At CD BioSciences, we specialise in providing tailored services to biotech companies, research institutes and drug-development organisations in North America and Europe, offering pre-clinical vaccine development solutions focused exclusively on human herpesviruses (HHVs). Our "Vaccine Candidate Construction & Evaluation" offering is designed to support your HHV-vaccine project from antigen design through to pre-clinical immunogenicity and efficacy assessment, aligned with the rigorous standards required for next-generation prophylactic or therapeutic herpesvirus vaccine programmes.
Why focus on HHV vaccine development?
The human herpesvirus family (Herpesviridae) includes several key pathogens — from alpha-herpesviruses such as Herpes Simplex Virus 1 and Herpes Simplex Virus 2 (HSV-1, HSV-2) and Varicella‑Zoster Virus (VZV), to beta-herpesviruses such as Human Cytomegalovirus (HCMV) and gamma-herpesviruses such as Epstein‑Barr Virus (EBV) and Kaposi's Sarcoma‑Associated Herpesvirus (KSHV/HHV-8). These viruses establish lifelong latency, often evade immunity, and in many cases contribute to significant disease burden including malignancies, immunocompromised-host infections and chronic viral shedding. For example, KSHV is causally associated with Kaposi's sarcoma and other proliferative disorders.
Despite decades of research, effective vaccines for many HHVs beyond VZV remain elusive. Challenges include latent infection reservoirs, immune-evasion mechanisms, complex antigenic composition, and the need to elicit durable humoral and cellular immunity. The scientific literature underscores these hurdles: for HSV, multiple subunit- and vector-based vaccine candidates have yielded limited efficacy, suggesting that combinatorial antigen and immune-modulation strategies may be required.
Given this landscape, our targeted solution for HHV-vaccine candidate construction & evaluation is built upon three pillars: (1) antigen design suited to latency/episomal viruses, (2) candidate assembly/evaluation in vitro and in vivo, and (3) translational readiness for pre-clinical immunogenicity/efficacy campaigns.
Our Core Capabilities & Service Modules
Antigen & Construct Design
- We perform detailed antigen-screening and epitope-mapping specific to HHVs (including latent- and lytic-phase antigens) to prioritise optimal vaccine targets.
- Our molecular biology team constructs expression vectors (DNA, mRNA, viral-vector, nanoparticle platforms) tailored to your chosen antigen format.
- We design and optimise the vaccine candidate construct (e.g., fusion proteins, chimeric glycoproteins, adjuvant-linker sequences) ensuring immune-relevant expression.
- We provide in vitro validation (expression, processing, post-translational modifications), with proprietary assays to confirm antigen integrity and immunologic potential.
- For gamma-herpesviruses (e.g., KSHV), targeting conserved structural glycoproteins (such as gH/gL/gB) has yielded promising pre-clinical data.
Candidate Production & Quality Control
- We support transient expression in mammalian systems, purification of antigenic protein (if applicable), formulation into the relevant vaccine format, and full QC (purity, identity, sterility, endotoxin, aggregation).
- For vector-based formats, we provide GMP-compatible plasmid preparation, vector production and titration, and functional verification (e.g., transduction efficiency, antigen expression).
- We maintain detailed documentation (batch records, analytical reports) to ensure traceability and high-quality deliverables suitable for pre-clinical dossiers.
In Vitro Immune Parameter Assessment
- We deliver antigen–dendritic cell co-culture assays, human PBMC stimulation (cytokine, proliferation, ELISpot for CD4/CD8), and antibody binding/neutralisation assays.
- Our neutralisation assays are customised for HHV species (e.g., KSHV, EBV, HSV) using established virus-cell models and may include latent-establishment assays when relevant.
- We offer epitope-specific readouts (mapping B‐cell and T-cell epitopes) and immune-checkpoint profiling (e.g., PD-1/LAG-3 on T-cells) if required.
In Vivo Immunogenicity & Efficacy Evaluation
- We design and execute rodent models (mouse, rat) or small animal surrogate models (e.g., murine gamma-herpesvirus models) to test vaccine candidates for immunogenicity, viral challenge, latency establishment and viral shedding. For example, an mRNA vaccine targeting MHV68 (a gamma-herpesvirus mouse model) prevented latent infection by targeting gH/gL/gB glycoproteins.
- Immune read-outs include serum neutralising antibody titres, mucosal IgA, antigen-specific CD4+ and CD8+ T-cell responses, cytokine profiling, and tissue-resident memory T-cells.
