The Impact of Improved Water, Sanitation, and Hygiene on Oral Rotavirus Vaccine Immunogenicity in Zimbabwean Infants: Substudy of a Cluster-randomized Trial

James A Church, Sandra Rukobo, Margaret Govha, Benjamin Lee, Marya P Carmolli, Bernard Chasekwa, Robert Ntozini, Kuda Mutasa, Monica M McNeal, Florence D Majo, Naume V Tavengwa, Lawrence H Moulton, Jean H Humphrey, Beth D Kirkpatrick, Andrew J Prendergast, James A Church, Sandra Rukobo, Margaret Govha, Benjamin Lee, Marya P Carmolli, Bernard Chasekwa, Robert Ntozini, Kuda Mutasa, Monica M McNeal, Florence D Majo, Naume V Tavengwa, Lawrence H Moulton, Jean H Humphrey, Beth D Kirkpatrick, Andrew J Prendergast

Abstract

Background: Oral vaccines have lower efficacy in developing compared to developed countries. Poor water, sanitation, and hygiene (WASH) may contribute to reduced oral vaccine immunogenicity.

Methods: We conducted a cluster-randomized 2 × 2 factorial trial in rural Zimbabwe. Pregnant women and their infants were eligible if they lived in clusters randomized to (1) standard of care (52 clusters); (2) improved infant feeding (53 clusters); (3) WASH: ventilated improved pit latrine, 2 hand-washing stations, liquid soap, chlorine, infant play space, and hygiene counseling (53 clusters); or (4) feeding plus WASH (53 clusters). This substudy compared oral rotavirus vaccine (RVV) seroconversion (primary outcome), and seropositivity and geometric mean titer (GMT) (secondary outcomes), in WASH vs non-WASH infants by intention-to-treat analysis.

Results: We included 801 infants with documented RVV receipt and postvaccine titer measurements (329 from 84 WASH clusters; 472 from 102 non-WASH clusters); 328 infants with prevaccination titers were included in the primary outcome. Thirty-three of 109 (30.3%) infants in the WASH group seroconverted following rotavirus vaccination, compared to 43 of 219 (19.6%) in the non-WASH group (absolute difference, 10.6% [95% confidence interval {CI}, .54%-20.7%]; P = .031). In the WASH vs non-WASH groups, 90 of 329 (27.4%) vs 107 of 472 (22.7%) were seropositive postvaccination (absolute difference, 4.7% [95% CI, -1.4% to 10.8%]; P = .130), and antirotavirus GMT was 18.4 (95% CI, 15.6-21.7) U/mL vs 14.9 (95% CI, 13.2-16.8) U/mL (P = .072).

Conclusions: Improvements in household WASH led to modest but significant increases in seroconversion to RVV in rural Zimbabwean infants.

Clinical trials registration: NCT01824940.

Keywords: Africa; WASH; infants; oral vaccine; rotavirus.

© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America.

Figures

Figure 1.
Figure 1.
Consolidated Standards of Reporting Trials (CONSORT) flow diagram for the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) rotavirus substudy. The CONSORT diagram for the full trial, with additional detail, can be found in Supplementary Figure 1. Abbreviations: GMT, geometric mean titer; HIV, human immunodeficiency virus; IgA, immunoglobulin A; IYCF, infant and young child feeding; RVV, rotavirus vaccine; SOC, standard of care; WASH, water, sanitation, and hygiene. aNo sample available, insufficient postvaccine sample or assay failure. bInsufficient or no prevaccine sample available.
Figure 2.
Figure 2.
Primary outcome (rotavirus vaccine seroconversion) and secondary outcomes (rotavirus vaccine seropositivity and immunoglobulin A geometric means titers) in water, sanitation, and hygiene (WASH) and non-WASH groups. Results shown for both infants who received at least 1 dose of rotavirus vaccine and infants who received 2 doses of rotavirus vaccine. Abbreviations: CI, confidence interval; GMT, geometric mean titer; IgA, immunoglobulin A; RR, relative risk; RVV, rotavirus vaccine.

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Source: PubMed

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