Background

​The extraordinary genetic diversity of HIV-1 has been a major barrier to the development of an effective prophylactic vaccine. HIV-1 exists in multiple clades (subtypes), and within these clades, significant genetic variability exists. This diversity enhances  the virus’s ability to evade immune responses, making it difficult to design a vaccine capable of providing broad protection. ​While novel vaccine designs offer a potential solution to the issue of diversity, regulatory approval is expected to be granted for specific clades for which there is clinical evidence.  

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Challenge

The client's key challenge was to develop and validate a methodology to infer vaccine efficacy across HIV-1 clades, leveraging existing clinical data for specific HIV subtypes, in order to gain regulatory approval for a broad indication that covers a wide range of HIV clades. 

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Approach

A panel of five globally renowned HIV experts was convened for a one-day virtual advisory board. To ensure alignment and provide comprehensive context, participants attended a pre-advisory board webinar. This session outlined the client’s clinical development programme, detailed the objectives of the advisory board, and introduced key discussion topics. A Q&A session allowed participants to address any preliminary questions. 

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Outcomes

• The advisory board confirmed the suitability of the client’s approach while giving clear and actionable recommendations for improving HIV strain selection and antigen characterization techniques. Innovative ELISA-based quantification techniques and proposed data analysis methods were endorsed as appropriate for assessing immune responses. 

• Recommendations provided during the advisory board informed refinements to the cross-clade research framework, enhancing its ability to generate actionable data for regulatory submissions.

• Outcomes from the advisory board contributed to the optimisation of the client’s evidence generation strategy and resulted in publication of the novel methodology in high impact factor journals.