- Challenge models can assess primary infection reduction, latency suppression, reactivation inhibition, and viral shedding reduction – all key endpoints for HHV vaccine efficacy.
- We also conduct biodistribution, vector-persistence (if applicable), and immunopathology studies to meet regulatory expectations for pre-clinical vaccine candidate packages.
Pre-Clinical Candidate Nomination Package
- As part of our end-to-end solution, we compile a comprehensive Candidate Nomination Package which includes: antigen rationale, construct details, production and QC summary, in-vitro assay data, in-vivo immunogenicity + efficacy data, safety-toxicity overview (if required), and risk-mitigation strategy focusing on HHV-specific challenges (latency, immune-escape, tumour-association).
- This package is tailored to support discussions with downstream development partners or for internal go/no-go decision making, but stops short of full clinical-stage work in line with our focus on research/early-development only.
Why Choose CD BioSciences for HHV Vaccine Candidate Construction & Evaluation?
- Specialised Focus on HHVs – Unlike general vaccine-CDMOs, we bring deep subject-matter expertise in human herpesviruses (alpha, beta and gamma sub-families), including latency biology, immune evasion, and viral oncogenesis. For example, recent reviews highlight that KSHV vaccine development remains neglected yet biologically tractable.
- Integrated Platform Covering Design to Nomination – We cover the full pre-clinical spectrum: from antigen design → construct generation → production/QC → in-vitro immune profiling → in-vivo immunogenicity/efficacy → nomination dossier. This end-to-end offering reduces hand-offs and shortens timelines.
- High-Quality Data – Our workflows are documented with rigorous scientific protocols, traceable QC data, peer-benchmarked methodologies and are executed by experienced virology and immunology scientists. This ensures we meet the standards required for authority, trustworthiness and expertise in an increasingly scrutinised regulatory and scientific environment.
- Tailored to Research & Pre-Clinical Stage – Our focus is exclusively on the research to preclinical domain; we do not engage in clinical-stage manufacturing or trials. This ensures our services are optimised, cost-efficient and focused on the critical early-stage translational gap.
- Partner-Friendly Collaboration Model – We work with US/European sponsors, providing clear milestone-based deliverables, secure data sharing (GDPR/US-data-protection compliant), and flexibility to adapt to customised HHV vaccine strategies — whether prophylactic, therapeutic, or latency-targeted.
Key Strengths in HHV Vaccine Candidate Construction & Evaluation
- Proven expertise in antigen-selection for latent/lytic viral antigens and immune correlates of protection.
- Access to virus-specific in-vitro and in-vivo models for HHVs, including surrogate gamma-herpesvirus murine models when human models are unavailable.
- Experienced team capable of developing immune-readout assays (ELISpot, neutralisation, mucosal immunity) customised to HHV challenges (e.g., ganglionic latency, mucosal shedding).
- Strong documentation and regulatory science awareness: we understand the unique regulatory considerations for viral vaccine candidates (e.g., oncogenic risk in KSHV vaccine development).
- Ability to deliver a ready-to-use nomination package that supports decision-making, downstream partner engagement, or investor briefing without clinical provisions.
Our Workflow: Step-by-Step
1. Project Kick-off & Target Definition
- Jointly define vaccine concept (prophylactic vs therapeutic), target HHV species/sub-type, antigen selection strategy, immune-endpoints and timeline.
- Conduct a literature and patent landscape scan (we can optionally provide this) to validate novelty and freedom-to-operate in HHV antigen space.
2. Antigen & Construct Design
- Epitope mapping, computational immunogen design, sequence optimisation, vector/format selection (mRNA, viral-vector, protein-subunit, nanoparticle).
- Construct generation, codon-optimisation, expression screening in cell lines.
3. Production & Analytical Characterisation
- Small scale GMP-compatible production of vaccine candidate, purification/formulation as applicable, full QC (SDS/PAGE, HPLC/SEC, antigenicity, sterility).
4. In Vitro Immune Function Assays
- Antigen presentation assays, dendritic cell activation, PBMC stimulation, antibody binding/neutralisation assays, epitope tracking, optional immune-checkpoint assays.
5. In Vivo Immunogenicity & Efficacy Studies
- Animal study design (mouse/rat/murine saline virus surrogate), immunisation schedule, sampling (blood, mucosa, ganglia/tissue where applicable), challenge studies (infection, latency, shedding).
