Project description
Enhancing rotavirus vaccine efficacy through early-life probiotics
Vaccines for contagious rotavirus are not effective in developing nations, possibly due to disruptions in gut microbe populations. Probiotic treatment helps restore gut microbe populations and increase the efficacy of the vaccines. Giving probiotics from birth to 1 month and 4- weekly booster doses in addition to education about water, sanitation and hygiene might be useful in reducing the risk of diarrhoea. Good hygiene, clean water, and vaccination are key. The EU-funded PRoRota project conducts a trial involving infants in Tanzania, Malawi and Côte d’Ivoire who will be randomised to receive probiotic or placebo. The study will assess diarrhoea incidence as the primary outcome, along with immune responses to the rotavirus vaccine and the risk of multidrug-resistant bacterial gut colonisation as secondary outcomes.
Objective
While rotavirus vaccines have reduced the incidence of childhood diarrhoea, their efficacies remain significantly lower in developing countries compared to high-income countries. One plausible factor is the disrupted gut microbiome among children in low-medium income countries (LMIC) settings. Our hypothesis is that probiotics can improve a destabilized gut microbiome, thereby improving vaccine immune responses, particularly oral vaccines such as rotavirus vaccines and treatment outcomes. We hypothesize that the provision of probiotics to infants from birth to one month and 4-weekly booster doses of probiotics, given as an adjunct to rotavirus vaccination and Water, Sanitation, and Hygiene (WASH) education, can reduce all-cause diarrhoea in infants. We will conduct a double-blind, placebo-controlled trial in 4000 newborns across Tanzania, Malawi, and Côte d'Ivoire. Infants will be randomized to receive probiotic or placebo boosters at 6, 10, and 14 weeks of age and followed until 6 months to measure diarrhoea incidence (primary outcome), immune response to the rotavirus vaccine, and risk of multidrug-resistant bacterial gut colonization (secondary outcomes). The intervention's safety, cost-effectiveness, and acceptability will also be evaluated. We shall also embed formative research that will assist us in designing enhanced WASH programs and use climate and diarrhoea disease burden to model predictive early warning systems. We anticipate that the findings from this 4-year project will directly inform global health policy, leading to improved rotavirus vaccine efficacy in LMICs. This will contribute to a significant reduction in diarrhoeal diseases and the risk of antimicrobial resistance (AMR), while also enabling the creation of early-warning systems for outbreak prediction. Additionally, the initiative will foster interdisciplinary research capacity and strengthening collaboration among partners.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences basic medicine immunology
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs vaccines
- natural sciences biological sciences microbiology
- medical and health sciences basic medicine pharmacology and pharmacy drug resistance antibiotic resistance
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.2.1 - Health
MAIN PROGRAMME
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Topic(s)
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Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
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Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions
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Call for proposal
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Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) HORIZON-JU-GH-EDCTP3-2025-04-two-stage
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5020 Bergen
Norway
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