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

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)2074-2081
Number of pages8
JournalClinical Infectious Diseases
Volume69
Issue number12
DOIs
StatePublished - Nov 27 2019

Fingerprint

Rotavirus Vaccines
Sanitation
Oral Hygiene
Hygiene
Water
Confidence Intervals
Vaccine Immunogenicity
Toilet Facilities
Zimbabwe
Hand Disinfection
Soaps
Intention to Treat Analysis
Rotavirus
Chlorine
Standard of Care
Developed Countries

Keywords

  • Africa
  • infants
  • oral vaccine
  • rotavirus
  • WASH

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

The Impact of Improved Water, Sanitation, and Hygiene on Oral Rotavirus Vaccine Immunogenicity in Zimbabwean Infants : Substudy of a Cluster-randomized Trial. / Church, James A.; Rukobo, Sandra; Govha, Margaret; Lee, Benjamin; Carmolli, Marya P.; Chasekwa, Bernard; Ntozini, Robert; Mutasa, Kuda; McNeal, Monica M.; Majo, Florence D.; Tavengwa, Naume V.; Moulton, Lawrence H.; Humphrey, Jean H.; Kirkpatrick, Beth D.; Prendergast, Andrew J.

In: Clinical Infectious Diseases, Vol. 69, No. 12, 27.11.2019, p. 2074-2081.

Research output: Contribution to journalArticle

Church, JA, Rukobo, S, Govha, M, Lee, B, Carmolli, MP, Chasekwa, B, Ntozini, R, Mutasa, K, McNeal, MM, Majo, FD, Tavengwa, NV, Moulton, LH, Humphrey, JH, Kirkpatrick, BD & Prendergast, AJ 2019, 'The Impact of Improved Water, Sanitation, and Hygiene on Oral Rotavirus Vaccine Immunogenicity in Zimbabwean Infants: Substudy of a Cluster-randomized Trial', Clinical Infectious Diseases, vol. 69, no. 12, pp. 2074-2081. https://doi.org/10.1093/cid/ciz140
Church, James A. ; Rukobo, Sandra ; Govha, Margaret ; Lee, Benjamin ; Carmolli, Marya P. ; Chasekwa, Bernard ; Ntozini, Robert ; Mutasa, Kuda ; McNeal, Monica M. ; Majo, Florence D. ; Tavengwa, Naume V. ; Moulton, Lawrence H. ; Humphrey, Jean H. ; Kirkpatrick, Beth D. ; Prendergast, Andrew J. / The Impact of Improved Water, Sanitation, and Hygiene on Oral Rotavirus Vaccine Immunogenicity in Zimbabwean Infants : Substudy of a Cluster-randomized Trial. In: Clinical Infectious Diseases. 2019 ; Vol. 69, No. 12. pp. 2074-2081.
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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.",
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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.

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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.

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