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Evaluation of the serological response to booster vaccinationin in patients receiving autologous hematopoietic stem cell transplantation

Evaluation of the serological response to the heterologous versus homologous booster vaccinationin in patients receiving autologous hematopoietic stem cell transplantation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20140818018842N24
Enrollment
90
Registered
2022-07-22
Start date
2022-07-22
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Multiple myeloma. Condition 2: Non-Hodgkin lymphoma. Condition 3: Hodgkin lymphoma. Condition 4: Myelodysplastic syndrome. Multiple myeloma and malignant plasma cell neoplasms Hodgkin lymphoma Hodgkin lymphoma Myelodysplastic syndromes

Interventions

Intervention 1: Intervention group 1: injection of one homologous booster dose of Pastocovac 4 weeks (±7 days) after receiving two doses of primary Pastocovac vaccine, that is injected intramuscularly

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients who have undergone autologous hematopoietic stem cell transplantation Between 6 months and 12 months after transplantation They have received two initial doses of Pastocovac vaccine At least one month after receiving the second dose

Exclusion criteria

Exclusion criteria: Treatment with rituximab during last 6 months Relapse of underlying disease Positive rapid COVID-19 test before booster dose vaccination Patients who do not consent to vaccination

Design outcomes

Primary

MeasureTime frame
SARS-CoV-2 antibody titers. Timepoint: before the start of the intervention and 4 weeks (±7 days) after the injection of the booster dose vaccine. Method of measurement: ChemoBind SARS-CoV-? IgG Test.

Secondary

MeasureTime frame
Probable Side effect: local pain, fever, fatigue, headache and sore throat. Timepoint: One week after vaccination. Method of measurement: Vaccine side effects checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLeyla Sharifi Aliabadi

Tehran University of Medical Sciences

ctu@sina.tums.ac.ir+98 21 8490 2635

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026