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Dengue virus vaccine development support

SSI Diagnostica Group’s involvement in vaccine development began over 40 years ago—then as Statens Serum Institut—by supplying antisera for quality control to a global vaccine manufacturer during the development of a pneumococcal vaccine.  

Today, SSI Diagnostica Group continues to provide leading vaccine developers including GSK with high-quality products and scientific expertise across multiple disease areas including Dengue virus. SSI Diagnostica Group (via our CTK Biotech portfolio) collaborated with Sanofi to develop and validate the OnSite Dengue IgG rapid diagnostic test, supporting pre-vaccination screening. The performance and clinical relevance of this kit was published in Microbiology Spectrum (ASM Journals, 2022)1.

Current context for dengue virus vaccines 

Dengue fever, caused by four distinct dengue virus serotypes (DENV‑1 to DENV‑4), presents well‑known challenges for vaccine developers, including serostatus considerations and the need for broad, durable protection against all dengue virus serotypes. Dengue vaccines currently licensed in various regions include Qdenga® (TAK003, Takeda) and Dengvaxia® (CYDTDV, Sanofi Pasteur) 2.

Our portfolio is structured to meet the evolving needs of vaccine developers from research & development all the way to post-market surveillance. 


Research and
development 

Pre-clinical 

Clinical 

Production 

Post market
surveillance 
Dengue Envelope Proteins 
Serotype-resolved antigens for immunogenicity assays, epitope mapping, and breadth profiling.  Dengue Envelope Proteins Serotype-resolved antigens for immunogenicity assays, epitope mapping, and breadth profiling.  
Dengue Type 1 Envelope protein Dengue Type 2 Envelope Protein  
Dengue Type 3 Envelope Protein
Dengue Type 4 Envelope Protein
Dengue NS1 Proteins  
For building and calibrating NS1 assays, measuring NS1-specific responses, and developing NS1-based diagnostic tools.
Dengue Type 1 NS1 Protein
Dengue Type 2 NS1 Protein  
Dengue Type 3 NS1 Protein
Dengue Type 4 NS1 Protein
Mouse Anti-Pan Dengue NS1 mAb  
Capture or detection reagent for NS1 assays across all serotypes.
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Rabbit Anti-Pan Dengue NS1 pAb 
Broad NS1 detection to enhance analytical sensitivity in assay development and QC.
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Mouse Anti-DNV Envelope Protein  
Monoclonal Antibodies
(Recognize all 4 dengue serotypes)
Tetravalent envelope protein detection and characterization; verifies envelope content and integrity in multivalent constructs. 
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Humanized Anti-DNV Envelope Protein IgG and IgM isotypes
(recognize all 4 dengue serotypes) 
Human-like positive controls for setting clinically relevant cut-offs and immune-profiling
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Recombinant serotype-specific Anti-DNV Envelope Protein antibodies
Specific for each of the 4 DNV serotypes, no cross-reactivity with other serotypes. Serotype-specific confirmation and cross-reactivity exclusion; identity and purity testing in antigen mixes. QC of vaccine immune response against all 4 DNV serotypes. 
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Research and
development 

Pre-clinical 

Clinical 
studies

Production 

Post market
surveillance 
OnSite® Dengue Ag Rapid Test*
Rapidly confirms or rules out acute dengue (day 1–9) to triage participants and classify endpoints. 
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OnSite®Dengue IgG/IgM Combo Rapid Test 
Know recent infection status; eliminate/include subjects with recent asymptomatic infections; confirm recent infection by ELISA 
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OnSite®Duo Dengue Ag-IgG/IgM Rapid Test
Know acute infection status; eliminate/include subjects with asymptomatic infections 
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OnSite Dengue IgG Rapid Test 
Determine any previous infection; eliminate/include subjects with previous infection; monitor enrollment numbers (Dengue seropositive vs seronegative) 
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Customization and contract manufacturing services 

Please note: Product availability may vary by country. Some products listed in the table might not be registered or available in all markets. For detailed information on distribution and registration status in your region, please contact SSI Diagnostica Group or your local representative.

Research & development

  • Supporting with consistent QC design

Preclinical trials

  • Assay development and immune response tracking

Clinical trials

  • IVD tests for pre-screening and testing of study participants
  • Raw material and support for in-house assays

Production

  • Scalable supply of validated reagents

Post market surveillance

  • Ongoing support for surveillance and refinement

Customization and contract manufacturing services:

  • Available across all development stages
  • Trusted by leading vaccine manufacturers for 40+ years
  • High quality IVD products (IVDD / IVDR) 
  • Stable supply by 100% in-house production
  • Global distribution (130+ countries)
  • Compliant with manufacturing, regulatory and environmental standards / requirements (ISO 13485, ISO 14001, 21 CFR 820) 

Get in touch with our team for any questions. Whether you are looking for more information about our products or have questions regarding our solutions, fill out the form and we will get back to you as soon as possible.




    References

    1. Liberal V, Forrat R, Zhang C, Pan C, Bonaparte M, Yin W, Zheng L, Viscardi V, Wu Y, Ataman-Önal Y, Savarino S, Chen C, Engelund A. Performance Evaluation of a Dengue IgG Rapid Diagnostic Test Designed to Determine Dengue Serostatus as Part of Prevaccination Screening. Microbiology Spectrum. 2022;10(3):e00711-21. doi:10.1128/spectrum.00711-21. ↩︎
    2. WHO position paper on dengue vaccines (May 2024), accessed 21 October 2025    ↩︎