Table 1.
Number of subjects available for analysis from studies with serotype 2 baseline immunogenicity measures and pre-challenge stool viral shedding quantities, by regimen, for studies IPV001 [11] and IPV002 [9]. All subjects were challenged with mOPV2 4 weeks following final vaccination, except for IPV001 Group 2, who were challenged 26 weeks following their last vaccination.
Study | Group | Regimen | Schedule | N‡ | Seroprotection rate* | Median NAb titre (log2)* | Pre-challenge shedding positivity** | Median log10 viral titer among shedders** |
---|---|---|---|---|---|---|---|---|
IPV001 | 1 | bOPV-bOPV-bOPV | 6-10-14 wks | 187 | 113/209 (54.1%) | 3.2 | 1/18 (5.6%) | 3.2 |
2 | bOPV-bOPV-bOPV | 6-10-14 wks | 179 | 124/210 (59.0%) | 3.2 | 0/13 (0.0%) | N/A | |
4/6/8† | bOPV-bOPV-bOPV + IPV |
6-10-14 wks 14 wks |
274 | 175/310 (56.5%) | 3.5 | 2/28 (7.1%) | 3.8 | |
5/7/9† | bOPV-bOPV-bOPV + IPV-IPV |
6-10-14 wks 14-36 wks |
519 | 327/590 (55.4%) | 3.2 | 1/63 (1.6%) | 4.1 | |
3 | tOPV-tOPV-tOPV | 6-10-14 wks | 81 | 62/99 (62.6%) | 3.5 | 1/15 (6.7%) | 3.8 | |
IPV002 | 1 | IPV–bOPV–bOPV | 2-4-6 months | 150 | 117/182 (64.3%) | 3.5 | 5/174 (2.9%) | 3.2 |
2 | IPV–IPV–bOPV | 2-4-6 months | 166 | 114/187 (61.0%) | 3.5 | 2/181 (1.1%) | 6.3 | |
3 | IPV–IPV–IPV | 2-4-6 months | 165 | 119/185 (64.3%) | 3.8 | 3/177 (1.7%) | 2.9 |
Number with available data for both pre-challenge serology and post-challenge shedding index endpoint (SIE).
Immediately prior to first vaccination.
4 weeks after last vaccination, immediately prior to mOPV2 challenge dose.
Combined across manufacturer group.