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1103 Clinical Impact of Sars-Cov-2 Vaccination in COVID-19 Outcomes in Patients Diagnosed with Hematologic Malignancies: Real-World Evidence of Two Years of PandemicClinically Relevant Abstract

Program: Oral and Poster Abstracts
Session: 203. Lymphocytes and Acquired or Congenital Immunodeficiency Disorders: Poster I
Hematology Disease Topics & Pathways:
Research, Clinical Research, Diseases, SARS-CoV-2/COVID-19, real-world evidence, Infectious Diseases
Saturday, December 10, 2022, 5:30 PM-7:30 PM

Moraima Jiménez, MD1,2*, Sandra Novoa Jáuregui, MD1*, Candela Fernández-Naval, PhD3*, Marc Bosch Schips, MD1*, Sofía Muzio, MD1*, Víctor Navarro Garcés4*, Cristina Andrés, PhD3*, Mónica Martínez-Gallo, PhD5*, Andrés Antón3*, Alba Cabirta1*, Angel Serna, MD1*, Daniel Medina2,6*, Soraya Peralta2,6*, Gemma Pujadas2,6*, Cristina Hernandez2,6*, Carlota Pagès, MSc2,6*, Tomás Pumarola3*, Mercedes Valentín1*, David Valcárcel, MD, PhD7, Manuel Hernández8*, Isabel Ruiz-Camps, MD, PhD9*, Marta Crespo, PhD2,6*, Juliana Esperalba, PhD3*, Pau Abrisqueta, MD, PhD1,2* and Francesc Bosch, MD, PhD1,2,6

1Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
2Department of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain
3Department of Microbiology, Vall d’Hebron Hospital Universitari, Vall d’Hebron Institut de Recerca (VHIR), Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
4Oncology Data Science (ODysSey) Group, Vall d’Hebron Institute of Oncology (VHIO), BARCELONA, Spain
5Department of Immunology, Vall d’Hebron Hospital Universitari, Vall d’Hebron Research Institute, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
6Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
7Hospital Universitari Vall d’Hebron, Barcelona, Spain
8Department of Immunology, Vall d’Hebron Hospital Universitari, Vall d’Hebron Research Institute, Vall d’Hebron Barcelona Hospital Campus. Department of Cell Biology, Physiology and Immunology, Autonomous University of Barcelona (UA), Barcelona, Spain
9Department of Infectious Diseases, Vall d´Hebron University Hospital, Passeig Vall d'Hebron 119-129, 08035, Barcelona, Spain

Background: Real-world data about the effectiveness of SARS-CoV-2 vaccination and implementation of booster campaigns in an immunocompromised population such as patients diagnosed with hematologic malignancies (HM) are scarce.

Our aim was to compare morbidity and mortality of COVID-19 according to SARS-CoV-2 vaccination status and immunological response to vaccination in a cohort of patients diagnosed with HM, considering a scenario affected by the succession of diverse virus variants and the advent of COVID-19 specific therapies.

Methods: We retrospectively collected clinical data from the patients with a current or prior history of HM at Vall d´Hebron Universitary Hospital who suffered a laboratory-confirmed SARS-CoV-2 infection between March 2020 and May 2022.

The main endpoints included severity of COVID-19 (WHO classification), rate of hospitalization, ICU admission, need for supplemental oxygen or COVID-19 specific therapy (steroids, antivirals, IL-6 inhibitors, hydroxychloroquine, anti-SARS-CoV-2 monoclonal antibodies). We also genotyped viral variants and assessed humoral immunogenicity induced by the vaccine (anti-spike[S] IgG >260 BAU/mL measured by LIAISON® Diasorin) or the infection (anti-nucleocapsid[N] IgM/IgG/IgA positivization by Elecsys® Roche).

