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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

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

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

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
      • Baltimore, Maryland, Forenede Stater, 21205
        • Johns Hopkins School of Public Health

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
  • 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

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
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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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.

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. januar 2005

Primær færdiggørelse (Faktiske)

1. april 2006

Studieafslutning (Faktiske)

1. april 2006

Datoer for studieregistrering

Først indsendt

21. oktober 2004

Først indsendt, der opfyldte QC-kriterier

21. oktober 2004

Først opslået (Skøn)

22. oktober 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. januar 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. januar 2008

Sidst verificeret

1. januar 2008

Mere information

Begreber relateret til denne undersøgelse

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 rDEN2/4delta30(ME) Vaccine

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Abonner