Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins
Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins for Post-exposure Rabies Treatment
Studienübersicht
Detaillierte Beschreibung
- Controlled trial study
- All 75 volunteers who had never had rabies immunization would be enrolled and designated into 3 groups.
group 1 : 25 Healthy volunteers age 18 - 60 yr who were attacked by mammals, possible exposed to rabies and had WHO category III exposure, all receive standard post - exposure rabies treatment with 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 IU/kg of equine rabies immune globulin (ERIG).
group 2 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,14 and 40 IU/kg of equine rabies immune globulin (ERIG).
group 3 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,28 and 40 IU/kg of equine rabies immune globulin (ERIG).
5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28, 90 and 360 for rabies neutralizing antibody titers (RNab).
The GMTs of RNab among both groups would be analyzed and compared.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Bangkok, Thailand, 10330
- Queen Saovabha Memorial Institute
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- healthy volunteers age 18-60 years.
Exclusion Criteria:
- received prior rabies immunization
- pregnancy
- immunocompromised conditions
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Rabies vaccine, IM day 0,3,7,28 with RIG
Healthy volunteers received rabies vaccination intramuscularly on day 0,3,7 and 28 with equine rabies immunoglobulin 40 IU/Kg on day 0.
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Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0. Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0. Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0.
Andere Namen:
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Experimental: Rabies vaccine, IM day 0,3,7,14 with RIG
Healthy volunteers received rabies vaccination intramuscularly on day 0,3,7 and 14 with equine rabies immunoglobulin 40 IU/Kg on day 0.
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Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0. Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0. Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0.
Andere Namen:
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Aktiver Komparator: Rabies vaccine, IM Day 0,3,7,14,28 with RIG
Rabies exposed victims receive rabies vaccination intramuscularly on Day 0,3,7,14,28 with equine rabies immunoglobulin 40 IU/Kg on day 0
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Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0. Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0. Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14
Zeitfenster: Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period
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Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14 would be determined on day 0,14, 28, 90 and 360.
Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.
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Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,28
Zeitfenster: Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period
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Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7 and 28 would be determined on day 0,14, 28, 90 and 360.
Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.
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Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Suda Sibunruang, MD, Queen Saovabha Memorial Institute
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RC5502
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