Evaluation of a Booster Dose of Pentavalent Rotavirus Vaccine Coadministered With Measles, Yellow Fever, and Meningitis A Vaccines in 9-Month-Old Malian Infants

Haidara, Fadima Cheick; Tapia, Milagritos D.; Sow, Samba O.; Doumbia, Moussa; Coulibaly, Flanon; Diallo, Fatoumata; Traoré, Awa; Kodio, Mamoudou; Kelly, Corey; Fitzpatrick, Meagan C.; Kotloff, Karen L.; Victor, John C.; Neuzil, Kathleen M.

doi:10.1093/infdis/jiy215

Cited by 24 publications

(32 citation statements)

References 26 publications

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“…Eligible infants resided in the study area, were generally healthy, and had been fully vaccinated according to the local immunization schedule. Details on the exclusion criteria have been published previously [25].…”

Section: Study Populationmentioning

confidence: 99%

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Validation of the Micronutrient and Environmental Enteric Dysfunction Assessment Tool and evaluation of biomarker risk factors for growth faltering and vaccine failure in young Malian children

et al. 2020

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Environmental enteric dysfunction (EED) is an intestinal disorder common among children in low-resource settings and is associated with increased risk of growth stunting, cognitive deficits, and reduced oral vaccine immunogenicity. The Micronutrient and EED Assessment Tool (MEEDAT) is a multiplexed immunoassay that measures biomarkers previously associated with child growth faltering and/or oral vaccine immunogenicity: intestinal fatty acidbinding protein (I-FABP), soluble CD14 (sCD14), insulin-like growth factor 1 (IGF-1), and fibroblast growth factor 21 (FGF21). MEEDAT also measures systemic inflammation (α1acid glycoprotein, C-reactive protein), ferritin, soluble transferrin receptor, retinol binding protein 4, thyroglobulin, and Plasmodium falciparum antigenemia (histidine-rich protein 2). The performance of MEEDAT was compared with commercially available enzyme-linked immunosorbent assays (ELISAs) using 300 specimens from Malian infant clinical trial participants. Regression methods were used to test if MEEDAT biomarkers were associated with seroconversion to meningococcal A conjugate vaccine (MenAV), yellow fever vaccine (YFV), and pentavalent rotavirus vaccine (PRV) after 28 days, or with growth faltering over 12 weeks. The Pearson correlations between the MEEDAT and ELISA results were 0.97, 0.86, 0.80, and 0.97 for serum I-FABP, sCD14, IGF-1, and FGF21, respectively. There were significant associations between I-FABP concentration and the probability of PRV IgG seroconversion and between IGF-1 concentration and the probability of YFV seroconversion. In multivariable models neither association remained significant, however there was a significant negative association between AGP concentration and YFV seroconversion. GLP-2 and sCD14 concentrations were significantly negatively associated with 12-week change in weight-forage z-score and weight-for-height z-score in multivariable models. MEEDAT performed well in comparison to commercially-available ELISAs for the measurement of four analytes for EED and growth hormone resistance. Adoption of MEEDAT in low-PLOS NEGLECTED TROPICAL DISEASES

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Section: Study Populationmentioning

confidence: 99%

“…In the RVI-PRV-01 trial, the parents were interviewed to collect baseline demographic (age and sex) and health information (known medical conditions and allergies), in order to confirm eligibility [25]. A study physician performed a physical examination of each infant prior to enrollment (day 0) and on days 7, 28, and 96 of follow-up.…”

Section: Data Collectionmentioning

confidence: 99%

Validation of the Micronutrient and Environmental Enteric Dysfunction Assessment Tool and evaluation of biomarker risk factors for growth faltering and vaccine failure in young Malian children

et al. 2020

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“…The remaining four abstracts were considered not relevant with respect to objectives or did not report data on co-administration of RV and meningococcal vaccines. Eleven studies provided information on the safety profile of co-administration of RV vaccines and meningococcal vaccines [20][21][22][23][24][25][26][27][28][29][30] and five studies reported data on immunogenicity. 21,22,24,29,31 No studies presented data on vaccine efficacy.…”

Section: Resultsmentioning

confidence: 99%

“…No vaccination-related SAE and no cases of intussusception were reported. 21 A review of the 4CMenB clinical development program reported results from a pooled sub-group analysis of two pivotal trials (5,515 participants) in which 303 infants had received at least one dose of RV vaccine (HRV or HBRV Table 3. Systemic adverse events (%) related to co-administration of HBRV and MenCC or their sequential administration 28. according to local recommendations) concomitantly with 4CMenB and other recommended vaccines.…”

Section: Co-administration Of Rv and Meningococcal Vaccines No Compamentioning

confidence: 99%

“…Two studies did not present data for a comparator group with individual RV vaccination. 21,24 In a phase 3b, placebo-controlled study conducted across six European countries (the Czech Republic, Finland, France, Germany, Italy, and Spain), HRV or placebo were coadministered with routine vaccines recommended in the respective countries. Immunogenicity results were available from 794 infants in the HRV group and 422 infants in the placebo group.…”

Section: Immunogenicitymentioning

confidence: 99%

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Systematic literature review on the safety and immunogenicity of rotavirus vaccines when co-administered with meningococcal vaccines

Pereira

Benninghoff

Moerman

2020

Human Vaccines & Immunotherapeutics

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This study is aimed to review the published evidence on safety, immunogenicity, and efficacy of rotavirus vaccines when co-administered with meningococcal vaccines in infants. A systematic literature search was performed in four databases containing peer-reviewed articles and conference abstracts. In total, twelve articles were included in the review; 11 provided information on safety and five on the immunogenicity of rotavirus vaccines following co-administration. No paper was found on efficacy. Additional routine vaccines were administered in all studies. The safety analysis was mainly focused on fever, vomiting, diarrhea, intussusception, and changes in eating habits. Overall, safety profiles and immune responses associated with rotavirus vaccination were comparable between infants co-administered with rotavirus and meningococcal vaccines and infants receiving rotavirus vaccines without meningococcal vaccines. Although data are limited, co-administration of rotavirus and meningococcal vaccines does not appear to interfere with the safety or immunogenicity of rotavirus vaccines.

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Vaccines for preventing rotavirus diarrhoea: vaccines in use

Hungerford

Pitan²,

Ndwandwe

et al. 2021

Cochrane Database of Systematic Reviews

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Evaluation of a Booster Dose of Pentavalent Rotavirus Vaccine Coadministered With Measles, Yellow Fever, and Meningitis A Vaccines in 9-Month-Old Malian Infants

Abstract: Receipt of pentavalent rotavirus vaccine at 9 months of age in Mali increased antibody levels and did not interfere with responses to measles vaccine and meningococcal A conjugate vaccine. Interference with yellow fever vaccine could not be ruled out.

Cited by 24 publications

References 26 publications

Validation of the Micronutrient and Environmental Enteric Dysfunction Assessment Tool and evaluation of biomarker risk factors for growth faltering and vaccine failure in young Malian children

Validation of the Micronutrient and Environmental Enteric Dysfunction Assessment Tool and evaluation of biomarker risk factors for growth faltering and vaccine failure in young Malian children

Systematic literature review on the safety and immunogenicity of rotavirus vaccines when co-administered with meningococcal vaccines

Vaccines for preventing rotavirus diarrhoea: vaccines in use

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