Table 1.
Dose Escalation Schedule for VAX2012Q Quadrivalent Vaccine Phase I Study (Final Schedule)
| Cohorta | N | Component Dose (mcg)b |
Aggregate Dose (mcg)c | Component Ratiod | Dose Level | |||
|---|---|---|---|---|---|---|---|---|
| VAX128C (H1N1) | VAX181 (H3N2) | VAX173 (B-YAM) | VAX172 (B-VIC) | |||||
| 1 | 20 | 1 | 1 | 1 | 1 | 4 | 1:1:1:1 | 1 |
| 2 | 48 | 2 | 2 | 2 | 2 | 8 | 1:1:1:1 | 2 |
| 3 | 51 | 2 | 4 | 4 | 4 | 14 | 1:2:2:2 | 3 |
| 4 | 48 | 2 | 4 | 6 | 6 | 18 | 1:2:3:3 | 4 |
| 5 | 49 | 3 | 3 | 3 | 3 | 12 | 1:1:1:1 | 5 |
| 6 | 51 | 2 | 2 | 2 | 2 | 8 | 1:1:1:1 | 2 |
| 7 | 49 | 3 | 3 | 3 | 3 | 12 | 1:1:1:1 | 5 |
| Total | 316 | |||||||
Abbreviations: B-YAM, B Yamagata lineage; B-VIC, B Victoria lineage; HAI, hemagglutination.
a Dose levels for groups 1–4 were prespecified at the beginning of the study. Study was paused after dose group 4 for interim safety and immunogenicity analyses, the results of which were used to inform dose levels for groups 5–7.
b VAX128C: HA1-2 subunit of A/California/07/2009 (H1N1; licensed vaccine year 2010 to present); VAX181: HA1-1L subunit from A/Perth/16/2009 (H3N2; licensed vaccine year 2010 and 2011); VAX173: HA1-2 subunit from B/Wisconsin/01/2010 (B-YAM; licensed vaccine year 2012); VAX172: HA1-2 subunit from B/Bangladesh/5945/2009 (B-VIC; licensed vaccine year 2009 to present). Refer to Materials and Methods for complete description of antigen constructs.
c Aggregate dose: total protein mass (mcg) of all 4 vaccine HAI antigens (components).
d Component ratio: relative amount of each vaccine component, by protein mass.