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Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3delta30/31-7164) in Healthy Adults

13 novembre 2013 aggiornato da: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase I Dose Comparison Study of the Safety and Immunogenicity of rDEN3delta30/31-7164, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 3

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 rDEN3delta30/31-7164.

This study will consist of two groups, with Group 1 enrolling first. Group 1 participants will be randomly assigned to receive either 10^3 PFU of rDEN3delta30/31-7164 or placebo subcutaneously in their deltoid. Participants will be monitored at the clinic for 30 minutes after receiving the immunization to monitor for adverse effects. After that, participants will be asked to return to the clinic approximately every other day for the next 16 days, and then on Day 21, 28, 42, and 180. At each visit participants will have physical and clinical exams, vital signs, measures, blood drawn, and will be asked about any adverse events they may have experience. Female participants will be given a pregnancy test. In addition, participants will be asked to measure their temperature 3 times a day and record it in a temperature diary for the first 16 days after immunization.

If less than 90% of the participants in Group 1 seroconvert to DEN3 then Group 2A will be enrolled. Group 2A will follow the same procedures as Group 1, but will receive a 10^5 PFU dose of rDEN3delta30/31-7164.

If more than 90% of the participants in Group 1 seroconvert to DEN3 then Group 2B will be enrolled. Group 2A will follow the same procedures as Group 1, but will receive a 10^1 PFU dose of rDEN3delta30/31-7164.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

56

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Maryland
      • Baltimore, Maryland, Stati Uniti
        • Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 50 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Adult male or non-pregnant female between 18 and 50 years of age, inclusive.
  • Good general health as determined by physical exam, laboratory screening, and review of medical history
  • Available for the duration of the study, approximately 26 weeks post-vaccination
  • Willing to use effective means of contraception for the duration of the trial

Exclusion Criteria:

  • Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
  • Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer to understand and cooperate with the requirements of the study protocol
  • Grade 1 or above values for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as protocol defined
  • Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating n the trial or would render the volunteer unable to comply with the protocol
  • Any significant alcohol or drug abuse in the past 12 months which has caused medical, occupational, or family problems, as indicated by volunteer history
  • History of a severe allergic reaction or anaphylaxis
  • Severe asthma (emergency room visit or hospitalization within the last 6 months)
  • Positive HIV-1 serology by screening and confirmatory assays
  • Positive for hepatitis C virus (HCV) by screening and confirmatory assays
  • Positive for hepatitis B virus (HBV) by hepatitis B surface antigen (HBsAg) screening
  • Any known immunodeficiency syndrome
  • Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days prior to Study Day 0
  • Receipt of a live vaccine within 4 weeks or a killed vaccine within the 2 weeks prior to Study Day 0 or anticipated receipt of any vaccine during the 42 days following Study Day 0
  • History of a surgical splenectomy
  • Receipt of blood products within the past 6 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 42 days following Study Day 0
  • History or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus)
  • Previous receipt of yellow fever or dengue vaccine (licensed or experimental)
  • Receipt of any investigational agent in the 30 days prior to Vaccination Day 0 or plan to participate in any investigational drug trials during the next 26 weeks
  • Definite plans to travel to a dengue endemic area
  • Pregnancy or breastfeeding

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Group 1
Group 1 will consist of healthy participants receiving an immunization of 10^3 PFU rDEN3delta30/31-7164
Biologico: rDEN3delta30/31-7164
A live attenuated, recombinant DEN3 candidate vaccine virus
Sperimentale: Group 2

Group 2A will consist of healthy participants who will receive an immunization of 10^5 PFU of rDEN3delta30/31-7164 vaccine or placebo. Group 2A participants will be enrolled if less that 90% of Group 1 participants seroconvert to DEN3 by Study Day 42.

Group 2B will consist of healthy participants who will receive an immunization of 10^1 PFU of rDEN3delta30/31-7164 vaccine or placebo. Group 2B participants will be enrolled if more that 90% of Group 1 participants seroconvert to DEN3 by Study Day 42.
Biologico: rDEN3delta30/31-7164
A live attenuated, recombinant DEN3 candidate vaccine virus

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Determine the safety of a single dose of the rDEN3Δ30/31-7164 vaccine, as assessed by the frequency, severity, and seriousness of vaccine related adverse events (AEs).
Lasso di tempo: Throughout study
Throughout study
Determine the immunogenicity of a single dose of the rDEN3delta30/31-7164 vaccine, as assessed by neutralizing antibody titers to DEN3 at 4 weeks and 6 weeks after vaccination
Lasso di tempo: Throughout study
Throughout study

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Assess the frequency, quantity, and duration of viremia after a single dose of vaccine
Lasso di tempo: Throughout study
Throughout study
Determine the number of vaccinees infected with rDEN3delta30/31-7164. Infection is defined as recovery of vaccine virus from the blood or serum of a volunteer and/or by seroconversion to DEN3 (a ≥4-fold rise in DEN3 neutralizing antibody titers).
Lasso di tempo: Throughout study
Throughout study
Compare the infectivity rates, safety, and immunogenicity of a single dose of rDEN3delta30/31-7164 vaccine between the dose level groups.
Lasso di tempo: Throughout study
Throughout study
Determine the durability of antibody response 26 weeks after vaccination
Lasso di tempo: At 26 weeks
At 26 weeks
Obtain an estimate for the Human Infectious Dose-50% (HID50) if dose dependent infectivity is observed
Lasso di tempo: Throughout study
Throughout study
Evaluate the phenotype of peripheral blood mononuclear cells at primary infection with the rDEN3delta30/31-7164 vaccine.
Lasso di tempo: Throughout study
Throughout study
Evaluate the cellular and humoral immune response to primary infection with the rDEN3delta30/31-7164 vaccine
Lasso di tempo: Throughout study
Throughout study

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaboratori

Johns Hopkins Bloomberg School of Public Health

Investigatori

  • Cattedra di studio: Anna Durbin, MD, Center for Immunization Research (CIR), Johns Hopkins School of Public Health

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2009

Completamento primario (Effettivo)

1 giugno 2011

Date di iscrizione allo studio

Primo inviato

27 gennaio 2009

Primo inviato che soddisfa i criteri di controllo qualità

27 gennaio 2009

Primo Inserito (Stima)

28 gennaio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

15 novembre 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 novembre 2013

Ultimo verificato

1 novembre 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CIR 257

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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