Table 2.
Norovirus vaccine studies: Human Studies.
| Vaccine Formulation | Mode of Immunization | Challenge | Immune Responses Post Vaccination | Protection Post Challenge | Reference |
|---|---|---|---|---|---|
| r GI.1 VLP | Oral | None | IgG and IgA antibody responses | NA | Ball et al., 1999 |
| GI.1 VLP | Oral | None | serum IgA and IgG responses; increased IgA ASCs;low-to-moderate mucosal IgA; transient rise in IFN-γ by PBMCS | Not tested | Tacket et al., 2003 |
| GI.1 VLP expressing TLR4 receptor | Intranasal | None | Serum NoV-specific IgA and IgG antibodies; IgA and IgG ASCs; HAI titers detected | Not tested | El-Kamary et al., 2010 |
| GI.1 VLP expressing TLR4 receptor | Intranasal | GI.1 virus (oral) | Anamnestic humoral response (B memory cells), NoV-specific IgA and IgG; and mucosal ASCs; High HGBA blocking titers | 62% of recipients protected against infection | Ramirez et al., 2012 |
| GI.1 VLP (baculovirus expression system) | Intranasal | Homologous challenge (GI.1) | Serum NoV-specific IgA response; presence of HBGA blocking antibodies | Protection and prevention of infection (70%). Delay of infection onset without a decrease in duration of illness | Atmar et al., 2011 |
| VLPs of 3 NoV strains (GI.1, GII.2, GII.1) | NA | Challenge study | Serum IgG and salivary IgA, Th1 cytokines (IFN-γ, TNF-α, IL-2) | NA | Lindesmith et al., 2005 |
| GI.1 1968 | NA | Challenge study | Cross-reactive IgG antibodies against a panel of GI VLPs; IFN-γ specific T cells | NA | Lindesmith et al., 2010 |
| GI.I/GII.4C VLPs | Intramuscular | No challenge | Cross-reactive serum IgG and cross blocking antibodies against non-vaccine strains | NA | Lindesmith et al., 2015 |
| GI.1 and GII.4 VLPs (bivalent) | Intramuscular | NA (phase 1 trial) | Serum antibodies response to GI.1 and GII.4, high HBGA blocking titers | Not tested | Treanor et al., 2014 |
| GI.1 and GII.4 VLPs (bivalent) | Intramuscular | Heterologous GII.4 virus (oral) | Robust antibody responses following first dose against GI.1 and GII.4; high HBGA blocking titers | Decrease in the incidence of acute illness | Atmar et al., 2015; Bernstein et al., 2015 |
| VLPs containing GI.1/GII.4 | Intramuscular | No challenge | Serum antibody response to GI.1 and GII.4 antigens following immunization (high frequencies of IgA-specific ASC against GI.1 VLPs) | NA | Sundararajan et el., 2015 |
NA, not applicable; ASC, antibody-secreting cells; HAI, hemagglutination inhibition assay; HBGA, histo-blood group antigens.