Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety.

BACKGROUND AND OBJECTIVES: The 9-valent human papillomavirus (9vHPV) vaccine Phase III immunogenicity study in 9- to 15-year-old boys and girls was extended to assess immunogenicity and effectiveness through 10 years after the last vaccine dose (NCT00943722). METHODS: Boys (n = 301) and girls (n = 971) who received three 9vHPV vaccine doses in the base study (day 1, months 2 and 6) enrolled in the extension. Serum was collected through month 126 for antibody assessments by competitive Luminex immunoassay and immunoglobulin G-Luminex immunoassay. For effectiveness analysis starting at age 16 years, genital swabs were collected (to assess HPV DNA by polymerase chain reaction) and external genital examinations conducted every 6 months. Primary analyses were conducted in per-protocol populations. RESULTS: Geometric mean antibody titers peaked around month 7, decreased sharply between months 7 and 12, then gradually through month 126. Seropositivity rates remained ≥81% by competitive Luminex immunoassay and ≥95% by immunoglobin G-Luminex immunoassay at month 126 for each 9vHPV vaccine type. After up to 11.0 (median 10.0) years of follow-up postdose 3, there were no cases of HPV6/11/16/18/31/33/45/52/58-related high-grade intraepithelial neoplasia or condyloma in males or females. Incidence rates of HPV6/11/16/18/31/33/45/52/58-related 6-month persistent infection in males and females were low (54.6 and 52.4 per 10000 person-years, respectively) and within ranges expected in vaccinated cohorts, based on previous human papillomavirus vaccine efficacy trials. CONCLUSIONS: The 9vHPV vaccine demonstrated sustained immunogenicity and effectiveness through ∼10 years post 3 doses of 9vHPV vaccination of boys and girls aged 9 to 15 years.

Shift in body fat distribution from lower body to upper body among urban Colombian women, 1988-1989 to 2007-2008.

OBJECTIVE: Body fat distribution may be a stronger predictor of metabolic risk than BMI. Yet, few studies have investigated secular changes in body fat distribution in middle-income countries or how those changes vary by socioeconomic status (SES). This study evaluated changes in body fat distribution by SES in Colombia, a middle-income country where BMI is increasing rapidly. DESIGN: We applied factor analysis to previously published data to assess secular changes in adiposity and body fat distribution in cross-sectional samples of urban Colombian women. Anthropometry was used to assess weight, height and skinfolds (biceps, triceps, subscapular, suprailiac, thigh, calf). SETTING: Cali, Colombia. PARTICIPANTS: Women (18-44 years) in 1988-1989 (n 1533) and 2007-2009 (n 577) from three SES groups. RESULTS: We identified an overall adiposity factor, which increased between 1988-1989 and 2007-2008 in all SES groups, particularly in the middle SES group. We also identified arm, leg and trunk adiposity factors. In all SES groups, leg adiposity decreased, while trunk and arm adiposity increased. CONCLUSIONS: Factor analysis highlighted three trends that were not readily visible in BMI data and variable-by-variable analysis of skinfolds: (i) overall adiposity increased between time periods in all SES groups; (ii) the adiposity increase was driven by a shift from lower body to upper body; (iii) the adiposity increase was greatest in the middle SES group. Factor analysis provided novel insights into secular changes and socioeconomic variation in body fat distribution during a period of rapid economic development in a middle-income country.

Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women.

BACKGROUND: A 9-valent human papillomavirus (HPV6/11/16/18/31/33/45/52/58; 9vHPV) vaccine was developed to expand coverage of the previously developed quadrivalent (HPV6/11/16/18; qHPV) vaccine. METHODS: Efficacy, immunogenicity, and safety outcomes were assessed in Latin American participants enrolled in 2 international studies of the 9vHPV vaccine, including a randomized, double-blinded, controlled with qHPV vaccine, efficacy, immunogenicity, and safety study in young women aged 16-26 years, and an immunogenicity and safety study in girls and boys aged 9-15 years. Participants (N=5312) received vaccination at Day 1, Month 2, and Month 6. Gynecological swabs were collected regularly in young women for cytological and HPV DNA testing. Serum was analyzed for HPV antibodies in all participants. Adverse events (AEs) were also monitored in all participants. RESULTS: The 9vHPV vaccine prevented HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical, vulvar, and vaginal dysplasia with 92.3% efficacy (95% confidence interval 54.4, 99.6). Anti-HPV6, 11, 16, and 18 geometric mean titers at Month 7 were similar in the 9vHPV and qHPV vaccination groups. Anti-HPV antibody responses following vaccination were higher among girls and boys than in young women. Most (>99%) 9vHPV vaccine recipients seroconverted for all 9 HPV types at Month 7. Antibody responses to the 9 HPV types persisted over 5 years. The most common AEs were injection-site related, mostly of mild to moderate intensity. CONCLUSIONS: The 9vHPV vaccine is efficacious, immunogenic, and well tolerated in Latin American young women, girls, and boys. These data support 9vHPV vaccination programs in Latin America, a region with substantial cervical cancer burden.

Local trends in diet in urban Colombia, 1990-1995 to 2008: little evidence of a nutrition transition among low-income women.

OBJECTIVES: To quantify changes in the diets of low-income women in Cali, Colombia between 1990-1995 and 2008, a period of increases in body size, and to situate these changes within national-level trends in food availability, as well as to compare these changes with those expected in countries undergoing a nutrition transition. METHODS: Individual dietary intake was assessed via 24-hour recalls in both 1990-1995 (n = 85) and 2008 (n = 88). Dietary data were analyzed for intake of energy, macronutrients, and specific food items. National-level trends in food availability were evaluated using data from the Food and Agriculture Organization. RESULTS: Total energy and protein intake did not change over time, but in 2008 women consumed proportionally more fat (23.0 vs. 19.1% of calories; P = 0.002) and less carbohydrate (66.5 vs. 71.0% of calories; P < 0.001) than in 1990-1995. The increased fat consumption is attributable to vegetable oils. This increase in vegetable oil consumption, and a decrease in starchy vegetable consumption, fit with both national-level trends in food supply, and the expectations of a nutrition transition. On the other hand, the increased consumption of non-starchy vegetables, and the stability in consumption of added sugars and animal-source proteins was contrary to the expectations of a nutrition transition. CONCLUSIONS: The changes in diet among low-income women in Cali, Colombia between 1990-1995 and 2008 partially match national-level trends in food supply and the theoretical expectations of a nutrition transition, but are nonetheless a localized phenomenon. They do not help explain concurrent changes in body size.

Stable isotopes (carbon, nitrogen, sulfur), diet, and anthropometry in urban Colombian women: investigating socioeconomic differences.

OBJECTIVES: We conducted stable isotope and dietary analyses of women from higher and lower socioeconomic status (SES) groups in Cali, Colombia. The objectives were to test between-group differences in stable isotope, dietary, and anthropometric characteristics, and to evaluate relationships between diet and stable isotope values. METHODS: Hair samples from 38 women (mean age 33.4) from higher and lower SES groups were analyzed for δ(13) C, δ(15) N, and δ(34) S values. Dietary intake was assessed via 24-h recalls. Anthropometric variables measured were body mass index, five body circumferences, and six skinfold thicknesses. RESULTS: Mean δ(13) C and δ(15) N values of the higher SES group (-16.4 and 10.3‰) were significantly greater than those of the lower SES group (-17.2 and 9.6‰; P < 0.01), but mean δ(34) S values did not differ significantly between groups (higher SES: 4.6‰; lower SES: 5.1‰). The higher SES group consumed a greater percentage of protein than the lower SES group (14% vs. 12% of energy; P = 0.03), but the groups did not differ in other dietary characteristics or in anthropometric characteristics. δ(13) C, δ(15) N, and δ(34) S values were not correlated with intake of the dietary items predicted (sugars, animal-source protein, and marine foods, respectively). The lower SES group was more variable in all three stable isotope values (P < 0.05), mirroring a trend toward greater dietary variability in this group. CONCLUSIONS: Stable isotope values revealed a difference between SES groups that was not explained by the dietary data. The relationship between diet and stable isotope composition is complex.

Exploring the multidimensionality of stature variation in the past through comparisons of archaeological and living populations.

