere hyppigheden, mængden og varigheden af viræmi i hver undersøgt dosiskohorte
Tidsramme: Gennem hele studiet
|
Gennem hele studiet
|
If both doses of vaccine are administered, to compare the infectivity rates, safety, and immunogenicity between dose groups
Tidsramme: At study completion
|
At study completion
|
At evaluere den immunopatologiske mekanisme af vaccine-associeret udslæt hos de frivillige, der er villige til at gennemgå hudbiopsi
Tidsramme: Gennem hele studiet
|
Gennem hele studiet
|
To assess the durability of the antibody response out to Day 180
Tidsramme: Throughout study
|
Throughout study
|
To determine the number of vaccinees infected with rDEN2/4delta30(ME)
Tidsramme: Throughout study
|
Throughout study
|
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
Tidsramme: Throughout study
|
Throughout study
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CIR 189
- H.22.03.09.26.A2
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Kliniske forsøg med rDEN2/4delta30(ME) Vaccine
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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