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Single-dose Live Oral Cholera Vaccine CVD 103-HgR Protects Against Human Experimental Infection With Vibrio cholerae O1 El Tor
No licensed cholera vaccine is presently available in the United States. Cholera vaccines available in other countries require 2 spaced doses. A single-dose cholera vaccine that can rapidly protect short-notice travelers to high-risk areas and help control explosive outbreaks where logistics render 2-dose immunization regimens impractical would be a major advance.PXVX0200, based on live attenuated Vibrio cholerae O1 classical Inaba vaccine strain CVD 103-HgR, elicits seroconversion of vibriocidal antibodies (a correlate of protection) within 10 days of a single oral dose. We investigated the protection conferred by this vaccine in a human cholera challenge model.
Consenting healthy adult volunteers, 18-45 years old, were randomly allocated 1:1 to receive 1 oral dose of vaccine (approximately 5 × 10(8) colony-forming units [CFU]) or placebo in double-blind fashion. Volunteers ingested approximately 1 × 10(5) CFU of wild-type V. cholerae O1 El Tor Inaba strain N16961 10 days or 3 months after vaccination and were observed on an inpatient research ward for stool output measurement and management of hydration.
The vaccine was well tolerated, with no difference in adverse event frequency among 95 vaccinees vs 102 placebo recipients. The primary endpoint, moderate (≥3.0 L) to severe (≥5.0 L) diarrheal purge, occurred in 39 of 66 (59.1%) placebo controls but only 2 of 35 (5.7%) vaccinees at 10 days (vaccine efficacy, 90.3%; P < .0001) and 4 of 33 (12.1%) vaccinees at 3 months (vaccine efficacy, 79.5%; P < .0001).
The significant vaccine efficacy documented 10 days and 3 months after 1 oral dose of PXVX0200 supports further development as a single-dose cholera vaccine.
NCT01895855.
Journal Article
Epidemics, empire, and environments : cholera in Madras and Quebec City, 1818-1910
\"Throughout the nineteenth century, cholera was a global scourge against human populations. Practitioners had little success in mitigating the symptoms of the disease, and its causes were bitterly disputed. What experts did agree on was that the environment played a crucial role in the sites where outbreaks occurred. In this book, Michael Zeheter offers a probing case study of the environmental changes made to fight cholera in two markedly different British colonies: Madras in India and Quebec City in Canada. The colonial state in Quebec aimed to emulate British precedent and develop similar institutions that allowed authorities to prevent cholera by imposing quarantines and controlling the disease through comprehensive change to the urban environment and sanitary improvements. In Madras, however, the provincial government sought to exploit the colony for profit and was reluctant to commit its resources to measures against cholera that would alienate the city's inhabitants. It was only in 1857, after concern rose in Britain over the health of its troops in India, that a civilizing mission of sanitary improvement was begun. As Zeheter shows, complex political and economic factors came to bear on the reshaping of each colony's environment and the urgency placed on disease control\"-- Provided by publisher.
Book
Efficacy and safety of a modified killed-whole-cell oral cholera vaccine in India: an interim analysis of a cluster-randomised, double-blind, placebo-controlled trial
Oral cholera vaccines consisting of killed whole cells have been available for many years, but they have not been used extensively in populations with endemic disease. An inexpensive, locally produced oral killed-whole-cell vaccine has been used in high-risk areas in Vietnam. To expand the use of this vaccine, it was modified to comply with WHO standards. We assessed the efficacy and safety of this modified vaccine in a population with endemic cholera.
In this double-blind trial, 107 774 non-pregnant residents of Kolkata, India, aged 1 year or older, were cluster-randomised by dwelling to receive two doses of either modified killed-whole-cell cholera vaccine (n=52 212; 1966 clusters) or heat-killed
Escherichia coli K12 placebo (n=55 562; 1967 clusters), both delivered orally. Randomisation was done by computer-generated sequence in blocks of four. The primary endpoint was prevention of episodes of culture-confirmed
Vibrio cholerae O1 diarrhoea severe enough for the patient to seek treatment in a health-care facility. We undertook an interim, per-protocol analysis at 2 years of follow-up that included individuals who received two completely ingested doses of vaccine or placebo. We assessed first episodes of cholera that occurred between 14 days and 730 days after receipt of the second dose. This study is registered with
ClinicalTrials.gov, number
NCT00289224.
31 932 participants assigned to vaccine (1721 clusters) and 34 968 assigned to placebo (1757 clusters) received two doses of study treatment. There were 20 episodes of cholera in the vaccine group and 68 episodes in the placebo group (protective efficacy 67%; one-tailed 99% CI, lower bound 35%, p<0·0001). The vaccine protected individuals in age-groups 1·0–4·9 years, 5·0–14·9 years, and 15 years and older, and protective efficacy did not differ significantly between age-groups (p=0·28). We recorded no vaccine-related serious adverse events.
