Comparison of the immunogenicity of Cervarix^® and Gardasil^® human papillomavirus vaccines for oncogenic non-vaccine serotypes HPV-31, HPV-33, and HPV-45 in HIV-infected adults

Figures & data

Table 1. Baseline HPV serostatus and HPV-DNA status at time of inclusion in the study

Characteristic	Cervarix® group (n = 45)	Gardasil® group (n = 46)
HPV serostatus and HPV DNA status^a
HPV-31
Seronegative, HPV DNA negative	12 (28)	14 (32)
Seronegative, HPV DNA positive	0	0
Seropositive, HPV DNA negative	27 (63)	24 (56)
Seropositive, HPV DNA positive	4 (9)	5 (12)
HPV-33
Seronegative, HPV DNA negative	18 (42)	22 (51)
Seronegative, HPV DNA positive	0	0
Seropositive, HPV DNA negative	21 (49)	19 (44)
Seropositive, HPV DNA positive	4 (9)	2 (5)
HPV-45
Seronegative, HPV DNA negative	22 (51)	26 (60)
Seronegative, HPV DNA positive	0	0
Seropositive, HPV DNA negative	20 (47)	15 (35)
Seropositive, HPV DNA positive	1 (2)	2 (5)

Data are no. (%) of patients. HPV, human papillomavirus. Two participants in the Cervarix® group and 3 participants in the Gardasil® group with inconclusive baseline HPV DNA status are not included.

Table 2. Geometric mean antibody titers (GMTs) and GMT ratios according to baseline seropositivity and anogenital human papillomavirus (HPV)

HPV-type	Baseline HPV sero- and DNA status	Month	Cervarix® group		Gardasil group®		GMT ratio	(95% CI)
			No.	GMT (95% CI)	No.	GMT (95% CI)
HPV-31	Seronegative, HPV-DNA negative	0	12	40	14	40	1
		7	12	214 (67–685)	14	139 (55–351)	1.55	(0.38–6.21)
		12	12	91 (42–196)	14	63 (41–98)	1.44	(0.64–3.22)
	Seropositive, HPV-DNA negative	0	27	166 (96–286)	24	156 (78–313)	1.06	(0.45–2.50)
		7	26	778 (421–1438)	24	1465 (575–3729)	0.53	(0.18–1.55)
		12	26	396 (219–716)	23	497 (182–1356)	0.80	(0.26–2.40)
	Seropositive, HPV-DNA positive	0	4	765^a	5	498^a	^b
		7	4	6071	5	520
		12	4	2849	5	876
HPV-33	Seronegative, HPV-DNA negative	0	18	40	22	40	1
		7	18	77 (48–122)	22	68 (44–105)	1.13	(0.61–2.10)
		12	18	64 (43–95)	21	54 (41–72)	1.18	(0.74–1.87)
	Seropositive, HPV-DNA negative	0	21	140 (72–271)	19	165 (81–338)	0.85	(0.33–2.16)
		7	20	420 (201–880)	19	526 (156–1771)	0.80	(0.21–3.10)
		12	20	235 (111–500)	19	400 (146–1091)	0.59	(0.18–1.96)
	Seropositive, HPV-DNA positive	0	4	659^a	2	470^a	^b
		7	4	801	2	1088
		12	4	242	2	615
HPV-45	Seronegative, HPV-DNA negative	0	22	40	26	40	1
		7	22	110 (71–172)	26	67 (49–91)	1.65	(0.98–2.77)
		12	22	51 (43–61)	25	51 (41–64)	1.00	(0.76–1.32)
	Seropositive, HPV-DNA negative	0	20	183 (96–348)	15	150 (83–273)	1.22	(0.51–2.92)
		7	19	576 (279–1189)	15	404 (232–703)	1.43	(0.57–3.58)
		12	19	299 (165–542)	15	239 (136–422)	1.25	(0.56–2.80)
	Seropositive, HPV-DNA positive	0	1	42^a	2	193^a	^b
		7	1	78	2	675
		12	1	40	2	118

GMT, geometric mean antibody titer computed using the log₁₀ transformation of titers; GMT ratio, Cervarix^® GMT divided by Gardasil^® GMT; CI, Confidence Interval. Two participants in the Cervarix® group and 3 participants in the Gardasil® group with inconclusive baseline HPV-DNA status are not included in Table 2. No participants were baseline seronegative and HPV-DNA positive for either HPV-type, hence the Seronegative, HPV-DNA positive groups are omitted from Table 2. ^aCIs not reported for subgroups with <5 participants. ^bGMTs not calculated if one or more subgroups <5 participants.

Figure 1. Seropositivity rates for neutralizing anti-HPV-31, -33, and -45 antibodies in baseline HPV-negative cohorts. Seropositivity rates for neutralizing anti-HPV-31, -33, and -45 antibodies measured by Pseudovirion-based neutralization assay at months 7 and 12. (HPV-negative cohorts, seronegative, and DNA-negative at baseline for HPV type analyzed). N, number of evaluable subjects; n, number of seropositive subjects, per vaccine, per timepoint. Percentages indicate seropositivity rates at each timepoint (seropositivity defined as PBNA ED₅₀ > 40). HPV, human papillomavirus; GMTs, geometric mean titers.

Figure 2. Gender-specific geometric mean titers (GMTs) and seropositivity rates for neutralizing anti-HPV-31, -33, and -45 antibodies in baseline HPV-negative cohorts. (A) Gender-specific geometric mean antibody titer computed using the log₁₀ transformation of titers as measured by Pseudovirion-based neutralization assay at months 7 and 12. (HPV-negative cohorts, seronegative, and DNA-negative at baseline for HPV type analyzed). N, number of evaluable subjects. *P < 0.05, **P < 0.001. HPV, human papillomavirus; GMTs, geometric mean titers. (B) Gender-specific seropositivity rates for neutralizing anti-HPV-31, -33, and -45 antibodies measured by Pseudovirion-based neutralization assay at months 7 and 12. (HPV-negative cohorts, seronegative, and DNA-negative at baseline for HPV type analyzed). N, number of evaluable subjects; n, number of seropositive subjects, per gender, per timepoint. Percentages indicate seropositivity rates at each timepoint (seropositivity defined as PBNA ED₅₀ > 40). HPV, human papillomavirus; GMTs, geometric mean titers.

Table 3. Week 28 human papillomavirus (HPV) DNA at 7 mo, according to baseline results

7 mo result	Cervarix® group	Gardasil® group
	Proportion (%) of participants	Proportion (%) of participants
HPV 31 DNA detected at 7 mo
All	4/39 (10)	4/41 (10)
Persistent infection	3/39 (8)	3/41 (7)
Incident infection	1/39 (3)	1/41 (2)
HPV 33 DNA detected at 7 mo
All	3/39 (8)	3/41 (7)
Persistent infection	2/39 (5)	1/41 (2)
Incident infection	1/39 (3)	2/41 (5)
HPV 45 DNA detected at 7 mo
All	1/39 (3)	0/41
Persistent infection	0/39
Incident infection	1/39 (3)

Results presented for those with known baseline HPV-DNA status. Six HPV-DNA tests were either missing or inconclusive at 7 mo. Persistent infection is the number with DNA detected at 7 mo among those with DNA of the same type detected at study entry. Incident infection is the number with DNA detected at 7 mo among those with DNA of that type not detected at entry.