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Safety and Immune Response to an Investigational Dengue Type 2 Vaccine

31. desember 2012 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

18

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20037
        • Johns Hopkins Project SAVE, Center for Immunization Research

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 50 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Participants will receive a single dose of placebo vaccine.
Annen: Placebo
Subkutan injeksjon av placebo
Eksperimentell: Dengue Virus Subtype 2 Vaccine
Participants will receive a single dose of investigational vaccine for dengue virus subtype 2.
Biologisk: Investigational Vaccine for Dengue Virus Subtype 2
Subcutaneous injection in upper arm of vaccine at dose of 10 plaque-forming units (PFU)
Andre navn:
  • rDEN2/4Δ30

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Immunogenicity of vaccine, as assessed by neutralizing antibody titers
Tidsramme: 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
Tidsramme: 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
Tidsramme: Measured at Days 28 and 42
Measured at Days 28 and 42

Sekundære resultatmål

Resultatmål
Tidsramme
Frequency, quantity, and duration of viremia
Tidsramme: 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
Tidsramme: Measured at study completion
Measured at study completion

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2010

Primær fullføring (Faktiske)

1. juni 2010

Studiet fullført (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først innsendt

19. februar 2010

Først innsendt som oppfylte QC-kriteriene

19. februar 2010

Først lagt ut (Anslag)

23. februar 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

3. januar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. desember 2012

Sist bekreftet

1. desember 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CIR 254
  • #20081980 (Annen identifikator: WIRB Protocol Number)

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