Clinical trial NCT05185817: Effectiveness of COVID-19 Vaccine in Hematopoietic Stem Cell Transplant Patients
Official title: Evaluation of COVID-19 Vaccine Effectiveness and Immunogenicity in Patients Receiving Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hematopoietic Stem Cell Transplantation (HSCT)
COVID-19 Vaccines
Immune System Tolerance
Keywords: hematopoietic stem cell transplantation, SARS-CoV-2 specific IgG , immune reconstitution, COVID-19 vaccine efficacy
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of COVID-19 vaccine effectiveness
timeFrame: 4 weeks (±7 days) post second COVID-19 vaccine
measure: Grade III-IV vaccine-related adverse reactions
timeFrame: 14 days after administration of each vaccine dose
Secondary outcomes:
measure: Incidence of Acute Graft versus host disease (GvHD)
timeFrame: 4-week (±7 days) after second and third (booster) dose of vaccine.
measure: GvHD prophylactic strategy affect immunological response
timeFrame: 4-week (±7 days) after third (booster) dose of vaccine.
measure: Immune cells recovery predicting the response to the COVID-19 vaccine
timeFrame: 4-week (±7 days) after third (booster) dose of vaccine.
measure: seroconversion after second dose of vaccine
timeFrame: 4-week (±7 days) after second dose of vaccine.
measure: seroconversion after second dose of vaccine
timeFrame: 4-week (±7 days) after second dose of vaccine.
measure: seroconversion after first dose of vaccine
timeFrame: 4-week (±7 days) after first dose of vaccine.
measure: seroconversion after third (booster) dose of vaccine
timeFrame: 4-week (±7 days) after third (booster) dose of vaccine.
measure: Incidence and severity of COVID-19 infections
timeFrame: 6 months following start of immunization
measure: Correlation of seroconversion with patient characteristics
timeFrame: 4-week (±7 days) after second and third (booster) dose of vaccine.
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hematology, Oncology, and Stem Cell Transplantation Research Center of shariaty Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Maryam Barkhordar, MD
role: PRINCIPAL_INVESTIGATOR
References: