Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age.

A 9-valent HPV (9vHPV) vaccine has been developed to protect against HPV type 6/11/16/18/31/33/45/52/58-related infection and disease. Previous safety analyses from 7 clinical trials conducted in 9vHPV vaccine recipients 9-26 years of age, including comparisons of 9vHPV and quadrivalent HPV (qHPV) vaccines in girls and women 16-26 years of age, showed that the 9vHPV vaccine was generally well tolerated. Additional safety analyses were conducted to include the results of new clinical studies. The safety profile of the 9vHPV vaccine in prior qHPV vaccine recipients (n = 3756 from 1 randomized controlled trial and 2 open-label extension studies) and young men (n = 248 9vHPV and n = 248 qHPV vaccine recipients from 1 randomized controlled trial) was evaluated. Vaccine was administered as a 3-dose regimen (at Day 1 and Months 2 and 6), and adverse events (AEs) were monitored. The most common AEs were injection-site events (91.1% and 79.0% in prior qHPV vaccine recipients and young men, respectively), the majority of which were mild. Discontinuations due to an AE were rare (0.2% and 0.0% among prior qHPV vaccine recipients and young men, respectively). In young men, the AE profile of the 9vHPV vaccine was generally similar to that of the qHPV vaccine. Overall, the 9vHPV vaccine was generally well tolerated in prior qHPV vaccine recipients and in young men, with an AE profile generally consistent with that previously reported with the broader clinical program.

Diversity of human papillomavirus in the anal canal of men: the HIM Study.

Human papillomavirus (HPV) infections are associated with the development of anogenital lesions in men. There are no reports describing the distribution of non-α HPV types in the anal canal of a sexually diverse group of men. The HPV Infection in Men (HIM) Study is a multicentre study on the natural history of HPV infection in Brazil, Mexico, and the USA. At baseline, 12% of anal canal PCR HPV-positive specimens were not typed by the Roche Linear Array, and were considered to be unclassified. Our goals were to characterize HPVs among these unclassified specimens at baseline, and to assess associations with participant socio-demographic and behavioural characteristics. Unclassified HPVs were typed by sequencing of amplified PGMY09/11 products or cloning of PGMY/GP + nested amplicons followed by sequencing. Further analysis was conducted with FAP primers. Of men with unclassified HPV in the anal canal, most (89.1%) were men who have sex with women. Readable sequences were produced for 62.8% of unclassified specimens, of which 75.2% were characterized HPV types. Eighteen, 26 and three different α-HPV, ß-HPV and γ-HPV types were detected, respectively. α-HPVs were more commonly detected among young men (18-30 years) than among older men (45-70 years), whereas ß-HPVs were more frequent among mid-adult men (31-44 years). ß-HPVs were more common among heterosexual men (85.0%) than among non-heterosexual men. All ß-HPVs detected among non-heterosexual men were ß2-HPV types. The high prevalence of ß-HPV in the anal canal of men who do not report receptive anal sex is suggestive of other forms of transmission that do not involve penile-anal intercourse.

Human papillomavirus prevalence at the USA-Mexico border among women 40 years of age and older.

The incidence of cervical cancer increases with age among USA Hispanics and women living in Latin America starting in the fourth decade of life. We conducted a study of women > or = 40 living at the USA-Mexico border to determine the prevalence and risk factors for human papillomavirus (HPV) infection detected by polymerase chain reaction. In all, 9.2% of participants tested HPV positive. Compared with women aged 50-59, odds ratios of 8.82 and 6.67 were observed for women > or = 60 and 40-49, respectively. Among women aged 40-49, both oncogenic and non-oncogenic HPV infections were detected; however, women > or = 60 were positive for predominantly oncogenic genotypes. HPV risk significantly increased with > or = 2 lifetime sexual partners in adjusted models. These data suggest that the prevalence of HPV infection may have a second peak among post-menopausal Hispanic women.

Chlamydial infection in women along the US-Mexico border.

Few studies have reported on sexually transmitted infections at the US-Mexico border, so the prevalence of Chlamydia trachomatis in this population remains uncertain. This binational project investigated the prevalence of, and risk factors for, C. trachomatis among women along the Arizona, US-Sonora, Mexico border. Women who self-referred for routine gynaecological care were invited to complete an interviewer-administered questionnaire and to undergo a Pap smear, C. trachomatis test, and HPV test. In 2270 women, C. trachomatis prevalence overall was 8.2% as measured by hybrid capture and 2.6% by enzyme immunoassay. Infection was associated with young age, a history of new sexual partner(s) in the previous three months, HPV infection, and proximity of clinic to the international border. Antibiotic use in the previous 30 days was associated with decreased odds of infection. Women in Arizona-Sonora border communities are at increased risk for C. trachomatis infection compared to women attending clinics in non-border locations.

Human papillomavirus infection at the United States-Mexico border: implications for cervical cancer prevention and control.

