Cross-neutralization Capacity of Immune Serum From Different Dosage of Sabin Inactivated Poliovirus Vaccine Immunization
2. november 2020 opdateret af: Sinovac Biotech Co., Ltd
Cross-neutralization Capacity of Immune Serum From Different Dosage of Sabin Inactivated Poliovirus Vaccine Immunization Against Multiple Individual Wild and Vaccine-derived Polioviruses, Supplementary Study of a Phase 2 Clinical Trial.
This study is a supplementary study of an already finished randomised, double-blinded, and placebo controlled phase 2 clinical trial of an Sabin strain inactivated poliovirus vaccine (sIPV) manufactured by Sinovac Biotech Ltd., Beijing China.
The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
- Biologisk: Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses
- Biologisk: Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses
- Biologisk: Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses
- Biologisk: Three doses of control wIPV, vaccinated within one-month interval between doses
- Biologisk: Three doses of control sIPV, vaccinated within one-month interval between doses
Detaljeret beskrivelse
This study is a open-labelled study conducted based on an already finished phase 2 study of the investigational sIPV in 600 healthy infants aged 2-months old. The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains. Paired pre-immune and post-immune serum from 250 participants of the phase 2 trial, with 50 in each group including the low-, medium- and high- dosage group, control wild poliovirus vaccine (wIPV) group and control sIPV group, was selected and sent to China Center for Disease Control and Prevention (CDC) for the cross-neutralization assay to determine the neutralizing antibody titer against 10 individual virus strains including Sabin strains (type 1, 2, and 3), Salk strains (Mahoney, MEF-1, and Saukett), cVDPV (type 1, 2, and 3) and Xinjiang wild strain of type 1(Xinjiang wIPV1).
All the subjects in this study had been vaccinated at the schedule of month 0,1, and 2 in the phase 2 clinical trial.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
250
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Jiangsu
-
Pizhou, Jiangsu, Kina, 221300
- Pizhou Center for Disease Control and Prevention
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
2 måneder til 2 måneder (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Participants of the already finished phase 2 clinical trial;
- Subjects who received the three-doses full schedule vaccination required in the phase 2 tril and can provide the backup paired pre-immune and post-immune serum collected in the phase trial;
- Provide written informed consent.
Exclusion Criteria:
- None.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Low-dosage experimental group
Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses
|
Antigen content: 7.5, 22.5, and 22.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
|
|
Eksperimentel: Medium-dosage experimental group
Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses
|
Antigen content: 15, 45, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
|
|
Eksperimentel: High-dosage experimental group
Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses
|
Antigen content: 22.5, 67.5, and 67.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
|
|
Aktiv komparator: Control wIPV group
Three doses of control wIPV, vaccinated within one-month interval between doses
|
Antigen content: 40, 8, and 32 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
|
|
Aktiv komparator: Control sIPV group
Three doses of control sIPV, vaccinated within one-month interval between doses
|
Antigen content: 30, 32, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Immunity index of seroconversion rate
Tidsramme: One month after three doses of vaccination
|
The seroconversion rates of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2， Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1)
|
One month after three doses of vaccination
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Immunity index of geometric mean titer (GMT)
Tidsramme: One month after three doses of vaccination
|
The GMT of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2， Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1)
|
One month after three doses of vaccination
|
|
Immunity index of geometric mean ratio (GMR)
Tidsramme: One month after three doses of vaccination
|
The GMR of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2， Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1)
|
One month after three doses of vaccination
|
|
Immunity index of seropositivity rate
Tidsramme: One month after three doses of vaccination
|
The seropositivity rate of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2， Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1)
|
One month after three doses of vaccination
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Yuemei Hu, Bachelor, Jiangsu Provincial Center for Disease Control and Prevention
Datoer for undersøgelser
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Studer store datoer
Studiestart (Faktiske)
20. juli 2019
Primær færdiggørelse (Faktiske)
10. december 2019
Studieafslutning (Faktiske)
10. januar 2020
Datoer for studieregistrering
Først indsendt
2. november 2020
Først indsendt, der opfyldte QC-kriterier
2. november 2020
Først opslået (Faktiske)
6. november 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. november 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2020
Sidst verificeret
1. november 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PRO-sIPV-1001-1
Plan for individuelle deltagerdata (IPD)
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