Elicit: Immune Response to Elasomeran Vaccination

Immune Response to Elasomeran Vaccination

What is the evidence for immune response and protection after Elasomeran vaccination?

Evidence demonstrates that elasomeran vaccination induces robust immune responses and clinical protection across most populations, though patients with hematologic malignancies and those on B-cell-depleting therapies show attenuated responses that improve with additional doses.

Abstract

Elasomeran vaccination demonstrates high efficacy in healthy populations, with risk ratios of 0.08 for preventing COVID-19 and breakthrough infection rates of 0.23%. In immunocompromised populations, humoral responses vary substantially by underlying condition: seropositivity rates reach 95.2% in lung cancer patients, 91.7% in multiple myeloma, and 82% in rheumatic disease patients, but only 60-66% in hematologic malignancies. Cellular immune responses occur in approximately 46% of cancer patients, with most mounting both CD4+ and CD8+ T-cell responses. Antibody titers decline substantially over time, decreasing from median 429 to 139 BAU/mL between 36 days and 3 months post-vaccination, with 10% of initially seropositive patients converting to seronegative status. Response heterogeneity is explained by specific mechanisms: B-cell-depleting therapies (anti-CD20, anti-CD38) profoundly suppress antibody production, disease remission predicts superior response (median titers 1242 vs 221.5 U/ml), and mRNA vaccines induce higher antibody levels than viral vector vaccines. Additional doses substantially improve seroconversion in immunocompromised patients, increasing rates from 26% after two doses to 71.7% after four doses in kidney transplant recipients and from 69.6% to 95.7% after a second dose in AML/MDS patients. Clinical protection remains robust in most immunocompromised populations, with breakthrough infection rates of only 0.5% in lung cancer patients. The evidence indicates that while elasomeran induces strong immune responses in most populations, patients with hematologic malignancies and those receiving B-cell-depleting therapies require additional doses and may need more frequent boosting to maintain protective immunity.

Methods

We analyzed 10 sources from an initial pool of 200, using 7 screening criteria. Each paper was reviewed for 8 key aspects that mattered most to the research question.

Results

Characteristics of Included Studies

Ten studies met the inclusion criteria, comprising two meta-analyses, one scoping review, and seven primary observational studies. Full text was available for six studies, while four studies were available only as abstracts.

Study Full text retrieved? Study Type Sample Size Population Vaccination Details
K. Mancuso et al., 2021 No Observational prospective study 96 MM patients BNT162b2 or mRNA-1273, 2 doses 3-4 weeks apart
M. Provencio et al., 2021 No Observational cohort (SOLID substudy) 1,976 lung cancer patients Various vaccines, 2-dose series
P. Ratajczak et al., 2023 Yes Meta-analysis of 8 RCTs 135,275 Healthy persons aged >16 BNT162b2 and mRNA-1273, 100 μg dose
Nina Kreuzberger et al., 2022 No Scoping review 318 studies, >5 million participants Immunocompromised populations Various vaccines including mRNA-1273
Narcis-George Manolache et al., 2021 Yes Observational cohort 231 IMID patients AZD1222, BNT162b2, mRNA-1273, or JNJ-78436735
V. Pozdnyakova et al., 2021 Yes Observational cohort (vaccine registry) 353 IBD patients mRNA-1273, BNT162b2, or Ad26.CoV2.S
S. Ehmsen et al., 2021 Yes Observational cohort 524 cancer patients mRNA vaccines, 2 doses
M. Seija et al., 2022 Yes Multicenter prospective observational 109 kidney transplant recipients Heterologous (4 doses) or homologous (3 doses) schemes
D. Martins-Branco et al., 2022 Yes Meta-analysis of 89 records 30,183 cancer patients (HM and SM) Various vaccines including mRNA-1273
A. Jain et al., 2021 No Observational cohort 46 (30 AML, 16 MDS) AML and MDS mRNA-1273, 2 doses

The studies predominantly enrolled immunocompromised populations, including patients with hematologic malignancies, solid tumors, transplant recipients, and autoimmune diseases.

Humoral Immune Response

Seropositivity Rates in Healthy vs Immunocompromised Populations

In the healthy population meta-analysis, both BNT162b2 and mRNA-1273 demonstrated high efficacy in preventing COVID-19. Among immunocompromised populations, seropositivity rates varied considerably by underlying condition.

Population Seropositivity Rate Quantitative Titers Time Point Assay Method
Healthy (meta-analysis) High efficacy (RR 0.08) Not specified 14 days post-dose 2 Not specified
Lung Cancer 95.2% GMT 655.45 BAU/mL (95% CI 593.5-723.8) 2 weeks Chemiluminescent microparticle immunoassay
Rheumatic Diseases 82% optimal response Responders: 245.4 ± 18.8 BAU/ml Post-vaccination Elecsys anti-SARS-CoV-2
IBD (mRNA-1273) 100% Log10: 4.20 at 2 weeks 2 weeks Abbott SARS-CoV-2 IgG-II
Multiple Myeloma 91.7% Median 435 U/ml (range 0.4-2500) 1 month ECLIA (Elecsys)
Solid Cancer 93% Median 429 BAU/mL at 36 days 36 days Not specified
Hematologic Cancer 66% Median 429 BAU/mL at 36 days 36 days Not specified
AML/MDS 95.7% after 2 doses Mean 3806.5 after dose 2 Day 57 Two-step ELISA
Kidney Transplant 71.7% (heterologous)
70.6% (homologous)		 Higher in Seroconversion-2D group Post-vaccination Anti-RBD IgG assay
Cancer Meta-Analysis 80% within first month Not specified 1 month Not specified

Safety and Tolerability

Safety data were limited across studies. The meta-analysis of RCTs found that BNT162b2 and mRNA-1273 administration was associated with higher proportions of adverse events compared to placebo, though serious adverse events showed no significant difference. Local reactions (injection site pain, fatigue, headache), and systemic reactions (fever) were noted, while specific serious adverse events were identified including hypersensitivity reactions and thromboembolism.

References