2. Assess the efficacy of the cold-chain independent virosomal vaccine delivered by combined mucosal immunization routes against repeated intrarectal challenges with the heterologous R5 clade B SHIVSF162P3. Protected RMs will be rechallenged with an R5 tier 2 clade C SHIV. 3. Optimize the GMP manufacturing process for the selected virosomal formulations for mucosal delivery, and 4. Perform toxicology studies to show good safety profiles of the adjuvanted, solid-form vaccines given by selected mucosal routes – and generate GMP vaccine for a Phase I trial to be conducted with the HVTN.
Neutralization-Sensitive R5-Tropic Simian-Human Immunodeficiency Virus SHIV-2873Nip, Which Carries env Isolated from an Infant with a Recent HIV Clade C Infection
Mucosal transmissibility of SHIV-2873Nip. Since approximately 90% of all new HIV infections are acquired by mucosal exposure during sexual contact or via mother-to-child transmission, candidate AIDS vaccines should protect against mucosal virus challenge. Preclinical vaccine safety and efficacy studies in primate models should thus focus on mucosal virus challenges (reviewed in reference 59). We sought to test whether SHIV-2873Nip could be transmitted mucosally.
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