Table 1.
Immunogenicity of Norwalk virus-like particle produced in plants and insect cells following mucosal delivery in Phase I trials.
| Study (year) |
Production system for NVLP |
Number of subjects/ group (n) |
Dosage of NVCP (µg) |
Formulation (adjuvant) |
Number of doses and route of administration |
Serum IgG GMT peak titer (response rate %) |
Serum IgA GMT peak titer (response rate %) |
Salivary IgA GMT peak titer (response rate %) |
Stool IgA GMT peak titer (response rate %) |
Vaginal IgA GMT peak titer (response rate %) |
Semenal IgA GMT peak titer (response rate %) |
Ref. |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ball et al. (1999) |
Baculovirus | 5 | 100 | Liquid in Milli-Q water (none) |
Two oral doses (days 1 and 21) |
320 (60%) | 90 (80%) | nd | (0%)† | nd | nd | [39] |
| Ball et al. (1999) |
Baculovirus | 15 | 250 | Liquid in Milli-Q water (none) |
Two oral doses (days 1 and 21) |
453 (100%) | 249 (80%) | nd | nr (10%) | nd | nd | [39] |
| Tacket et al. (2000) |
Transgenic potato |
10 | ~215– 542‡ |
Diced, raw potato (none) |
Two oral doses (days 1 and 21) |
3200 (10%) | nd | nd | 38 (20%) | nd | nd | [40] |
| Tacket et al. (2000) |
Transgenic potato |
10 | ~215– 542‡ |
Diced, raw potato (none) |
Three oral doses (days 0, 7, 21) |
468 (30%) | nd | nd | 48 (40%) | nd | nd | [40] |
| Tacket et al. (2003) |
Baculovirus | 10 | 250 | Liquid in Milli-Q water (none)§ |
Two oral doses (days 0 and 21) |
3140 (90%) | nr (90%) | 541 (40%) | 977 (28.5%) |
2256 (80%) | 1913 (25%) |
[41] |
| Tacket et al. (2003) |
Baculovirus | 10 | 500 | Liquid in Milli-Q water (none)§ |
Two oral doses (days 0 and 21) |
2670 (70%) | nr (60%) | 319 (30%) | 1245 (42.9%) |
265 (66.7%) |
(0%)† | [41] |
| Tacket et al. (2003) |
Baculovirus | 10 | 2000 | Liquid in Milli-Q water (none)§ |
Two oral doses (days 0 and 21) |
2731 (80%) | nr (100%) | 308 (50%) | 454 (30%) | (0%)† | 460 (25%) | [41] |
| El-Kamary et al. (2007) Tacket et al. (2009) |
Baculovirus | 5 | 5 | Dry powder containing chitosan (MPL at 25 µg) |
Two doses intranasally (days 0 and 21) |
nr (0%) | nr (0%) | nr | nr | nd | nd | [60,61] |
| El-Kamary et al. (2007) Tacket et al. (2009) |
Baculovirus | 5 | 15 | Dry powder containing chitosan (MPL at 25 µg) |
Two doses intranasally (days 0 and 21) |
nr (20%) | nr (40%) | nr | nr | nd | nd | [60,61] |
| El-Kamary et al. (2007) Tacket et al. (2009) |
Baculovirus | 5 | 50 | Dry powder containing chitosan (MPL at 25 µg) |
Two doses intranasally (days 0 and 21) |
nr (75%) | nr (25%) | nr | nr | nd | nd | [60,61] |
| Tacket et al. (2009) |
Baculovirus | 20 | 50 | Dry powder containing chitosan (MPL at 25 µg) |
Two doses intranasally (days 0 and 21) |
nr (56%) | nr (72%) | nd | nd | nd | nd | [61] |
| Tacket et al. (2009) |
Baculovirus | 20 | 100 | Dry powder containing chitosan (MPL at 25 µg) |
Two doses intranasally (days 0 and 21) |
nr (63%) | nr (79%) | nd | nd | nd | nd | [61] |
†
No converters.
‡
150 g of potato corresponded to ~215–542 µg NVCP.
§
Preceded by a sodium bicarbonate buffer (500 mg in 60 ml of milli-Q water).
GMT: Geometric mean titer; MPL: Monophosphoryl lipid A; nd: Not determined; nr: Not reported; NVCP: Norwalk virus capsid protein; NVLP: Norwalk virus-like particle.