# Evaluation of Safe and Immunogenic Dose of AD Vaccine in aged non-human primates: Prelude to Phase 1 Preventive Vaccinations

> **NIH NIH U01** · INSTITUTE FOR MOLECULAR MEDICINE · 2021 · $419,490

## Abstract

Project Summary
Immunotherapy is still considered a very promising therapeutic strategy for AD prevention when
certain conditions are met. Data from various immunotherapeutic studies support our long-
standing tenet that immunogenic AD vaccines could at least delay disease progression when they
target both Aβ and Tau pathological molecules at an early stage of the disease before AD
manifestation or even in asymptomatic healthy people at risk of AD. Recently FDA announced
emergency accelerated approval of mAb Aducanumab for treatment of early AD. However, it is
impractical to use very expensive mAbs as a preventive treatment of healthy subjects due to the
need for frequent (monthly) administration of high concentrations (700-800mg per IV injection) of
this immunotherapeutic. In contrast, almost all effective vaccines are effective when they are used
as a preventive treatment. Accordingly, in this administrative supplement to U01 AG060965, we
propose to test the overall safety and immunogenicity of a dual vaccine (DUVAC) targeting Aβ
and Tau in non-human primates that more closely resemble the human immune system. These
data will support the submission of INDs to the FDA for future clinical trials that will allow us to
treat asymptomatic healthy subjects at risk to MCI with extremely immunogenic Aβ and tau
vaccines based on the same and very immunogenic MultiTEP platform and novel adjuvant
AdvaxCpG. Our proprietary vaccine platform can stimulate adaptive immunity, providing broad
coverage of human MHC polymorphisms and activating both naive Th cells and pre-existing
memory Th cells generated in response to conventional vaccines and/or infections with various
pathogens during one's lifespan without the activation of harmful autoreactive T cells. These
"non-self" Th cells should activate B cells and induce the production of therapeutically potent
antibodies specific to pathological Aβ and Tau in humans, similar to that in non-human primates.
Completing studies in aged monkeys along with data from AG060965 safety/toxicology studies in
diseased mice should strongly support our IND submission for the first-in-human preventive dual
Aβ/tau vaccine with healthy people at risk of MCI or earlier based on research blood, CSF, brain
biomarkers.

## Key facts

- **NIH application ID:** 10433497
- **Project number:** 3U01AG060965-03S2
- **Recipient organization:** INSTITUTE FOR MOLECULAR MEDICINE
- **Principal Investigator:** Michael G Agadjanyan
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $419,490
- **Award type:** 3
- **Project period:** 2019-02-01 → 2023-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10433497

## Citation

> US National Institutes of Health, RePORTER application 10433497, Evaluation of Safe and Immunogenic Dose of AD Vaccine in aged non-human primates: Prelude to Phase 1 Preventive Vaccinations (3U01AG060965-03S2). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10433497. Licensed CC0.

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