title: Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix™: A retrospective laboratory analysis.
abstract: In 2010, porcine circovirus type 1 (PCV1) material was unexpectedly detected in the oral live-attenuated human rotavirus (RV) vaccine, Rotarix™ (GSK Vaccines, Belgium). An initial study (NCT01511133) found no immunologic response against PCV1 in 40 vaccinated infants. As a follow-up, the current study (NCT02153333), searched for evidence of post-vaccination serologic response to PCV1 in a larger number of archived serum samples. Unlike the previous study, serum anti-PCV1 antibodies were assessed with an adapted Immuno Peroxidase Monolayer Assay (IPMA) using a Vero-adapted PCV1 strain. Samples from 596 infants who participated in clinical trials of the human RV vaccine were randomly selected and analyzed. The observed anti-PCV1 antibody seropositivity rate 1-2 months post-dose 2 was approximately 1% [90% Confidence Interval (CI): 0.3-2.6] (3/299 samples) in infants who received the human RV vaccine and 0.3% [90% CI: 0.0-1.6] (1/297 samples) in those who received placebo; the difference between the groups was -0.66 [90% CI: -2.16-0.60]. One subject in the vaccinated group was also seropositive before vaccination. Notably, the seropositivity rate observed in vaccinated subjects was below that observed during assay qualification in samples from unvaccinated subjects outside of this study (2.5%; 5/200 samples). No serious adverse events had been reported in any of the 4 subjects providing anti-PCV1 positive samples during the 31-day post-vaccination follow-up period in the original studies. In conclusion, the presence of PCV1 in the human RV vaccine is considered to be a manufacturing quality issue and does not appear to pose a safety risk to vaccinated infants.
authors.affiliation: a GSK Vaccines , King of Prussia , PA , USA.
authors.forename: Htay Htay
authors.initials: HH
authors.lastname: Han
authors.affiliation: b GlaxoSmithKline Pharmaceuticals Pvt. Ltd. , Bangalore , India.
authors.forename: Naveen
authors.initials: N
authors.lastname: Karkada
authors.affiliation: b GlaxoSmithKline Pharmaceuticals Pvt. Ltd. , Bangalore , India.
authors.forename: Girish
authors.initials: G
authors.lastname: Jayadeva
authors.affiliation: a GSK Vaccines , King of Prussia , PA , USA.
authors.forename: Gary
authors.initials: G
authors.lastname: Dubin
mesh_terms: D017925:Circovirus / Q000276:immunology*; D004340:Drug Contamination; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007223:Infant; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D012189:Retrospective Studies; D022243:Rotavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D010919:Placebos; C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated
keywords: PCV1; Rotarix™; human rotavirus vaccine; porcine circovirus type 1; serology