Dose Response and Efficacy of a Live, Attenuated Human Rotavirus Vaccine in Mexican Infants

Ruíz-Palacios, Guillermo M.; Guerrero, M. Lourdes; Bautista-Márquez, Aurora; Ortega-Gallegos, Hilda; TUZ-DZIB, FERNANDO; Reyes-González, Leticia; Rosales-Pedraza, Gustavo; Martínez-López, Julia; Castañón-Acosta, Erika; Cervantes, Yolanda; Costa-Clemens, SueAnn; DeVos, Beatrice

doi:10.1542/peds.2006-2630

Cited by 45 publications

(35 citation statements)

References 21 publications

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“…RV1 vaccinederived virus has a lower ID 50 (∼10 5 PFU/mL or less) that may present a higher chance of viral transmission. 17 Transmission of rotavirus vaccine strain RV1 to unvaccinated individuals has been assessed in many studies [18][19][20][21][22][23][24][25] but only documented as occurring in 3. [18][19][20] In studies documenting RV1 transmission, seroconversion varied from 2% to 6% among placebo recipients.…”

Section: Discussionmentioning

confidence: 99%

Safety of Rotavirus Vaccine in the NICU

Monk¹,

Motsney²,

Wade

2014

Pediatrics

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BACKGROUND AND OBJECTIVE: Rotavirus vaccination is discouraged during hospitalization given concerns regarding live attenuated virus transmission, although recommended upon discharge. Infants should have vaccination initiated by 104 days of age or they become age-ineligible. Our institution believed the known risk of severe disease in unvaccinated infants outweighed the theoretical risk of transmission. We routinely administer RotaTeq (RV5) to age-eligible hospitalized infants on enteral feeds. The objective of this study was to determine the safety of RV5 vaccination among vaccinated (VI) and unvaccinated infants (UVI) within the NICU. METHODS: A retrospective review identified VI between 2008 and 2010, and UVI geographically located near VI within 15 days of vaccination. We screened for gastrointestinal symptoms among UVI by using an electronic medical record query (trigger tool) to identify infants with orders for bowel rest, abdominal imaging, and antibiotics. Trigger-positive infants had full chart review. RESULTS: Most VI (76%) were either asymptomatic (25% [24 of 96]) or symptomatic but unchanged from baseline (51% [49 of 96]) postvaccination. Although 24% of VI had clinical status changes postvaccination, none were directly attributed to RV5. Among 801 neighboring UVI, 10 (1.2%) had clinical status changes, none directly attributed to RV5, but mostly bacterial sepsis or preexisting gastrointestinal pathology. Two UVI underwent stool analysis; both negative for rotavirus. CONCLUSIONS: RV5 was well tolerated in hospitalized infants, with most postvaccination symptoms attributed to preexisting symptoms. UVI seemed to have a low risk of symptomatic transmission. Inpatient administration ensures that age-eligible infants are vaccinated regardless of hospital duration. Prospective evaluation of safety and transmissibility is needed.

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Section: Discussionmentioning

confidence: 99%

Safety of Rotavirus Vaccine in the NICU

Monk¹,

Motsney²,

Wade

2014

Pediatrics

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“…The immune response to live oral rotavirus vaccines differs between infants in developed and developing countries. The immune seroconversion response observed in the previous rotavirus vaccine study in South Africa was lower than that seen in studies in Latin America [10][11][12]. In addition, early rotavirus vaccine trials in Africa, with alternative rotavirus vaccine candidates, demonstrated poor or no efficacy [13][14][15].…”

mentioning

confidence: 99%

Comparison of 2 Different Regimens for Reactogenicity, Safety, and Immunogenicity of the Live Attenuated Oral Rotavirus Vaccine RIX4414 Coadministered with Oral Polio Vaccine in South African Infants

et al. 2010

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“…22 RV1 also is frequently shed by immunized children (approximately 50%-80%), mainly during the 7 days following the first dose; and transmission to contacts has been documented. [23][24][25] A unique study of 100 twin pairs in Dominican Republic estimated that the risk of household transmission of RV1 to the unimmunized twin (all asymptomatic cases) was 19%. 26 In contrast, shedding of RV5 has been detected at different frequencies (9% and 21% in healthy infants 27,28 and 55% in premature infants 29 ), and even though transmission to unimmunized children has been documented, it seems to occur only occasionally.…”

Section: What Could Be the Mechanism(s) Of Herd Immunity?mentioning

confidence: 99%

Rotavirus vaccination and herd immunity: an evidence-based review

Seybolt¹,

Bégué²

2012

PHMT

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Until recently, rotavirus was the most common cause of diarrhea in infants and young children with over 100 million cases and 400,000 deaths every year worldwide. Yet, its epidemiology is changing rapidly with the introduction of two rotavirus vaccines in the mid 2000s. Both vaccines were shown to be highly efficacious in prelicensure studies to reduce severe rotavirus disease; the efficacy being more pronounced in high-and middle-income countries than in low-income countries. Herd immunity -the indirect protection of unimmunized individuals as a result of others being immunized -was not expected to be a benefit of rotavirus vaccination programs since the vaccines were thought to reduce severe disease but not to decrease virus transmission significantly. Postlicensure studies, however, have suggested that this assumption may need reassessment. Studies in a variety of settings have shown evidence of greater than expected declines in rotavirus disease. While these studies were not designed specifically to detect herd immunity -and few failed to detect this phenomenon -the consistency of the evidence is compelling. These studies are reviewed and described here. While further work is needed, clarifying the presence of herd immunity is not just an academic exercise but an important issue for rotavirus control, especially in lower income countries where the incidence of the disease is highest and the direct protection of the vaccines is lower.

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Dose Response and Efficacy of a Live, Attenuated Human Rotavirus Vaccine in Mexican Infants

Abstract: This new oral, live, attenuated human rotavirus vaccine was safe, immunogenic, and highly efficacious in preventing any and, more importantly, severe rotavirus gastroenteritis in healthy infants. This vaccine produced comparable protection to natural infection.

Cited by 45 publications

References 21 publications

Safety of Rotavirus Vaccine in the NICU

Safety of Rotavirus Vaccine in the NICU

Comparison of 2 Different Regimens for Reactogenicity, Safety, and Immunogenicity of the Live Attenuated Oral Rotavirus Vaccine RIX4414 Coadministered with Oral Polio Vaccine in South African Infants

Rotavirus vaccination and herd immunity: an evidence-based review

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