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

NCT05185817 | Unknown Phase 2

• 1 other identifier: 1400-2-101-54534
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• Incidence of Acute Graft versus host disease (GvHD)

  4-week (±7 days) after second and third (booster) dose of vaccine.

• GvHD prophylactic strategy affect immunological response

  4-week (±7 days) after third (booster) dose of vaccine.

• Immune cells recovery predicting the response to the COVID-19 vaccine

  4-week (±7 days) after third (booster) dose of vaccine.

• seroconversion after second dose of vaccine

  4-week (±7 days) after second dose of vaccine.

• seroconversion after second dose of vaccine

  4-week (±7 days) after second dose of vaccine.

Study Arms (1)

vaccine

EXPERIMENTAL

Patients who are a candidate for HSCT within the the Hematology, Oncology, and Stem Cell Transplantation Research Center of Shariaty Hospital, and agree to be vaccinated with an approved vaccine against the COVID-19 virus.

Biological: Pasocovac vaccine

Interventions

Pasocovac vaccine BIOLOGICAL

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.

vaccine

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Hematology, Oncology, and Stem Cell Transplantation Research Center of shariaty Hospital

Tehran, 1417713135, Iran

RECRUITING

Study Officials

• Maryam Barkhordar, MD

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryam Barkhordar, MD

CONTACT

0098 913 1856733; barkhordarm.n@gmail.com

Leila Sharifi Aliabadi, Master

CONTACT

0098 912 549 2213; ctu@sina.tums.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 11, 2022
• Study Start: November 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2023
• Last Updated: May 9, 2022

Record last verified: 2021-10

Locations

IR (1)