Adult stature variation is commonly attributed to differential stress-levels during development. However, due to selective mortality and heterogeneous frailty, a population's tall stature may be more indicative of high selective pressures than of positive life conditions. This article examines stature in a biocultural context and draws parallels between bioarchaeological and living populations to explore the multidimensionality of stature variation in the past. This study investigates: 1) stature differences between archaeological populations exposed to low or high stress (inferred from skeletal indicators); 2) similarities in growth retardation patterns between archaeological and living groups; and 3) the apportionment of variance in growth outcomes at the regional level in archaeological and living populations. Anatomical stature estimates were examined in relation to skeletal stress indicators (cribra orbitalia, porotic hyperostosis, linear enamel hypoplasia) in two medieval bioarchaeological populations. Stature and biocultural information were gathered for comparative living samples from South America. Results indicate 1) significant (P < 0.01) differences in stature between groups exposed to different levels of skeletal stress; 2) greater prevalence of stunting among living groups, with similar patterns in socially stratified archaeological and modern groups; and 3) a degree of regional variance in growth outcomes consistent with that observed for highly selected traits. The relationship between early stress and growth is confounded by several factors-including catch-up growth, cultural buffering, and social inequality. The interpretations of early life conditions based on the relationship between stress and stature should be advanced with caution.

Clinical characteristics and HPV type in recurrent respiratory papillomatosis in Colombia.

OBJECTIVE: Describe factors associated with aggressive forms of recurrent respiratory papillomatosis (RRP). MATERIALS AND METHODS: One hundred eighty-nine RRP cases diagnosed between 1985 and 2009 were identified in pathological records. HPV was detected by the SPF-10 method with broad spectrum primers, (version 1). RESULTS: 113 patients had only one surgery (less aggressive) and 76, two or more interventions (more aggressive). The likelihood of aggressive lesions decreased with increasing age at diagnosis and HPV-11 was associated with no significant increase in the risk of aggressiveness. CONCLUSIONS: The age at diagnosis was the main determinant of RRP aggressiveness.

Clinical characteristics and HPV type in recurrent respiratory papillomatosis in Colombia / Características clínicas y genotipo de VPH en papilomatosis respiratoria recurrente en Colombia

Objective. Describe factors associated with aggressive forms of recurrent respiratory papillomatosis (RRP). Materials and methods. One hundred eighty-nine RRP cases diagnosed between 1985 and 2009 were identified in pathological records. HPV was detected by the SPF-10 method with broad spectrum primers, (version 1). Results. 113 patients had only one surgery (less aggressive) and 76, two or more interventions (more aggressive). The likelihood of aggressive lesions decreased with increasing age at diagnosis and HPV-11 was associated with no significant increase in the risk of aggressiveness. Conclusions. The age at diagnosis was the main determinant of RRP aggressiveness.

Objetivo. Describir factores asociados con formas agresivas de papilomatosis respiratoria recurrente (PRR). Material y métodos. Se identificaron 189 casos de PRR diagnosticados entre 1985-2009 en registros patológicos. VPH fue detectado por el método SPF-10 con cebadores de amplio espectro, (versión 1). Resultados. 113 casos presentaron una intervención quirúrgica (menos agresivas) y 76, dos o más intervenciones (más agresivas). La probabilidad de lesiones agresivas disminuyó con el aumento de la edad al momento del diagnóstico y el VPH-11 se asoció con aumento no significativo del riesgo de agresividad. Conclusiones. La edad al momento del diagnóstico fue el principal determinante de la agresividad de PRR.

Socioeconomic status, stature, and obesity in women: 20-year trends in urban Colombia.

OBJECTIVES: Ongoing social and economic changes in developing countries are associated with increases in body size, and most notably increases in the prevalence of obesity. The social patterning of these changes in terms of socioeconomic status (SES) is not well documented. The aim of this study was to assess the changes in stature, body mass index (BMI) and fatness in adult women in urban Cali, Colombia between 1988-1989 and 2007-2008. METHODS: We compared the results of anthropometric surveys completed in 1988-1989 and 2007-2008 of nonpregnant, nonlactating women, 18-44 years of age. Samples in both studies were stratified by SES. We calculated age-standardized prevalence rates to assess time trends in obesity. Body fatness was assessed by skinfold thicknesses. RESULTS: Stature increased in all SES groups and remained positively associated with SES. BMI increased only in the lower SES group, from 24.4 to 25.9 kg/m(2) and remained negatively associated with SES. The age-standardized prevalence of obesity increased from 7.9 to 17.0% in the lower SES group, but only from 4.5 to 8.2% in the middle SES group, and was unchanged in the upper SES group. Body fatness increased in all SES groups, but only in the upper body. CONCLUSION: The increased stature in all SES groups is indicative of general improvements in socioeconomic conditions. The increased prevalence of obesity in the lower SES groups is in keeping with the findings in other middle-income developing countries.

