Sex: F
Vaccine: HPV4
Symptoms: Delivery, Exposure during pregnancy
Clinical narrative: Information has been received from a physician via a literature article titled as stated below, concerning a pregnant female who on an unknown date was vaccinated with a dose of HPV. On an unknown date, the patient delivered a normal infant. This report was part of post-marketing surveillance program. Follow up information has been received from a physician via a literature article. The observer-blind, randomized, age-stratified, head-to-head study (NCT00423046) comparing immunogenicity and safety of HPV-16/18 and HPV-6/11116/18 vaccines in healthy women aged 18-45 y was completed. Five y after vaccination, in subjects from the Month 60 according-to-protocol cohort (seronegative and DNA negative for HPV type analyzed at 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-6/11116/18 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-6/11116/18 vaccine group were seropositive for HPV-16. For HPV-18, the majority (98.1%-100%) of subjects in HPV-16/18 vaccine group were seropositive; however, seropositive rates in HPV-6/11116/18 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 and anti-HPV-18 nAb were higher in HPV-16/18 vaccine group than in HPV-6/11116/18 vaccine group. Based on the 5-y data, piece-wise and modified power-law models predicted a longer durability of nAb response for HPV-16/18 vaccine compared to HPV-6/1116/18 vaccine. Beyond the differences apparent between the vaccines in terms of immunogenicity and modeled persistence of antibody responses, comparative studies including endpoints would be needed to determine whether differences exist in duration of vaccine induced protection. From Month 0 to Month 60, the proporation 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) I 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-6/11116/18 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 2.4% (n=13) in HPV-6/11/16/18 vaccine group. In terms of serious adverse events (SAEs), one subject in the HPV-16/18 vaccine group was diagnosed and died from metastatic renal cell carcinoma 287 d after the last dose of vaccine. The event was considered by the investigator to be unrelated to vaccination. Two SAEs were considered to be possibly related to vaccination: one was a grand mal convulsion in a subject in the HPV-16/18 vaccine group and one was a spontaneous abortion in a subject in the HPV-6/11/16/18 vaccine group. The most commonly identified NOCD and NOAD was hypothyroidism, with the reporting frequencies similar between the groups, and all cases were considered to be unrelated to the vaccines. 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 vaccines groups, respectively. This is one of several reports from the same source. Additional information has been requested. Reporter information and narrative were updated.