Do Oral Cholera Vaccine and Water, Sanitation, and Hygiene Combine to Provide Greater Protection Against Cholera? Results From a Cluster-Randomized Trial of Oral Cholera Vaccine in Kolkata, India.

India WASH cholera clinical trial oral cholera vaccine (OCV)

Journal

Open forum infectious diseases
ISSN: 2328-8957
Titre abrégé: Open Forum Infect Dis
Pays: United States
ID NLM: 101637045

Informations de publication

Date de publication:
Jan 2024
Historique:
received: 18 07 2023
medline: 26 1 2024
pubmed: 26 1 2024
entrez: 26 1 2024
Statut: epublish

Résumé

Oral cholera vaccine (OCV) and incremental improvements in household water, sanitation, and hygiene (WASH) within cholera-endemic areas can reduce cholera risk. However, we lack empiric evaluation of their combined impact. We evaluated a cluster-randomized, placebo-controlled trial of OCV (Shanchol) in Kolkata, India. The study population included 108 777 individuals, and 106 879 nonpregnant individuals >1 year of age were eligible to receive 2 doses of OCV or placebo. We measured cholera risk in all household members assigned to OCV vs placebo and in all members of households with "Better" vs "Not Better" WASH, where WASH was classified according to validated criteria. Protection was measured by Cox proportional hazard models. Residence in an OCV household was associated with protective effectiveness (PE) of 54% (95% CI, 42%-64%; These findings suggest that the combination of a vaccine policy and improved WASH reduces cholera risk more than either would alone, although the magnitude of either intervention was not affected by the other. Future randomized trials investigating OCV and WASH interventions separately and together are recommended to further understand the interaction between OCV and WASH.

Sections du résumé

Background UNASSIGNED
Oral cholera vaccine (OCV) and incremental improvements in household water, sanitation, and hygiene (WASH) within cholera-endemic areas can reduce cholera risk. However, we lack empiric evaluation of their combined impact.
Methods UNASSIGNED
We evaluated a cluster-randomized, placebo-controlled trial of OCV (Shanchol) in Kolkata, India. The study population included 108 777 individuals, and 106 879 nonpregnant individuals >1 year of age were eligible to receive 2 doses of OCV or placebo. We measured cholera risk in all household members assigned to OCV vs placebo and in all members of households with "Better" vs "Not Better" WASH, where WASH was classified according to validated criteria. Protection was measured by Cox proportional hazard models.
Results UNASSIGNED
Residence in an OCV household was associated with protective effectiveness (PE) of 54% (95% CI, 42%-64%;
Conclusions UNASSIGNED
These findings suggest that the combination of a vaccine policy and improved WASH reduces cholera risk more than either would alone, although the magnitude of either intervention was not affected by the other. Future randomized trials investigating OCV and WASH interventions separately and together are recommended to further understand the interaction between OCV and WASH.

Identifiants

pubmed: 38274552
doi: 10.1093/ofid/ofad701
pii: ofad701
pmc: PMC10810060
doi:

Types de publication

Journal Article

Langues

eng

Pagination

ofad701

Informations de copyright

© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

Déclaration de conflit d'intérêts

Potential conflicts of interest. All authors: No reported conflicts.

Auteurs

Justin Im (J)

International Vaccine Institute, Seoul, Republic of Korea.

Md Taufiqul Islam (MT)

International Centre for Diarrheal Disease Research, Dhaka, Bangladesh.

Faisal Ahmmed (F)

International Centre for Diarrheal Disease Research, Dhaka, Bangladesh.

Deok Ryun Kim (DR)

International Vaccine Institute, Seoul, Republic of Korea.

Birkneh Tilahun Tadesse (BT)

International Vaccine Institute, Seoul, Republic of Korea.

Sophie Kang (S)

International Vaccine Institute, Seoul, Republic of Korea.

Farhana Khanam (F)

International Centre for Diarrheal Disease Research, Dhaka, Bangladesh.

Fahima Chowdhury (F)

International Centre for Diarrheal Disease Research, Dhaka, Bangladesh.

Tasnuva Ahmed (T)

International Centre for Diarrheal Disease Research, Dhaka, Bangladesh.

Md Golam Firoj (MG)

International Centre for Diarrheal Disease Research, Dhaka, Bangladesh.

Asma Binte Aziz (AB)

International Vaccine Institute, Seoul, Republic of Korea.

Masuma Hoque (M)

International Centre for Diarrheal Disease Research, Dhaka, Bangladesh.

Hyon Jin Jeon (HJ)

International Vaccine Institute, Seoul, Republic of Korea.
Cambridge Institute of Therapeutic Immunology and Infectious Disease, School of Clinical Medicine, University of Cambridge, Cambridge, UK.

Suman Kanungo (S)

ICMR-National Institute of Cholera and Enteric Diseases, Kolkata, India.

Shanta Dutta (S)

ICMR-National Institute of Cholera and Enteric Diseases, Kolkata, India.

Khalequ Zaman (K)

International Centre for Diarrheal Disease Research, Dhaka, Bangladesh.

Ashraful Islam Khan (AI)

International Centre for Diarrheal Disease Research, Dhaka, Bangladesh.

Florian Marks (F)

International Vaccine Institute, Seoul, Republic of Korea.
Cambridge Institute of Therapeutic Immunology and Infectious Disease, School of Clinical Medicine, University of Cambridge, Cambridge, UK.
Madagascar Institute for Vaccine Research, University of Antananarivo, Antananarivo, Madagascar.
Heidelberg Institute of Global Health, University of Heidelberg, Heidelberg, Germany.

Jerome H Kim (JH)

International Vaccine Institute, Seoul, Republic of Korea.

Firdausi Qadri (F)

International Centre for Diarrheal Disease Research, Dhaka, Bangladesh.

John D Clemens (JD)

International Vaccine Institute, Seoul, Republic of Korea.
International Centre for Diarrheal Disease Research, Dhaka, Bangladesh.
Fielding School of Public Health, University of California-Los Angeles, Los Angeles, California, USA.
Vaccine Innovation Center, School of Medicine, Korea University, Seoul, Republic of Korea.

Classifications MeSH