Safety and immunogenicity of single dose of tetanus-diphtheria (Td) vaccine among non/partially immune children against diphtheria and/or tetanus, Hyderabad, India, 2007.

In Hyderabad, India, diphtheria is common among children aged 5-19 years. On account of low coverage of diphtheria vaccine boosters recommended under the universal immunization programme, a large proportion of children were susceptible/partially immune against diphtheria and/or tetanus. We evaluated immunogenicity and safety of single dose of indigenously developed tetanus-diphtheria (Td) vaccine (diphtheria-toxoid < or =5 Lf) among 483 school children from Hyderabad aged 7-17 years and susceptible/partially immune against diphtheria and/or tetanus. Serological testing 6 weeks after vaccination indicated that vaccine was highly immunogenic with >96% sero-protected against both antigens. The immune response observed indicated a booster response to previously acquired immunity. Administration of additional dose of Td vaccine to the older school children and replacing the tetanus toxoid vaccine with Td in the school health programme would considerably reduce diphtheria burden in Hyderabad.

Colposcopically observed vascular changes in the cervix in relation to the hormonal levels and menstrual cycle.

OBJECTIVE: We assessed colposcopically observed vascular changes occurring in the cervix in relation to cyclical hormonal variation in healthy women. MATERIALS AND METHODS: Thirty women with regular menstrual cycles and willing to remain sexually abstinent during a menstrual cycle were enrolled. Colposcopy was performed during the peak of the estrogen and progesterone levels. RESULTS: The mean (+/-SD) diameter of the largest visible blood vessel differed significantly between the estrogenic phase (0.38 +/- 0.14 mm) as compared with the progestogenic phase (0.47 +/- 0.12 mm; p <.01). The blood vessels were more prominent and dense and had a well-defined outline during the progestogenic phase than the estrogenic phase; however, these differences were not statistically significant. There was borderline increase in the interleukin 8 level during the estrogenic phase. CONCLUSIONS: Physiological changes of increased vascularity of the cervix observed colposcopically during the progestogenic phase are normal. If such changes do not correspond to the menstrual cycle phase in women using vaginal microbicides in early-phase clinical trials, presence of inflammatory markers should be evaluated. Elevated interleukin 8 during the estrogenic phase needs further evaluation.

Declining HIV incidence among patients attending sexually transmitted infection clinics in Pune, India.

OBJECTIVE: A recent report suggesting declining HIV transmission rates in southern India has been based on HIV seroprevalence data to estimate HIV incidence. We analyzed HIV incidence rates among 3 cohorts (male, female non-sex worker, female sex worker [FSW]) presenting to sexually transmitted infection (STI) clinics in Pune, India over 10 years. METHODS: Between 1993 and 2002, consenting HIV-uninfected individuals were enrolled in a prospective study of the risks for HIV seroconversion. Standardized HIV incidence estimates were calculated separately for the 3 cohorts. RESULTS: HIV acquisition risk declined by more than 70% for FSWs (P = 0.02) and men (P < 0.001) attending the STI clinics. There was no significant reduction in HIV incidence among women attending STI clinics (P = 0.74). The decline in HIVacquisition risk among male patients with STIs was associated with an increase in reported condom use with recent FSW contact and a decrease in genital ulcer disease. CONCLUSIONS: We report the first direct evidence for a decline in HIV incidence rates in FSWs and male patients with STIs over time. The lack of change in HIV infection risk among non-sex worker women highlights the need for additional targeted HIV prevention interventions.

Comparison of capillary based microflurometric assay for CD4+ T cell count estimation with dual platform Flow cytometry.

The CD4+ T cell count estimation is an important monitoring tool for HIV disease progression and efficacy of anti-retroviral treatment (ART). Due to availability of ART at low cost in developing countries, quest for reliable cost effective alternative methods for CD4+ T cell count estimation has gained importance. A simple capillary-based microflurometric assay (EasyCD4 System, Guava Technology) was compared with the conventional flow cytometric assay for estimation of CD4+ T cell counts in 79 HIV infected individuals. CD4+ T cell count estimation by both the assays showed strong correlation (r = 0.938, p < 0.001, 95% CI 0.90 to 0.96). The Bland Altman plot analysis showed that the limits of variation were within agreeable limits of +/- 2SD (-161 to 129 cells/mm3). The Easy CD4 assay showed 100% sensitivity for estimating the CD4+ T cell counts < 200 cells/mm3 and < 350 cells/mm3 and 97% sensitivity to estimate CD4+ T cell count < 500 cells/mm3. The specificity ranged from 82 to 100%. The Kappa factor ranged from 0.735 for the CD4+ T cell counts < 350 cells/mm3 to 0.771 for < 500 cells/mm3 CD4+ T cell counts. The system works with a simple protocol, is easy to maintain and has low running cost. The system is compact and generates minimum amount of waste. Hence the EasyCD4 System could be applied for estimation of CD4+ T cell counts in resource poor settings.

