Correlation Study of Isotype Switching and Neutralizing Capacity to the COVID-19 Variants Strain
19. oktober 2021 oppdatert av: Wu Jiang, Centers for Disease Control and Prevention, China
Study on the Correlation of Isotype Switching, Neutralizing Antibody Titer and Cross Immunity Against COVID-19 Variants After Primary and Booster Vaccination
The level of neutralizing antibody was detected by using the constructed pseudovirus covid-19 variant at baseline , 1 month , 6 months and 12 months after primary vaccination, within 15 days after booster immunization at 12 months .
and the ability of IgG subclasses to neutralize and cross immunization of variant strains was analyzed.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Detaljert beskrivelse
In 150 individuals who received primary and booster COVID-19 inactivated vaccine, the neutralization ability of antibodies against covid-19 mutant after primary and booster immunization was evaluated by constructing pseudotyped SARS-CoV-2 variants.
The contribution and influence of IgG subclasses on neutralization capacity were assessed by Elisa assay.
All participants were recruited aged between 18 and 59 years old.
Every participant was familiarized with the aim of the study and asked to sign an informed consent agreement and was required blood sampling at the day 0 of first dose vaccine and 1 month, 6 months after 2nd dose of primary immunization.
All participants had received 1 dose of booster immunization at 12 months after fully primary vaccination.
Then 150 people were divided into four groups, Blood samples were taken on days 0,3,7,10 and 14 to detect neutralizing antibodies and IgG subclasses separately.
every sample was detected SARS-CoV-2 variants strain Alpha, Beta and Delta neutralizing antibody, and RBD-IgG1, IgG2, IgG3, and IgG4.
every individual was conducted a detailed analysis correlation of isotype switching, neutralizing antibody titer and cross immunity against COVID-19 variants after primary and booster vaccination.
Studietype
Observasjonsmessig
Registrering (Faktiske)
150
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Beijing, Kina, 100013
- Center for Disease Control and Prevention
-
-
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 59 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
The healthy people aged between 18 and 59, and have not been infected with COVID-19, have not been vaccinated with COVID-19 vaccine, and agree to collect blood samples.
Beskrivelse
Inclusion Criteria:
- Between the ages of 18 and 59
- Healthy
- No vaccination with COVID-19 before become participant
- Agreed to take a blood sample
Exclusion Criteria:
- who cannot take the COVID-19 vaccine due to some personal reasons
- history of SARS-CoV, SARS-CoV-2, or Middle East respiratory syndrome infection
- high-risk epidemiology history within 14 days before enrolment (eg, travel or residence history in communities with case reports, or contact history with someone infected with SARS-CoV-2)
- axillary temperature of more than 37·0℃
- history of allergy to any vaccine component.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Neutralizing capabilities to variant COVID-19 after primary and booster vaccination
Tidsramme: Baseline，After fully vaccinated 1 and 6 months，Within 15 days after booster immunization at 12 months
|
The titers of neutralizing antibodies against live SARS-CoV-2 and Pseudotyped SARS-CoV-2 Variants strain Alpha, Beta and Delta at baseline, after fully vaccinated 1 and 6 months and Within 15 days after booster immunization at 12 months. The neutralizing antibodies was defined as a change from seronegative at baseline to seropositive or a four-fold titer increase. The positive cutoff of the titer for neutralizing antibodies was 1/30. |
Baseline，After fully vaccinated 1 and 6 months，Within 15 days after booster immunization at 12 months
|
|
Titer of Subclass of IgG after primary and booster vaccination
Tidsramme: Baseline，After fully vaccinated 1 and 6 months，Within 15 days after booster immunization at an interval of 12 months
|
The titers of Subclass RBD-specific IgG1, IgG2,IgG3 and IgG4 at baseline, after fully vaccinated 1 and 6 months and Within 15 days after booster immunization at an interval of 12 months.
The positive for IgG1, IgG2,IgG3 and IgG4 antibodies are defined as the sample titer value ≥1/20.
|
Baseline，After fully vaccinated 1 and 6 months，Within 15 days after booster immunization at an interval of 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Titer of subclass of IgG at different points in time after booster vaccination
Tidsramme: 0,3,7,10,14 days
|
Titer of subclass of IgG at 0,3,7,10,14 days after booster vaccination.
The positive for IgG1, IgG2,IgG3 and IgG4 antibodies are defined as the sample titer value ≥1/20.
|
0,3,7,10,14 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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 (Faktiske)
20. juli 2020
Primær fullføring (Faktiske)
10. oktober 2021
Studiet fullført (Forventet)
30. oktober 2021
Datoer for studieregistrering
Først innsendt
19. oktober 2021
Først innsendt som oppfylte QC-kriteriene
19. oktober 2021
Først lagt ut (Faktiske)
21. oktober 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. oktober 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. oktober 2021
Sist bekreftet
1. oktober 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BJCDCWJ202102
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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Nei
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