The United States-Mexico border is a region comprised of a country with one of the highest rates of invasive cervical cancer (Mexico) and a country with one of the lowest rates (United States). Recent evidence clearly indicates that human papillomavirus (HPV) infection is the cause of cervical cancer. The distribution of specific types of HPV is known to vary in different regions of the world, as do the cofactors that may inhibit or promote HPV carcinogenesis. Estimating the prevalence of oncogenic HPV is needed for guiding vaccine development. The purpose of this study was to determine the prevalence of oncogenic and nononcogenic HPV types and risk factors for HPV among women residing along the United States-Mexico border. A cross-sectional study of 2319 women, ages 15-79 years, self-referring for gynecological care was conducted between 1997 and 1998. HPV was detected by PCR using the PYGMY 09/11 L1 consensus primer, and HPV genotyping was conducted using the reverse line blot method. Overall, the HPV prevalence was 14.4% with no significant differences observed by country after adjustment for age. HPV 16 was the most commonly detected HPV type in both the United States and Mexico. Among women with high-grade squamous intraepithelial lesions, HPV types 58, 45, 51, 31, 35, 55, and 73 were most common in Mexico, and HPV types 18, 31, 35, 51, 52, and 58 were most common in the United States. In both countries, HPV prevalence declined linearly with age from 25% among women ages 15-19 years to 5.3% among women 56-65 years. Factors significantly independently associated with HPV infection were older age [adjusted odds ratio (AOR) = 0.15 for ages 56-65 years compared with those 15-19 years], a marital status other than married (AOR = 1.58-3.29), increased numbers of lifetime male partners (AOR = 3.8 for > or =10 partners compared with 1 partner), concurrent infection with Chlamydia trachomatis (AOR = 1.79), ever use of Norplant (AOR = 2.69), and current use of injectable contraceptives (AOR = 2.29). Risk factors for HPV infection did not differ by country. Results from this study suggest that in addition to HPV 16 and 18, HPV types 31, 45, 51, and 58 should be considered for inclusion in an HPV prevention vaccine for distribution in Mexico.

Design and results of the USA-Mexico border human papillomavirus (HPV), cervical dysplasia, and Chlamydia trachomatis study.

OBJECTIVE: Mexico has one of the highest mortality rates of invasive cervical cancer in the world. This is particularly true for the states in northern Mexico that border on the United States of America. In addition, Hispanics in the United States have higher rates than do non-Hispanics in the country. Therefore, a binational team was formed to focus on this problem and to determine the risk factors and prevalence of cervical dysplasia and human papillomavirus (HPV) infection, the sexually transmitted disease (STD) known to cause cervical cancer. Chlamydia trachomatis infection, a common STD and potential HPV cofactor, was also assessed. METHODS: Research was conducted in 1997 and 1998 in the border region of two states, Arizona in the United States and Sonora in Mexico, applying a cross-sectional study of women attending clinics for routine gynecologic care. Clinical measurements included Pap smears, HPV infection by both polymerase chain reaction (PCR) and Hybrid Capture (HC), and C. trachomatis status by HC and enzyme-linked immunoassay (EIA). A total of 2,436 women were enrolled (mean age 33.3 years +/- 10.3 years). RESULTS: The overall prevalence of abnormal cytology was 9.3%, with a significant difference in the prevalence in Mexico (11.4%) vs. the United States (6.6%). Of the participants, 14.5% of them tested positive for HPV by PCR, with no significant difference between the two countries, in spite of a lower behavioral risk profile for the Mexican women. Overall prevalence of C. trachomatis was found to be greater by HC than by EIA (8.2% vs. 3.0%), and in Mexico higher by both methods. CONCLUSIONS: An important accomplishment of the project was the implementation of a quality control program for Pap smear collection, which resulted in a significant reduction in inadequate smears in Mexico. Despite numerous potential logistical barriers, the binational team successfully conducted a large-scale study in the border area and developed an infrastructure for future research.

Risk factors for high-risk type human papillomavirus infection among Mexican-American women.

Minority women in the United States experience a disproportionately high burden of the more than 2 million yearly cases of squamous intraepithelial lesions of the cervix. Risk factors for squamous intraepithelial lesions of the cervix are infection with the sexually acquired human papillomavirus (HPV), an early age at first intercourse, history of multiple sexual partners, oral contraceptive use, high parity, lower socioeconomic status, poor diet, immunosuppression, and promiscuous male sexual partners. Although Hispanics are the largest growing minority population in the United States, few HPV risk factor studies have either included or focused on Hispanics in the United States. To determine risk factors for HPV infection among Mexican-American women, we conducted a cross-sectional study from 1992-1995. Nine hundred and seventy-one women, 18-47 years of age, with cytology results were included in this analysis. Overall, 13.2% of participants were HPV positive by the Hybrid Capture tube method for high-risk types 16, 18, 31, 33, 35, 45, 51, 52, or 56. Age [adjusted odds ratio (AOR) = 0.3 for ages >36 years compared with ages 18-20] and duration of oral contraceptive use (AOR = 0.4 for > or =4 years relative to nonusers) were inversely associated with these high-risk types of HPV infection. Marital status (AOR = 1.9 among single women compared with married) and lifetime number of sexual partners (AOR = 2.3 for women > or =5 partners relative to monogamous women) were positively associated with an increased risk. Participants born in Mexico were significantly (P < 0.05) older, had fewer sex partners, and older age at first intercourse. Despite this lower behavioral risk profile, women born in Mexico were significantly more likely (AOR = 1.9; CI = 1.2-3.2) to have an HPV infection compared with United States-born, Mexican-American women after adjustment for potential confounders. Collectively, these results suggest that an unmeasured factor, such as the sexual behavior of the male partner, may be influencing HPV risk. Further research is needed to define this factor and to assess cultural norms of sexual behavior.