- Immunological read-outs (antibody titres, T cell responses, memory cell formation), viral endpoints (viral load, shedding, latency reactivation).
- Toxicology and safety screen (behavioural, histopathology, biodistribution/persistence for vector formats).
6. Data Integration & Candidate Nomination Package
- Assemble all data into a comprehensive dossier including: background & rationale, construct details, manufacturing summary, in-vitro & in-vivo data, immune correlations, risk/mitigation summary, next-step recommendations.
- Deliver a clear recommendation and decision-point: nominate lead candidate for downstream development (outside our remit, i.e., clinical manufacture/trials).
7. Handover and Support for Next Stage
- Provide data summarisation tools (e.g., charts, tables, slide deck) and offer optional consultative support for downstream partner engagements (licensing, investor brief, academic collaboration).
- Ensure all deliverables adhere to regulatory-quality documentation standards, thereby enhancing the credibility of your vaccine programme in the drug-development ecosystem.
FAQs
Q1: Which HHV types do you support for vaccine candidate development?
A1: We support all major human herpesviruses (alpha, beta, gamma sub-families) for research and pre-clinical vaccine candidate work — including HSV-1, HSV-2, VZV, HCMV, HHV-6/7, EBV, KSHV/HHV-8. However, our work remains strictly pre-clinical: we do not provide clinical manufacturing or trial-services.
Q2: Can you design a therapeutic vaccine (i.e., for latent infection or reactivation) vs a preventive vaccine?
A2: Yes. We understand the unique challenges of therapeutic HHV vaccine development (e.g., targeting latent reservoirs, eliciting tissue-resident T cells, suppressing reactivation). Our antigen design, immuno-assays and in-vivo models incorporate these aspects. For example, the prime/pull strategy and checkpoint-blockade approaches for HSV therapeutic vaccines have been reviewed in recent literature.
Q3: What immunological endpoints do you measure?
A3: Our standard immunological panel includes: binding and neutralising antibody titres, antigen-specific CD4+/CD8+ T-cell responses (ELISpot, ICS), mucosal immune responses (IgA where relevant), memory T-cell markers, tissue-resident T cells (in ganglia or mucosa where model permits), viral load/latency/ shedding endpoints and biodistribution/persistence in vector formats.
Q4: Are your workflows compatible with GLP or GMP?
A4: Our standard service provides research-grade and pre-clinical data. For vector and antigen production we use GMP-capable facilities; however, full GMP production or GLP toxicity studies are not included under this service unless specifically contracted. We can collaborate with GMP/GLP vendors if required.
Q5: How do you manage the safety and oncogenic risk concerns specific to HHVs (e.g., KSHV)?
A5: We incorporate risk-assessment for vaccine constructs in HHV context — for example avoiding replicating viruses, deleting oncogenic gene loci, rigorous biodistribution/persistence analysis, and careful selection of antigen/immune-modulation format. For KSHV, recent reviews emphasise the need for vaccines that are safe, inexpensive and deliverable in high-risk populations rather than relying on replicating vectors.
Conclusion
In summary, CD BioSciences delivers a highly specialised, end-to-end pre-clinical vaccine development solution for human herpesviruses, culminating in the nomination of a lead vaccine candidate ready for downstream development. Our focus on HHV biology, combined with integrated antigen-construction, production, immune-evaluation and in-vivo efficacy workflows, uniquely position us to support your next-generation HHV vaccine programme. Whether you are aiming for prophylactic prevention of HHV infection, suppression of viral latency/reactivation or vaccine-enabled control of HHV-associated proliferative disorders, we can partner with you to de-risk and accelerate your translation path.
References
- Bai L, et al. A review of HSV pathogenesis, vaccine development, and emerging prospects. Viruses. 2024;16(3):xxx.
- Johnston C, Koelle DM, Wald A. Current status and prospects for development of an HSV vaccine. J Infect Dis. 2013;207(3):383-391.
- Chentoufi AA, BenMohamed L. Combinatorial Herpes Simplex Vaccine Strategies. Front Immunol. 2022;13:849515.
- Casper C, et al. KSHV (HHV-8) vaccine: promises and potential pitfalls for a vaccine to prevent a virus associated with cancer. npj Vaccines. 2022;7:108.
- Yin Y, et al. A Bivalent mRNA Vaccine Efficiently Prevents Murine Gammaherpesvirus 68 Latent Infection. Vaccines. 2025;13(8):830.