Efficacy trial of Vi polysaccharide vaccine against typhoid fever in south-western China
To test the efficacy of locally produced Vi vaccine over a time period of longer than one year. A double-blinded, randomized field trial was performed in Guangxi Zhuang Autonomous Region in south-western China, using 30 micrograms doses of locally produced Vi. Enrolled subjects were 3-50 years of ag...
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| Published in | Bulletin of the World Health Organization Vol. 79; no. 7; pp. 625 - 631 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Genève
Organisation mondiale de la santé
01.07.2001
World Health Organization The World Health Organization |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0042-9686 1564-0604 |
| DOI | 10.1590/S0042-96862001000700007 |
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| Abstract | To test the efficacy of locally produced Vi vaccine over a time period of longer than one year.
A double-blinded, randomized field trial was performed in Guangxi Zhuang Autonomous Region in south-western China, using 30 micrograms doses of locally produced Vi. Enrolled subjects were 3-50 years of age, although the majority (92%) were school-aged children, who have the highest rate of typhoid fever in this setting. A total of 131,271 people were systematically allocated a single dose of 30 micrograms of Vi polysaccharide or saline placebo. The study population was followed for 19 months, with passive surveillance conducted in the Ministry of Health and the Regional Health and Anti-epidemic Centre (HAEC). Clinically suspected cases of typhoid fever were confirmed by blood culture, or by serological reaction with O-antigen (Widal tests).
After 19 months, there were 23 culture-confirmed cases of typhoid fever in the placebo group versus 7 cases in the Vi group (Protective efficacy (PE) = 69%; 95% CI = 28%, 87%). Most of the isolates were from school-aged children: 22 cases in the placebo group versus 6 in the Vi group (PE = 72%; 95% CI = 32%, 82%). No serious post-injection reactions were observed. The locally produced Vi polysaccharide vaccine showed levels of protective efficacy similar to those for Vi vaccine produced in industrial countries.
The slightly higher dose of vaccine did not seem to alter efficacy significantly in China. |
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| AbstractList | To test the efficacy of locally produced Vi vaccine over a time period of longer than one year. A double-blinded, randomized field trial was performed in Guangxi Zhuang Autonomous Region in south-western China, using 30 micrograms doses of locally produced Vi. Enrolled subjects were 3-50 years of age, although the majority (92%) were school-aged children, who have the highest rate of typhoid fever in this setting. A total of 131,271 people were systematically allocated a single dose of 30 micrograms of Vi polysaccharide or saline placebo. The study population was followed for 19 months, with passive surveillance conducted in the Ministry of Health and the Regional Health and Anti-epidemic Centre (HAEC). Clinically suspected cases of typhoid fever were confirmed by blood culture, or by serological reaction with O-antigen (Widal tests). After 19 months, there were 23 culture-confirmed cases of typhoid fever in the placebo group versus 7 cases in the Vi group (Protective efficacy (PE) = 69%; 95% CI = 28%, 87%). Most of the isolates were from school-aged children: 22 cases in the placebo group versus 6 in the Vi group (PE = 72%; 95% CI = 32%, 82%). No serious post-injection reactions were observed. The locally produced Vi polysaccharide vaccine showed levels of protective efficacy similar to those for Vi vaccine produced in industrial countries. The slightly higher dose of vaccine did not seem to alter efficacy significantly in China. Objective To test the efficacy of locally produced Vi vaccine over a time period of longer than one year. Methods A double-blinded, randomized field trial was performed in Guangxi Zhuang Autonomous Region in south-western China, using 30 µg doses of locally produced Vi. Enrolled subjects were 3-50 years of age, although the majority (92%) were school-aged children, who have the highest rate of typhoid fever in this setting. A total of 131 271 people were systematically allocated a single dose of 30 µg of Vi polysaccharide or saline placebo. The study population was followed for 19 months, with passive surveillance conducted in the Ministry of Health and the Regional Health and Anti-epidemic Centre (HAEC). Clinically suspected cases of typhoid fever were confirmed by blood culture, or by serological reaction with O-antigen (Widal tests). Findings After 19 months, there were 23 culture-confirmed cases