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Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects

2 dicembre 2014 aggiornato da: Novartis Vaccines

A Phase III, Multicenter, Observer-blind, Safety and Immunogenicity Study of Rabies Vaccine and Japanese Encephalitis Vaccine Administered Concomitantly and/or Separately According to 1 of 2 Different Preexposure Prophylaxis Schedules to Healthy Adult Subjects.

Establish non-inferiority of the immune response and evaluate the safety and tolerability of Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to either of 2 schedules for preexposure prophylaxis.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

661

Fase

  • Fase 3

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

  • Austria
    • Vienna
      • Kinderspitalgasse 15, Vienna, Austria, A-1090
        • Institute of Specific Prophylaxis and Tropical Medicine Center for Pathophysiology, Infectious Diseases and Immunology Medical University of Vienna
  • Germania
    • Hamburg
      • Bernhard-Nocht-Strasse 74, Hamburg, Germania, D-20359
        • Bernhard Nocht Institute for Tropical Medicine
  • Svizzera
    • Zürich
      • Rämistrasse 71, Zürich, Svizzera, CH-8006
        • The University of Zurich

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 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Males and females between 18 and 65 years of age (inclusive).
  2. Subjects who have given written consent.
  3. Individuals in good health as per investigator judgement.

Exclusion Criteria:

  1. If female, pregnancy or unwillingness to practice acceptable contraception.
  2. If female, pregnant or breast-feeding or any positive/indeterminate pregnancy test.
  3. Contraindication or precaution against Rabies and Japanese Encephalitis vaccination.
  4. Unable to comprehend and to follow all required study procedures for the whole period of the study.
  5. Participating in any other clinical trial 30 days prior to first study visit.
  6. History of previous rabies/rabies immunoglobulin and/or Japanese Encephalitis immunization.
  7. Receiving or planning to receive anti-malarial medications (e.g. Mefloquine) 14 days prior to Day 1 vaccination through Day 43.
  8. Received any other vaccines within 2 weeks prior to enrollment in this study or plan to receive any vaccine within 4 weeks from the study vaccines.
  9. Ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
  10. Individuals who are part of study personnel or close family members conducting this study.
  11. Body temperature ≥38 degrees Celsius (≥ 100.4° F) within 3 days of intended study vaccination.
  12. Plans to travel within the next year to areas where Rabies and/or Japanese Encephalitis vaccine may be considered or offered. This includes but is not limited to India, Asia, Pacific-Rim, African countries.

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: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: R/JE - Conv
Subjects received Rabies and Japanese Encephalitis (JE) vaccines following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
Biologico: Rabies
Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).
Biologico: Japanese Encephalitis
Subjects received two doses of Japanese Encephalitis vaccine.
Altro: Placebo
Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
Sperimentale: R/JE - Acc
Subjects received Rabies and JE vaccines following the accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
Biologico: Rabies
Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).
Biologico: Japanese Encephalitis
Subjects received two doses of Japanese Encephalitis vaccine.
Altro: Placebo
Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
Comparatore attivo: R - Conv
Subjects received Rabies vaccine following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
Biologico: Rabies
Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).
Altro: Placebo
Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
Comparatore attivo: JE - Conv
Subjects received JE vaccine following the conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
Biologico: Japanese Encephalitis
Subjects received two doses of Japanese Encephalitis vaccine.
Altro: Placebo
Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination
Lasso di tempo: Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule)

Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule.

As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.
Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule)
Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination
Lasso di tempo: Day 28 after last active vaccination (day 36 - group that received accelerated schedule, day 57 - group that received conventional schedule)

Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule.

As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.
Day 28 after last active vaccination (day 36 - group that received accelerated schedule, day 57 - group that received conventional schedule)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination
Lasso di tempo: Day 57 (28 days after last active vaccination)

Immune response was measured as the RVNA GMCs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.

Data were adjusted using ANOVA model, as per protocol specification.
Day 57 (28 days after last active vaccination)
PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination
Lasso di tempo: Day 57 (28 days after last active vaccination)

Immune response was measured as the PRNT50 GMTs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.

Data were adjusted using ANOVA model, as per protocol specifications.
Day 57 (28 days after last active vaccination)
Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination
Lasso di tempo: Day 36 and day 57 (28 days after last active vaccination)

Immune response was measured as the percentages of subjects with RVNA concentration ≥0.5 IU/mL 28 days after last active vaccination, ie, day 36 for the group that received the accelerated schedule and day 57 for the group that received the conventional schedule.

