Sven-Eric Olsson

A Pooled Analysis of Continued Prophylactic Efficacy of Quadrivalent Human Papillomavirus (Types 6/11/16/18) Vaccine against High-grade Cervical and External Genital Lesions

Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18–related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or VaIN 2/3). Mean follow-up time was 42 months post dose 1. Vaccine efficacy against HPV 6/11/16/18–related high-grade cervical lesions in the per-protocol and intention-to-treat populations was 98.2% [95% confidence interval (95% CI), 93.3-99.8] and 51.5% (95% CI, 40.6-60.6), respectively. Vaccine efficacy against HPV 6/11/16/18–related high-grade vulvar and vaginal lesions in the per-protocol and intention-to-treat populations was 100.0% (95% CI, 82.6-100.0) and 79.0% (95% CI, 56.4-91.0), respectively. Efficacy in the intention-to-treat population tended to be lower in older women, women with more partners, and women with abnormal Pap test results. The efficacy of quadrivalent HPV vaccine against high-grade cervical and external anogenital neoplasia remains high through 42 months post vaccination.

Improved use of contraceptives, attitudes toward pornography, and sexual harassment among female university students

This study describes sexual behavior over a 10-year period in a female student population. The use of condoms at first coitus increased from 40% to 77%. Sexually transmitted diseases decreased from 26% to 14%, and abortions from 11% to 5.5%. One-fourth of students had had anal intercourse, and 86% had performed oral sex. Half of the women had read pornography. The majority of women with experience of oral sex graded it as positive, whereas they graded anal sex as mostly negative. Twelve percent of the women had been sexually harassed, mainly by their male peers (80%).

Anal sphincter lacerations and upright delivery postures—a risk analysis from a randomized controlled trial

ObjectiveTo evaluate obstetric sphincter lacerations after a kneeling or sitting position at second stage of labor in a multivariate risk analysis model.Materials and methodsTwo hundred and seventy-one primiparous women with normal pregnancies and spontaneous labor were randomized, 138 to a kneeling position and 133 to a sitting position. Medical data were retrieved from delivery charts and partograms. Risk factors were tested in a multivariate logistic regression model in a stepwise manner.ResultsThe trial was completed by 106 subjects in the kneeling group and 112 subjects in the sitting group. There were no significant differences with regard to duration of second stage of labor or pre-trial maternal characteristics between the two groups. Obstetrical sphincter tears did not differ significantly between the two groups but an intact perineum was more common in the kneeling group (p<0.03) and episiotomy (mediolateral) was more common in the sitting group (p<0.05). Three grade IV sphincter lacerations occurred in the sitting group compared to none in the kneeling group (NS). Multivariate risk analysis indicated that prolonged duration of second stage of labor and episiotomy were associated with an increased risk of third- or fourth-degree sphincter tears (p<0.01 and p<0.05, respectively). Delivery posture, maternal age, fetal weight, use of oxytocin, and use of epidural analgesia did not increase the risk of obstetrical anal sphincter lacerations in the two upright postures.ConclusionObstetrical anal sphincter lacerations did not differ significantly between a kneeling or sitting upright delivery posture. Episiotomy was more common after a sitting delivery posture, which may be associated with an increased risk of anal sphincter lacerations. Upright delivery postures may be encouraged in healthy women with normal, full-term pregnancy.

Baseline demographic characteristics of subjects enrolled in international quadrivalent HPV (types 6/11/16/18) vaccine clinical trials

ABSTRACT Background: In Phase II/III trials, administration of quadrivalent human papillomavirus (HPV) (types 6/11/16/18) L1 virus-like-particle vaccine was highly effective in preventing HPV6/11/16/18-related cervical intraepithelial neoplasia and non-invasive cervical cancer in women aged 16–26 years who were naïve to these HPV types at enrollment. However, the makeup and extent of catch-up vaccination programs among young women is unclear, because a proportion of this population will likely already have been exposed to one or more vaccine-HPV-types. Objective: Herein we analyze baseline data from the quadrivalent HPV vaccine clinical trial program to investigate variables which may help shape catch-up vaccine implementation policies. Methods: Female adolescents and young adults aged 16–26 years were randomized into five clinical trials. Baseline data regarding demographics, sexual history, pregnancy history, and other characteristics were collected at enrollment. At the baseline gynecological examination during enrollment, specimens were obtained for Pap testing. Swabs of external genital, lateral vaginal, and cervical sites for HPV polymerase chain reaction (PCR) testing were taken, and serum samples were obtained for HPV serology testing. Regional analyses of data were conducted. Results: Overall, 72 % of subjects enrolled worldwide were naïve by both serology and PCR to all four vaccine HPV types. Few subjects were seropositive and/or PCR positive for more than two vaccine-related HPV types. Of all subjects with HSIL at enrollment, 78 % were positive to at least one vaccine-related HPV type at enrollment. Regional differences in HPV and STD prevalence were evident. Study limitations included under-representation of women with ≥4 sexual partners and possible underestimation of prior HPV exposure. Conclusions: Our findings demonstrate that sexually active 16–26 year-old women with ≤4 life time sex partners (LSP) in North America, Europe, Latin America, and Asia Pacific are generally naïve to most or all types targeted by the quadrivalent HPV6/11/16/18 vaccine and that they are at subsequent risk for infection and disease caused by these types.

Increased use of condoms among female university students: A 5-year follow-up of sexual behavior

Objective. To ascertain any changes in sexual behavior and attitudes as an indication of the impact of intensified information activities aiming at decreasing the risk of spread of sexually transmitted diseases among university students.

Effects of specially tailored information on Swedish university students sexual behavior.

In independent surveys concerning sexual behavior among university students in Uppsala, Sweden, in 1989 and 1990, we found that condoms were infrequently used and that up to 25% of the sexually experienced students had a history of having had at least one sexually transmitted disease (STD). We targeted an information campaign toward the same students (approximately 20,000) in 1990. Our aims were (1) to increase the knowledge of STDs and alert the students to the high frequency of STDs in the student population, (2) to encourage students to have an STD checkup at the local STD clinic, and (3) to induce a positive attitude toward condoms. We evaluated the effects of the campaign, using before and after classroom surveys, a separate survey of students who attended the STD clinic, and a focus group analysis. Although the information campaign was successful, in that students became more aware of STDs and showed increased knowledge about the high frequency of STDs in their own population, fewer than 1% of the target population went for an STD checkup at the local STD clinic. Overall, the campaign was well received by the students but failed to induce any measurable changes in attitudes during the short observation period.