Table 4.
Parameter | Meaning | Phase I data | Phase I & II data | ||
---|---|---|---|---|---|
Mean | 95% CI | Mean | 95% CI | ||
Fixed effects | |||||
δAb | Antibody decay rate (day−1) | 0.029 | [0.027; 0.033] | ||
Women | 0.0251 | [0.0223; 0.0283] | |||
Men | 0.0353 | [0.0296; 0.0421] | |||
Antibody half-life (days) | 24 | [22; 26] | |||
Women | 27.6 | [24.5; 31.1] | |||
Men | 19.6 | [16.4; 23.4] | |||
δS | SL ASCs decay rate (day−1) | 0.231 | [0.15; 0.36] | 0.333 | [0.326; 0.340] |
SL ASCs half-life (days) | 3.0 | [1.9; 4.7] | 2.08 | [2.04; 2.13] | |
δL | LL ASCs decay rate (year−1) | 3.16 × 10−4 | [1.46; 7.03] × 10−4 | 1.25 × 10−4 | |
LL ASCs half-life (years) | 6.0 | [2.7; 13] | 15.0 | ||
ϕS | SL ASCs influx (EU/mL/day) | 2755 | [1852; 4100] | ||
Mean Age (31.3 years) | 3057 | [2418; 3865] | |||
FC ΔAge = + 1 yeara | 0.934 | [0.915; 0.954] | |||
ϕL | LL ASCs influx (EU/mL/day) | ||||
African part. | 16.6 | [13.7; 20.1] | 10.2 | [9.01; 11.4] | |
Eur. part. | 70.7 | [54.0; 92.7] | 36.6 | [27.3; 49.2] | |
α | Scaling factor—lab effects | ||||
αfocus | 1.04 | [0.93; 1.16] | |||
αQ2sol | 1.00 | [0.98; 1.02] | |||
Random effects | |||||
Sd of RE on ϕS | 0.92 | [0.83; 1.01] | 0.84 | [0.56; 1.13] | |
Sd of RE on ϕL | 0.85 | [0.78; 0.92] | 0.88 | [0.81; 0.96] | |
Sd of RE on δAb | 0.30 | [0.24; 0.36] | 0.35 | [0.29; 0.41] | |
Error model | |||||
σAb | Sd of error model | 0.10 | [0.10; 0.10] | 0.107 | [0.101; 0.112] |
CI confidence interval, EU ELISA units, Eur. European, FC fold change, LL ASCs long-lived antibody-secreting cells, Part. participants, RE random effects, SL ASCs short-lived antibody-secreting cells, Sd standard deviation.
aRepresents the multiplicative factor to apply to the value of ϕS, obtained for the mean age, for an increase in participant age of 1 year: ϕS(Mean Age + 1 year) = ϕS(Mean Age) × FC(ΔAge = +1). Therefore, the percentage of decrease of ϕS for a participant X years older than the mean age is given by 100×(1−FC(ΔAge = +1)X).