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Single-Shot ChAd3-MARV Vaccine in Modified Formulation Buffer Shows 100% Protection of NHPs
Courtney L Finch1, Thomas H King1, Kendra J Alfson2
1Sabin Vaccine Institute, Washington, DC 20037, USA.
Abstract:
Marburg virus (MARV) is a virus of high human consequence with a case fatality rate of 24-88%. The global health and national security risks posed by Marburg virus disease (MVD) underscore the compelling need for a prophylactic vaccine, but no candidate has yet reached regulatory approval. Here, we evaluate a replication-defective chimpanzee adenovirus type 3 (ChAd3)-vectored MARV Angola glycoprotein (GP)-expressing vaccine against lethal MARV challenge in macaques. The ChAd3 platform has previously been reported to protect against the MARV-related viruses, Ebola virus (EBOV) and Sudan virus (SUDV), and MARV itself in macaques, with immunogenicity demonstrated in macaques and humans. In this study, we present data showing 100% protection against MARV Angola challenge (versus 0% control survival) and associated production of GP-specific IgGs generated by the ChAd3-MARV vaccine following a single dose of 1 × 1011 virus particles prepared in a new clinical formulation buffer designed to enhance product stability. These results are consistent with previously described data using the same vaccine in a different formulation and laboratory, demonstrating the reproducible and robust protective efficacy elicited by this promising vaccine for the prevention of MVD. Additionally, a qualified anti-GP MARV IgG ELISA was developed as a critical pre-requisite for clinical advancement and regulatory approval.
Insights
A single dose of a novel chimpanzee adenovirus type 3-vectored Marburg virus vaccine demonstrated 100% protection in macaques. This vaccine shows promise for preventing Marburg virus disease, with a new assay developed for clinical advancement.
Area of Science:
- Virology
- Vaccinology
- Immunology
Background:
- Marburg virus disease (MVD) poses significant global health and national security risks due to its high case fatality rate (24-88%).
- No prophylactic vaccine for MVD is currently approved, highlighting an urgent need for effective prevention strategies.
- The chimpanzee adenovirus type 3 (ChAd3) vector platform has shown prior success against related filoviruses and Marburg virus itself.
Purpose of the Study:
- To evaluate the efficacy of a replication-defective ChAd3-vectored Marburg virus Angola glycoprotein (GP)-expressing vaccine against lethal Marburg virus challenge in a macaque model.
- To assess the immunogenicity and protective capabilities of a new clinical formulation of the ChAd3-MARV vaccine.
Main Methods:
- Macaques were vaccinated with a single dose of the ChAd3-MARV vaccine (1 × 1011 virus particles) in a novel clinical formulation.
- Vaccinated macaques and a control group were subsequently challenged with lethal Marburg virus Angola.
- Survival rates and the production of Marburg virus GP-specific IgGs were monitored.
- A qualified anti-GP Marburg virus IgG ELISA was developed and validated.
Main Results:
- The ChAd3-MARV vaccine conferred 100% protection against lethal Marburg virus Angola challenge in macaques.
- Control animals exhibited 0% survival, underscoring the vaccine's efficacy.
- Vaccination induced the production of Marburg virus GP-specific IgGs.
- The results were reproducible across different formulations and laboratories.
Conclusions:
- A single dose of the ChAd3-MARV vaccine provides robust and reproducible protection against Marburg virus challenge.
- The vaccine's efficacy, coupled with the development of a qualified diagnostic assay, supports its advancement towards clinical use for Marburg virus disease prevention.
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