BTCV: Preclinical Immunological Assay Validation Data

Serum Institute of India Pvt. Ltd. developed and validated serological assays for a novel bivalent typhoid conjugate vaccine (BTCV). The dataset contains results from quantitative IgG ELISA and functional Serum Bactericidal Assay (SBA) tests used to assess immunogenicity against Salmonella Typhi and Salmonella Paratyphi A in preclinical models. These validated assays are intended for evaluating vaccine efficacy in upcoming clinical trials.

Use Cases

• Validating assay precision and linearity for anti-Vi and anti-OSP IgG based on described ICH guideline parameters.
• Assessing non-interference between Vi-TT and OSP-DT vaccine arms using results from single-dose GLP-TOX studies.
• Benchmarking functional antibody response via Serum Bactericidal Assay (SBA) data for future clinical sample analysis.

Strengths

• Assays were validated for key parameters including Precision, Linearity/accuracy, robustness, and specificity per ICH guidelines.
• Demonstrated a non-interference immune response between the two conjugate arms (Vi-TT and OSP-DT) in GLP-TOX studies.

Limitations

• Column names and row counts are not provided, limiting understanding of the data structure.
• The dataset size (775909) is given without units, making its scale ambiguous.
• Data is from preclinical models; applicability to human clinical samples requires further verification.

Provenance

Source

Vinay Gavade, associated with the Serum Institute of India Pvt. Ltd. (SIIPL).

Collection Method

In-house development and validation of immunological assays (ELISA and SBA) for preclinical vaccine evaluation.

Freshness

Last updated on 2026-03-18.