This modified killed-whole-cell oral vaccine, compliant with WHO standards, is safe, provides protection against clinically significant cholera in an endemic setting, and can be used in children aged 1·0–4·9 years, who are at highest risk of developing cholera in endemic settings.
Bill & Melinda Gates Foundation, Swedish International Development Cooperation Agency, Governments of South Korea, Sweden, and Kuwait.
Journal Article
Africa in the time of cholera : a history of pandemics from 1817 to the present
\"This book combines evidence from natural and social sciences to examine the impact on Africa of seven cholera pandemics since 1817\"--Provided by publisher.
Book
5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India: a cluster-randomised, double-blind, placebo-controlled trial
Efficacy and safety of a two-dose regimen of bivalent killed whole-cell oral cholera vaccine (Shantha Biotechnics, Hyderabad, India) to 3 years is established, but long-term efficacy is not. We aimed to assess protective efficacy up to 5 years in a slum area of Kolkata, India.
In our double-blind, cluster-randomised, placebo-controlled trial, we assessed incidence of cholera in non-pregnant individuals older than 1 year residing in 3933 dwellings (clusters) in Kolkata, India. We randomly allocated participants, by dwelling, to receive two oral doses of modified killed bivalent whole-cell cholera vaccine or heat-killed Escherichia coli K12 placebo, 14 days apart. Randomisation was done by use of a computer-generated sequence in blocks of four. The primary endpoint was prevention of episodes of culture-confirmed Vibrio cholerae O1 diarrhoea severe enough for patients to seek treatment in a health-care facility. We identified culture-confirmed cholera cases among participants seeking treatment for diarrhoea at a study clinic or government hospital between 14 days and 1825 days after receipt of the second dose. We assessed vaccine protection in a per-protocol population of participants who had completely ingested two doses of assigned study treatment.
69 of 31 932 recipients of vaccine and 219 of 34 968 recipients of placebo developed cholera during 5 year follow-up (incidence 2·2 per 1000 in the vaccine group and 6·3 per 1000 in the placebo group). Cumulative protective efficacy of the vaccine at 5 years was 65% (95% CI 52–74; p<0·0001), and point estimates by year of follow-up suggested no evidence of decline in protective efficacy.
Sustained protection for 5 years at the level we reported has not been noted previously with other oral cholera vaccines. Established long-term efficacy of this vaccine could assist policy makers formulate rational vaccination strategies to reduce overall cholera burden in endemic settings.
Bill & Melinda Gates Foundation and the governments of South Korea and Sweden.
Journal Article
Evidence! : how Dr. John Snow solved the mystery of cholera
\"The story of Dr. John Snow, who traced London's cholera outbreak to a single water pump\"-- Provided by publisher.
Book
A double-blind, randomised phase III clinical trial to evaluate safety, immunogenicity, non-inferiority & lot to lot consistency of single component oral cholera vaccine BBV131 (Hillchol®) in comparison to Shanchol
Cholera is a vaccine-preventable disease that has faced a surge in outbreaks and a shortage of vaccines. The new generation oral cholera vaccine (OCV) BBV131, featuring a simplified single stable O1 Hikojima strain, aims to enhance production efficiency and affordability. This study evaluates BBV131's immune profile, safety, and non-inferiority compared to Shanchol™ in healthy adults and children. Adding BBV131 to the vaccine stockpile could improve supply, simplify logistics, and ease administration efforts.
In this randomised, modified, double-blind, multi-centre, phase III trial, 1800 participants were recruited across 10 clinical trial sites across India. Participants were stratified into three age groups (adults >18 years, children ≥5 to <18 years, and infants ≥1 to <5 years) and were randomised in a 3:1 ratio to receive either BBV131 or Shanchol™. All participants received two doses of the vaccine orally on days 0 and 14. Immunogenicity was assessed through blood samples collected at baseline, two weeks after each dose, and follow-ups at days 28, 56, 90, and 180. The primary endpoint focused on the proportion of participants achieving >4-fold increase in vibriocidal antibody titres against Ogawa and Inaba serotypes 14 days post two doses. While secondary endpoints included Geometric Mean Titre (GMT) measurements and safety. Safety was evaluated throughout the study, reporting solicited and unsolicited adverse events (AEs). Another cohort of 1800 was added to the above study as an addendum to expand the safety database.
Of the 1800 enrolled participants, 1794 completed the study. Post-vaccination, the percentage of participants in the BBV131 group who exhibited a > 4-fold increase in anti-V. cholerae antibody titres were 68.25 % for Ogawa and 69.52 % for Inaba—demonstrating non-inferiority to Shanchol™, with a lower limit of 95 % CI above the non-inferiority margin. The safety profile revealed 257 AEs among 236 participants (13.1 %), with similar incidence across age groups and between vaccines; common AEs included dry mouth and headache.
The findings indicate that BBV131 demonstrates non-inferior immunogenicity and comparable safety to Shanchol™ in healthy Indian adults and children, supporting its potential as an effective OCV. Clinical Trial Registration: CTRI/2022/01/039734.
Journal Article