Immune Response to Third Dose of SARS-CoV-2 Vaccine in Solid Organ Transplant

Sponsor
Pontificia Universidad Catolica de Chile (Other)
Overall Status
Recruiting
CT.gov ID
NCT05124509
Collaborator
(none)
126
Enrollment
1
Location
3.8
Anticipated Duration (Months)
33.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: Three doses of SARS-CoV-2 BNT162b2 vaccine (observational)
  • Biological: Two doses of CoronaVac and one dose of BNT162b2 SARS-CoV-2 vaccine (observational)

Study Design

Study Type:
Observational
Anticipated Enrollment :
126 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Solid Organ Transplant Recipients
Actual Study Start Date :
Oct 6, 2021
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Jan 30, 2022

Arms and Interventions

ArmIntervention/Treatment
Three doses of BNT162b2 vaccine

Solid organ transplant patients who received three doses of BNT162b2

Biological: Three doses of SARS-CoV-2 BNT162b2 vaccine (observational)
Two doses of SARS-CoV-2 BNT162b2 mRNA vaccine, followed by a booster (3rd) dose of SARS-CoV-2 BNT162b2 mRNA vaccine.

Two doses of Coronavac and one of BNT162b2 vaccine

Solid organ transplant patients who received two doses of CoronaVac and one dose of BNT162b2

Biological: Two doses of CoronaVac and one dose of BNT162b2 SARS-CoV-2 vaccine (observational)
Two doses of CoronaVac SARS-CoV-2 inactivated vaccine, followed by a booster (3rd) dose of BNT162b2 mRNA vaccine.

Outcome Measures

Primary Outcome Measures

  1. IgG seropositivity 8-12 weeks after third dose BNT162b2 (booster) vaccine. [8-12 weeks after booster vaccine]

Secondary Outcome Measures

  1. Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster) vaccine. [8-12 weeks after booster vaccine]

  2. Neutralizing geometric mean titers 8 to 12 weeks after third dose of BNT162b2 (booster) vaccine. [8-12 weeks after booster vaccine]

Other Outcome Measures

  1. The number of IFN-y-spot forming T cells SARS-CoV-2 specific after third dose of BNT162b2 (booster) vaccine. [8-12 weeks after booster vaccine]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Pontificia Universidad Católica de ChileSantiagoChile

Sponsors and Collaborators

  • Pontificia Universidad Catolica de Chile

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT05124509
Other Study ID Numbers:
  • 210405014E
First Posted:
Nov 18, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021