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

NCT05124509 | Completed

• 1 other identifier: 210405014E
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  8-12 weeks after booster vaccine

Secondary Outcomes (2)

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

  8-12 weeks after booster vaccine

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

  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.

  8-12 weeks after booster vaccine

Study Arms (2)

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 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)

Interventions

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.

Three doses of BNT162b2 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.

Two doses of Coronavac and one of BNT162b2 vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Solid organ transplant patients in the last 10 years and currently under immunosuppressive therapy

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Pontificia Universidad Católica de Chile

Santiago, Chile

Location

Related Publications (1)

• Dib M, Le Corre N, Ortiz C, Garcia D, Ferres M, Martinez-Valdebenito C, Ruiz-Tagle C, Ojeda MJ, Espinoza MA, Jara A, Arab JP, Rabagliati R, Vizcaya C, Ceballos ME, Sarmiento M, Mondaca S, Vinuela M, Pastore A, Szwarcfiter V, Galdames E, Barrera A, Castro P, Galvez NM, Soto JA, Bueno SM, Kalergis AM, Nervi B, Balcells ME. SARS-CoV-2 vaccine booster in solid organ transplant recipients previously immunised with inactivated versus mRNA vaccines: A prospective cohort study. Lancet Reg Health Am. 2022 Dec;16:100371. doi: 10.1016/j.lana.2022.100371. Epub 2022 Sep 23.

  PMID: 36185969 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 18, 2021
• Study Start: October 6, 2021
• Primary Completion: December 13, 2021
• Study Completion: January 3, 2022
• Last Updated: January 12, 2022

Record last verified: 2022-01

Locations

CL (1)