Efficacy of live, attenuated, human rotavirus vaccine 89–12 in infants: a randomised placebo-controlled trial

Bernstein, David I.; Sack, David A.; Rothstein, Edward; Reisinger, Keith S.; Smith, Vicki; O'Sullivan, Donna; Spriggs, Dale R.; Ward, Richard L.

doi:10.1016/s0140-6736(98)12106-2

Cited by 206 publications

(106 citation statements)

References 14 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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“…In the early 89-12 studies: "20 units/mL IgA was chosen as the cut-off point because it is well above the assay limit of detection (5 times) and it has been previously used as evidence of a natural RV infection.". 63 Although in the early RV5-precursor studies, 10 units/ml was chosen as a CO, this seems to have been abandoned in the later studies in which increments between preimmune samples and samples taken after the last vaccine dose are reported as "seroresponse" rates and not seroconversion rates ( Table 4).…”

Section: Technical Aspects Of the Immunological Assays Usedmentioning

confidence: 99%

Correlates of protection for rotavirus vaccines: Possible alternative trial endpoints, opportunities, and challenges

Ángel

Steele

Franco

2014

Human Vaccines & Immunotherapeutics

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Rotavirus (RV) is a major vaccine-preventable killer of young children worldwide. Two RV vaccines are globally commercially available and other vaccines are in different stages of development. Due to the absence of a suitable correlate of protection (CoP), all RV vaccine efficacy trials have had clinical endpoints. These trials represent an important challenge since RV vaccines have to be introduced in many different settings, placebo-controlled studies are unethical due to the availability of licensed vaccines, and comparator assessments for new vaccines with clinical endpoints are very large, complex, and expensive to conduct. A CoP as a surrogate endpoint would allow predictions of vaccine efficacy for new RV vaccines and enable a regulatory pathway, contributing to the more rapid development of new RV vaccines. The goal of this review is to summarize experiences from RV natural infection and vaccine studies to evaluate potential CoP for use as surrogate endpoints for assessment of new RV vaccines, and to explore challenges and opportunities in the field.

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“…Jung soo Kim, 1 chong-Woo Bae, 2 Kyung-Yil Lee, 3 Moon sung park, 4 Young Youn choi, 5 Kwang-Nam Kim, 6 Jong Duck Kim,7 Won-soon park, 8 Jong-Beom sin, 9 ellen ai-Rhan Kim, 10 sang-Geel Lee, 11 chun soo Kim,12 sung-Ho cha, 13 Young Jin Hong, 14, * son-Moon shin, 15 Gyu-Hong shim, 16 Kyong Min choi,…”

Section: Immunogenicity Reactogenicity and Safety Of A Human Rotavirmentioning

confidence: 99%

Immunogenicity, reactogenicity and safety of a human rotavirus vaccine (RIX4414) in Korean infants: A randomized, double-blind, placebo-controlled, phase IV study

Kim

Bae

Lee

et al. 2012

Human Vaccines & Immunotherapeutics

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Efficacy of live, attenuated, human rotavirus vaccine 89–12 in infants: a randomised placebo-controlled trial

Cited by 206 publications

References 14 publications

Safety of Rotavirus Vaccine in the NICU

Safety of Rotavirus Vaccine in the NICU

Correlates of protection for rotavirus vaccines: Possible alternative trial endpoints, opportunities, and challenges

Immunogenicity, reactogenicity and safety of a human rotavirus vaccine (RIX4414) in Korean infants: A randomized, double-blind, placebo-controlled, phase IV study

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