of typhoid fever in the placebo group versus 7 cases in the Vi group (Protective efficacy (PE) = 69%; 95% CI = 28%, 87%). Most of the isolates were from school-aged children: 22 cases in the placebo group versus 6 in the Vi group (PE = 72%; 95% CI = 32%, 82%). No serious post-injection reactions we,re observed. The locally produced Vi polysaccharide vaccine showed levels of protective efficacy similar to those for Vi vaccine produced in industrial countries. Conclusion The slightly higher dose of vaccine did not seem to alter efficacy significantly in China. Keyword Typhoid-paratyphoid vaccines/administration and dosage; Polysaccharides, Bacterial/immunology; Typhoid fever/immunology; Placebos; Clinical trials, Phase II; China (source: MESH). Mots cles Vaccin antityphoparatyphoidique/administration et posologie; Polyosides bacteriens/immunologie; Fievre typhoide/immunologie; Placebo; Essai clinique phase II; Chine (source: INSERM). Palabras clave Vacunas tifoide-paratifoide/administracion y dosificacion; Polisacaridos bacterianos/inmunologia; Fiebre tifoidea//inmunologia; Placebos; Ensayos clinicos fase II; China (fuente: BIREME). Bulletin of the World Health Organization, 2001, 79: 625-631. To test the efficacy of locally produced Vi vaccine over a time period of longer than one year.OBJECTIVETo test the efficacy of locally produced Vi vaccine over a time period of longer than one year.A double-blinded, randomized field trial was performed in Guangxi Zhuang Autonomous Region in south-western China, using 30 micrograms doses of locally produced Vi. Enrolled subjects were 3-50 years of age, although the majority (92%) were school-aged children, who have the highest rate of typhoid fever in this setting. A total of 131,271 people were systematically allocated a single dose of 30 micrograms of Vi polysaccharide or saline placebo. The study population was followed for 19 months, with passive surveillance conducted in the Ministry of Health and the Regional Health and Anti-epidemic Centre (HAEC). Clinically suspected cases of typhoid fever were confirmed by blood culture, or by serological reaction with O-antigen (Widal tests).METHODSA double-blinded, randomized field trial was performed in Guangxi Zhuang Autonomous Region in south-western China, using 30 micrograms doses of locally produced Vi. Enrolled subjects were 3-50 years of age, although the majority (92%) were school-aged children, who have the highest rate of typhoid fever in this setting. A total of 131,271 people were systematically allocated a single dose of 30 micrograms of Vi polysaccharide or saline placebo. The study population was followed for 19 months, with passive surveillance conducted in the Ministry of Health and the Regional Health and Anti-epidemic Centre (HAEC). Clinically suspected cases of typhoid fever were confirmed by blood culture, or by serological reaction with O-antigen (Widal tests).After 19 months, there were 23 culture-confirmed cases of typhoid fever in the placebo group versus 7 cases in the Vi group (Protective efficacy (PE) = 69%; 95% CI = 28%, 87%). Most of the isolates were from school-aged children: 22 cases in the placebo group versus 6 in the Vi group (PE = 72%; 95% CI = 32%, 82%). No serious post-injection reactions were observed. The locally produced Vi polysaccharide vaccine showed levels of protective efficacy similar to those for Vi vaccine produced in industrial countries.FINDINGSAfter 19 months, there were 23 culture-confirmed cases of typhoid fever in the placebo group versus 7 cases in the Vi group (Protective efficacy (PE) = 69%; 95% CI = 28%, 87%). Most of the isolates were from school-aged children: 22 cases in the placebo group versus 6 in the Vi group (PE = 72%; 95% CI = 32%, 82%). No serious post-injection reactions were observed. The locally produced Vi polysaccharide vaccine showed levels of protective efficacy similar to those for Vi vaccine produced in industrial countries.The slightly higher dose of vaccine did not seem to alter efficacy significantly in China.CONCLUSIONThe slightly higher dose of vaccine did not seem to alter efficacy significantly in China. Keyword Typhoid-paratyphoid vaccines/administration and dosage; Polysaccharides, Bacterial/immunology; Typhoid fever/immunology; Placebos; Clinical trials, Phase II; China (source: MESH). OBJECTIVE: To test the efficacy of locally produced Vi vaccine over a time period of longer than one year. METHODS: A double-blinded, randomized field trial was performed in Guangxi Zhuang Autonomous Region in south-western China, using 30 mg doses of locally produced Vi. Enrolled subjects were 3-50 years of age, although the majority (92%) were school-aged children, who have the highest rate of typhoid fever in this setting. A