# Vaccine and adjuvant Clinical GMP product development and DNA Technology platform enhancements

> **NIH NIH U19** · WISTAR INSTITUTE · 2024 · $1,211,603

## Abstract

Project 3 Summary
Project 3 is primarily focused on the product production aspects of this IPCAVD proposal (Specific Aim 1). It is
directed by a leading HIV vaccine development organization – Inovio Pharmaceuticals (INO) who have advanced
multiple clinical DNA vaccine programs. Inovio has extensive expertise in development of synthetic DNA
vaccines and advanced in vivo electroporation delivery. The central goal of Project 3 is to cGMP manufacture
and deliver product for 2 DNA immunogen constructs in years 4 and 5 of the program. Using Inovio’s advanced
process technology the experienced team will manage CMC aspects of producing product with specific state-of-
the-art manufacturing facilities for drug substance and drug product activities resulting in vialed doses, and
support IND submission to be delivered in year 5 of the program. Additionally, Inovio will support the use of the
next generational compact, portable, hand-held intradermal EP delivery device, CELLECTRA™ 3PSP. This
device will be provided and employed for the preclinical studies across all animal models throughout this
program. 3PSP will be available to support the subsequent clinical trials which will be initiated by the HVTN. In
Specific Aim 2 Project 3 will collaborate with Project 1 to evaluate and advance the development of dual antigen
and cytokine DNA constructs. Our development work with the dual promoter IL-12 constructs, will provide the
blueprint for these dual promoter constructs that will express a HIV antigen and cytokine adjuvant. Project 3 will
provide coordination and support of the NHP studies throughout the duration of the project which will include
immunogenicity and IND-enabling studies to advance the development HIV vaccine constructs originating from
Project 1 and 2. In Specific Aim 3, we will evaluate DNA vaccine delivery employing transformative skin delivery
protocols in clinically relevant models, including guinea pigs and NHPs, integrating needleless jet delivery with
skin electroporation. In summary, Project 3 will provide high quality concentrated drug product for subsequent
HVTN clinical testing and advance the development of novel HIV DNA vaccine constructs and delivery platforms.

## Key facts

- **NIH application ID:** 10751017
- **Project number:** 5U19AI166916-02
- **Recipient organization:** WISTAR INSTITUTE
- **Principal Investigator:** Trevor Smith
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,211,603
- **Award type:** 5
- **Project period:** 2022-12-08 → 2027-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10751017

## Citation

> US National Institutes of Health, RePORTER application 10751017, Vaccine and adjuvant Clinical GMP product development and DNA Technology platform enhancements (5U19AI166916-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10751017. Licensed CC0.

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