Identification of Strains of RotaTeq Rotavirus Vaccine in Infants With Gastroenteritis Following Routine Vaccination

Abstract

During replication and excretion of RotaTeq vaccine, reassortment of parental strains can occur. Shedding of RotaTeq vaccine strains in 7 of 13 infants was associated with underlying medical conditions that may have altered their immune function. The benefits of vaccination outweigh any small risk of vaccine-associated gastroenteritis.

Analysis by rotavirus gene 6 reverse transcriptase-polymerase chain reaction assay of rotavirus-positive gastroenteritis cases observed during the vaccination phase of the Rotavirus Efficacy and Safety Trial (REST)

“…The median clinical severity scores for the RVGE cases among vaccine recipients attributed to vaccine virus were less than the clinical severity scores of RVGE cases attributed to wild-type rotavirus, as follows: for RVGE cases attributed to vaccine virus, the median clinical severity score was 4 (range, 1-11) and for RVGE cases attributed to wild-type rotavirus, the median clinical severity score was 6 (range, [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17]. The median clinical severity score of RVGE cases among placebo recipients was 10 (range, [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19], which is indicative of moderate-to-severe RVGE.…”

“…The median clinical severity score of RVGE cases among placebo recipients was 10 (range, [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19], which is indicative of moderate-to-severe RVGE. The median score reduction between the wild-type RVGE cases among placebo recipients and vaccine-type RVGE among vaccine recipients was 6 (95% confidence interval [CI]: 4, 7); whereas, the median score reduction between the wild-type RVGE cases among placebo recipients and wild-type RVGE among vaccine recipients was 4 (95% CI: -1, 7).…”

“…In total, only 17 recipients with stool samples that contained vaccine virus strains were collected based on a suspected AGE episode, but only 6 (35%) of these 17 stool samples met the established clinical AGE definition and the vaccine virus strains among these varied. Postmarketing surveillance has shown similar reassortment in vivo at low frequencies in several vaccinated populations, [13][14][15] and these reassorted vaccine strains have occasionally caused gastroenteritis symptoms in vaccine recipients and, in some rare instances, may have transmitted the virus to close contacts. 16,17 These findings are not unexpected as RV5 is a live viral vaccine, which replicates in the recipients' gut and was observed in prelicensure studies.…”

Progress with rotavirus vaccines: summary of the Tenth International Rotavirus Symposium

“…Vaccine-derived reassortant rotaviruses have been detected in association with gastroenteritis in a limited number of patients in a few countries that have implemented rotavirus vaccination programs [23][24][25]. The rotavirus genome is composed of 11 doublestranded RNA gene segments, and two rotavirus strains infecting the same cell can swap genomic segments ( reassortment) to produce progeny with a mosaic genome containing individual genes from each parent.…”

Vaccine preventable viral diseases and risks associated with waterborne transmission

“…Rotavirus antigen was detected in the stools of infants for more than a week after their first dose of pentavalent rotavirus vaccine [73]. A recent study in Australia, where the pentavalent RotaTeq is in use since 2007 [74], has shown some circulation of parental as well reassortant vaccine strains in both vaccinated children and subjects sampled in the community in the course of routine surveillance. Also, transmission of vaccine-derived rotavirus (RotaTeq) has been documented in a vaccinee sibling in US, resulting into symptomatic infection that the authors hypothesize may have involved reassortment with a co-infecting wild-type rotavirus [75].…”