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Safety and Immune Response to an Investigational Dengue Type 2 Vaccine

31 december 2012 bijgewerkt door: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase I Evaluation of the Safety and Immunogenicity of rDEN2/4 Δ30(ME) Dengue Serotype 2 Vaccine Given at 10^1 PFU in Healthy Flavivirus-naïve Adult Subjects

Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. This study will test whether a vaccine developed to prevent infection with dengue virus type 2 causes a response in people's immune system and is safe.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Dengue viruses cause approximately 50 million cases of dengue fever and 1.5 million cases of the more severe diseases dengue hemorrhagic fever (DHS) and dengue shock syndrome (DSS) every year. There are four subtypes of the virus, and infection with one offers no protection from infection by the others. In fact, most cases of DHS and DSS occur in people infected by more than one subtype. In areas of the world where multiple subtypes of dengue are common, vaccines must be developed against each of the subtypes of dengue virus. This study will examine the safety and immune response of an investigational vaccine for preventing dengue virus type 2.

Participation in this study will last about 6 weeks. Participants will be randomly assigned to be injected with either the investigational study vaccine or a placebo. Participants will have a five in six chance of receiving the vaccine. The first study visit will take place on the vaccination day, on which participants will undergo a physical examination, blood draw, and pregnancy test and then receive the vaccine. Participants will be given a thermometer and temperature card and be told to record their temperatures three times per day for 16 days after vaccination. Participants will come to follow-up visits every other day for the 16 days after vaccination and then 3, 4, and 6 weeks after vaccination (Days 21, 28, and 42). Assessments completed during these visits will include a questionnaire about how the participant is feeling, pregnancy test, review of temperature cards, blood draw, and physical exam. Blood drawn will be analyzed to check participants' health, determine the amount of vaccine and antibodies in the blood, test markers in white blood cells and genes, and look for proteins that are important for fighting dengue infection.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

18

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • District of Columbia
      • Washington, District of Columbia, Verenigde Staten, 20037
        • Johns Hopkins Project SAVE, Center for Immunization Research

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 50 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Good general health as determined by physical examination, laboratory screening, and review of medical history
  • Available for the duration of the study, approximately 6 weeks post-vaccination
  • Female participants of childbearing potential must be willing to use effective contraception for the duration of the trial

Exclusion Criteria:

  • Currently breastfeeding or pregnant
  • Exhibits evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
  • Presence of a behavioral, cognitive, or psychiatric disease that affects the ability of the participant to understand and cooperate with the requirements of the study protocol
  • Has screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in protocol
  • Presence of any condition that would jeopardize the safety or rights of the participant or would render the participant unable to comply with the protocol
  • Significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by participant history
  • History of a severe allergic reaction or anaphylaxis
  • Presence of severe asthma, defined as requiring emergency room visit or hospitalization within the last 6 months
  • Presence of HIV infection, determined by screening and confirmatory assays
  • Presence of hepatitis C virus (HCV) infection, determined by screening and confirmatory assays
  • Presence of hepatitis B virus (HBV) infection, determined by hepatitis B surface antigen (HBsAg) screening
  • Presence of any known immunodeficiency syndrome
  • Uses anticoagulant medications
  • Has used corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 days prior to or following vaccination. An immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg prednisone or equivalent per day for greater than or equal to 14 days.
  • Has received a live vaccine within 28 days or a killed vaccine within 14 days prior to vaccination or anticipates receipt of any vaccine during the 42 days following vaccination
  • Has no spleen
  • Has received blood products within the past 6 months, including transfusions or immunoglobulin, or anticipates receipt of any blood products or immunoglobulin during the 42 days following vaccination
  • History or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus)
  • Has received a flavivirus vaccine (licensed or experimental)
  • Anticipates receipt of any investigational agent in the 42 days before or after vaccination
  • Has definite plans to travel to a dengue endemic area during the study

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo
Participants will receive a single dose of placebo vaccine.
Ander: Placebo
Subcutane injectie van placebo
Experimenteel: Dengue Virus Subtype 2 Vaccine
Participants will receive a single dose of investigational vaccine for dengue virus subtype 2.
Biologisch: Investigational Vaccine for Dengue Virus Subtype 2
Subcutaneous injection in upper arm of vaccine at dose of 10 plaque-forming units (PFU)
Andere namen:
  • rDEN2/4Δ30

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Immunogenicity of vaccine, as assessed by neutralizing antibody titers
Tijdsspanne: Measured at 4 and 6 weeks after vaccination
Measured at 4 and 6 weeks after vaccination
Safety of vaccine, as assessed by the frequency of vaccine-related adverse events (AEs), graded by severity
Tijdsspanne: Measured throughout study
Measured throughout study
Number of vaccinees infected with this dengue virus subtype 2 (DEN2) candidate vaccine, as defined by either recovery of vaccine virus from the blood of vaccinated participants and/or by seroconversion to DEN2
Tijdsspanne: Measured at Days 28 and 42
Measured at Days 28 and 42

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Frequency, quantity, and duration of viremia
Tijdsspanne: Measured after vaccination
Measured after vaccination
Comparison of infectivity rates, safety, and immunogenicity of a single dose of DEN2 vaccine from this trial to those variables on previous trials
Tijdsspanne: Measured at study completion
Measured at study completion

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2010

Primaire voltooiing (Werkelijk)

1 juni 2010

Studie voltooiing (Werkelijk)

1 juni 2010

Studieregistratiedata

Eerst ingediend

19 februari 2010

Eerst ingediend dat voldeed aan de QC-criteria

19 februari 2010

Eerst geplaatst (Schatting)

23 februari 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

3 januari 2013

Laatste update ingediend die voldeed aan QC-criteria

31 december 2012

Laatst geverifieerd

1 december 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CIR 254
  • #20081980 (Andere identificatie: WIRB Protocol Number)

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