Table 2.
Immunogenicity profiles of avian H5N1 virus-based vaccines with and without adjuvants.
Manufacturer (trade name) | Antigen | HA dose (μg) | Seroconversion† without adjuvant (%) |
Seroconversion with adjuvant (%) |
Ref. |
---|---|---|---|---|---|
Sanofi Pasteur‡ | Inactivated split virus | 90‡ | 57 | [28,72,73] | |
A/Vietnam/1194/2004 | 45 | 41 | |||
30 | 52 | 67 (alum)# | |||
15 | 24 | 86 (AF03) | |||
7.5 | 13 | 89 (AF03) | |||
3.8 | 81 (AF03) | ||||
1.9 | 72 (AF03) | ||||
Novartis§ | Inactivated subunit | 45 | 29 | [25,74,75] | |
A/Vietnam/1203/2004 | 30 | 18 | 14 (alum) | ||
15 | 24 | 7 (alum) | |||
7.5 | 34 | 3 (alum) | |||
Inactivated subunit | 30 | 18 | |||
A/Vietnam/1203/2004 | 15 | 24 | 63 (MF59) | ||
7.5 | 34 | 23–73 (MF59) | |||
3.8 | 65 (MF59) | ||||
GSK§ | Inactivated split virus | 30 | 41 | 85 (AS03) | [76,77] |
A/Vietnam/1194/2004 | 15 | 35 | 96 (AS03) | ||
7.5 | 16 | 90 (AS03) | |||
3.8 | 4 | 84–94 (AS03) | |||
CSL¶ | Inactivated split virus | 45 | 49 (alum) | [78] | |
A/Vietnam/1194/2004 | 30 | 48 (alum) | |||
15 | 35 (alum) | ||||
7.5 | 34 (alum) | ||||
Baxter§ | Vero cell-derived inactivated whole virion | 15 | 68†† | [11,14] | |
(A/Vietnam/1203/2004) | 7.5 | 62 | |||
3.8 | 41 |
Data are from studies in adult subjects, employing the same clade of H5N1 virus antigen and administered following two immunizations either 21 or 28 days apart. Direct comparisons are not possible due to differences in reagents and methodologies to determine HI titers. Ranges are provided in instances where referenced studies contain the same antigen dose level.
HA inhibition assays with titer ≥1:40 or ≥fourfold increase in hemagglutination inhibition titer.
FDA approved.
EU approved.
Australia approved.
No significant difference between non-alum vaccine group.
Calculated based on subjects achieving ≥1:20 using the microneutralization assay.
HA: Hemagglutinin; HI: Hemagglutination inhibition.