Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV

NCT07279298 | Not Yet Recruiting

• 1 other identifier: SDSCTI20250014
• Study Type: observational
• Target: 1,097
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the real-world effectiveness of two preventive immunization strategies against Respiratory Syncytial Virus (RSV)-associated severe acute respiratory infection in infants less than six months of age in Bogotá, Colombia. The strategies include maternal vaccination with RSVpreF administered between 28 and 36 weeks of gestation and neonatal immunization with nirsevimab for infants born to mothers who did not receive RSVpreF during pregnancy. Using a test-negative case-control design embedded in the city's sentinel surveillance system, infants hospitalized for severe respiratory infection will be systematically tested for RSV. Comparative vaccine effectiveness will be estimated to determine the impact of maternal RSV vaccination and neonatal monoclonal antibody immunization on RSV-associated hospitalizations, intensive care admissions, and mortality. The study will generate real-world evidence to inform local and regional public health decisions and guide the implementation of cost-effective hybrid immunization strategies against RSV in middle-income settings.

Conditions

Respiratory Syncytial Virus Infections; Severe Acute Respiratory Infection; Bronchiolitis, Viral; Viral Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• Hospitalization for RSV-associated Severe Acute Respiratory Infection

  Proportion of infants hospitalized with laboratory-confirmed Respiratory Syncytial Virus (RSV)-associated severe acute respiratory infection, defined as meeting the district operational criteria for SARI and testing positive for RSV by RT-PCR or validated antigen testing within ≤48 hours of hospital admission. The measure compares the likelihood of RSV-related hospitalization among infants exposed to maternal RSVpreF vaccination, neonatal nirsevimab administration, or no RSV-specific immunization.

  From birth up to 6 months of age (≤180 days of life)

Study Arms (2)

Case (RSV-positive test result)

An infant younger than six months of age, resident in Bogotá, hospitalized for severe acute respiratory infection (SARI) and meeting the district operational criteria for SARI, who has a respiratory specimen collected within ≤48 hours of hospital admission (or repeated within 24-48 hours if the first result was negative) that tests positive for Respiratory Syncytial Virus (RSV) by RT-PCR or a validated antigen assay. Only infants born ≥5 weeks after the start of the maternal RSVpreF vaccination campaign are eligible for inclusion.

Biological: RSVpreF vaccine (Abrysvo) and Nirsevimab (Beyfortus) or unexposed

Control (RSV-negative test result)

An infant younger than six months of age, resident in Bogotá, hospitalized for severe acute respiratory infection (SARI) and meeting the same operational criteria as cases, who has a respiratory specimen collected within ≤48 hours of admission (or repeated within 24-48 hours if needed) that tests negative for RSV. Controls may test positive for other respiratory viruses or bacteria. Only infants born ≥5 weeks after the start of the maternal RSVpreF vaccination campaign are eligible.

Biological: RSVpreF vaccine (Abrysvo) and Nirsevimab (Beyfortus) or unexposed

Interventions

RSVpreF vaccine (Abrysvo) and Nirsevimab (Beyfortus) or unexposed BIOLOGICAL

Maternal vaccination administered between 28 and 36 weeks of gestation and Single-dose monoclonal antibody administered to newborns whose mothers did not receive effective RSVpreF vaccination or unexposed

Case (RSV-positive test result); Control (RSV-negative test result)

Eligibility Criteria

• Age: 1 Day - 180 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants younger than six months residing in Bogotá, Colombia, hospitalized for severe acute respiratory infection in sentinel hospitals and tested for RSV within 48 hours of admission. The population includes infants exposed to maternal RSVpreF vaccination, neonatal nirsevimab, or neither intervention. Extremely preterm infants (≤32 weeks gestation) and those hospitalized for non-respiratory conditions are excluded.

