. Author manuscript; available in PMC: 2017 Dec 1.

Published in final edited form as: Epidemiol Methods. 2016 Jan 23;5(1):93–112. doi: 10.1515/em-2015-0007

Table 3.

Estimated VE^*(t = 39) × 100% in the New Setting (HVTN 702) Under Different Estimation and Modeling Approaches¹

S(1^*) Distribution

ACN Assump.

\hat{V E} * (t = 39) \times 100 %

Est. (95% CI) γ = 1

Ign. int.²

95% EUI¹

Same as RV144 (Fig. 3A)

for X = 0

34.6 (11.1, 65.8)

(27.7, 43.3)

(8.9, 82.2)

Higher³ for X^* = 0 (Fig. 3B)

for X = 0

36.1 (11.0, 65.9)

(28.9, 45.2)

(8.8, 82.4)

Higher³ for X^* = 1 (Fig. 3C)

for X = 0

36.6 (11.0, 65.9)

(29.3, 45.7)

(8.8, 82.4)

Higher³ for All (Fig. 3D)

for X = 0

38.1 (10.6, 67.0)

(30.5, 47.6)

(8.5, 83.7)

Same as RV144 (Fig. 4A)

for X = 1

38.0 (14.0, 67.2)

(30.4, 47.5)

(10.9, 84.1)

Higher³ for X^* = 0 (Fig. 4B)

for X = 1

42.7 (14.0, 68.5)

(34.2, 53.4)

(11.2, 85.7)

Higher³ for X^* = 1 (Fig. 4C)

for X = 1

39.2 (14.0, 68.5)

(31.3, 49.0)

(11.2, 85.7)

Higher³ for All (Fig. 4D)

for X = 1

43.9 (16.5, 75.5)

(35.1, 54.9)

(13.2, 94.3)

Higher⁴ for All

for X = 0

40.7 (6.7, 74.2)

(31.8, 50.9)

(2.6, 93.4)

Higher⁴ for All

for X = 1

55.8 (23.2, 94.0)

(44.8, 70.1)

(19.3, 100)

Model Adding a v = 1 Strain Assuming

\hat{V E} (t = 39, v = 1 ∣ s_{1}, x) = \hat{V E} (t = 39, v = 0 ∣ s_{1}, x)

Higher³ for All

for X = 0

52.3 (15.1, 92.7)

(41.8, 65.3)

(12.0, 100)

Higher³ for All

for X = 1

60.3 (23.6, 100)

(48.2, 75.4)

(18.8, 100)

Higher⁴ for All

for X = 0

55.8 (6.3, 100)

(44.1, 69.6)

(0.0, 100)

Higher⁴ for All

for X = 1

76.7 (33.3, 100)

(61.5, 96.3)

(26.9, 100)

The estimation is done as described in Table 2, except for new elements listed in this table.

Computed for ϕ(t, v|s₁, x) = γ with γ ranging over [ $\frac{1}{Γ}$ Γ] for Γ = 1.25, where ϕ(t, v|s₁, x) ≡ VE^*(t = 39, v|s₁, x)/VE(t = 39, v|s₁, x).

Estimation scenario of equal support of (X^*, S(1^*)) and (X, S(1)), where the distribution of S(1^*) follows a modification of F̂^*(s₁|x) from RV144 data (Figure 2) by moving a random sample of 75% of the original S_i(1) values with percentile p ≤ 0.50 in RV144 to the percentile p^* = p + 0.50.

⁴

Estimation scenario of equal support of (X^*, S(1^*)) and (X, S(1)), where the distribution of S(1^*) is uniformly distributed in the highest range of immune responses supported by the binding assay, [9, 10.1].