Table 2.
Current State of SUDV and MARV gaps as of the end of 2019
| Category | Gap | Current Status SUDV | Current Status MARV |
|---|---|---|---|
| Clinical | Safety and Immunogenicity Data | Phase 1 data from ChAd3, Ad5, DNA constructs. Phase 1 underway for multivalent Ad26/MVA. | Phase 1 data from DNA construct. Phase 1 underway for ChAd3 and multivalent Ad26/MVA. |
| Dose Selection | No dose selection for further studies. | No dose selection for further studies. | |
| Immune Assays | Qualified immune assays needed. | Qualified immune assays needed. | |
| Non-Clinical | Efficacy in Nonhuman Primates | Proof of concept available for VSV, VRP, VLP, Ad5, DNA, ChAd3. | Proof of concept available for VSV, VLP, DNA, Ad5, ChAd3. |
| GLP Toxicology | GLP toxicology for ChAd3 and multivalent Ad26/MVA. | GLP toxicology for ChAd3 and multivalent Ad26/MVA. | |
| Concurrence on Animal Species, Route of Challenge, and Challenge Strains | No official concurrence on animal species, virus strain, or route of challenge. | No official concurrence on animal species, virus strain, or route of challenge. | |
| Chemistry, Manufacturing, and Controls | Lot Release Assays | Development, qualification, and validation required for key non-compendial assays. | Development, qualification, and validation required for key non-compendial assays. |
| Small Scale Process Development | Lab-scale development for ChAd3, DNA, and Ad26/MVA vectors. | Lab-scale development for ChAd3, DNA, and Ad26/MVA vectors. | |
| GMP Manufactured Lots | GMP lots available for ChAd3 and Ad26/MVA. Additional material needed for all candidates. | GMP lots available for ChAd3 and Ad26/MVA. Additional material needed for all candidates. | |
| Stability Data to Support Clinical Studies | Limited understanding of stability profiles. | Limited understanding of stability profiles. |
*VRP = Viral Replicon, VLP = Virus-Like Particle, VSV = Vesicular Stomatitis Virus, GLP = Good Laboratory Practices, cGMP = current Good Manufacturing Practices, Ad5 = Adenovirus serotype 5, Ad26 = Adenovirus serotype 26, ChAd3 = Chimpanzee Adenovirus serotype 3, MVA = Modified Vaccinia Ankara.