ÎÚÑ»´«Ã½

ASH Research Collaborative Publishes Preliminary Results of Largest Prospective mRNA Vaccine Efficacy Trial in Individuals with SCD to Date

(SAN DIEGO, Dec. 12, 2023) – New research presented by the  (ASH RC) during the 65th ASH Annual Meeting revealed that individuals living with sickle cell disease (SCD) exhibited similar side effects and levels of protection against COVID-19 when compared to the general population after receiving a COVID-19 mRNA vaccine.

This study represents the largest prospective investigation to date on COVID-19 vaccine efficacy among individuals living with SCD and the first to evaluate vaccine safety and antibody response in young children living with SCD.

“We performed this study because of previous evidence suggesting that individuals with SCD do not mount as robust or sustained of an immune response following vaccinations as the general population. There were also concern expressed by patients that the newer mRNA vaccine technology might induce pain crises, a unique complication that affects those with SCD. We wanted to understand how we can best protect those living with SCD from severe illness from COVID-19 infection,” explained Charles Abrams, MD, hematologist at Penn Medicine, Chair of the , and a study’s senior author. “Reassuringly, we found that our study participants had similar immune responses as the general population and largely did not experience major complications as a consequence of receiving a mRNA vaccine.”

SCD is the most common inherited red blood cell disorder in the United States, affecting an estimated 100,000 people. According to the Centers for Disease Control and Prevention, SCD affects one out of every 365 Black or African American births and one out of every 16,300 Hispanic American births. The condition can cause severe pain, joint and organ damage, and stroke.

Some prior studies highlighted significantly worse outcomes in children and adults living with SCD who contracted COVID-19 in comparison to the general public, making those living with sickle cell disease a high-risk population and priority target for vaccination efforts.

The ASH RC SCD CTN investigators enrolled 59 previously unvaccinated participants ranging in age from 1 – 53 years, 47 of whom received at least one dose of the monovalent vaccine. . Forty one participantswho received two vaccination doses contributed baseline pre-vaccination and two-month post vaccination blood samples, and 37 of the participants also provided a 6-month post-vaccination sample.  . Researchers assessed the reactivity of IgG antibodies – proteins produced by the body in response to infection – against the receptor binding domain (where the antibody binds to combat the virus) of the SARS-CoV-2 spike protein. Side effects were assessed by telephone visits with the participants 2-3 days after each vaccine dose. 

This study demonstrated that individuals with SCD who were vaccinated with a COVID mRNA vaccine generated anti-SARS-CoV-2 antibodies similar to the general population. Also similar to most people, their antibody titers decreased over time but were still present six months after vaccination.

This prospective study was conducted across eight clinical sites within the ASH RC Sickle Cell Disease Clinical Trials Network (SCD Network), including Johns Hopkins University School of Medicine; Prisma Health Children’s Hospital; Duke University Medical Center, UT Southwestern Medical Center; Medical College of Wisconsin; University of California, San Fransisco General Hospital; Children’s National Hospital; and Montefiore Medical Center.

“In establishing the Clinical Trials Network, ASH has demonstrated the Society’s continued commitment to improving the lives of individuals living with sickle cell disease,” said Dr. Abrams. “This study, sponsored by ASH, is the first to run entirely within the CTN. These results are crucial to the management of SCD and help hematologists better understand the implications of future mRNA vaccines.”

About the ASH Research Collaborative
The ASH Research Collaborative (ASH RC) is a non-profit organization established by the ÎÚÑ»´«Ã½ (ASH) to improve the lives of people affected by blood diseases by fostering collaborative partnerships to accelerate progress in hematology. The foundation of the ASH RC is its  and . Through the ASH RC’s state-of-the-art data-sharing platforms and patient-centric approach to enrollment, design, and execution of clinical trials for SCD, the ASH RC is making it quicker and more efficient for companies to develop new treatments to help those suffering from hematologic conditions, and to maximize the value of those treatments post-approval. The ASH RC aims to transform research and practice in malignant and classical hematologic diseases throughout the world, for the benefit of patients and the hematology community.

About ASH
The ÎÚÑ»´«Ã½ (ASH) (hematology.org) is the world’s largest professional society of hematologists dedicated to furthering the understanding, diagnosis, treatment, and prevention of disorders affecting the blood. For more than 60 years, the Society has led the development of hematology as a discipline by promoting research, patient care, education, training, and advocacy in hematology.

ASH’s flagship journal, Blood () is the most cited peer-reviewed publication in the field, and Blood Advances () is an open-access, online journal that publishes more peer-reviewed hematology research than any other academic journal worldwide. Two new journals will be joining the Blood Journals portfolio in 2024, Blood Neoplasia () and Blood Vessels, Thrombosis & Hemostasis ().

Contact:  
Kira Sampson, ÎÚÑ»´«Ã½  
[email protected]; 202-499-1796