# SDMC: HIV Vaccine Trials Network

> **NIH NIH UM1** · FRED HUTCHINSON CANCER CENTER · 2024 · $31,992,488

## Abstract

PROJECT SUMMARY/ABSTRACT
This application proposes to continue as the Statistical and Data Management Center (SDMC) for the HIV
Vaccine Trials Network (HVTN). To meet the statistical and data management goals described in RFA-AI-19-
002, and ultimately to achieve the scientific goal of the HVTN − to develop a safe and globally effective HIV
vaccine − seven specific aims will be addressed: Aim 1, to accomplish all specific aims using high-quality, timely,
cost-efficient, and secure data management and safety monitoring by adhering to clinical data management
standards and regulatory requirements and by using state-of-the-art, CDISC Standards compliant data systems
that enable data exchange and provisioning; Aim 2, to provide innovative statistical/computational biology study
design and data analysis for standardized, phase 1-2a clinical trials that evaluate safety and immunogenicity of
candidate HIV vaccines, including “fast-track” iterative trials to screen vaccines for their ability to elicit broadly
neutralizing antibodies, and that evaluate safety, pharmacokinetics, and immunological functions of directly
administered broadly neutralizing monoclonal antibodies (mAbs); Aim 3, to support the HVTN Laboratory Center
with data management, statistical methods, and data analysis for developing immunological and virological
assays and data analysis pipelines, toward vaccine immunogenicity characterization, systems vaccinology, and
modeling of mAb concentrations and functions; Aim 4, to provide robust and efficient design and analysis of
phase 2b test-of-concept and phase 3 trials to assess vaccine efficacy or mAb efficacy to prevent HIV infection,
including strategies for integrating other HIV prevention modalities into trial designs; Aim 5, to employ novel
quantitative methods for assessing within the phase 2b and 3 efficacy trials correlates of vaccine or mAb
protection, where the correlates are based on markers measuring immune responses to vaccination or mAb
concentration, human immune genetics, and genetic and immunological features of HIV viruses; Aim 6, to adapt
the functions of Aims 1−5 to vaccine or mAb clinical trials of HIV-exposed and HIV-unexposed infants; and Aim
7, to adapt applicable functions of Aims 1−6 for tuberculosis vaccine clinical trials. Novel quantitative
methodologies will be developed in support of the specific aims, to increase the efficiency, rigor, and scientific
impact of the HVTN program. The research will be accomplished in harmonization with the HVTN Leadership
and Operations Core and the HVTN Laboratory Center, and in collaboration with other HIV/AIDS research
networks. Aim 5 encapsulates the HVTN’s research approach to achieving a globally effective HIV vaccine, in
that: (1) Iterative evaluation of refined versions of partially effective vaccine and mAb regimens will be required;
(2) Correlates of vaccine protection are the key scientific tool for driving this iterative evaluation; (3) All Aim 1−4
research activiti...

## Key facts

- **NIH application ID:** 10798117
- **Project number:** 5UM1AI068635-19
- **Recipient organization:** FRED HUTCHINSON CANCER CENTER
- **Principal Investigator:** Peter B. Gilbert
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $31,992,488
- **Award type:** 5
- **Project period:** 2006-06-29 → 2027-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10798117

## Citation

> US National Institutes of Health, RePORTER application 10798117, SDMC: HIV Vaccine Trials Network (5UM1AI068635-19). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10798117. Licensed CC0.

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