- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05124509
Immune Response to Third Dose of COVID-19 Vaccine in Solid Organ Transplant
Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Solid Organ Transplant Recipients
The Coronavirus Disease 2019 (COVID-19) pandemic has claimed over 5 million lives globally. Fortunately, a substantial and growing number of SARS-CoV-2 vaccines with very high efficacy have been developed, manufactured, and rapidly approved. Novel mRNA vaccines such as the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) have reported a stunning >94% efficacy against COVID-19. However, global access has not been equitable, with many low- and middle-income countries having no vaccine access or access under emergency use mainly to traditional inactivated SARS-CoV2-2 vaccines such as BBIBP-CorV (Sinopharm Beijing), CoronaVac (Sinovac) and BBV152 (Bharat Biotech). Emerging studies have shown that lower concentrations of neutralizing antibodies (Nab) are attained after CoronaVac than after an mRNA-based vaccine in healthy individuals. This difference seems to be more pronounced in immunocompromised patients who are at higher risk of severe COVID-19 and death from COVID-19. As such, several countries including the United States, Israel and Chile have recommended a third vaccine dose for high-risk populations. However, it is not currently known which is the best vaccine combination regarding immunogenicity, particularly in these vulnerable patients.
This observational study will explore the humoral and cellular response to a SARS-CoV-2 BNT162b2 vaccine booster in solid organ transplant patients who received two previous doses of the inactivated Coronavac or two doses of BNT162b2 vaccines.
Studieöversikt
Status
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
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Santiago, Chile
- Pontificia Universidad Catolica de Chile
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Solid organ transplant patients in the last 10 years and currently under immunosuppressive therapy
- Vaccination with two doses of Coronavac vaccine or BNT162b2 vaccines, followed by a booster dose (3d dose) of BNT162b2 vaccine administered in the previous 8-12 weeks.
Exclusion Criteria:
- Previous SARS-CoV-2 infection
- Booster vaccine (3rd dose) administered less than 8 weeks or more than 12 weeks before enrolment
- Intravenous immunoglobulin therapy 60 days before enrolment
- Previous SARS-CoV-2 vaccine different from CoronaVac or BNT162b2
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Three doses of BNT162b2 vaccine
Solid organ transplant patients who received three doses of BNT162b2
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Two doses of SARS-CoV-2 BNT162b2 mRNA vaccine, followed by a booster (3rd) dose of SARS-CoV-2 BNT162b2 mRNA vaccine.
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Two doses of Coronavac and one of BNT162b2 vaccine
Solid organ transplant patients who received two doses of CoronaVac and one dose of BNT162b2
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Two doses of CoronaVac SARS-CoV-2 inactivated vaccine, followed by a booster (3rd) dose of BNT162b2 mRNA vaccine.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
IgG seropositivity 8-12 weeks after third dose BNT162b2 (booster) vaccine.
Tidsram: 8-12 weeks after booster vaccine
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8-12 weeks after booster vaccine
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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster) vaccine.
Tidsram: 8-12 weeks after booster vaccine
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8-12 weeks after booster vaccine
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Neutralizing geometric mean titers 8 to 12 weeks after third dose of BNT162b2 (booster) vaccine.
Tidsram: 8-12 weeks after booster vaccine
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8-12 weeks after booster vaccine
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Andra resultatmått
Resultatmått |
Tidsram |
---|---|
The number of IFN-y-spot forming T cells SARS-CoV-2 specific after third dose of BNT162b2 (booster) vaccine.
Tidsram: 8-12 weeks after booster vaccine
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8-12 weeks after booster vaccine
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Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 210405014E
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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