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Published on: January 28, 2019
Evaluation of non-specific effects of human rotavirus vaccination in medical risk infants
Josephine A P van Dongen1, Elsbeth D M Rouers2, Marc J M Bonten3
1Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
Insights
Rotavirus vaccination showed minimal non-specific effects on hospitalization, respiratory illness, and eczema in high-risk infants. This study investigated these effects up to 18 months of age.
Area of Science:
- Pediatrics
- Immunology
- Public Health
Background:
- The World Health Organization (WHO) recommends investigating non-specific effects of vaccines.
- Non-specific effects of rotavirus vaccines in infants are not well-established.
- This study focused on medical risk infants, a vulnerable population.
Purpose of the Study:
- To evaluate the non-specific effects of rotavirus vaccination in infants with medical risk conditions.
- To assess the impact of rotavirus vaccination on hospitalization, respiratory illness, and eczema.
- To provide evidence for vaccination strategies in high-risk infant populations.
Main Methods:
- A quasi-experimental before-after study design was employed.
- Compared cohorts of rotavirus-vaccinated and unvaccinated infants with medical risk conditions.
- Outcomes including acute hospitalization, respiratory illness, and eczema were prospectively collected and analyzed using time-to-event and regression models.
Main Results:
- The analysis included 496 unvaccinated and 719 vaccinated medical risk infants.
- Rotavirus vaccination showed no significant effect on acute hospitalization (aHR 0.91; 95% CI 0.76-1.16).
- No significant effects were observed for acute respiratory illness (aIRR 1.05; 95% CI 0.96-1.15) or eczema (aIRR 0.89; 95% CI 0.69-1.15).
Conclusions:
- Rotavirus vaccination demonstrated no or minimal non-specific effects in medical risk infants.
- Findings suggest limited impact on acute hospitalization, respiratory illness, or eczema.
- Further research may be warranted to fully elucidate long-term non-specific vaccine effects.
Background:
The WHO recommends research into non-specific effects of vaccination. For rotavirus vaccines, these have not yet been well established. We studied non-specific effects up to 18 months of age using data from a quasi-experimental before-after study comparing cohorts of rotavirus vaccinated and unvaccinated infants with medical risk conditions.
Methods:
Infants were enrolled at six weeks of age before and after a stepped-wedge implementation of a hospital-based risk-group rotavirus vaccination program. Other infant vaccinations were administered according to the Dutch National Immunization Program and similar in both cohorts. Non-specific effect outcomes were prospectively collected using monthly questionnaires and included acute hospitalization (excluding for acute gastroenteritis), monthly incidence of acute respiratory illness and eczema. We used time-to-event analysis and negative binomial regression to assess the effect of at least one dose of rotavirus vaccination for each of these outcomes. Findings The analysis included 496 rotavirus unvaccinated and 719 vaccinated medical risk infants. In total, 1067 (88%) were premature, 373 (31%) small for gestational age and 201 (17%) had a congenital pathology. The adjusted hazard ratio for first acute hospitalization was 0·91 (95 %CI 0·76;1·16) for rotavirus vaccinated versus unvaccinated infants. Adjusted incidence rate ratio for acute respiratory illness was 1·05 (95 %CI 0·96;1·15) and for eczema 0·89 (95 %CI 0·69;1·15).
Conclusion:
The results suggest no, or minimal non-specific effects from rotavirus vaccination on acute hospitalization, acute respiratory illness or eczema in medical risk infants.
Trial Registration:
as NTR5361 in the Dutch trial registry, www.trialregister.nl.
