Table 2.
Study | Vaccine type | Safety |
Immunogenicity (D14)a |
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---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Local AR |
|
Systemic AR |
Sero conversion |
RVNA titer [GMT(95%CI) /Subjects, IU/ml] |
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Local pain | Erythema | Pruritus | Edema | Induration | Headache | Fever | Myalgia | Weakness | ||||||
Benjavongkulchai (1997) | PCECV | 13/72 | 1/72 | 0/72 | 0/72 | 0/72 | 1/72 | 16/72 | 15/72 | 0/72 | 55/55 | 1.86(NR)/22 | ||
Benjavongkulchai (1997) | HDCV | 3/40 | 1/40 | 0/40 | 0/40 | 0/40 | 1/40 | 0/40 | 0/40 | 0/40 | 38/39 | 3.10(NR)/39 | ||
Fang (2014) | PVRV | 0/28 | 0/28 | 0/28 | 1/28 | 0/28 | 0/28 | 1/28 | 0/28 | 0/28 | NRb | NR | ||
Fang (2014) | PCECV | 2/33 | 0/33 | 0/33 | 1/33 | 0/33 | 0/33 | 1/33 | 0/33 | 0/33 | NR | NR | ||
Bose (2016), 1 | PVRV | 20/30 | 3/30 | 2/30 | 2/30 | 5/30 | 7/30 | 4/30 | 3/30 | 11/30 | 27/27 | 20.57(17.03 ~ 24.84)/27 |
||
Bose (2016), 1 | PCECV | 21/31 | 0/31 | 3/31 | 3/31 | 4/31 | 5/31 | 2/31 | 5/31 | 9/31 | 29/29 | 16.01(12.46 ~ 20.57)/29 |
||
Bose (2016), 2 | PVRV | 13/30 | 0/30 | 1/30 | 1/30 | 1/30 | 5/30 | 1/30 | 2/30 | 7/30 | 27/27 | 16.47(13.39 ~ 20.26)/27 |
||
Bose (2016), 2 | PCECV | 9/31 | 0/31 | 0/31 | 1/31 | 1/31 | 2/31 | 0/31 | 2/31 | 4/31 | 29/29 | 14.13(11.42 ~ 17.47)/29 |
||
Ashwathnarayana (2009) | PCECV | 1/50 | 0/50 | 1/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 50/50 | 6.88(6.11 ~ 7.75)/50 |
||
Ashwathnarayana (2009) | PVRV | 1/50 | 0/50 | 1/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 0/50 | 48/48 | 6.65(5.91 ~ 7.49)/48 |
||
Ramezankhani (2016) | PVRV | 27/702 | 9/702 | 7/702 | 4/702 | 0/702 | 8/702 | 11/702 | 6/702 | 5/702 | NR | NR | ||
Ramezankhani (2016) | PCECV | 28/747 | 8/747 | 1/747 | 2/747 | 0/747 | 16/747 | 10/747 | 5/747 | 11/747 | NR | NR | ||
Li (2020) | HDCV | 6/150 | 0/150 | 2/150 | 3/150 | 2/150 | 4/150 | 3/150 | 1/150 | 0/150 | 149/150 | 21.47(18.91 ~ 24.36)/150 |
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Li (2020) | PVRV | 7/150 | 0/150 | 1/150 | 3/150 | 1/150 | 4/150 | 3/150 | 0/150 | 1/150 | 148/150 | 20.78(18.21 ~ 23.71)/150 |
||
Chen (2018) | HDCV | 7/200 | 2/200 | 2/200 | 2/200 | 5/200 | 1/200 | 3/200 | 0/200 | 5/200 | NR | NR | ||
Chen (2018) | PVRV | 11/200 | 5/200 | 6/200 | 5/200 | 4/200 | 6/200 | 25/200 | 1/200 | 26/200 | NR | NR | ||
Lu (2010) | PCECV | 19/300 | 1/300 | 11/300 | 1/300 | 4/300 | 4/300 | 3/300 | 0/300 | 8/300 | NR | NR | ||
Lu (2010) | PVRV | 15/300 | 1/300 | 13/300 | 1/300 | 4/300 | 5/300 | 4/300 | 0/300 | 9/300 | NR | NR | ||
Huang (2018) | HDCV | 1/53 | 0/53 | 0/53 | 0/53 | 0/53 | 1/53 | 1/53 | 0/53 | 1/53 | NR | NR | ||
Huang (2018) | PVRV | 5/58 | 0/58 | 0/58 | 0/58 | 0/58 | 1/58 | 2/58 | 0/58 | 3/58 | NR | NR | ||
Pooled PVRV | 99/1548 | 18/1548 | 31/1548 | 17/1548 | 15/1548 | 36/1548 | 51/1548 | 12/1548 | 62/1548 | 250/252 | - | |||
Pooled PCECV | 93/1264 | 10/1264 | 16/1264 | 8/1264 | 9/1264 | 28/1264 | 32/1264 | 27/1264 | 32/1264 | 163/168 | - | |||
Pooled HDCV | 17/443 | 3/443 | 4/443 | 5/443 | 7/443 | 7/443 | 7/443 | 1/443 | 6/443 | 263/267 | - | |||
RR, 95%CI (HDCV vs. PVRV) | 0.51 (0.20 ~ 0.98)* |
0.79 (0.12 ~ 2.63) |
1.15 (0.17 ~ 3.72) |
1.04 (0.26 ~ 2.83) |
1.82 (0.41 ~ 5.19) |
0.74 (0.15 ~ 2.36) |
0.20 (0.03 ~ 0.64)* |
0.46 (0.02 ~ 2.10) |
0.25 (0.06 ~ 0.73)* |
1.00 (0.75 ~ 1.34) |
0.03 (−0.26 ~ 0.32) |
|||
RR, 95%CI (HDCV vs. PCECV) | 0.49 (0.20 ~ 0.95)* |
1.58 (0.19 ~ 5.79) |
2.35 (0.24 ~ 9.99) |
1.33 (0.20 ~ 4.73) |
2.24 (0.38 ~ 6.86) |
1.60 (0.24 ~ 5.73) |
0.27 (0.03 ~ 0.92)* |
0.32 (0.01 ~ 1.36) |
0.48 (0.08 ~ 1.65) |
1.00 (0.68 ~ 1.46) |
0.16 (−0.17 ~ 0.49) |
|||
RR, 95%CI (PVRV vs. PCECV) | 1.08 (0.65 ~ 1.87) |
0.71 (0.19 ~ 1.67) |
0.67 (0.18 ~ 1.66) |
1.07 (0.29 ~ 2.62) |
0.98 (0.34 ~ 2.25) |
0.57 (0.17 ~ 1.35) |
1.07 (0.27 ~ 2.91) |
1.82 (0.41 ~ 5.85) |
0.61 (0.24 ~ 1.21) |
1.00 (0.71 ~ 1.39) |
0.13 (−0.03 ~ 0.28) |
a: Immunogenicity data were obtained 14 days after the first vaccination dose. b: NR represents not reported. *: Difference was statistically significant.