Pre-clinical Immunogenicity & Efficacy Package

HHV-Targeted Vaccine & Immunotherapy Solutions by CD BioSciences

At CD BioSciences, we recognise that vaccine and immunotherapy development for human herpesviruses (HHVs) — including alpha-, beta- and gamma-herpesviruses — presents unique immunological and virological challenges. Our dedicated Pre-clinical Immunogenicity & Efficacy Package is designed to support research-stage and pre-clinical (pre-IND) programmes for clients in the Americas and Europe: biotechnology companies, research institutions and academic labs pursuing HHV-targeted vaccines, therapeutic vaccines or immunomodulatory approaches.

This service is distinctively tailored for HHV-related antigens or platforms; it is not intended for full clinical development support but rather directed at the discovery → lead-candidate → pre-clinical phase.

Why HHV Immunogenicity & Efficacy Require Specialized Support

Despite decades of efforts, no fully licensed vaccine exists for many HHVs (for example, Herpes Simplex Virus 1/Herpes Simplex Virus 2 or Kaposi's Sarcoma‑Associated Herpesvirus). The reasons are multifactorial: latent infection reservoirs, immune evasion strategies, complex antigenic landscapes and the recurring/reactivating nature of infection. For example, pre-clinical models show that some vaccine candidates fail to boost neutralising antibody titres or provide durable protection in HHV-1 seropositive hosts.

Thus, robust immunogenicity and efficacy studies are critical early in development, including: antigen design, adjuvant/formulation evaluation, cellular immunology (especially T cell and tissue-resident memory responses), challenge or surrogate models of infection/reactivation, and durable protection metrics.

Our package is built to tackle exactly these requirements, with a focus on HHV biology.

Our Pre-clinical Immunogenicity & Efficacy Package – What We Offer

We provide a modular yet integrated set of services covering key pillars of pre-clinical immunology and challenge-efficacy work for HHV-directed vaccine or immunotherapy programmes:

1. Study design & advisory support

• A dedicated project kick-off with experienced virology and immunology scientists specializing in herpesviruses: we define endpoints, animal or in vitro models, immunological assays, sample size/power, timelines and regulatory considerations.
• Built-in quality and reproducibility frameworks: e.g., assay CV tracking, LAL endotoxin screening, biomarker validation, GLP-style documentation (where applicable) and clear SOPs for repeatability.
• Advisory on HHV-specific immunology: e.g., selection of antigens for latent vs lytic phases, identification of immune-correlates of protection (neutralising versus ADCC, tissue-resident T cells, CD8+ memory subsets) based on recent literature.

2. Immunogenicity assessment

Our laboratory portfolio supports extensive immunogenicity characterisation:

• Humoral immunity: ELISA for antigen-specific IgG/IgA, neutralising antibody titres, antibody-dependent cell-mediated cytotoxicity (ADCC) or phagocytosis assays where relevant (especially for HHV vaccine candidates). For example, in an HSV model ADCC activity correlated with protection more strongly than neutralising antibodies.
• Cellular immunity: Flow cytometry and intracellular cytokine staining (ICS) for CD4+ and CD8+ T cells (IFN-γ, TNF-α, IL-2, etc.), tetramer or peptide-stimulated responses, evaluation of memory T-cell subsets (T_EM, T_CM, T_RM), and tissue-resident populations in mucosal or ganglionic tissue as relevant.
• Functional immunology: Proliferation assays, ELISpot, cytokine multiplex profiling, activation marker readouts (e.g., PD-1, granzyme B), and work on tissue-resident immunity in relevant HHV models (e.g., sensory ganglia, mucosal sites).
• Longitudinal sampling: Time-course analyses to monitor kinetics of response (prime → boost → memory), durability of immunity, and immune biomarker modelling.

