Customized for Vaccine Development

Customized for Vaccine Development

Lab scientists in white coats working in a modern, well-lit laboratory setting.

Comprehensive Support Across All Stages of Development

Comprehensive Support Across All

Stages of Development

From early discovery through clinical development and post-licensure, SeromYx’s Systems Serology platform helps vaccine developers understand the functional immune mechanisms that drive protection.

We support natural infection studies, controlled human infection models, field efficacy trials, and post-licensure analyses by identifying functional correlates of protection and immune signatures linked to efficacy. Our data informs critical decisions around antigen and adjuvant selection, dose optimization, manufacturing process changes, and comparison of vaccine candidates against licensed products.

Pathogens Studied Using Systems Serology

Our Systems Serology platform has been applied across a wide range of infectious diseases to support vaccine development, immunogenicity assessment, and immune correlate discovery. The pathogens below represent viruses, bacteria, parasites, and fungi that have been studied using SeromYx’s comprehensive Fc-mediated antibody profiling and functional immune analysis.

  • Viruses (26)

    Coronaviruses

    SARS-CoV-1, SARS-CoV-2, MERS, Common cold coronaviruses (NL63, OC43)

    Flaviviruses & Others

    Dengue, Zika, Yellow fever

    Retroviruses

    HIV, SHIV, SIV, Endogenous retroviruses

    Herpesviruses

    HSV-1, HSV-2, Epstein-Barr virus, Varicella zoster

    Other Viruses

    Influenza, Measles, Mumps, RSV, Hep B, Hep C, HPV, Merkel Cell Polyomavirus, Crimean-Congo Hemorrhagic Fever, Rift Valley Fever

  • Fungus

    Aspergillus spp.

  • Parasite

    Plasmodium falciparum

  • Bacteria (14)

    • Bordetella pertussis
    • Clostridium botulinum
    • Clostridium tetani
    • Corynebacterium diphtheriae
    • Klebsiella pneumoniae
    • Mycobacterium tuberculosis
    • Neisseria meningitidis
    • Pseudomonas aeruginosa
    • Salmonella typhi
    • Shigella spp.
    • Staphylococcus aureus
    • Streptococcus agalactiae
    • Streptococcus pneumoniae
    • Vibrio cholerae

Viruses (26)

Fungi

Parasite

Bacteria (14)

Coronaviruses
SARS-CoV-1, SARS-CoV-2, MERS, Common cold coronaviruses (NL63, OC43)


Flaviviruses & Others
Dengue, Zika, Yellow fever


Retroviruses
HIV, SHIV, SIV, Endogenous retroviruses


Herpesviruses
HSV-1, HSV-2, Epstein-Barr virus, Varicella zoster


Other Viruses
Influenza, Measles, Mumps, RSV, Hep B, Hep C, HPV, Merkel Cell Polyomavirus, Crimean-Congo Hemorrhagic Fever, Rift Valley Fever

Aspergillus spp.

Plasmodium falcioarum

Bordetella pertussis

Clostridium botulinum

Clostridium tetani

Corynebacterium diphtheriae

Klebsiella pneumoniae

Mycobacterium tuberculosis

Neisseria meningitidis

Pseudomonas aeruginosa

Salmonella typhi

Shigella spp.

Staphylococcus aureus

Streptococcus agalactiae

Streptococcus pneumoniae

Vibrio cholerae

DISCOVERY

Systems Serology identifies antibody features linked to disease outcomes.


Profiling hospitalized COVID-19 patients revealed distinct antibody responses: survivors showed a spike (S)-focused, functional profile, while non-survivors had nucleocapsid (N)-biased, less effective antibodies. Just five key antibody features predicted clinical trajectory, supporting early risk stratification and biomarker development. These findings highlight the importance of spike-specific functional antibodies for vaccine targeting.


  • Differentiates survivors and non-survivors using key antibody signatures
  • Links enhanced S-specific phagocytosis and complement activity to protection
  • Informs vaccine antigen selection and immune monitoring strategies
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LEAD SELECTION

Prioritize candidates by protective antibody functions, not just quantity.


