Immune Response to Third Dose of COVID-19 Vaccine in Solid Organ Transplant

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05124509
• Other study ID #: 210405014E
• Status: Completed
• Start date: October 6, 2021
• Est. completion date: January 3, 2022

Study information

• Verified date: January 2022
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: January 3, 2022
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection
• Solid Organ Transplant
• Vaccine Response Impaired

Intervention

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 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.

Locations

Country	Name	City	State
Chile	Pontificia Universidad Católica de Chile	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	IgG seropositivity 8-12 weeks after third dose BNT162b2 (booster) vaccine.		8-12 weeks after booster vaccine
Secondary	Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster) vaccine.		8-12 weeks after booster vaccine
Secondary	Neutralizing geometric mean titers 8 to 12 weeks after third dose of BNT162b2 (booster) vaccine.		8-12 weeks after booster vaccine