Effects of a new Helicobacter pylori infection on height and weight in Colombian children.

PURPOSE: The aim of the study is to investigate whether a new infection caused by Helicobacter pylori in preschool children transiently or permanently affects height and weight. METHODS: A cohort of 347 children from three day care centers was followed up for a median of 494 days. Breath tests and anthropometric measurements were performed every 2 to 4 months. The lag effect of a new infection on linear growth during a period of 8 months was analyzed by using mixed-effects models. RESULTS: One hundred five children (30.3%) became infected during the follow-up period and accumulated 92 person-years of follow-up. A significant decrease in growth velocity was observed during the first 4 months after infection. There was no height catch-up in infected children, and after 8 months, an infected child had a cumulative difference of 0.24 cm (growth velocity; 95% confidence interval, 0.22-0.26) compared with an uninfected child. Newly infected children experienced a small decrease in weight at the first visit compared with uninfected children, which became nonsignificant after the second visit without catch-up. CONCLUSIONS: This study shows a significant and nontransient effect of infection caused by H. pylori on height and weight. Potential interventions that target infected preschool children are likely to prevent growth retardation.

Anthropometric characteristics of pregnant women in Cali, Colombia and relationship to birth weight.

Anthropometric dimensions were collected from 46 pregnant women living in Cali, Colombia to gain a better understanding of how poor, urban women deal with the demands of pregnancy and to identify relationships between maternal characteristics and infant birth weight. Height, weight, skinfold thicknesses (subscapular, suprailiac, thigh, calf, and triceps), and circumferences (hip, thigh, calf, and mid-upper arm) were measured on all women. Infant measurements were weight and length. The women were measured in the second and third trimesters, and a subsample (n = 16) was measured twice in the third trimester. Mean birth weight was 3,137.6 +/- 488.5 g (n = 44), and mean length was 49.8 +/- 3.0 cm. All but three of the infants were full-term, and the incidence of low birth weight (LBW) was 9%. The 46 women showed a significant increase in weight (P < 0.001); subscapular, suprailiac, and mid-thigh skinfold thicknesses (P < or = 0.01) and in hip, thigh, and calf circumferences (P < or = 0.01) between trimesters 2 and 3. Women who gave birth to both normal birth weight (NBW) and LBW infants showed significant increases in weight (P < 0.001 and P = 0.02, respectively), but only women who had NBW infants showed significant increases in the suprailiac skinfold and hip circumference (P < 0.001). In the third trimester, attained weight, skinfold thicknesses, and circumferences tended to be greater in women who had NBW infants. In general, this group of women gained less weight and had a greater incidence of LBW infants compared with women in developed countries, but changes in skinfold thicknesses over the course of pregnancy were similar compared with other studies.

Food and macronutrient intake of economically disadvantaged pregnant women in Colombia.

The objective of this article is to assess changes in diet composition, defined in terms of macronutrient intake and types of foods consumed, in pregnancy in poor urban women in Colombia. The subjects were 20 pregnant and 20 matched nonpregnant, nonlactating (NPNL) women 19 to 35 years of age. The pregnant women were studied in three measurement rounds at 14.0 +/- 3.6, 27 +/- 2.2, and 35 +/- 1.7 weeks gestation, and the NPNL women in three measurement rounds approximately 3 months apart. Dietary intake was obtained from estimated food records and macronutrient composition from published sources. Types of foods consumed were aggregated into 16 groups: alcohol; breads; candy; coffee, chocolate; juices; fruit; legumes; meat, fish, offal; dairy; vegetable dishes; other; rice, pasta; tubers, plantains; salads; soft drinks; and soups. Macronutrient intakes showed nonsignificant increases in pregnancy. There were no significant differences between pregnant and NPNL women, except for carbohydrate intake in late pregnancy (P = 0.03). Carbohydrate, fat, and protein provided 74%, 17%, and 12% of dietary energy, respectively, in pregnant women at baseline, and did not change significantly. Except for a decrease in fruits, the types of foods consumed did not change significantly in pregnancy. There were no between-group differences in types of foods consumed except for the greater number of fruits consumed by pregnant women at baseline (P = 0.004). We conclude that in this population there were no changes in diet composition in pregnancy, except for an increase in fruit consumption in Round 1. Am. J. Hum. Biol. 11:753-762, 1999. Copyright 1999 Wiley-Liss, Inc.

