EFFECTIVENESS OF MONOVALENT HUMAN ROTAVIRUS VACCINE AGAINST ADMISSION TO HOSPITAL FOR ACUTE ROTAVIRUS DIARRHOEA IN SOUTH AFRICAN CHILDREN: A CASE-CONTROL STUDY

Monday, 10th of November 2014

EFFECTIVENESS OF MONOVALENT HUMAN ROTAVIRUS VACCINE AGAINST ADMISSION TO HOSPITAL FOR ACUTE ROTAVIRUS DIARRHOEA IN SOUTH AFRICAN CHILDREN: A CASE-CONTROL STUDY

The Lancet Infectious Diseases, Volume 14, Issue 11, Pages 1096 - 1104, November 2014

Published Online: 08 October 2014

Dr Michelle J Groome MBBCh a b , Nicola Page PhD e, Margaret M Cortese MD f, Jocelyn Moyes MBBCh c e, Prof Heather J Zar PhD g, Constant N Kapongo FCPaeds[SA] h, Christine Mulligan MBChB g, Ralph Diedericks FCP[Paed] g, Cheryl Cohen MBBCh c e, Jessica A Fleming PhD i, Mapaseka Seheri PhD j, Prof Jeffrey Mphahlele PhD j, Sibongile Walaza MBBCh e, Kathleen Kahn PhD d k l, Dr Meera Chhagan m *, A Duncan Steele PhD i j n †, Umesh D Parashar MBBS f, Elizabeth R Zell MStat o, Prof Shabir A Madhi PhD a b e

Summary below; full text is at http://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2814%2970940-5/fulltext

Background

The effectiveness of the rotavirus vaccine under conditions of routine use in an African setting with a high prevalence of HIV infection needs to be established. We assessed the vaccine effectiveness of monovalent human rotavirus vaccine in preventing admission to hospital for acute rotavirus diarrhoea, after its introduction at age 6 and 14 weeks into South Africas national immunisation programme.

Methods

This case-control study was done at seven hospitals in South Africa between April 19, 2010, and Oct 31, 2012. The hospitals were located in a range of urban, peri-urban, and rural settings, with varying rates of population HIV infection. Cases were children aged from 18 weeks to 23 months who were age-eligible to have received at least one dose of the human rotavirus vaccine (ie, those born after June 14, 2009) admitted to hospital with laboratory-confirmed acute rotavirus diarrhoea, and the primary control group was children admitted to hospital with diarrhoea testing negative for rotavirus. A second control group comprised children admitted to a subset of three of the seven hospitals with respiratory illness. The primary endpoint was adjusted vaccine effectiveness (1 — adjusted odds ratio × 100%) in children aged from 18 weeks to 23 months and was calculated by unconditional logistic regression. This study is registered on the South African National Clinical Trial Register, number DOH-27-0512-3247.

Findings

Of 540 rotavirus-positive cases, 278 children (52%) received two doses, 126 (23%) one dose, and 136 (25%) no doses of human rotavirus vaccine, compared with 1434 rotavirus-negative controls of whom 856 (60%) received two doses, 334 (23%) one dose, and 244 (17%) no doses. Adjusted vaccine effectiveness using rotavirus-negative controls was 57% (95% CI 40—68) for two doses and 40% (16—57) for one dose; estimates were similar when respiratory controls were used as the control group. Adjusted vaccine effectiveness for two doses was similar between age groups 18 weeks—11 months (54%, 95% CI 32—68) and 12—23 months (61%, 35—77), and was similar in HIV-exposed-uninfected (64%, 95% CI 34—80) and HIV-unexposed-uninfected children (54%, 31—69).

Interpretation

Human rotavirus vaccine provided sustained protection against admission to hospital for acute rotavirus diarrhoea during the first and second years of life. This finding is encouraging and establishes the public health value of rotavirus vaccine in an African setting, especially as rotavirus vaccines are introduced into an increasing number of African countries.

Funding

GAVI Alliance (with support from PATH).

a Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Johannesburg, South Africa

b Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, Johannesburg, South Africa

c School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

d MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

e National Institute for Communicable Diseases: a Division of National Health Laboratory Service, Sandringham, South Africa

f Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA

g Department of Paediatrics and Child Health, Red Cross War Memorial Childrens Hospital, University of Cape Town, Cape Town, South Africa

h Department of Paediatrics, Ngwelezane Hospital, Empangeni, South Africa

i PATH, Seattle, WA, USA

j MRC/Diarrhoeal Pathogens Research Unit, Department of Virology, Medunsa Campus, University of Limpopo/National Health Laboratory Service, Pretoria, South Africa

k Centre for Global Health Research, Umeå University, Umeå, Sweden

l INDEPTH Network, Accra, Ghana

m Department of Paediatrics and Child Health, University of KwaZulu-Natal, South Africa

n Bill & Melinda Gates Foundation, Seattle, Washington, USA

o Stat-Epi Associates Inc, FL, USA

Correspondence to: Dr Michelle J Groome, New Nurses Residence, 11th Floor West Wing, Chris Hani Baragwanath Academic Hospital, Chris Hani Road, Soweto, 2013, South Africa

* Dr Chhagan died in August, 2014

† Denotes current affiliation