Dataset Information

Prevalence and Incidence of Human Papillomavirus (HPV) Infection Before and After Pregnancy: Pooled Analysis of the Control Arms of Efficacy Trials of HPV-16/18 AS04-Adjuvanted Vaccine.

ABSTRACT: Objective:Data on human papillomavirus (HPV) prevalence around pregnancy were inconsistent. We assessed HPV prevalence before and after pregnancy, HPV incidence after pregnancy, and risk factors for HPV infection. Method:Data from 15 754 women in control arms of 5 AS04-HPV-16/18 vaccine efficacy trials were analyzed, including 3001 women with at least 1 pregnancy. Results of HPV deoxyribonucleic acid testing on cervical samples were available. We analyzed risk factors, including age, region, pregnancy and its outcomes, duration from pregnancy resolution to collection of first postresolution cervical sample, previous HPV infection, cigarette smoking, and number of sexual partners with Cox regression. Results:Prevalence of high-risk oncogenic (hr)-HPV types was similar before and after pregnancy (20.8% vs 19.8%). Incidence of hr-HPV was 40.1 per 1000 person-years (95% confidence interval [CI], 23.4-64.2) at 0-3 months, 266.7 (95% CI, 217.4-323.7) at 3-6 months, and 95.7 (95% CI, 83.9-108.7) at >6 months after pregnancy. Risk factors associated with HPV infection after pregnancy are previous HPV infection, elective abortion, and younger age at pregnancy resolution. Conclusions:Pregnancy could not be confirmed as a risk factor for HPV infection in this population despite an increased incidence detected 3-6 months after pregnancy resolution. Most women remained HPV negative after pregnancy. Clinical Trial Registration:NCT001226810 (HPV-008 trial), NCT00294047 (HPV-015 trial), NCT00316693 and NCT00929526 (HPV-032/063 trials), and NCT00779766 (HPV-039 trial).

SUBMITTER: Chen J

PROVIDER: S-EPMC6892569 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Prevalence and Incidence of Human Papillomavirus (HPV) Infection Before and After Pregnancy: Pooled Analysis of the Control Arms of Efficacy Trials of HPV-16/18 AS04-Adjuvanted Vaccine.

Chen Jing J Gopala Kusuma K Akarsh P K PK Struyf Frank F Rosillon Dominique D

Open forum infectious diseases 20191204 12

<h4>Objective</h4>Data on human papillomavirus (HPV) prevalence around pregnancy were inconsistent. We assessed HPV prevalence before and after pregnancy, HPV incidence after pregnancy, and risk factors for HPV infection.<h4>Method</h4>Data from 15 754 women in control arms of 5 AS04-HPV-16/18 vaccine efficacy trials were analyzed, including 3001 women with at least 1 pregnancy. Results of HPV deoxyribonucleic acid testing on cervical samples were available. We analyzed risk factors, including a ...[more]

PMID: 31824976

Similar Datasets

Project description:PurposeThe purpose of this study is to further evaluate the safety of the human papillomavirus (HPV)-16/18-AS04-adjuvanted vaccine (HPV-16/18-vaccine Cervarix®, GlaxoSmithKline, Belgium) through a pooled analysis of data from 42 completed/ongoing clinical studies.MethodsUnsolicited adverse events (AEs) were reported for 30 days after each dose. Medically significant conditions, serious AEs (SAEs), potential immune-mediated diseases (pIMDs) and pregnancy outcomes were captured until study completion. Events leading to subject withdrawal were reviewed. Relative risks compared incidences of spontaneous abortion and pIMDs in controlled studies.ResultsThirty one thousand one hundred seventy-three adolescent girls/women received HPV-16/18-vaccine alone (HPV group), 2166 received HPV-16/18-vaccine coadministered with another vaccine and 24 241 were controls. Mean follow-up was 39 months (range 0-113.3). Incidences of unsolicited AEs reported within 30 days after any dose were similar between HPV and Control groups (30.8%/29.7%). During the entire study period, reports of medically significant conditions (25.0%/28.3%) and SAEs (7.9%/9.3%) were also similarly distributed between groups. Deaths were rare: HPV (alone/coadministered) n = 25, controls n = 20 (n = 18 in blinded groups). pIMDs within 1 year were reported by 0.2% of HPV-16/18 vaccinees and controls. For each pIMD event category, no increased relative risks were reported for HPV-16/18 vaccinees versus controls. Coadministration did not change the overall safety profile. Pregnancy outcomes and withdrawal rates were similar between groups.ConclusionsAnalysis of safety data arising from 57 580 subjects and 96 704 HPV-16/18-vaccine doses shows that the incidences and distribution of AEs were similar among HPV-16/18-vaccine recipients and controls. No new safety signals were identified. The data confirm previous findings that HPV-16/18-vaccine has an acceptable benefit-risk profile in adolescent girls and adult women.

Dataset Information

Prevalence and Incidence of Human Papillomavirus (HPV) Infection Before and After Pregnancy: Pooled Analysis of the Control Arms of Efficacy Trials of HPV-16/18 AS04-Adjuvanted Vaccine.

Publications

Prevalence and Incidence of Human Papillomavirus (HPV) Infection Before and After Pregnancy: Pooled Analysis of the Control Arms of Efficacy Trials of HPV-16/18 AS04-Adjuvanted Vaccine.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets