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OpenTrials
Completed

NCT Number: NCT05124509

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Three doses of SARS-CoV-2 BNT162b2 vaccine (observational)

Biological

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)

Biological

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

Primary outcomes

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

    Time frame: 8-12 weeks after booster vaccine

Secondary outcomes

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

    Time frame: 8-12 weeks after booster vaccine

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

    Time frame: 8-12 weeks after booster vaccine

Other outcomes

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

    Time frame: 8-12 weeks after booster vaccine

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 18, 2021
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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