Results: A total of 326 patients developed COVID-19, 182 vaccinated cases between 03/21 and 05/22, and 134 unvaccinated cases between 03/20 and 02/22. Both groups were similar in age (median 68 and 71 years) and gender (51% and 46% women, respectively). In both cohorts the main diagnosis was lymphoma (46% and 43%), the majority of patients were under active treatment (73% and 58%) and the most frequent active therapy was anti-CD20 monoclonal antibodies+/- chemotherapy (35% and 30%) (Table 1).

Among the 113 vaccinated sequenced cases, 80% were omicron (predominantly BA.1 [36%] and BA.1.1 [28%]), 19% delta (B.1.617.2 [6%] and AY lineage [15%]) and 1% alfa variant. Genotype analysis of 87 unvaccinated cases showed predominance of B.1 and B.1.177 lineages in 53% and 35% of the cases, respectively.

The vaccines most frequently administered were mRNA-1273 (70%) and BNT162b2 (25%). A 5% of patients were partially vaccinated (one dose), 26% fully vaccinated (2 doses), whereas 67% received a third boost dose and 2% a fourth dose prior infection.

Considering patients with available basal serology prior infection, only 20% (1/5) of partially vaccinated, 39% (13/33) of fully vaccinated patients, and 47% (42/90) of boosted patients had developed positive anti-S IgG antibodies. In 38% (34/90) of patients with basal negative anti-N antibodies a seroconversion was observed after the infection.

In the unvaccinated cohort the most frequent COVID-19 specific therapies administered were hydroxychloroquine (46%), steroids (28%), lopinavir/ritonavir (20%) and tocilizumab (19%); while in the vaccinated cohort were remdesivir (38%), steroids (28%), tocilizumab (14%) and anti-SARS-CoV-2 monoclonal antibodies (7%).

In comparison with the unvaccinated cohort of patients, vaccinated patients had less severe (17% vs. 27%; p=0.006) and critical (12% vs 38%; p=<0.001) COVID-19, lower rates of hospitalization (32% vs. 80%; p=<0.001) and fewer patients needed supplemental oxygen (28% vs. 64%; p=<0.001). Admission rates to ICU were similar between both cohorts. Mortality rate was lower in the vaccinated patients in comparison with the unvaccinated cohort (HR: 0.48 (95%CI 0.31-0.74); p=<0.001) (Figure 1).

Of note, only 15% (6/39) of patients who suffered a severe/critical infection had developed humoral vaccine immunogenicity. In contrast, 56% (50/89) of mild/moderate cases had created vaccine-induced seroconversion. None of the 17 vaccinated patients who died had developed anti-S antibodies.

Finally, in 23% (30/131) of the vaccinated cohort the follow-up RT-PCR remained persistently positive >21 days.

Conclusion: In this real-world analysis, and despite the heterogeneity of infection by different viral variants and treatment availability for COVID-19 during the evolution of the pandemic, vaccination has resulted widely effective at reducing need of hospitalization, severity and mortality of the SARS-CoV-2 infection in patients with HM. Patients who develop a suboptimal humoral immunogenicity after vaccination are at higher risk to develop a severe/critical infection and would benefit from an early intervention.

Disclosures: Cabirta: Jazz: Honoraria; Janssen: Honoraria; Astra-Zeneca: Honoraria. Valcárcel: Astellas, Amgen, BMS/Celgene, Grifols, Jazz, Novartis, Sanofi, Sobi,: Consultancy, Honoraria, Speakers Bureau; Gebro, Janssen: Honoraria, Speakers Bureau. Abrisqueta: Janssen: Consultancy, Honoraria, Speakers Bureau; AstraZeneca: Consultancy, Honoraria, Speakers Bureau; BMS: Consultancy, Honoraria, Speakers Bureau; AbbVie: Consultancy, Honoraria, Speakers Bureau; Roche: Consultancy, Honoraria; Sandoz: Honoraria; Incyte: Consultancy. Bosch: Karyospharm: Honoraria; Celgene/BMS: Consultancy, Honoraria; Roche: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; Astra Zeneca: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Mundipharma: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Lilly: Consultancy, Honoraria; Beigene: Consultancy, Honoraria.

*signifies non-member of ASH