Abstract
ABSTRACTIn 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.
Highlights
Rotavirus (RV) is the most common cause of acute gastroenteritis in infants and young children worldwide.[1]
We observed a post-vaccination anti-porcine circovirus type 1 (PCV1) antibody seropositivity rate of 1% [90% Confidence Interval (CI): 0.3–2.6] in recipients of the human RV vaccine (3/299 samples) and 0.3% [90% CI: 0.0–1.6] in the placebo group (1/296 samples)
Since 10week-old infants have a limited exposure to PVC1, the origin of the anti-PCV1 antibodies measured in this infant is unknown
Summary
Rotavirus (RV) is the most common cause of acute gastroenteritis in infants and young children worldwide.[1] Before the introduction of the currently available RV vaccines, RV gastroenteritis accounted for approximately 2 million hospitalizations and 500,000 deaths annually among children younger than 5 y.2,3. World Health Organization has recommended that RV vaccination should be included in national infant immunization programs.[4]. The oral live-attenuated human RV vaccine (RotarixTM, GSK Vaccines, Belgium) has been shown to be efficacious and well-tolerated for preventing severe RV gastroenteritis in largescale clinical trials undertaken in Latin America, Europe, Asia, Africa, Japan and China.[5,6,7,8,9,10,11,12] considerable reductions in hospital admissions and mortality due to RV gastroenteritis and all-cause diarrhea have been achieved in various settings around the world following inclusion of the vaccine into national infant immunization schedules.[13,14,15,16,17,18,19,20] From launch until December 2015, it is estimated that 310 million doses were distributed to markets worldwide
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