As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.
Day 36 and day 57 (28 days after last active vaccination)
Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination
Lasso di tempo: Day 15 and day 36 (28 after last active vaccination)

Immune response was measured as the percentage of subjects with PRNT50 titer of ≥1:10 7 days after last active vaccination, ie, day 15 for the group that received the accelerated schedule and day 36 for the group that received the conventional schedule.

As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.
Day 15 and day 36 (28 after last active vaccination)
Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL
Lasso di tempo: Day 1, 8, 15, 36, 57, 91, 181 and Day 366
To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the percentage of subjects with RVNA concentrations ≥0.5 IU/mL on days 1, 8, 15, 36, 57, 91, 181, and 366.
Day 1, 8, 15, 36, 57, 91, 181 and Day 366
Kinetics of Rabies Immune Response Measured as the RVNA GMCs
Lasso di tempo: Day 1, 8, 15, 36, 57, 91, 181, and 366
To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the RVNA GMCs on days 1, 8, 15, 36, 57, 91, 181, and 366.
Day 1, 8, 15, 36, 57, 91, 181, and 366
Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10
Lasso di tempo: Days 1, 15, 22, 36, 57, 91, 181 and 366
To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the percentage of subjects with PRNT50 titer ≥1:10 on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).
Days 1, 15, 22, 36, 57, 91, 181 and 366
Kinetics of JE Immune Response Measured as PRNT50 GMTs
Lasso di tempo: Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule)
To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the PRNT50 GMTs on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).
Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule)
Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination
Lasso di tempo: Day 1 through day 7 after each vaccination (on day 1, 4, 8 and 29)
Safety was assessed as the number of subjects who reported solicited local adverse events (AEs) after each rabies vaccination given according to accelerated or conventional schedule as follows: from day 1 through day 7 (vaccination on day 1; all Rabies groups), day 4 through day 10 (vaccination on day 4; in R/JE - Acc group only), day 8 through day 14 (vaccination on day 8; all Rabies groups), or day 29 through day 35 (vaccination on day 29; R/JE - Conv and R - Conv groups).
Day 1 through day 7 after each vaccination (on day 1, 4, 8 and 29)
Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination
Lasso di tempo: Day 1 through day 7 after each vaccination (on day 1, 8 and 29)
Safety was assessed as the number of subjects who reported solicited local AEs after each JE vaccination given according to accelerated or conventional schedule as follow: from day 1 through day 7 (vaccination on day 1; all JE groups), day 8 through day 14 (vaccination on day 8; R/JE - Acc group only), or day 29 through day 35 (vaccination on day 29; R/JE - Con and JE - Conv groups).
Day 1 through day 7 after each vaccination (on day 1, 8 and 29)
Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection
Lasso di tempo: Day 1 through day 7 after each injection (day 1, 4, 8 and 29)
Safety was assessed as the number of subjects who reported solicited local AEs after each placebo injection given according to accelerated and conventional schedule as follow: from day 1 through day 7 (injection on day 1; R - Conv and JE - Conv groups), day 4 through day 10 (injection on day 4; in R/JE - Conv, R - Conv and JE - Conv groups), day 8 through day 14 (injection on day 8; in R/JE - Conv, R - Conv and JE - Conv groups), and day 29 through day 35 (injection on day 29; R/JE - Acc, R - Con and JE - Conv groups).
Day 1 through day 7 after each injection (day 1, 4, 8 and 29)
Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination
Lasso di tempo: Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29)
Safety was assessed as the number of subjects who reported solicited systemic AEs and other indicators of reactogenicity after each vaccination given according to accelerated and conventional schedule.
Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29)
Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57
Lasso di tempo: Day 1 through Day 57
Safety was assessed as the number of subjects who reported unsolicited AEs after any vaccination given according to accelerated and conventional schedule.
Day 1 through Day 57

Collaboratori e investigatori

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

Sponsor

Novartis Vaccines

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 agosto 2012

Completamento primario (Effettivo)

1 dicembre 2012

Completamento dello studio (Effettivo)

1 ottobre 2013

Date di iscrizione allo studio

Primo inviato

2 agosto 2012

Primo inviato che soddisfa i criteri di controllo qualità

7 agosto 2012

Primo Inserito (Stima)

10 agosto 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

8 dicembre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 dicembre 2014

Ultimo verificato

1 dicembre 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • V49_23
  • 2011-005173-23 (Numero EudraCT)

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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