Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a literature article, concerning a pregnant female who on an unknown date was vaccinated with a dose of GARDASIL. On an unknown date, the patient delivered a normal infant. This report was part of a post-marketing surveillance program. Follow-up information has been received from another published article on 02-MAR-2015. The observer-blind randomized, age-stratified, head-to-head study comparing immunogenicity and safety of HPV-16/18 and HPV-6/11/16/18 vaccines in healthy women aged 18-45 years (y) old was completed. Five years after vaccination, in subjects from the month 60 according-to-protocol cohort (seronegative and DNA negative for HPV type analyzed at baseline), serum neutralizing antibody (nAb) responses induced by HPV-16/18 vaccine remained 7.8-fold (18-26-y stratum), 5.6-fold (27-35-y stratum) and 2.3-fold (36-45-y stratum) higher than those induced by HPV-6/11/16/18 vaccine for HPV-16, For HPV-18, the fold differences were 12.1, 13.0 and 7.8, respectively. At Month 60, all (100%) subjects in HPV-16/18 vaccine group and the majority (95.7%-97.5%) in HPV-6/11/16/18 vaccine group were seropositive for HPV-16. For HPV-18, the majority (98.1%-100%) of subject in HPV-16/18 vaccine group were seropositive; however, seropositivity rates in HPV-6/11/16/18 vaccine group decreased considerably (61.1%-76.9%) across the 3 age strata. In the total vaccinated cohort (received = 1 dose regardless of baseline HPV serostatus and DNA status), geometric mean titers for anti-HPV-16 and anti-HPV-18 nAb were higher in HPV-16/18 vaccine group. Based on the 5-y data, piece-wise and modified power-low models predicted a longer durability of nAb response for HPV-16/18 vaccine compared to HPV-6/11/16/18 vaccine. Beyond the differences apparent between the vaccines in terms of immunogenicity and modeled persistence of antibody responses, comparative studies including clinical endpoints would be needed to determine whether differences exist in duration of vaccine induced protection. Safety From Month 0 to Month 60, the proportion of subjects reporting events in the HPV-16/18 and HPV-6/11/16/18 vaccine groups (TVC) were comparable: serious adverse events (SAEs), 8% (n=44) in HPV-16/18 vaccine group and 6.7% (n=37) in HPV-6/11/16/18 vaccine group; medically significant conditions (MSCs), 46.8% (n=259) in HPV-16/18 vaccine group and 40.9% (n=226) in HPV-6/11/16/18 vaccine group; new onset chronic diseases (NOCDs), 7.1% (n=39) in HPV-16/18 vaccine group and 7.8% (n=43) in HPV-6/11/16/18 vaccine group; and new onset autoimmune diseases (NOADS), 1.3% (n=7) in HPV-16/18 vaccine group and 2.4% (n=13) in HPV-6/11/16/18 vaccine group. A total of 172 pregnancies were reported up to Month 60, with similar outcomes between vaccine groups. There were 71.9% (n=69) and 73.7% (n=56) live infants, respectively, in the HPV-16/18 and HPV-6/11/16/18 vaccine groups, with no unanticipated anomalies or outcomes. Fifteen (15.6%) and 11 cases (14.5%) of spontaneous abortion with no apparent congenital anomaly were reported in the HPV-16/18 and HPV-6/11/16/18 vaccine groups, respectively. Six (6.3%) and 3 cases (3.9%) of elective termination with no apparent congenital anomaly were reported in the HPV-16/18 and HPV-6/11/16/18 vaccine groups, respectively. This is one of several reports from the same literature. Additional information has been requested. Reporter, literature information and the narrative have been updated.