Systems Serology enables comparison of vaccine regimens based on their ability to elicit key protective antibody functions. Screening HIV vaccine candidates revealed wide variation in ADCP levels despite similar antibody titers. Changes in adjuvants and dosing shifted functional profiles, helping developers select candidates that induce higher-quality immune responses. This accelerates confident, data-driven down-selection for clinical advancement.


  • Differentiates vaccine leads by antibody function, not just titer
  • Reveals impact of formulation and regimen on immune quality
  • Supports efficient selection of candidates with greater clinical potential
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ASSAY DEVELOPMENT, VALIDATION, QUALIFICATION

Robust immune profiling beyond neutralization for clinical trials.


SeromYx developed and qualified a Systems Serology assay under WHO and GCLP standards to measure antibody-dependent functions in SARS-CoV-2 vaccine trials. The assay delivers precise, specific, and sensitive measurement of Fc effector activities (ADCP, ADCD, ADNKA), supporting secondary endpoints in Phase 3 studies and regulatory filings. This validated platform is adaptable for diverse vaccine programs requiring advanced immune monitoring.


  • Ensures reproducible, regulatory-grade immune data across cohorts
  • Measures extra-neutralizing Fc functions linked to protection
  • Scalable qualification framework for broad vaccine applications
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CLINICAL EFFICACY TESTING

Uncovering antibody mechanisms linked to protection beyond neutralization.


A head-to-head study of mRNA-1273 and BNT162b2 vaccines showed both induced strong humoral responses, but mRNA-1273 elicited higher IgA titers, enhanced Fcγ receptor binding, and greater functional activity (ADNP, ADNKA). Systems Serology mapped distinct Fc effector functions, offering mechanistic insights into their differing real-world efficacy and supporting identification of immune correlates of protection.


  • Differentiates vaccine-induced functional antibody profiles linked to protection
  • Detects spike-specific Fc activities beyond neutralization
  • Provides mechanistic insight for clinical trial correlates and disease attenuation
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MANUFACTURING SCALE-UP

Integrating antibody avidity with Fc effector profiling to enhance vaccine assessment.


By combining Systems Serology with surface plasmon resonance (SPR)–based avidity measurements, this study uncovered distinct immune profiles differentiating two vaccine manufacturing processes. While one process drove higher effector function with lower avidity, the other generated stronger avidity with reduced effector activity. Multivariate modeling highlighted avidity, NK cell IFNγ responses, and IgG1 as key features distinguishing the processes, providing mechanistic insight into how manufacturing influences vaccine-induced immunity.


  • Links antibody avidity with functional immune readouts
  • Differentiates immune profiles across vaccine manufacturing processes
  • Provides mechanistic insight to guide vaccine design and optimization
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SCIENTIFIC RESOURCES

Immune correlates of protection against RSV following Ad26.RSV.preF–RSV preF vaccination of adults aged >60 years

August 31, 2026
Abstract: Respiratory syncytial virus (RSV) is a leading cause of respiratory illness and there is no universally accepted serological correlate of protection (CoP). We evaluated serum pre-fusion immunoglobulin G binding (preF-IgG) and RSV-A2 neutralizing antibodies (RSV-nAb) in adults aged >60 years following vaccination with investigational Ad26.RSV.preF–RSV preF vaccine. PreF-IgG and RSV-nAb measured pre-vaccination (Day 1) and Day 15 post-vaccination were assessed as CoPs against RSV-mediated acute respiratory infection (ARI) and lower respiratory tract disease (LRTD). An increase in both preF-IgG and RSV-nAb at Day 15 was significantly associated with reduced occurrence of RSV-mediated ARI and LRTD during follow-up. Based on controlled vaccine-efficacy curves and Prentice criteria, both markers were identified as CoPs for RSV-mediated ARI and LRTD. These results were validated using samples from a second randomized, phase 3 efficacy trial. Comprehensive profiling of preF-specific antibody responses showed that preF IgG3 and IgG2 may also contribute to protection from RSV.