Rate of hospitalization and inpatient care costs for HIV-1-infected patients in Pune, India.

BACKGROUND: The transition of human immunodeficiency virus (HIV) infection to acquired immune deficiency syndrome (AIDS) has begun in India, and an increase in AIDS-related hospitalizations and deaths is an anticipated challenge. We estimated the rates of hospitalization and inpatient care costs for HIV-1-infected patients. METHODS: Data were analysed on 381 HIV-1-infected persons enrolled in a HIV-1 discordant couples' cohort between September 2002 and March 2004. Inpatient care costs were extracted from select hospitals where the study patients were hospitalized and the average cost per hospitalization was calculated. RESULTS: A majority of the patients were in an advanced state of HIV-1 disease with the median CD4 counts being 207 cells/cmm (range: 4-1131 cells/cmm). In all, 63 participants who did not receive antiretroviral therapy required hospitalization, 53 due to HIV-1-related illnesses and the remaining 10 due to worsening of pre-existing conditions. The overall HIV-1-related hospitalization rate was 34.2 per 100 person-years (95% CI: 26.94-42.93). The median duration of HIV-1-related hospitalization was 10 days (range 2-48 days) and the median cost was Rs 17,464 (range: Rs 400-63,891). CONCLUSION: It is necessary to strengthen the inpatient care infrastructure and supporting diagnostic set-up, and work out economically optimized treatment algorithms for HIV-1-infected patients. Although this analysis does not cover all costs and may not be generalizable, these baseline data might be a useful reference while planning related studies accompanying the government-sponsored programme to roll out antiretroviral therapy to AIDS patients.

Comparative acceptability study of the Reality female condom and the version 4 of modified Reddy female condom in India.

OBJECTIVE: Affordable, acceptable and effective female controlled options are required worldwide for prevention of human immunodeficiency virus (HIV) infection and other sexually transmitted diseases. We carried out a comparative acceptability study of Reality and Reddy (version 4) female condoms. METHODS: Sixty eligible couples were enrolled and randomly assigned to use either Reality or Reddy condom first. They used three Reality condoms and three Reddy condoms each with at least one condom use per week. RESULTS: Reddy female condom had a significantly better acceptability than Reality condom among women who were less educated and who had not used male condom before. In spite of higher acceptability score, participants were less confident about the Reddy condom for protecting them from HIV disease or pregnancy as compared to a male condom. CONCLUSIONS: Female condoms are being introduced in India. This study has generated data that is suggestive of optimism for this female controlled option.

Cervical squamous intra-epithelial changes and human papillomavirus infection in women infected with human immunodeficiency virus in Pune, India.

In view of the dual burden of HIV infection and cervical cancers in India, this study was undertaken to estimate the prevalence of Pap smear abnormalities and human papillomavirus infection among HIV-infected women. Consecutive HIV-infected women attending voluntary counseling testing clinics were enrolled. Written informed consent, demographic information, Pap smears, cervical swabs for HPV typing and a blood sample for CD4+ cell count were collected. Treatment for opportunistic and sexually transmitted infections and reproductive tract infections was provided. Women with Pap smear abnormality were referred for further intervention. Between January 2003 and May 2004, 287 HIV-infected women were enrolled. Pap smear abnormalities were seen in 6.3% women and were more common among women aged 30 and above (P=0.042) and those who had suffered from opportunistic infections (P=0.004). In multivariate analysis, Pap smear abnormalities were associated independently with opportunistic infections (P=0.02, AOR 3.8, 95% CI 1.2--11.5). Of the 100 random cervical specimens screened for HPV 16 and 18 genotypes, 33% (95 CI 23.9--43.1) were positive for HPV 16/18. Of the 122 patients who returned for a follow-up visit, 5 patients (4.1%) who did not have Pap smear abnormality at baseline, had developed Pap smear abnormality. The incidence of Pap smear abnormalities was 5.5 per 100 person year of follow-up. In order to prevent thousands of deaths due to cervical cancer in India, there is a need for strengthening the Pap smear screening program and HPV vaccine development.