SummaryBackgroundAn increase in worldwide HPV vaccination could be facilitated if fewer than three doses of vaccine are as effective as three doses. We originally aimed to compare the immunogenicity and frequency of persistent infection and cervical precancerous lesions caused by vaccine-targeted HPV after vaccination with two doses of quadrivalent vaccine on days 1 and 180 or later, with three doses on days 1, 60, and 180 or later, in a cluster-randomised trial. Suspension of the recruitment and vaccination due to events unrelated to our study meant that some enrolled girls could not be vaccinated and some vaccinated girls received fewer than the planned number of vaccinations by default. As a result, we re-analysed our data as an observational cohort study.MethodsOur study was designed to be done in nine locations (188 clusters) in India. Participants were unmarried girls aged 10–18 years vaccinated in four cohorts: girls who received three doses of vaccine on days 1, 60, and 180 or later, two doses on days 1 and 180 or later, two doses on days 1 and 60 by default, and one dose by default. The primary outcomes were immunogenicity in terms of L1 genotype-specific binding antibody titres, neutralising antibody titres, and antibody avidity after vaccination for the vaccine-targeted HPV types 16, 18, 6, and 11 and incident and persistent infections with these HPVs. Analysis was per actual number of vaccine doses received. This study is registered with ISRCTN, number ISRCTN98283094; and with ClinicalTrials.gov, number NCT00923702.FindingsVaccination of eligible girls was initiated on Sept 1, 2009, and continued until April 8, 2010. Of 21 258 eligible girls identified at 188 clusters, 17 729 girls were recruited from 178 clusters before suspension. 4348 (25%) girls received three doses, 4979 (28%) received two doses on days 1 and 180 or later, 3452 (19%) received two doses at days 1 and 60, and 4950 (28%) received one dose. Immune response in the two-dose HPV vaccine group was non-inferior to the three-dose group (median fluorescence intensity ratio for HPV 16 1·12 [95% CI 1·02–1·23] and for HPV 18 1·04 [0·92–1·19]) at 7 months, but was inferior in the two-dose default (0·33 [0·29–0·38] for HPV 16 and 0·51 [0·43–0·59] for HPV 18) and one-dose default (0·09 [0·08–0·11] for HPV 16 and 0·12 [0·10–0·14] for HPV 18) groups at 18 months. The geometric mean avidity indices after fewer than three doses by design or default were non-inferior to those after three doses of vaccine. Fewer than three doses by design and default induced detectable concentrations of neutralising antibodies to all four vaccine-targeted HPV types, but at much lower concentration after one dose. Cervical samples from 2649 participants were tested and the frequency of incident HPV 16, 18, 6, and 11 infections was similar irrespective of the number of vaccine doses received. The testing of at least two samples from 838 participants showed that there was no persistent HPV 16 or 18 infections in any study group at a median follow-up of 4·7 years (IQR 4·2–...
VIA screening by primary health workers statistically significantly reduced cervical cancer mortality. Our study demonstrates the efficacy of an easily implementable strategy that could prevent 22000 cervical cancer deaths in India and 72600 deaths in resource-poor countries annually.
Cervix and Breast cancers are the most common cancers among women worldwide and extract a large toll in developing countries. In May 1998, supported by a grant from the NCI (US), the Tata Memorial Hospital, Mumbai, India, started a clusterrandomized, controlled, screening-trial for cervix and breast cancer using trained primary health workers to provide healtheducation, visual-inspection of cervix (with 4% acetic acid-VIA) and clinical breast examination (CBE) in the screening arm, and only health education in the control arm. Four rounds of screening at 2-year intervals will be followed by 8 years of monitoring for incidence and mortality from cervix and breast cancers. The methodology and interim results after three rounds of screening are presented here. Good randomization was achieved between the screening (n 5 75360) and control arms (n 5 76178). In the screening arm we see: High screening participation rates; Low attrition; Good compliance to diagnostic confirmation; Significant downstaging; Excellent treatment completion rate; Improving case fatality ratios. The ever-screened and never-screened participants in the screening arm show significant differences with reference to the variables religion, language, age, education, occupation, income and health-seeking behavior for gynecological and breast-related complaints. During the same period, in the control arm we see excellent participation rate for health education; Low attrition and a good number of symptomatic referrals for both cervix and breast.Of the estimated 470,000 new cases of cervix cancer diagnosed each year worldwide, 80% occur in developing countries and around 27% occur in India from where 126,000 new cases are diagnosed annually and over 71,000 deaths because of cervix cancer are reported each year.1,2 Nearly 70% of cervix cancer patients in India present at stages III and IV.3 Around 20% of women who develop cervix cancer die within the first year of diagnosis and the 5-year relative survival rate is 50%. 4 Breast cancer is the most common cancer among women worldwide and is also the leading cause of cancer deaths in women. Breast cancer is responsible for an estimated 189,000 and 184,000 deaths in developed and developing countries respectively thus accounting for 16% and 12% of all cancer deaths in women. Although the age-standardized incidence of breast cancer is generally lower in developing countries than in developed countries (23.1 vs. 63.2 per 100,000 women), incidence rates are seen to vary widely between and within countries. Breast cancer is already more common than cervix cancer in a number of developing countries.5 Data from developing countries suggests that age-standardized incidence rates of breast cancer are rising rapidly in low-incidence regions such as Africa and Asia. 6 There are no organized screening programmes for cervix and breast cancers in India. Cervix Cytology and Mammography based screening programmes are difficult to organize in India because of issues related to absence of trained manpower, infrastructu...
This is a review paper comprehensively encompassing the different aspects of tobacco control with particular reference to the Indian scenario. The information on prevalent tobacco habits in India, health hazards and environmental hazards due to tobacco use, passive smoking and its impact, economics of tobacco, legislation to control tobacco in India, the tobacco cessation services and the way ahead for effective tobacco control are discussed. Tobacco is a leading preventable cause of death, killing nearly six million people worldwide each year. Reversing this entirely preventable manmade epidemic should be our top priority. This global tobacco epidemic kills more people than tuberculosis, HIV/AIDS and malaria combined. This epidemic can be resolved by becoming aware of the devastating effects of tobacco, learning about the proven effective tobacco control measures, national programmes and legislation prevailing in the home country and then engaging completely to halt the epidemic to move toward a tobacco-free world. India is the second largest consumer of tobacco globally, and accounts for approximately one-sixth of the world's tobacco-related deaths. The tobacco problem in India is peculiar, with consumption of variety of smokeless and smoking forms. Understanding the tobacco problem in India, focusing more efforts on what works and investigating the impact of sociocultural diversity and cost-effectiveness of various modalities of tobacco control should be our priority.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.