3. Pre-clinical efficacy / challenge and surrogate models

• In vivo efficacy studies: We design and execute challenge or surrogate infection models in relevant species (mouse, guinea pig, etc) for HHV candidates (e.g., HSV-1/2, EBV, KSHV) including prophylactic or therapeutic regimen. For example, in a murine HSV-2 superinfection model the ΔgD-2 vaccine provided full protection in HSV-1-seropositive mice.
• Latency/reactivation studies: Because latency is a hallmark of many HHVs (especially gamma-herpesviruses like KSHV/HHV-8 and EBV), our service includes assessment of latent reservoir size (e.g., ganglionic or lymphoid tissues), reactivation assays (viral re-emergence under stimulus), shedding analysis, and surrogate endpoints.
• Biodistribution & shedding: For live-virus or vector-based vaccine candidates we can incorporate viral biodistribution and shedding studies (tissue tropism, viral load qPCR in tissues/fluids over time) to support safety and mechanistic insight.
• Efficacy endpoints: Survival, morbidity/mortality, reduction of viral load (qPCR/PFU), prevention of ganglionic seeding or re-activation, histopathology, immunopathology.
• Modelling antigen/adjuvant/formulation impact: We correlate immunogenicity readouts with efficacy outcomes—enabling your team to optimise antigen design, adjuvant choice, dosing schedule, route of administration and formulation.

4. Data integration, reporting & regulatory-ready deliverables

• Comprehensive final report: including study design, assay validation, raw and analysed data, statistical treatment, and interpretation in the context of HHV-specific immunology and virology.
• Regulatory-style documentation: Although not a full IND-enabling CRO service, we provide QA-certified data packages, certificate of analysis (CoA) for immunology reagents, traceability, method validation/sensitivity, GLP-style audit trail where feasible.
• Presentation-ready deliverables: Graphs, tables, executive summary, slide decks for internal or external preclinical review, support for regulatory briefing or investor updates.
• Post-study consult: After study completion, we offer consultative debriefing to discuss next steps (e.g., lead optimisation, scale-up planning, IND gap-analysis) and align with your HHV pipeline strategy.

Why CD BioSciences is Your Partner of Choice

Deep HHV Domain Expertise

Our team is built around virologists, immunologists and translational scientists who specialise in the human herpesvirus family (alpha, beta and gamma). We understand latency mechanisms, immune evasion, viral kinetics, reactivation biology and the unique immunological correlates that underlie HHV vaccine/therapeutic development. For example, the review on herpesvirus immunological considerations emphasises that tissue-resident memory CD8+ T cells at mucosal sites are critical for herpes vaccine efficacy.

We apply that insight directly into study design.

Research-Stage & Pre-clinical Focus (HHV-specific)

We intentionally focus only on research-stage and pre-clinical services (including discovery, lead generation, candidate nomination) and do not support full clinical-stage development. This allows us to deliver deep scientific support tailored to the specific challenges of early-stage HHV programmes—precisely the phase where attrition is highest and scientific rigour is most critical.

Quality, Traceability and Scientific Rigor

We apply robust quality control frameworks—assay validation, reagent traceability, data integrity (audit trail), consistent documentation and transparent methodologies—which help support future regulatory-submission readiness.

In addition, we align our approach with best-practice immunology and virology standards—e.g., evaluation of CD8+ T cell subsets, antibody‐dependent cytotoxicity, latency/reactivation models, biodistribution/shredding studies—with reference to the published literature.

Strategic Program Advisory & Customisation

Because HHV vaccine and therapy programmes often require bespoke assay development, reference panels and challenge models, we design each project collaboratively with your team. You'll engage directly with senior scientists to define milestones, select antigens/formulations, identify key immunological endpoints and set success criteria appropriate for HHV biology.

We also integrate strategic advisory support: what endpoints might matter to regulators or investors, how to interpret immune responses in the context of latent HSV/EBV/KSHV infection, how to plan for downstream translation—even though we do not perform clinical work ourselves.

