# Development of Ad26/Env Vaccines for HIV

> **NIH NIH U19** · BETH ISRAEL DEACONESS MEDICAL CENTER · 2022 · $2,799,999

## Abstract

The goal of this IPCAVD program is to develop Ad26/Env vaccines for HIV-1 by a highly collaborative and
multifaceted research program involving leading investigators in academia and industry. Our overall
hypothesis is that an optimized Ad26/Env mosaic vaccine will induce highly functional antibodies that
will protect humans against acquisition of multiple HIV-1 clades. The significance of this program is the
potential actual development of a safe and effective global HIV-1 vaccine, the unparalleled commitment of a
major pharmaceutical company to this HIV-1 vaccine, and the opportunity for major scientific advances in our
understanding of immune correlates of protection.
In our current IPCAVD program (U19 AI096040), we have developed alternative serotype adenovirus vectors,
bioinformatically optimized HIV-1 mosaic antigens, and stable Env gp140 protein immunogens. We have shown
that the Ad26-Env/Gag/Pol prime, Env gp140 protein boost (Ad26/Env) vaccine afforded unprecedented
protective efficacy against acquisition of infection following heterologous SIVmac251 challenges in rhesus
monkeys, as well as robust protection against SHIV-SF162P3 challenges. Protection correlated with
polyfunctional antibody responses as determined by systems serology. We have also advanced the Ad26/Env,
Ad26/MVA, and Ad26/MVA/Env mosaic vaccines into phase 1/2a clinical trials in the United States, East Africa,
South Africa, and Thailand. Over the next 5 years of this IPCAVD program, we propose to define the extent
and mechanism of protection achieved by our lead Ad26/Env vaccine regimen in rhesus monkeys, to
advance our lead vaccine regimen into phase 2b/3 efficacy studies in humans, and to develop an
improved next generation HIV-1 vaccine candidate. To accomplish the goals of this IPCAVD program, we
propose the following Projects and Cores:
Project 1. Preclinical Development of Ad26/Env Vaccines for HIV
Project 2. Manufacturing and Clinical Development of Ad26/Env Vaccines for HIV
Core A. Administrative Core
Core B. Immunology Core
Core C. NHP Core

## Key facts

- **NIH application ID:** 10339362
- **Project number:** 5U19AI128751-05
- **Recipient organization:** BETH ISRAEL DEACONESS MEDICAL CENTER
- **Principal Investigator:** Dan H. Barouch
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $2,799,999
- **Award type:** 5
- **Project period:** 2018-02-01 → 2025-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10339362

## Citation

> US National Institutes of Health, RePORTER application 10339362, Development of Ad26/Env Vaccines for HIV (5U19AI128751-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10339362. Licensed CC0.

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