Fc-optimized GITR antibody enhances a CD4 T cell–dendritic cell crosstalk to promote antitumor immunity

August 13, 2026
The Fc Review: When you engineer the Fc to enhance one mechanism, what else changes? A recent Nature Cancer study takes a closer look at that question using an agonistic anti-GITR antibody, showing how Fc optimization can influence not only FcγR engagement and Treg depletion, but other immune pathways contributing to antitumor activity. Background: GITR is a stimulatory immune checkpoint receptor being explored as a target for cancer immunotherapy. While agonistic anti-GITR antibodies have shown promise preclinically, clinical efficacy has been limited. Because FcγR engagement can contribute to the activity of these antibodies, the authors used Fc protein engineering and glycoengineering to alter interactions with different human FcγRs and examine how those changes affected antitumor activity. The study highlights: Fc variants with enhanced engagement of activating FcγRIIa or FcγRIIIa increased antitumor activity, while preferentially enhancing engagement of inhibitory FcγRIIb did not improve tumor control. Combining G236A with reduced fucosylation enhanced engagement of both activating FcγRIIa and FcγRIIIa, without enhanced binding to FcγRIIb. This combined variant showed greater antitumor activity than variants enhancing either activating receptor individually in the tested model. Fc-active variants depleted Tregs within the tumor. However, the optimized variant and IgG1 produced similar Treg depletion despite differences in therapeutic activity, pointing to an additional FcγR-mediated mechanism. The Fc-optimized antibody also increased dendritic cell activation, and the authors found that conventional DCs, particularly cDC1s, were required for the Fc-mediated antitumor effect in their models. Further experiments connected this activity to CD4 T cell–DC engagement, with downstream CD4 T cell cytotoxicity and enhanced CD8 T cell activity

C1q and immunoglobulins mediate activity-dependent synapse loss in the adult brain

July 30, 2026
The Fc Review: Stepping a little outside therapeutic antibody and vaccine development this week to highlight a fascinating piece of fundamental antibody biology. A recent Science study uncovers an unexpected role for antibody-mediated complement activity in the adult mouse brain, showing that locally produced IgM and C1q work together to drive activity-dependent synapse elimination.  While this work is still early and was performed in mice, it offers an interesting look at how #antibody effector mechanisms may extend beyond the roles we typically think about. Background: Antibodies are typically viewed through the lens of infection, vaccination, or therapeutic development. Their effector functions, including complement activation, are well established as key mechanisms for eliminating pathogens and diseased cells. This study asks whether antibody-mediated complement activity also contributes to normal brain physiology. Using mouse models, the authors investigated how neuronal activity influences complement-mediated synapse remodeling and whether adaptive immune components participate in this process. The study highlights: Increased neuronal activity triggered localized C1q deposition and complement-dependent synapse loss in the adult mouse hippocampus. Activity-dependent recruitment of antibody-secreting B-lineage cells led to local production of antigen-specific IgM, which contributed to C1q deposition at synapses. Reducing neuronal hyperactivity in a mouse model of Alzheimer's disease decreased C1q deposition and partially restored synaptic density. The findings identify a previously unrecognized interaction between adaptive immunity, complement biology, and neuronal circuit remodeling in the adult brain.

Frequently Asked Questions (FAQ)

  • Can you analyze clinical trial samples?

    Yes. Our platform supports preclinical through clinical-stage vaccine programs, including natural infection studies, controlled human infection models, and field efficacy trials.

  • Can you identify immune signatures associated with protection?

    Yes. Using systems-level analytics, we identify multivariate immune features that associate with protection, durability, or reduced disease severity.

  • When is the best time to engage SeromYx in a program?

    We provide value across all phases, but especially during:

    • Candidate down-selection
    • Phase I/II immunogenicity studies
    • Correlate of protection investigations

  • What are the sample requirements for vaccine studies?

    Sample volume requirements vary depending on the assay panel selected. In general, we require approximately 25–150 µL per assay when performed in isolation against a single antigen.


    When multiple assays are combined within an integrated panel, overall sample requirements may decrease due to optimized assay design.


    If sample volume is limited, particularly for clinical trial cohorts, we can develop a tailored strategy to maximize data generation while conserving material. We encourage teams to contact us for a study-specific estimate as it may fall outside the range provided above.