Association of serum anti-rotavirus immunoglobulin A antibody seropositivity and protection against severe rotavirus gastroenteritis

Figures & data

Table 1. Rota-037; number and percentage of subjects with any RVGE/severe RVGE by rotavirus IgA antibody concentration

Concentration one month post-vaccination	RV1 group	Placebo group
	n/N (%)	n/N (%)
Any RVGE
<20	83/1025 (8.10)	127/1026 (12.38)
(20–50)	12/319 (3.76)	6/52 (11.54)
(50–100)	13/319 (4.08)	2/48 (4.17)
(100–250)	14/345 (4.06)	1/59 (1.69)
(250–500)	11/255 (4.31)	2/49 (4.08)
(500–1000)	7/231 (3.03)	1/31 (3.23)
≥1000	4/276 (1.45)	2/65 (3.08)
Total	144/2770 (5.20)	141/1330 (10.60)
Severe RVGE
<20	29/1025 (2.83)	47/1026 (4.58)
(20–50)	5/319 (1.57)	4/52 (7.69)
(50–100)	7/319 (2.19)	0/48 (0.00)
(100–250)	5/345 (1.45)	1/59 (1.69)
(250–500)	2/255 (0.78)	1/49 (2.04)
(500–1000)	2/231 (0.87)	1/31 (3.23)
≥1000	1/276 (0.36)	1/65 (1.54)
Total	51/2770 (1.84)	55/1330 (4.14)

N, Number of subjects with RV IgA in the concentration interval; n, Number of subjects with RV IgA in the concentration interval who reported RVGE; %, (n/N) x 100.

Table 2. Prentice criteria applied to Rota-037 study

Model	Parameter	Parameter description	Estimated odds ratio (95% CI)	Log-likelihood ratio test	2 sided P value
Any RVGE
Model 1	β	Vaccine group	0.46 (0.36; 0.59)	38.19	<0.0001
Model 2	γ	Seropositivity rate	0.33 (0.25; 0.44)	71.22	<0.0001
Model 3	β	Vaccine group	0.65 (0.50;0.84)	10.83	0.001*
	γ	Seropositivity rate	0.39 (0.29; 0.52)	43.86	<0.0001
Severe RVGE
Model 1	β	Vaccine group	0.43 (0.29; 0.64)	17.53	<0.0001
Model 2	γ	Seropositivity rate	0.39 (0.25; 0.59)	21.12	<0.0001
Model 3	β	Vaccine group	0.57 (0.38; 0.87)	7.04	0.008*
	γ	Seropositivity rate	0.48 (0.30; 0.75)	10.64	0.001

All models look at effect on RVGE: Model 1 assesses the vaccine group effect, Model 2 assesses the seropositivity effect; Model 3 assesses the part of vaccine group effect not captured by the seropositivity effect. *The estimated proportion of treatment effect explained by seropositivity is 43.6% for any RVGE and 32.7% for severe RVGE.²⁷

Figure 1. Meta-analysis: Scatter plots of the relative risk (RR) with 95% CIs for efficacy and immunogenicity by study. Scatter plots between the relative risk of reporting RVGE ( = 1−VE) and the relative risk of seronegative concentration one month post-vaccination ( = 1−VEI).

Vesikari T, Karvonen A, Prymula R, Schuster V, Tejedor JC, Cohen R, Meurice F, Han HH, Damaso S, Bouckenooghe A. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet 2007; 370:1757 - 63; http://dx.doi.org/10.1016/S0140-6736(07)61744-9; PMID: 18037080

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