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Published on: January 28, 2019
Safety of Rotavirus Vaccination in a Growing Care Unit (Intermediate-care Neonatal Unit) in Japan
Hiroki Miura1, Masahiko Manabe1, Masaru Ihira2
1From the Department of Pediatrics, Fujita Health University School of Medicine.
Insights
In-hospital rotavirus vaccination (RV1) in neonatal step-down units is safe, with no serious adverse events or detectable transmission. This approach ensures high-risk infants receive crucial immunization, preventing missed vaccination opportunities.
Area of Science:
- Neonatal care
- Vaccinology
- Infectious disease prevention
Background:
- Rotavirus vaccination prevents severe gastroenteritis but is often withheld during neonatal hospitalization due to transmission concerns.
- Limited data exists on the safety of in-hospital rotavirus vaccination in neonatal step-down units.
Purpose of the Study:
- To evaluate the safety and potential transmission of monovalent rotavirus vaccine (RV1) administered during hospitalization in a neonatal step-down care setting.
- To assess the feasibility of in-hospital vaccination to prevent missed immunization opportunities in high-risk infants.
Main Methods:
- A prospective cohort study was conducted in a Japanese growing care unit (neonatal step-down unit).
- Infants received monovalent rotavirus vaccine (RV1); stool samples were analyzed for vaccine-strain RNA using real-time quantitative RT-PCR.
- Adverse events and vaccine-strain shedding were monitored under routine contact precautions.
Main Results:
- RV1 vaccine-strain RNA was detected in 68.4% of postvaccination stool samples from vaccinated infants.
- No serious adverse events were observed, and no evidence of horizontal transmission was found.
- In-hospital vaccination allowed six infants who exceeded the age limit at discharge to receive vaccination.
Conclusions:
- Monovalent rotavirus vaccine (RV1) administration in neonatal step-down units is safe, with no detectable transmission or serious adverse events.
- In-hospital vaccination is a viable strategy to ensure high-risk infants receive timely rotavirus immunization.
- This approach addresses missed vaccination opportunities among vulnerable hospitalized neonates.
Background:
Rotavirus vaccination effectively prevents severe rotavirus gastroenteritis; however, administration during neonatal hospitalization is often avoided because of theoretical concerns regarding vaccine-virus transmission. Data on the safety of in-hospital rotavirus vaccination in neonatal step-down care settings remain limited.
Methods:
We conducted a 1-year prospective cohort study in a Japanese growing care unit, a step-down neonatal unit comparable to Level II-III neonatal intensive care units in the United States. Hospitalized infants were monitored for adverse events and vaccine-strain shedding after administration of monovalent rotavirus vaccine (RV1). Stool samples were collected weekly and analyzed using RV1 strain-specific real-time quantitative reverse transcription polymerase chain reaction targeting the NSP2 gene. Routine contact precautions, including gown and glove use for all patient care activities and environmental cleaning, were consistently implemented.
Results:
Among 237 infants included in the analysis, 15 received a total of 19 doses of RV1 during hospitalization. RV1 vaccine-strain RNA was detected in 26 of 38 postvaccination stool samples (68.4%). No RV1 strain RNA was detected in unvaccinated infants or in samples collected before vaccination. No serious adverse events were observed, and no evidence of horizontal transmission was identified. Six vaccinated infants exceeded the upper age limit for vaccine initiation at discharge and would have missed vaccination opportunities without in-hospital vaccination.
Conclusions:
RV1 vaccination was not associated with detectable transmission or serious adverse events in a neonatal step-down care setting under routine contact precautions, supporting its potential safety and role in preventing missed vaccination opportunities among high-risk infants.
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