Analysis of the effect of the 9-valent HPV vaccine in patients with cervical cytological ASC-US combined with HR-HPV positivity

doi:10.12092/j.issn.1009-2501.2026.04.005

Abstract

Abstract:

AIM: To evaluate the effects of the nine-valent HPV vaccine on lesion progression and prognosis in patients with cervical atypical squamous cells of undetermined significance (ASC-US) combined with high-risk HPV (HR-HPV) positivity. METHODS: Using a prospective observational cohort study design, 178 eligible patients with cervical ASC-US combined with HR-HPV positivity were consecutively recruited at Wusong Hospital, affiliated to Zhongshan Hospital of Fudan University, from January 2022 to September 2024. Based on colposcopy-directed histopathology, participants were classified into a squamous intraepithelial lesion (SIL) group and a cervicitis group; the SIL group included low-grade (LSIL) and high-grade (HSIL) lesions. After completion of standard treatment, participants in each diagnostic category were randomized (1:1) to a vaccination arm or a no-vaccination (control) arm. High-risk human papillomavirus (HR-HPV) viral load and p16/Ki-67 dual-stain status were compared between arms at enrollment (baseline), 6 months, and 12 months. RESULTS: At enrollment, there were no statistically significant differences in HR-HPV viral load or p16/Ki-67 dual staining positivity rate between the vaccine and non-vaccine groups (P>0.05). At the 6-month follow-up, vaccine recipients in the SIL group exhibited significantly lower HPV16 and other 12-type HR-HPV viral loads compared to non-vaccine group (P<0.05); In the cervicitis group, vaccine recipients also had significantly lower HPV16 viral load than non-vaccine recipients (P<0.05). Moreover, the p16/Ki-67 dual staining positivity rate in the vaccine group was lower than that in the non-vaccine group (P<0.05). At the 12-month follow-up, both HR-HPV viral load and the p16/Ki-67 dual staining positivity rate in the vaccine group were significantly lower than those in the non-vaccine group, with statistically significant differences (P<0.05). CONCLUSION: Vaccination with the nine-valent HPV vaccine is an effective strategy for preventing HPV infection and can improve the prognosis in patients with cervical ASC-US and HR-HPV positivity.

Key words: HPV vaccine, ASC-US, HR-HPV, viral load, p16/Ki67

CLC Number:

Shuna TIAN, Jiayan SHI, Yaxin XING, Junhong NING, Qizhen CHEN. Analysis of the effect of the 9-valent HPV vaccine in patients with cervical cytological ASC-US combined with HR-HPV positivity[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2026, 31(4): 467-473.

Figures/Tables 7

References 30

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Influencing factors	Vaccinated group	Unvaccinated group	χ2 value	P value
Age (years)			1.65	>0.05
20-25	15	10
26-35	20	18
36-45	10	12
Parity			0.19	>0.05
≤2 times	35	30
>2 times	10	10
Number of sexual partners			1.29	>0.05
<3	40	32
≥3	5	8

Influencing factors	Vaccinated group	Unvaccinated group	χ2 value	P value
Age (years)			1.65	>0.05
20-25	15	10
26-35	20	18
36-45	10	12
Parity			0.19	>0.05
≤2 times	35	30
>2 times	10	10
Number of sexual partners			1.29	>0.05
<3	40	32
≥3	5	8

Influencing factors	Vaccinated group	Unvaccinated group	χ2 value	P value
Age (years)			1.75	>0.05
20-25	18	12
26-35	22	20
36-45	8	10
Parity			0.12	>0.05
≤2 times	35	32
>2 times	13	10
Number of sexual partners			0.16	>0.05
<3	36	33
≥3	12	9

Influencing factors	Vaccinated group	Unvaccinated group	χ2 value	P value
Age (years)			1.75	>0.05
20-25	18	12
26-35	22	20
36-45	8	10
Parity			0.12	>0.05
≤2 times	35	32
>2 times	13	10
Number of sexual partners			0.16	>0.05
<3	36	33
≥3	12	9

Time point	HPV type	Vaccinated group	Unvaccinated group	P value
At baseline
	HPV16	5.17±0.26	4.73±0.24	0.158
	HPV18	5.31±0.24	5.04±0.23	0.162
	Other 12 types	4.79±0.23	4.65±0.27	0.170
6 months later
	HPV16	4.43±0.26	5.01±0.3	0.042
	HPV18	4.58±0.25	4.02±0.26	0.068
	Other 12 types	4.31±0.27	5.16±0.24	0.040
12 months later
	HPV16	4.31±0.24	4.47±0.25	0.015
	HPV18	3.37±0.24	3.57±0.25	0.012
	Other 12 types	3.21±0.21	4.28±0.22	0.014