Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infants
IntroductionRotavirus-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 ai...
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Frontiers Media S.A.
2024-02-01
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| Series: | Frontiers in Public Health |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpubh.2024.1356932/full |
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| author | Mercedes Macías-Parra Patricia Vidal-Vázquez Jesús Reyna-Figueroa Miguel Ángel Rodríguez-Weber Hortensia Moreno-Macías Inés Hernández-Benavides Sofía Fortes-Gutiérrez Vesta Louise Richardson Paola Vázquez-Cárdenas |
| author_facet | Mercedes Macías-Parra Patricia Vidal-Vázquez Jesús Reyna-Figueroa Miguel Ángel Rodríguez-Weber Hortensia Moreno-Macías Inés Hernández-Benavides Sofía Fortes-Gutiérrez Vesta Louise Richardson Paola Vázquez-Cárdenas |
| author_sort | Mercedes Macías-Parra |
| collection | DOAJ |
| description | IntroductionRotavirus-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.MethodsThis 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.ResultsOut 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.ConclusionThe 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. |
| first_indexed | 2024-03-07T22:56:17Z |
| format | Article |
| id | doaj.art-7448b2604ba8421386141a1fd7967d77 |
| institution | Directory Open Access Journal |
| issn | 2296-2565 |
| language | English |
| last_indexed | 2024-03-07T22:56:17Z |
| publishDate | 2024-02-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Public Health |
| spelling | doaj.art-7448b2604ba8421386141a1fd7967d772024-02-23T04:27:35ZengFrontiers Media S.A.Frontiers in Public Health2296-25652024-02-011210.3389/fpubh.2024.13569321356932Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infantsMercedes Macías-Parra0Patricia Vidal-Vázquez1Jesús Reyna-Figueroa2Miguel Ángel Rodríguez-Weber3Hortensia Moreno-Macías4Inés Hernández-Benavides5Sofía Fortes-Gutiérrez6Vesta Louise Richardson7Paola Vázquez-Cárdenas8Dirección General, Instituto Nacional de Pediatría, Mexico City, MexicoSubdirección de Investigación Biomédica, Hospital General Dr. Manuel Gea González, Mexico City, MexicoUnidad de Enfermedades Infecciosas y Epidemiología, Instituto Nacional de Perinatología, Mexico City, MexicoUnidad de Investigación Clínica, Instituto Nacional de Pediatría, Mexico City, MexicoUniversidad Autónoma Metropolitana, Mexico City, MexicoUnidad de Investigación Clínica, Instituto Nacional de Pediatría, Mexico City, MexicoSubdirección de Investigación Biomédica, Hospital General Dr. Manuel Gea González, Mexico City, MexicoCoordinación del Servicio de Guardería para el Desarrollo Integral Infantil, Dirección de Prestaciones Económicas y Sociales, Instituto Mexicano del Seguro Social, Mexico City, MexicoSubdirección de Investigación Biomédica, Hospital General Dr. Manuel Gea González, Mexico City, MexicoIntroductionRotavirus-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.MethodsThis 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.ResultsOut 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.ConclusionThe 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.https://www.frontiersin.org/articles/10.3389/fpubh.2024.1356932/fullrotavirusvaccine interchangeabilityRV1RV5immunogenicitysafety |
| spellingShingle | Mercedes Macías-Parra Patricia Vidal-Vázquez Jesús Reyna-Figueroa Miguel Ángel Rodríguez-Weber Hortensia Moreno-Macías Inés Hernández-Benavides Sofía Fortes-Gutiérrez Vesta Louise Richardson Paola Vázquez-Cárdenas Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infants Frontiers in Public Health rotavirus vaccine interchangeability RV1 RV5 immunogenicity safety |
| title | Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infants |
| title_full | Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infants |
| title_fullStr | Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infants |
| title_full_unstemmed | Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infants |
| title_short | Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infants |
| title_sort | immunogenicity of rv1 and rv5 vaccines administered in standard and interchangeable mixed schedules a randomized double blind non inferiority clinical trial in mexican infants |
| topic | rotavirus vaccine interchangeability RV1 RV5 immunogenicity safety |
| url | https://www.frontiersin.org/articles/10.3389/fpubh.2024.1356932/full |
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