TY - JOUR
T1 - The Impact of Improved Water, Sanitation, and Hygiene on Oral Rotavirus Vaccine Immunogenicity in Zimbabwean Infants
T2 - Substudy of a Cluster-randomized Trial
AU - Church, James A.
AU - Rukobo, Sandra
AU - Govha, Margaret
AU - Lee, Benjamin
AU - Carmolli, Marya P.
AU - Chasekwa, Bernard
AU - Ntozini, Robert
AU - Mutasa, Kuda
AU - McNeal, Monica M.
AU - Majo, Florence D.
AU - Tavengwa, Naume V.
AU - Moulton, Lawrence H.
AU - Humphrey, Jean H.
AU - Kirkpatrick, Beth D.
AU - Prendergast, Andrew J.
N1 - Publisher Copyright:
© 2019 The Author(s).
PY - 2019/11/27
Y1 - 2019/11/27
N2 - 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.
AB - 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.
KW - Africa
KW - WASH
KW - infants
KW - oral vaccine
KW - rotavirus
UR - http://www.scopus.com/inward/record.url?scp=85075805281&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85075805281&partnerID=8YFLogxK
U2 - 10.1093/cid/ciz140
DO - 10.1093/cid/ciz140
M3 - Article
C2 - 30770931
AN - SCOPUS:85075805281
SN - 1058-4838
VL - 69
SP - 2074
EP - 2081
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 12
ER -