Optimization and validation of an ELISA assay for the determination of antibody responses to CN54gp140 and AIDSVAX BE for use in the Phase IIb PrEPVacc vaccine trial.

Gombe, Ben; Streatfield, Claire; Leal, Lorna; Opio, Solomon; Joseph, Sarah; Weber, Jonathan; Hare, Jonathan; Kaleebu, Pontiano; Serwanga, Jennifer; (2022) Optimization and validation of an ELISA assay for the determination of antibody responses to CN54gp140 and AIDSVAX BE for use in the Phase IIb PrEPVacc vaccine trial. PloS One, 17 (11). e0275927-. ISSN 1932-6203 DOI: https://doi.org/10.1371/journal.pone.0275927

Abstract

PrEPVacc is an international, multi-centre, double-blind vaccine study comparing experimental combination vaccine regimens including DNA/AIDSVAX BE and DNA/CN54gp140 with placebo control. Simultaneously, daily oral PrEP is compared for efficacy against daily Truvada in the context of the current PrEP availability situation at the study sites. An important clinical trial outcome is the accurate measurement of in vivo antibody titer induced through vaccination. Here we report the validation of two ELISAs for CN54gp140 and AIDSVAX BE at Uganda Virus Research Institute that demonstrates precision, specificity, and robustness for assessing the reciprocal antibody end point titer in human serum. This is a critical endpoint for determining whether vaccination can provide any protection against HIV in populations at risk of acquiring HIV.

Additional Information

Item Type	Article
Faculty and Department	MRC Uganda > UG-HIV Care MRC Uganda > UG-Basic Science
PubMed ID	36327320
Elements ID	196227
Official URL	http://dx.doi.org/10.1371/journal.pone.0275927