Sex: U
Vaccine: RV1
Symptoms: Gastroenteritis rotavirus, Gene sequencing, Polymerase chain reaction positive, Rotavirus test positive, Vaccination failure
Clinical narrative: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a infant subject who received Rotavirus vaccine for prophylaxis. On an unknown date, less than a year after receiving Rotavirus vaccine and Rotavirus vaccine, the subject developed vaccination failure. Serious criteria included GSK medically significant. Additional event(s) included diarrhea rotavirus with serious criteria of GSK medically significant. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included diarrhea rotavirus (unknown). The investigator considered that there was a reasonable possibility that the vaccination failure and diarrhea rotavirus may have been caused by Rotavirus vaccine. It was unknown if the investigator considered the vaccination failure and diarrhea rotavirus to be related to Rotavirus vaccine. Relevant Tests: Lab tests were performed on an unspecified dates. The patient's stool specimen was collected and rotavirus diarrhoea (RVD) was determined by RV antigen detection in diarrheal specimens using the enzyme immunoassay. RVD stool specimens underwent total nucleic acid extraction. Reverse-transcription polymerase chain reaction (RT-PCR) was performed on total nucleic acid extracts. The amplicons underwent Sanger sequencing. Sequences were analysed, followed by Basic Local Alignment Search Tool (BLAST) analysis to determine the P genotype of each infecting strain. [In this study, Lea and Leb antigen phenotyping was performed on stored saliva specimens. Infants were defined as Lewis-positive (Le+) if either Le a or Le b antigen was detected. Secretor status was inferred from Lewis phenotyping Le a+b- infants were defined as nonsecretors (se); Le a-b+ and Le a+b+ (partial-secretor) infants were defined as (Secretors) Se (results not provided for this patient)]. Subsequently the patient was diagnosed with rotavirus diarrhoea with P[25] genotype. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Gene sequencing result was see text unknown. On an unknown date, Polymerase chain reaction result was see text unknown. On an unknown date, Rotavirus test positive result was P[25] genotype. On an unknown date, Stool analysis result was see text. Additional information was provided. This case was reported in a literature and described the suspected vaccination failure in an infant of unspecified age and gender who was vaccinated with unspecified ROTARIX (GlaxoSmithKline) for prophylaxis. The patient was part of study with the objective to determine the effects of secretor status and Lewis phenotype on susceptibility to natural rotavirus (RV) infection and oral RV vaccine underperformance, A substudy among infants participating in an RV1 vaccine effectiveness (VE) trial Oral Polio Vaccines in Developing Countries (PROVIDE) in a specific country was conducted from 2010 to 2014. Infants were enrolled within 7 days of life randomized 1:1 to receive RV1 or no RV1 at 10 and 17 weeks, followed with active community-based diarrheal surveillance. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On unspecified dates, at 10 and 17 weeks of age, the patient received 2 doses of ROTRIX (batch number not provided) per protocol. On an unspecified date, through the 1st year of life, an unknown period after vaccination. The patient developed first episode of rotavirus diarrhoea. The patient's stool specimen was collected and rotavirus diarrhoea (RVD) was determined by RV antigen detection in diarrheal specimens using the enzyme immunoassay. RVD stool specimens underwent total nucleic acid extraction. Reverse-transcription polymerase chain reaction (RT-PCR) was performed on total nucleic acid extracts. The amplicons underwent Sanger sequencing. Sequences were analysed, followed by Basic Local Alignment Search Tool (BLAST) analysis to determine the P genotype of each infecting strain. [In this study, Lea and Leb antigen phenotyping was performed on stored saliva specimens. Infants were defined as Lewis-positive (Le+) if either Le a or Le b antigen was detected. Secretor status was inferred from Lewis phenotyping Le a+b- infants were defined as nonsecretors (se); Le a-b+ and Le a+b+ (partial-secretor) infants were defined as (Secretors) Se (results not provided for this patient)]. Subsequently the patient was diagnosed with rotavirus diarrhoea with P[25] genotype. The case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered as serious due to suspected vaccination failure. The treatment was unknown. The outcome of the event was not provided. The author considered the event RVD casually related to ROTARIX. The author concluded "we demonstrated in a cohort of infants that non secretors were at decreased risk of RVD due to complete protection from P[4] RVs. This effect could significantly impact estimates of VE, particularly in regions with high frequencies of non-secretors and P[4] RV. We found no evidence of resistance to P[8] RVs as a mechanism for decreased vaccine effectiveness. Le -infants appeared to be protected from P[8] RVD, but this effect was offset by a markedly increased risk for RVD and vaccine failure due to P[6] infection. Secretor status, Lewis phenotype, and RV genotype should be accounted for in future oral RV vaccine trials." This is 1 of 2 valid cases reported in this literature article. Lab Comments: Lab tests were performed on an unspecified dates. The patient's stool specimen was collected and rotavirus diarrhoea (RVD) was determined by RV antigen detection in diarrheal specimens using the enzyme immunoassay. RVD stool specimens underwent total nucleic acid extraction. Reverse-transcription polymerase chain reaction (RT-PCR) was performed on total nucleic acid extracts. The amplicons underwent Sanger sequencing. Sequences were analysed, followed by Basic Local Alignment Search Tool (BLAST) analysis to determine the P genotype of each infecting strain. [In this study, Lea and Leb antigen phenotyping was performed on stored saliva specimens. Infants were defined as Lewis-positive (Le+) if either Le a or Le b antigen was detected. Secretor status was inferred from Lewis phenotyping Le a+b infants were defined as nonsecretors (se); Le ab+ and Le a+b+ (partial-secretor) infants were defined as (Secretors) Se (results not provided for this patient)]. Subsequently the patient was diagnosed with rotavirus diarrhoea with P[25] genotype.