You may qualify if:

• Age: Infants younger than 6 months at the time of hospital admission.
• Residence: Maternal residence in Bogotá, Colombia, verified through clinical record, identification document, or health system registry.
• Clinical Condition: Hospitalization due to severe acute respiratory infection (SARI) meeting the district operational definition (presence of fever, cough, and/or signs of respiratory distress, requiring inpatient management).
• Laboratory Testing: Respiratory specimen collected and tested for RSV by RT-PCR or validated antigen test within ≤48 hours of hospital admission, or repeated within 24-48 hours if initial test is negative.
• Exposure Eligibility Window: Infant born ≥5 weeks after the start of the RSVpreF maternal vaccination campaign in Bogotá, ensuring opportunity for maternal immunization.

You may not qualify if:

• Prematurity: Infants born at ≤32 weeks of gestation.
• Healthcare-associated respiratory infection: Symptom onset \>48 hours after hospital admission for another condition.
• Non-respiratory hospital admission: Primary reason for hospitalization unrelated to respiratory disease (e.g., trauma, elective surgery).
• Vaccination status unverifiable: Inability to confirm maternal RSVpreF vaccination status after reasonable attempts to verify through registry, vaccination card, or prenatal documentation.
• Duplicate episodes: Readmission for the same respiratory episode ≤14 days after discharge (only the first episode will be included).
• Delayed sampling: First respiratory sample obtained \>48-72 hours after initial admission to the health system.
• Lethal congenital conditions: Congenital or genetic disorders incompatible with life or that substantially alter the expected clinical course.
• Concurrent interventional study participation: Enrollment in another clinical trial that may affect respiratory outcomes.
• Inability to establish mother-infant linkage due to adoption, loss of parental custody, or absence of biological maternal records.

Sponsors & Collaborators

• Bogotá District Health Secretariat: lead

Related Publications (15)

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• Everard ML. The relationship between respiratory syncytial virus infections and the development of wheezing and asthma in children. Curr Opin Allergy Clin Immunol. 2006 Feb;6(1):56-61. doi: 10.1097/01.all.0000200506.62048.06.

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• Mezarina Esquivel, Hugo Antonio, Rojas Medina, Aurea Rosa, Bada Mancilla, Carlos Alfonso, Castañeda Campozano, Ruth Elizabeth, & Carhuancho Aguilar, José Raphael. (2016). Características clínicas y epidemiológicas de la infección respiratoria aguda grave por virus sincitial respiratorio en menores de 5 años. Horizonte Médico (Lima), 16(3), 6-11.

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• Galvis, Clara Esperanza, Troncoso, Gloria, Agudelo-Pérez, Sergio, Romero, Héctor, Parra Buitrago, Andrea, & Gutiérrez, Iván Felipe. (2024). Consenso de expertos sobre las recomendaciones de profilaxis con palivizumab para el Virus Sincitial Respiratorio en niños en Colombia. Infectio, 28(3), 180-191. Epub September 12, 2024.https://doi.org/10.22354/24223794.1189

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• Perez Marc G, Vizzotti C, Fell DB, Di Nunzio L, Olszevicki S, Mankiewicz SW, Braem V, Rearte R, Atwell JE, Bianchi A, Fuentes N, Zadoff R, Vecchio G, Gabriela Abalos M, Fan R, Del Carmen Morales G, Gessner BD, Jodar L, Libster R, Rearte A; BERNI study working group. Real-world effectiveness of RSVpreF vaccination during pregnancy against RSV-associated lower respiratory tract disease leading to hospitalisation in infants during the 2024 RSV season in Argentina (BERNI study): a multicentre, retrospective, test-negative, case-control study. Lancet Infect Dis. 2025 Sep;25(9):1044-1054. doi: 10.1016/S1473-3099(25)00156-2. Epub 2025 May 5.

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Related Links

• cost analysis
• Boletin epidemuiologico

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Bronchiolitis, Viral

Interventions

abrysvo; nirsevimab

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Bronchiolitis; Bronchitis; Respiratory Tract Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Julián Alfredo Fernández Niño

  Bogotá District Health Secretariat

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julián Alfredo Fernández Niño

CONTACT

+573203891056; jafernandez@saludcapital.gov.co

Maria Fernanda Tovar Romero

CONTACT

+573124321118; mftovar@saludcapital.gov.co

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share