Effectiveness of COVID-19 Vaccine in Hematopoietic Stem Cell Transplant Patients

COVID-19 Vaccines Clinical Trial

— ESCVHSCT  

Official title:

Evaluation of COVID-19 Vaccine Effectiveness and Immunogenicity in Patients Receiving Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05185817
• Other study ID #: 1400-2-101-54534
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: October 2021
• Source: Tehran University of Medical Sciences
• Contact: Maryam Barkhordar, MD
• Phone: 0098 913 1856733
• Email: barkhordarm.n[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

COVID-19 vaccinations are predicted to be a huge success in pandemic control. However, the majority of the studies were conducted on healthy individuals, and the efficiency of COVID-19 vaccination in post-transplant patients is uncertain. In the setting of HSCT, the extreme immunosuppression caused by the conditioning regimen and the graft versus host disease (GvHD) preventive regimen clearly has an impact on the efficacy and immunogenicity of the COVID-19 vaccine. Given the importance of eliciting early SARS-Cov-2 protective immunity in patients who are undergoing Allo-HSCT and the EBMT recommendation to endorse vaccination as early as 3 months after allo-HCT [7], we conduct this prospective study to investigate the safety and immunogenicity of three doses Pastucovac (an RBD-based SARS-Cov-2 vaccine) at the early post-transplant period in adult Iranian patients who are undergoing Allo-HSCT. We also want to see whether there are any possible predictors, such as the effect of clinical characteristics and lymphocyte subpopulations at the time of vaccination on the serologic response following immunization. The findings of this study will serve to guide future COVID-19 vaccination recommendations in this population, such as the optimal starting time, interval time, and so on.

Description:

From the start of the study until the sample size of 100 patients is attained, all consecutive adult patients who are candidates for Allo-SCT at HORCSCT, sign a research project consent to administer SARS-CoV-2 vaccination with Pastucovac, and sign a permission to take pre-and post-vaccination blood samples for deposit to the research database, are enrolled in the study. At baseline (before conditioning) and day +30 post-transplant, peripheral blood samples are taken to test particular lymphocyte subpopulations and SARS-CoV-2 IgG titers.

All enrolled post-Allo-SCT participants who meet the inclusion criteria including; age ≥ 18 years, successfully engraftment with full donor chimerism, absence of grade 3,4 acute GvHD or severe extensive chronic GvHD, no receive more than 0.5 mg/kg prednisolone, and no positive RT-PCR test for COVID-19 following HSCT are recruited to study from 3 to 12 months after Allo-HSCT and vaccinated with 2 doses of Pastucovac, with a 4-week (±7 days) interval and a booster dose with an 8-week (±7 days) interval from the second dose. Peripheral blood samples are collected before the first dose of vaccine to assess certain immune reconstitution and SARS-CoV-2 IgG titer. The serologic response against the SARS-CoV-2 spike protein (anti-S) is assessed in serum four weeks (± one week) after the first vaccine dose (before the second vaccine), four weeks (± one week) after the second dose, and four weeks (± one week) after the booster dose (third dose).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Age = 18 years, successfully engraftment with full donor chimerism, absence of grade 3,4 acute GvHD or severe extensive chronic GvHD, no receive more than 0.5 mg/kg prednisolone, and no positive RT-PCR test for COVID-19 following HSCT

Exclusion Criteria:

Patients who are not candidates for the COVID-19 vaccine after transplantation due to severe complications.

Patients who do not consent to vaccination after transplantation

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Vaccines
• Hematopoietic Stem Cell Transplantation (HSCT)
• Immune System Tolerance

Intervention

Biological:
• Pasocovac vaccine
All enrolled post-Allo-SCT participants who meet the inclusion criteria are recruited to study from 3 to 12 months after Allo-HSCT and vaccinated with 2 doses of Pastucovac, with a 4-week (±7 days) interval and a booster dose at an 8-week (±7 days) interval from the second dose.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Hematology, Oncology, and Stem Cell Transplantation Research Center of shariaty Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of COVID-19 vaccine effectiveness	defined as a rising = 4-fold in SARS-CoV-2 binding antibody titer compared to the pre-vaccine titer	4 weeks (±7 days) post second COVID-19 vaccine
Primary	Grade III-IV vaccine-related adverse reactions	Prevalence of reactogenicity, Serious Adverse Events (SAE), and Suspected Unexpected Serious Adverse Reaction (SUSAR)	14 days after administration of each vaccine dose
Secondary	Incidence of Acute Graft versus host disease (GvHD)	Measuring how the acute GvHD affect the response to the vaccine	4-week (±7 days) after second and third (booster) dose of vaccine.
Secondary	GvHD prophylactic strategy affect immunological response	Measuring how early prophylactic immuno-suppression tapering affect the response to the vaccine	4-week (±7 days) after third (booster) dose of vaccine.
Secondary	Immune cells recovery predicting the response to the COVID-19 vaccine	Measuring how early post HSCT Immune subsets reconstitution including T cells, NK cells, and B cells predict the seroconversion after second dose of vaccine.	4-week (±7 days) after third (booster) dose of vaccine.
Secondary	seroconversion after second dose of vaccine	defined as a rising = 4-fold in SARS-CoV-2 binding antibody titer compared to the pre-vaccine titer in patients starting their vaccination course 3-6 months after HSCT	4-week (±7 days) after second dose of vaccine.
Secondary	seroconversion after second dose of vaccine	defined as a rising = 4-fold in SARS-CoV-2 binding antibody titer compared to the pre-vaccine titer in patients starting their vaccination course 6-12 months after HSCT.	4-week (±7 days) after second dose of vaccine.
Secondary	seroconversion after first dose of vaccine	defined as a rising = 4-fold in SARS-CoV-2 binding antibody titer compared to the pre-vaccine titer	4-week (±7 days) after first dose of vaccine.
Secondary	seroconversion after third (booster) dose of vaccine	defined as a rising = 4-fold in SARS-CoV-2 binding antibody titer compared to the pre-vaccine titer	4-week (±7 days) after third (booster) dose of vaccine.
Secondary	Incidence and severity of COVID-19 infections	Determine incidence and severity of COVID-19 infections by 6 months following immunization with a SARS-CoV-2 vaccine.	6 months following start of immunization
Secondary	Correlation of seroconversion with patient characteristics	Determine how the patients characteristics including age, sex, performance score, and underlying disease affect on seroconversion	4-week (±7 days) after second and third (booster) dose of vaccine.