- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02559921
Safety and Immunogenicity Study of Recombinant Human Rabies Immunoglobin (rhRIG) in Combination With Rabies Vaccine for Human Use With Human Rabies Immune Globulin (HRIG) in Combination With Rabies Vaccine for Human Use in Healthy Adult Subjects.
19. januar 2016 oppdatert av: Beijing Chaoyang District Centre for Disease Control and Prevention
This study evaluates the rabies virus neutralizing antibody (RVNA) activities ,safety and tolerability of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects.The study has 7 groups.Subjects will receive rhRIG(20 IU/kg)only, rhRIG(40 IU/kg)only,HRIG(20 IU/kg)only, rhRIG(20 IU/kg)in combination with rabies vaccine for human use, rhRIG(40 IU/kg)in combination with rabies vaccine for human use,HRIG(20 IU/kg)in combination with rabies vaccine for human use,and placebo in combination with rabies vaccine for human use,respectively.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
300
Fase
- Fase 2
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 55 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Male or female subjects aged at least 18 years but not more than 55 years;
- According to medical history, physical examination and clinical judgment of investigator at enrollment, subjects should have no significant health problems, or their health status or medication treatment remain stable;
- Subjects and their spouses should use adequate contraceptive methods from the screening day to Day 90;
- Male subjects must agree not to donate sperm from the first day of enrollment to Day 90;
- Subjects should sign a written Informed Consent Form;
Exclusion Criteria:
- Previous exposure or immunization histories of rabies (rabies vaccine and/or immunoglobulin);
- According to the clinical judgment of investigator, subjects had clinically significant acute disease or infection, including pyrexia (>37.0℃) within 2 weeks before the initial dose;
- After review of medical history or physical examination results, it is found that subjects have medical histories of abnormalities of heart, liver, kidney, blood, digestive tract, nervous system, spirit and metabolism;
- Subjects are pregnant or plan to become pregnant or are breast-feeding during the study;
- According to the judgment of investigator, subjects have clinically significant immunodeficiency or medical history and/or family history of autoimmune disease;
- According to the judgment of investigator, subjects have known or suspected clinically significant anaphylaxis or hypersensitivity reactions;
- Immunization has been arranged for the subjects within the next 3 months after the initial dose;
- Subjects have used immunosuppressive preparations or other immunomodulating agents for more than 14 days within 6 months before the initial dose of study drug;
- Subjects used hormone agents within 3 days before the initial dose;
- Subjects donated blood or lost a lot of blood within 56 days before the initial dose;
- Subjects donated plasma within 7 days before the initial dose;
- Subjects received transfusion of blood or blood products within 6 months before the initial dose;
- It is suspected that subjects do not follow study procedures;
- Intake of alcohol within 12 hours before the initial dose;
- Subjects smoke more than 20 cigarettes a day;
- Subjects are obviously allergic to antibiotics;
- Any other conditions which may affect trial assessment at the discretion of the investigator;
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: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: rhRIG(20 IU/kg)only
Subjects received rhRIG(20 IU/kg) on day 0
|
|
|
Eksperimentell: rhRIG(40 IU/kg)only
Subjects received rhRIG(40 IU/kg) on day 0
|
|
|
Aktiv komparator: HRIG(20 IU/kg)only
Subjects received HRIG(20 IU/kg)on day 0
|
|
|
Eksperimentell: rhRIG(20 IU/kg)+ vaccine
Subjects received rhRIG(20 IU/kg)in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28
|
|
|
Eksperimentell: rhRIG(40 IU/kg)+ vaccine
Subjects received rhRIG(40 IU/kg)in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28
|
|
|
Eksperimentell: HRIG(20 IU/kg)+ vaccine
Subjects received HRIG(20 IU/kg)in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28
|
|
|
Placebo komparator: placebo + vaccine
Subjects received placebo in combination with rabies vaccine for human use on day 0 and received vaccine only on days 3,7,14,28
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Evaluate the detection rate of the rabies virus neutralizing antibody (RVNA) activities of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects
Tidsramme: 42 days
|
42 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Evaluate the rate of adverse reactions of rhRIG or HRIG in combination with rabies vaccine for human use (Vero cells) in healthy subjects
Tidsramme: 42 days
|
42 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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
- Li L, Li Y, Bai Y, Li G, Zhang J, Yang L, Zhao W, Zhao W, Luo F, Zhao Q, Zhang Z, Liu Y, Li S, Lu Q, Wang H, Zhang J, Zhang Y, Gao J, Shi N. Neutralizing antibody activity, safety and immunogenicity of human anti-rabies virus monoclonal antibody (Ormutivimab) in Chinese healthy adults: A phase Ⅱb randomized, double-blind, parallel-controlled study. Vaccine. 2022 Oct 6;40(42):6153-6162. doi: 10.1016/j.vaccine.2022.09.022. Epub 2022 Sep 16.
- Zhang J, Shi N, Li G, Li L, Bai Y, Yang L, Zhao W, Gao J, Wei J, Zhao W, Zhai L, Huo P, Ren L, Yu L, Li Y. Population Pharmacodynamic Analyses of Human Anti-Rabies Virus Monoclonal Antibody (Ormutivimab) in Healthy Adult Subjects. Vaccines (Basel). 2022 Jul 29;10(8):1218. doi: 10.3390/vaccines10081218.
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. desember 2014
Primær fullføring (Faktiske)
1. august 2015
Studiet fullført (Faktiske)
1. desember 2015
Datoer for studieregistrering
Først innsendt
23. september 2015
Først innsendt som oppfylte QC-kriteriene
24. september 2015
Først lagt ut (Anslag)
25. september 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. januar 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. januar 2016
Sist bekreftet
1. september 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- cycdc2015-3
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .