Detection of PCV-2 DNA in stool samples from infants vaccinated with RotaTeq^®

Abstract

Rotarix® and RotaTeq® vaccines have led to a dramatic reduction in rotavirus disease worldwide. However, the detection of porcine circovirus type 1 (PCV-1) and 2 (PCV-2) DNA in these vaccines raised some safety concerns. Studies examining shedding of rotavirus in stool from rotavirus vaccine recipients have been performed but no published data exist regarding the shedding of PCV virus in stools of vaccinees. The goal of this study was to determine if PCV-1 and/or PCV-2 is shed in the feces of infants vaccinated with RotaTeq®. Using multiple PCR assays for detection of PCV DNA, we tested for PCV-1 and PCV-2 in 826 stool swab samples collected serially during the first 9 d after vaccination from 102 children vaccinated with RotaTeq®. Since the vaccine is recommended and uptake is high, we did not have samples from unvaccinated infants. A total of 235 (28.5%) samples from 59 vaccine recipients were positive for PCV-2 DNA by one or more assays used in this study. PCV-1 DNA was not detected in RotaTeq® or any of the stool swab extracts. Twenty-two of the 102 vaccine recipients (21.6%) shed RotaTeq® vaccine strain and 10 of these vaccinees (9.8%) were shedding both PCV DNA and rotavirus vaccine RNA. PCV DNA was detected up to 9 d post vaccination and was most frequently detected in the first 5 d after vaccination. This study demonstrated shedding of PCV-2 DNA by RotaTeq® vaccinees but we did not find evidence that this DNA was associated with viable PCV. Findings from this study support the continued use of current rotavirus vaccines.

Shedding of porcine circovirus type 1 DNA and rotavirus RNA by infants vaccinated with Rotarix®

“…7 In our study, Rotarix Ò PCV-1 DNA was detected in one infant each as late as day 7, 13, 15, 31 and 36. In the last 3 infants, several earlier samples did not have Rotarix Ò PCV-1 DNA detected.…”

“…All extractions were performed according to the manufacturer's instructions. TNA extracts were analyzed immediately by real-time PCR (qPCR) for PCV-1 DNA 7 and for Rotavirus group A by a duplex qRT-PCR targeting the NSP3 gene of RVA and using Xeno Ò RNA as an internal control. 15 Remaining TNA was stored at ¡80 C until further testing.…”

“…19 The qPCR assay, targeting PCV-1 strains found either in Rotarix Ò vaccine or as a wild-type, was run under previously described conditions. 7 All PCV-1 qPCR positive samples were sequenced using a previously published PCR assay. 7 During data analysis, we speculated that there might be competition between the viruses, RVA and PCV-1, for the limited surface area of the magnetic bead used during the MagNA Pure extraction, as this was observed during a similar study for RotaTeq Ò vaccinees.…”

“…7 All PCV-1 qPCR positive samples were sequenced using a previously published PCR assay. 7 During data analysis, we speculated that there might be competition between the viruses, RVA and PCV-1, for the limited surface area of the magnetic bead used during the MagNA Pure extraction, as this was observed during a similar study for RotaTeq Ò vaccinees. 7 The decision to re-extract and re-analyze the samples was further supported by comparing the results of 50 randomly selected samples from the current study, for which we found an increase of 19% and 2% for Rotarix Ò RVA RNA and Rotarix Ò PCV-1 DNA detection, respectively, for samples extracted using the Master Pure kit (data not shown).…”

Vaccines against human diarrheal pathogens

“…39 Since 2006, two new licensed rotavirus vaccines Rotarix® and RotaTeq® are available and drastically reduced worldwide infection rates. 40,41 Rotarix® is based on a monovalent, live, attenuated human G1P [8] (glycoprotein VP7 defines the G serotypes, protease-sensitive protein VP4 defines P serotypes) rotavirus strain (G1 serotype, P [8] genotype), the most common worldwide, but also prevents infections by serotypes G3, G4 and G9. 42,43 This attenuated strain was found in a child at Cincinnati Children's Hospital.…”