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

Phase 2

• 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; Myelodysplastic syndromes

• Registration Number: IRCT20140818018842N24
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Background/Purpose: Optimizing vaccine efficacy is of particular concern in patients undergoing hematopoietic stem cell transplantation (HSCT), which mainly have an inadequate immune response to primary SARS-CoV-2 vaccination. This investigation aimed to explore the potential prime-boost COVID-19 vaccination strategies following autologous (auto-) HSCT. Methods: In a randomized clinical trial, patients who had already received two primary doses of receptor-binding domain (RBD) tetanus toxoid (TT) conjugated SARS-CoV-2 vaccine during three to nine months after auto-HSCT were randomized to receive either a homologous RBD-TT conjugated or heterologous inactivated booster dose four weeks after the primary vaccination course. The primary outcome was comparing the anti-S IgG Immune status ratio (ISR) four weeks after the heterologous versus homologous booster dose. The assessment of safety and reactogenicity adverse events was considered as the secondary outcome.(IRCT Id IRCT20140818018842N24) Results: Sixty-one auto-HSCT recipients were recruited and randomly assigned to receive either homologous or heterologous booster doses four weeks after the primary vaccination course. The mean ISR was 3.40 (95% CI: 2.63- 4.16) before the booster dose with a 90.0% seropositive rate. The ISR raised to 5.12 (95% CI: 4.15- 6.08) with a 100% seropositive rate after heterologous (P= 0.0064) and to 3.42 (95% CI: 2.67- 4.17) with a 93.0% seropositivity after the homologous booster doses (P= 0.96). In addition, the heterologous group suffered more AEs following the booster dosage than the homologous group, but this difference was not statistically significant (p = 0.955). In multivariable analysis, the primeboost vaccination strategy (heterologous versus homologous), the level of ISR before the booster dose, and the length of time between auto-HSCT and booster dose were the positive predictors of serologic response to a booster dose. No serious adverse event is attributed to booster vaccination. Conclusion: In patients who were primed with two SARS-CoV-2 vaccine doses during the first year after auto-HSCT, heterologous prime-boost COVID-19 vaccination with inactivated platform resulted in considerably enhanced serologic response and non-significantly higher reactogenicity adverse events than homologous RBD-TT conjugated prime-boost COVID-19 vaccination strategy. KEYWORDS SARS-CoV-2, heterologous prime boost COVID-19 vaccination, hematopoietic stem cell transplantation, RBD subunit vaccine, inactivated vaccines, immunogenicity

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 90

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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