Evaluation of Safety, Immunogenicity and Efficacy of an Attenuated Rotavirus Vaccine, RIX4414

Salinas, Belén; Schael, Irene Pérez; Linhares, Alexandre C.; Palacios, Guillermo M. Ruiz; Guerrero, M. Lourdes; Yarzábal, Juan Pablo; Cervantes, Yolanda; Clemens, Sue Ann Costa; Damaso, Silvia; Hardt, Karin; Vos, B. De

doi:10.1097/01.inf.0000178294.13954.a1

Cited by 203 publications

(172 citation statements)

References 41 publications

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“…This study demonstrated that in an Indian setting, two doses of RIX4414 vaccine were immunogenic: seroconversion rate of 58.3% at one month after receiving the second dose. Vaccination with RIX4414 vaccine had a mild reactogenicity profile in Indian with similar profile observed in other trials 9,10 and there were no safety concerns during the study.…”

Section: Introductionmentioning

confidence: 60%

Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants

Narang¹,

Bose²,

Pandit³

et al. 2009

Human Vaccines

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Section: Introductionmentioning

confidence: 60%

Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants

Narang¹,

Bose²,

Pandit³

et al. 2009

Human Vaccines

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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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“…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%

“…[13][14][15][16][17][18][19] A pre-licensure study was conducted in Korea to assess the immunogenicity and safety of RIX4414 vaccine. The immunogenicity results of the pre-licensure study indicated that two doses of RIX4414 were immunogenic (seroconversion rate: 66.7%) when administered to healthy Korean infants.…”

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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Evaluation of Safety, Immunogenicity and Efficacy of an Attenuated Rotavirus Vaccine, RIX4414

Abstract: Two doses of RIX4414 are highly efficacious, providing cross-protection (G1 and G9 strains, prevalent during this study) and early protection against any and severe rotavirus gastroenteritis and hospitalization to infants in Latin America.

Cited by 203 publications

References 41 publications

Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants

Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants

Safety of Rotavirus Vaccine in the NICU

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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