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Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized,
Mercedes Macías-Parra1, Patricia Vidal-Vázquez2, Jesús Reyna-Figueroa3
1Dirección General, Instituto Nacional de Pediatría, Mexico City, Mexico.
Insights
Mixed rotavirus vaccine schedules using Rotarix (RV1) and RotaTeq (RV5) are as effective and safe as standard schedules. This flexibility aids global rotavirus prevention efforts.
Area of Science:
- Pediatric infectious diseases
- Vaccinology
- Immunology
Background:
- Rotavirus-associated diarrheal diseases pose a significant global health burden, especially in infants under five.
- Rotarix (RV1) and RotaTeq (RV5) are effective rotavirus vaccines but have distinct schedules and limited interchangeability data.
- Optimizing rotavirus vaccine administration is crucial for public health.
Purpose of the Study:
- To evaluate the immunogenicity, reactogenicity, and safety of mixed Rotarix (RV1) and RotaTeq (RV5) vaccine schedules.
- To compare mixed schedules against standard RV1 and RV5 schedules in infants.
- To provide evidence supporting flexible rotavirus vaccination strategies.
Main Methods:
- A randomized, double-blind study involving 1,498 infants aged 6-10 weeks.
- Infants received various combinations of RV1 and RV5, with standard schedules as controls.
- Immunogenicity assessed via IgA antibody levels; safety monitored for adverse events and intussusception.
Main Results:
- Mixed rotavirus vaccine schedules demonstrated non-inferiority in immunogenicity compared to standard schedules.
- No significant differences in immunogenic response were observed between mixed and standard groups.
- Safety profiles were comparable across all groups, with no increased risk of serious adverse events or intussusception.
Conclusions:
- Mixed rotavirus vaccine schedules are immunogenically and clinically non-inferior to standard regimens.
- Findings support the flexibility of rotavirus vaccination strategies, beneficial for vaccine supply and logistical challenges.
- This research contributes to optimizing global rotavirus vaccination programs for enhanced pediatric coverage.
Introduction:
Rotavirus-associated diarrheal diseases significantly burden healthcare systems, particularly affecting infants under five years. Both Rotarix™ (RV1) and RotaTeq™ (RV5) vaccines have been effective but have distinct application schedules and limited interchangeability data. This study aims to provide evidence on the immunogenicity, reactogenicity, and safety of mixed RV1-RV5 schedules compared to their standard counterparts.
Methods:
This randomized, double-blind study evaluated the non-inferiority in terms of immunogenicity of mixed rotavirus vaccine schedules compared to standard RV1 and RV5 schedules in a cohort of 1,498 healthy infants aged 6 to 10 weeks. Participants were randomly assigned to one of seven groups receiving various combinations of RV1, and RV5. Standard RV1 and RV5 schedules served as controls of immunogenicity, reactogenicity, and safety analysis. IgA antibody levels were measured from blood samples collected before the first dose and one month after the third dose. Non-inferiority was concluded if the reduction in seroresponse rate in the mixed schemes, compared to the standard highest responding scheme, did not exceed the non-inferiority margin of -0.10. Reactogenicity traits and adverse events were monitored for 30 days after each vaccination and analyzed on the entire cohort.
Results:
Out of the initial cohort, 1,365 infants completed the study. Immunogenicity analysis included 1,014 infants, considering IgA antibody titers ≥20 U/mL as seropositive. Mixed vaccine schedules demonstrated non-inferiority to standard schedules, with no significant differences in immunogenic response. Safety profiles were comparable across all groups, with no increased incidence of serious adverse events or intussusception.
Conclusion:
The study confirms that mixed rotavirus vaccine schedules are non-inferior to standard RV1 and RV5 regimens in terms of immunogenicity and safety. This finding supports the flexibility of rotavirus vaccination strategies, particularly in contexts of vaccine shortage or logistic constraints. These results contribute to the global effort to optimize rotavirus vaccination programs for broader and more effective pediatric coverage.Clinical trial registration: ClinicalTrials.gov, NCT02193061.
