Persistence of immune response to HPV-16/18 AS04-adjuvanted cervical cancer vaccine in women aged 15-55 years

Figures & data

Figure 1 Subject disposition. n, number of subjects; 15–25 years, subjects 15–25 years of age at the time of first vaccine dose; 26–45 years, subjects 26–45 years of age at the time of first vaccine dose; 46–55 years, subjects 46–55 years of age at the time of first vaccine dose.

Figure 2 Antibody levels in women between 15 and 55 years of age initially seronegative for HPV-16 or HPV-18 antibodies (ATP immunogenicity cohort). GMT, geometric mean titer; Error bars, 95% confidence interval; 15–25 years, subjects 15–25 years of age at the time of first vaccine dose; 26–45 years, subjects 26–45 years of age at the time of first vaccine dose; 46–55 years, subjects 46–55 years of age at the time of first vaccine dose; Natural infection: GMTs of subjects from Study HPV-008 who were (a) HPV-16 or (b) HPV-18 DNA-negative and seropositive at baseline (i.e., who had cleared a natural infection. GMTs were (a) 29.8 EL.U/ml and (b) 22.7 EL.U/ml11; Plateau phase: GMTs of subjects from Study HPV-007 in women aged 15–25 years at Months 45–50 after the first vaccine dose (Total cohort). GMTs were (a) 397.8 EL.U/ml and (b) 297.3 EL.U/ml.9

Figure 3 Study design. n, number of subjects.

Table 1 Number of women reporting medically significant adverse events, serious adverse events, fatal serious adverse events or new onset of chronic diseases [classified by Medical Dictionary for Regulatory Activities (MedDRA) Primary System Organ Class and Preferred Term] and number of pregnancies and pregnancy outcomes over the 48 months of follow-up (total vaccinated cohort)

		Age group, n (%)
Safety outcome		15–25 years (N = 229)	26–45 years (N = 226)	46–55 years (N = 211)
Medically significant AEs		28 (12.2)	36 (15.9)	32 (15.2)
SAEs		6 (2.6)	8 (3.5)	11 (5.2)
Fatal SAEs†		0 (0.0)	0 (0.0)	2 (0.9)
NOCDs		6 (2.6)	4 (1.8)	2 (0.9)
Pregnancies	Total	22	30	1
	Normal infant	20	22	1
	Premature birth	1	1*	-
	Spontaneous abortion/miscarriage	1	6	-
	Elective termination	-	1	-

AE, adverse event; SAE, serious adverse event; NOCD, new onset of chronic disease; n, number of events. N, number of subjects per age group in the total vaccinated cohort.

* Subject gave birth to a female infant diagnosed with a congenital anomaly: an open ductus Botalli and an aneurysm of the aortic arch.

† 2 fatal SAEs reported (1 suicide, 1 road accident), both considered by the investigator to be unrelated to vaccination.

Harper DM, Franco EL, Wheeler CM, Moscicki AB, Romanowski B, Roteli-Martins CM, et al. Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial. Lancet 2006; 367:1247 - 1255

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