Address the Burden of Respiratory Syncytial Virus (RSV) among infants in sub-Saharan Africa (PREVENT-RSV)

The PREVENT-RSV project (Preparing for RSV Evidence to Validate Effective Nirsevimab Trial) is a major research initiative led by the Ifakara Health Institute to address the growing burden of Respiratory Syncytial Virus (RSV) among infants in sub-Saharan Africa.

Background and Rationale

RSV is a leading cause of lower respiratory tract infections (LRTIs) in infants globally and contributes significantly to infant mortality, particularly in low- and middle-income countries. Despite recent advances such as maternal vaccines and monoclonal antibodies like Nirsevimab, there is limited evidence on how these interventions perform in real-world African settings. Critical gaps remain in understanding their effectiveness, safety, cost-effectiveness, and feasibility within health systems like those in Tanzania.

Project Objective

The project aims to generate robust, policy-relevant evidence on RSV prevention strategies by evaluating:

• Clinical effectiveness of interventions
• Safety in mothers and infants
• Feasibility of implementation in resource-limited settings
• Cost-effectiveness to inform national decision-making

Study Design and Approach

PREVENT-RSV uses a two-phase strategy:

Phase 1: Preparatory Phase
This phase focuses on:

• Collecting retrospective data on infant hospitalizations and LRTI incidence
• Assessing feasibility using local epidemiological data
• Engaging stakeholders, including communities and regulators
• Securing ethical and regulatory approvals
• Planning resources and budgeting for the trial

Phase 2: Intervention Phase
This phase will implement a multicentre, double-blind randomized controlled trial in Kilombero and Bagamoyo districts. The study will compare three approaches:

• Maternal RSV vaccination during pregnancy
• Neonatal protection using Nirsevimab at birth
• Standard care (comparator)

The primary outcome will be the rate of laboratory-confirmed RSV-related hospitalizations among infants.

Expected Impact

By generating high-quality local evidence, PREVENT-RSV aims to:

• Reduce infant hospitalizations and deaths from RSV
• Support equitable access to effective prevention tools
• Guide national and regional health policies
• Strengthen health systems’ capacity to deliver new interventions

Ultimately, the project represents a critical step toward improving child health and advancing health equity across sub-Saharan Africa.