Vaccine Development

Our mission is to identify a suitable Strep A vaccine candidate for clinical development and progress it through early clinical trials in Australia.

We’ve scoped the global Strep A vaccine landscape and selected a lead vaccine candidate that met our criteria for development. We’re currently negotiating a partnership with the lead vaccine developer and preparing for clinical trials in 2022.

We’re firmly focused on demonstrating proof of concept in humans of the vaccine candidate and will establish partnerships for future clinical trials and vaccine licensure.

Our initial aim for the lead candidate will be to demonstrate the safe and effective prevention of Strep A-related pharyngitis.

Advancing a lead Strep A vaccine candidate through phase 1 and phase 2 efficacy trials along the clinical development pathway is a critical first step as recommended in the World Health Organisation vaccine development technology roadmap.

We aim to:

Demonstrate safety and efficacy of the lead vaccine candidate for pharyngitis prevention in children living in urban Australia.
Establish global partnerships to facilitate later stage clinical trials and licensure of the vaccine.
Consult with Indigenous communities to increase the likelihood of Aboriginal Australians being among the first populations in the world to be the beneficiaries of a proven safe and effective Strep A vaccine.

Core Activities

Clinical trials including a phase 1 safety study in adults and a phase 2 efficacy study to prevent pharyngitis in children of a lead vaccine candidate.
Establishment of qualified immune assays to support evaluation of clinical trials, as well as natural infection studies and contribution to the Strep A field in general.
Establishment of a consortium of funders to fully fund the program and its next steps to licensure.

Clinical Development

ASAVI’s clinical development strategy is to develop a vaccine for the prevention of pharyngitis to stop post-Strep A immune mediated diseases such as acute rheumatic fever (ARF) and rheumatic heart disease (RHD). This approach is similar to the vaccines that target acute human papilloma virus (HPV) infection to prevent cervical cancer.
Our clinical development strategy will first focus on the demonstration of safety and efficacy of the vaccine candidate in low-risk populations, before embarking on clinical trials in populations at higher risk for the development of ARF and RHD.
ASAVI aims to transition a lead Strep A vaccine candidate from the preclinical stage through early clinical testing. This includes:
- a phase 1 study in adults to demonstrate safety,
- followed by phase 2 safety and efficacy studies in young children.
We will also test our selected vaccine in a controlled human infection study, building on work done by our team and other partners
We’re working with our partners to understand the requirements for clinical studies to support licensure.

Assay Development

Currently, there is no standardised pipeline of immunogenicity assays to support the development of Strep A vaccines.
Therefore, we are investing in developing qualified and standardised immune assays to support our clinical development program.
Our assays to meet primary immunogenicity endpoints and regulatory requirements, while also supporting robust decision making during clinical development.
Using multiplex technology, our focus is to develop assays to measure the magnitude, breadth, depth and functionality of vaccine induced antibody responses.
ASAVI will contribute to the field by making our assays available for research.

Aboriginal and Torres Strait Islander peoples are referred to as Indigenous Australians throughout this website.

Learn more about our program

Epidemiology

Community Engagement & Capacity Building