Clinical immunogenicity assessment of HIV/AIDS vaccines: current progress and future perspectives.
- 1Division of HIV/AIDS and Sex-Transmitted Virus Vaccines, National Institutes for Food and Drug Control (NIFDC), State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, Beijing, People's Republic of China.
- 2School of Pharmacy, China Pharmaceutical University, Nanjing, People's Republic of China.
Abstract
Developing a safe and effective HIV-1 vaccine remains the cornerstone of global efforts to terminate the AIDS pandemic. However, the virus's immense genetic diversity and the persistent absence of a universal Correlate of Protection (CoP) present formidable barriers. Concomitant with the iterative evolution of vaccine design - spanning from protein subunits to mRNA and germline-targeting platforms - immunogenicity evaluation frameworks have undergone a critical paradigm shift. The field has transitioned from relying on conventional serological assays to embracing comprehensive, high-dimensional immune profiling. This review delineates the trajectory of milestone clinical trials, including RV144, the HVTN series, and the AMP studies, to systematically summarize advancements in assessing both humoral and cellular immunity. We comprehensively examine core methodologies, such as Binding Antibody Multiplex Assays (BAMA), pseudovirus neutralization, Enzyme-Linked Immunospot (ELISpot), and Intracellular Cytokine Staining (ICS). Furthermore, we highlight a pivotal transition in evaluative logic: moving beyond a singular focus on neutralizing antibody titres to integrate Fc-mediated effector functions (e.g. Antibody-Dependent Cellular Cytotoxicity (ADCC) and Phagocytosis (ADCP)) and the synergistic roles of polyfunctional T-cells. We also explore the transformative potential of burgeoning frontiers, including systems serology, single-cell B-cell receptor (BCR) sequencing, and mucosal immunity evaluation. Ultimately, we recommend that future evaluation frameworks combine single-cell multi-omics technologies with artificial intelligence algorithms and integrate multi-dimensional data for analysis, thereby providing a solid theoretical and technical foundation for the design of next-generation HIV vaccines.
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BibTeX
@article{yu2026clinical,
title = {{Clinical immunogenicity assessment of HIV/AIDS vaccines: current progress and future perspectives.}},
author = {Hang Yu and Xi Wu and Tingting Li and Jianhui Nie},
journal = {Emerging microbes \& infections},
year = {2026},
month = oct,
doi = {10.1080/22221751.2026.2751675},
url = {https://europepmc.org/article/MED/42888914},
note = {CC BY},
}
RIS
TY - JOUR
TI - Clinical immunogenicity assessment of HIV/AIDS vaccines: current progress and future perspectives.
AU - Hang Yu
AU - Xi Wu
AU - Tingting Li
AU - Jianhui Nie
PY - 2026
DA - 2026/10/22
JO - Emerging microbes & infections
DO - 10.1080/22221751.2026.2751675
UR - https://europepmc.org/article/MED/42888914
AB - Developing a safe and effective HIV-1 vaccine remains the cornerstone of global efforts to terminate the AIDS pandemic. However, the virus's immense genetic diversity and the persistent absence of a universal Correlate of Protection (CoP) present formidable barriers. Concomitant with the iterative evolution of vaccine design - spanning from protein subunits to mRNA and germline-targeting platforms - immunogenicity evaluation frameworks have undergone a critical paradigm shift. The field has transitioned from relying on conventional serological assays to embracing comprehensive, high-dimensional immune profiling. This review delineates the trajectory of milestone clinical trials, including RV144, the HVTN series, and the AMP studies, to systematically summarize advancements in assessing both humoral and cellular immunity. We comprehensively examine core methodologies, such as Binding Antibody Multiplex Assays (BAMA), pseudovirus neutralization, Enzyme-Linked Immunospot (ELISpot), and Intracellular Cytokine Staining (ICS). Furthermore, we highlight a pivotal transition in evaluative logic: moving beyond a singular focus on neutralizing antibody titres to integrate Fc-mediated effector functions (e.g. Antibody-Dependent Cellular Cytotoxicity (ADCC) and Phagocytosis (ADCP)) and the synergistic roles of polyfunctional T-cells. We also explore the transformative potential of burgeoning frontiers, including systems serology, single-cell B-cell receptor (BCR) sequencing, and mucosal immunity evaluation. Ultimately, we recommend that future evaluation frameworks combine single-cell multi-omics technologies with artificial intelligence algorithms and integrate multi-dimensional data for analysis, thereby providing a solid theoretical and technical foundation for the design of next-generation HIV vaccines.
SN - 2222-1751
ER -