Cost-effective and Time-efficient

By specialising purely in research and pre-clinical HHV services, we maintain streamlined workflows that avoid unnecessary clinical-stage overhead. We provide clear, milestone-based pricing, fully transparent study scope and deliverables, enabling you to budget and plan with confidence.

Typical Workflow & Deliverables

Below is a schematic of how the Pre-clinical Immunogenicity & Efficacy Package is typically delivered:

1. Project Initiation & Study Design (Weeks 0-2): Kick-off meeting, technical review of antigen/format, finalisation of study protocol, immunology panel, animal model selection, quality plan and reporting timeline.
2. Reagent/Assay Readiness (Weeks 2-6): Preparation of antigens, flow cytometry panels, ELISA/neutralisation assays, sample collection SOPs, reagent QC and baseline assay biometrics (CV, sensitivity, LOD).
3. Immunisation Phase (Weeks 4-12): Prime/boost regimen in small animal model, sample collection at defined time-points (e.g., pre-immunisation, post-prime, post-boost, memory time-point).
4. Assay Execution & Data Generation (Weeks 12-18): Humoral and cellular immunology assays, tissue harvests (for T_RM/resident memory where applicable), viral challenge or surrogate infection, biodistribution/shedding if applicable, qPCR/viral load readouts, histopathology.
5. Data Analysis & Reporting (Weeks 18-22): Statistical analysis, immune response kinetics, correlation of immunogenicity with efficacy endpoints, interpretation of results in HHV context (latent vs lytic, reactivation risk).
6. Final Deliverables & Strategic Consultation (Weeks 22-24): Comprehensive report (PDF), raw data files (Excel/FlowJo), slide deck summary, QA-certified documentation, project debrief with senior scientist and next-step recommendations.

Deliverables include:

• Study protocol & amendment log
• Assay validation summary (where new assays developed)
• Immunogenicity data: antibody titres, neutralisation/ADCC, T cell ICS, memory subset phenotyping, tissue-resident memory data (if applicable)
• Efficacy data: viral load reduction, survival/morbidity, latency/reactivation metrics, shedding/biodistribution where included
• Interpretation of immune correlates and model relevance to HHV biology
• Quality/traceability documentation (reagent CoAs, audit trail, sample tracking)
• Strategic advisory memo: what the data imply for your next milestone (e.g., IND gap-analysis, formulation optimisation, antigen redesign)

In summary, the Pre-clinical Immunogenicity & Efficacy Package from CD BioSciences offers a specialist, high-quality, research-stage service for human herpesvirus vaccine and immunotherapy programmes. By combining HHV-specific virology and immunology expertise, robust assay development and validation, comprehensive in vivo challenge and latency modelling, and regulatory-aware documentation, we enable our clients to advance their HHV-directed programmes from lead generation to nomination with confidence.

Whether you are developing a prophylactic vaccine against HSV, a therapeutic vaccine for EBV-associated malignancy, or a novel immunomodulatory platform targeting KSHV latency, our service is designed to accelerate your path with scientific rigour and clear deliverables.

FAQs

References

1. Aschner C. B., Knipe D. M., Herold B. C. Model of vaccine efficacy against HSV-2 superinfection in HSV-1-seropositive mice. npj Vaccines, 5:35 (2020).
2. Singer M. et al. Immunological considerations for the development of a herpes vaccine: CD8+ T cells, tissue-resident memory and latent reservoirs. Microorganisms, 12(9):1846 (2024).
3. Kumar N. et al. Vaccine formulation and optimisation for human herpesvirus vaccines: antigenicity, immunogenicity, physicochemical characteristics. ACS Pharm. Sci. Tech., 2020.
4. Smith C. Herpesvirus vaccines: challenges and future prospects. Herpesviridae, 1(12):13347 (2010).
5. Kamel S. Exploring human herpesviruses as vaccine vectors: immunogenicity and vector design. PMC, 2023.

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