Household headship and nutritional status: Female-headed versus male/dual-headed households.

Approximately one-third of all poor urban households in Latin America are headed by females. This study compares the nutritional status of women and children from female-headed (FHH) and male/dual headed (MHH/DHH) households in economically disadvantaged neighborhoods in Cali, Colombia. Data collected included socioeconomic indicators, anthropometric dimensions, dietary intake, and interviews documenting household composition. Classification of household headship was based on the acknowledged head and the primary economic provider of the household. Of the households in this study, 81 (80%) were from MHH/DHHs and 20 (20%) from FHHs. FHHs had fewer material possessions and lived in houses made of less expensive materials compared to MHH/DHHs. However, there were no significant differences in the nutritional status of women or children in FHHs vs MHH/DHHs. Most women had BMIs within the normal range (19-29 kg/m2 ). The majority of children (95%) had weight-for-height z-scores within ±2 of the NCHS references. These results suggest that while FHHs in Cali were economically poorer, the women studied appeared to have had access to sufficient food sources for themselves and their children. Am. J. Hum. Biol. 10:699-709, 1998. © 1998 Wiley-Liss, Inc.

Comparative study of flex heart rate in colombian children and in pregnant, lactating, and non-pregnant, nonlactating women.

The heart rate (HR) value employed to separate resting and active portions of the calibration curves used to estimate energy expenditure (EE) from minute-by-minute HR recordings is called the flex-HR. The present study has characterized it, the resting HR and the average daily HR during the awake portion of the day (12-14 h) by comparing age, gender and nutritional status effects related to measured maximum oxygen consumption (V̇ O 2 max; ml/min/kg body weight)in school-aged Colombian children (145 boys and 132 girls), 6-16 years of age. The same HR variables have been individually measured in nutritionally normal, nonpregnant, nonlactating (NPNL; n = 48), pregnant (n = 26), and lactating (n = 18) women, 19-43 years of age, on three occasions separated by 3 months. In general, the flex-HR followed the differences observed in resting and average daily HRs. All three values decreased with age in children, were higher in girls than boys, and did not exhibit differences between nutritionally normal and undernourished children. All three HRs had a statistically significant negative relationship with V̇ O 2 max in boys but not in girls. NPNL and lactating women showed no significant change in the mean values of the repeated HR measurements but exhibited maximum individual differences of flex-HR of -56 to +42 beats/min. Pregnant women had higher HRs in all 3 rounds of measurement compared to NPNL subjects. The data support the generalization that the flex-HR method of estimating EE is appropriate in groups of subjects but not in individuals, and that individual calibration of subjects close to the time of application to the making of EE measurements is an important feature of its use. Am. J. Hum. Biol. 9:647-657, 1997. © Wiley-Liss, Inc.

Energy expenditures of urban Colombian girls and women.

Anthropometry, basal metabolic rate (BMR), and resting energy expenditure (RMR) measured by indirect calorimetry and total daily energy expenditure (TDEE) by the minute-by-minute heart rate (HR) method have been studied in 52 school-aged girls 6-16 years and 46 nonpregnant, nonlactating women 19-43 years of age. BMR, RMR, and TDEE increased with age in children, reaching approximate adult values by 15 years. TDEE averaged 9.29 ± 2.32 MJ/d in women 19-43 years. The ratio RMR/BMR averaged 1.27 ± 0.29 across all age groups. TDEE/BMR varied from 1.41 ± 0.28 to 1.62 ± 0.37 in the girls and averaged 1.78 ± 0.43 in adults. Application of empirical equations to estimates of BMR showed that those of Schofield gave values of +3.1% (P = 0.03) and of Henry and Rees -3.8% (P = 0.052) of measured BMR (Schofield [1985] Hum Nutr Clin Nutr 39C [Suppl 1]:5-41; Henry and Rees [1991] Eur J Clin Nutr 45:177-185). The pattern of daily energy expenditure is highly variable across age groups during the awake portion of the day (0700-2000 hours). In the averaged data of women at home, there is a gradual increase in the morning, a decline at noon, followed by some increase in the early afternoon and decline in late afternoon and early evening. © 1996 Wiley-Liss, Inc.