total of 131 271 people were systematically allocated a single dose of 30 mg of Vi polysaccharide or saline placebo. The study population was followed for 19 months, with passive surveillance conducted in the Ministry of Health and the Regional Health and Anti-epidemic Centre (HAEC). Clinically suspected cases of typhoid fever were confirmed by blood culture, or by serological reaction with O-antigen (Widal tests). FINDINGS: After 19 months, there were 23 culture-confirmed cases of typhoid fever in the placebo group versus 7 cases in the Vi group (Protective efficacy (PE) = 69%; 95% CI = 28%, 87%). Most of the isolates were from school-aged children: 22 cases in the placebo group versus 6 in the Vi group (PE = 72%; 95% CI = 32%, 82%). No serious post-injection reactions were observed. The locally produced Vi polysaccharide vaccine showed levels of protective efficacy similar to those for Vi vaccine produced in industrial countries. CONCLUSION: The slightly higher dose of vaccine did not seem to alter efficacy significantly in China. OBJECTIVE: To test the efficacy of locally produced Vi vaccine over a time period of longer than one year. METHODS: A double-blinded, randomized field trial was performed in Guangxi Zhuang Autonomous Region in south-western China, using 30 micrograms doses of locally produced Vi. Enrolled subjects were 3-50 years of age, although the majority (92%) were school-aged children, who have the highest rate of typhoid fever in this setting. A total of 131,271 people were systematically allocated a single dose of 30 micrograms of Vi polysaccharide or saline placebo. The study population was followed for 19 months, with passive surveillance conducted in the Ministry of Health and the Regional Health and Anti-epidemic Centre (HAEC). Clinically suspected cases of typhoid fever were confirmed by blood culture, or by serological reaction with O-antigen (Widal tests). FINDINGS: After 19 months, there were 23 culture-confirmed cases of typhoid fever in the placebo group versus 7 cases in the Vi group (Protective efficacy (PE) = 69%; 95% CI = 28%, 87%). Most of the isolates were from school-aged children: 22 cases in the placebo group versus 6 in the Vi group (PE = 72%; 95% CI = 32%, 82%). No serious post-injection reactions were observed. The locally produced Vi polysaccharide vaccine showed levels of protective efficacy similar to those for Vi vaccine produced in industrial countries. CONCLUSION: The slightly higher dose of vaccine did not seem to alter efficacy significantly in China. To test the efficacy of locally produced Vi vaccine over a time period of longer than one year. A double-blinded, randomized field trial was performed in Guangxi Zhuang Autonomous Region in south-western China, using 30 micrograms doses of locally produced Vi. Enrolled subjects were 3-50 years of age, although the majority (92%) were school-aged children, who have the highest rate of typhoid fever in this setting. A total of 131,271 people were systematically allocated a single dose of 30 micrograms of Vi polysaccharide or saline placebo. The study population was followed for 19 months, with passive surveillance conducted in the Ministry of Health and the Regional Health and Anti-epidemic Centre (HAEC). Clinically suspected cases of typhoid fever were confirmed by blood culture, or by serological reaction with O-antigen (Widal tests). After 19 months, there were 23 culture-confirmed cases of typhoid fever in the placebo group versus 7 cases in the Vi group (Protective efficacy (PE) = 69%; 95% CI = 28%, 87%). Most of the isolates were from school-aged children: 22 cases in the placebo group versus 6 in the Vi group (PE = 72%; 95% CI = 32%, 82%). No serious post-injection reactions were observed. The locally produced Vi polysaccharide vaccine showed levels of protective efficacy similar to those for Vi vaccine produced in industrial countries. The slightly higher dose of vaccine did not seem to alter efficacy significantly in China. |
| Audience | Professional Academic |
| Author | QIN, M WANG, M. L ZHANG, S. L DING, Z. S WANG, J. H YANG, Y WANG, H. F TANG, H. A XIE, G. Z WU, C. G WANG, W. Y LI, Y. H GU, Q. W WANG, L. Y JIANG, X. M WANG, B. R TAN, W. S YANG, H. H WANG, X. C LI, G. L |
| AuthorAffiliation | Guangxi Health and Anti-epidemic Centre (GHAEC), 80 Taoyuan Road, Nanning, Guangxi 530021, China |
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| DOI | 10.1590/S0042-96862001000700007 |
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| DocumentTitleAlternate | Ensayo de la eficacia de la vacuna antitifoídica basada en el polisacárido Vi en el suroeste de China |
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| Keywords | Human Vaccine Typhoid Infection Prevention Immunoprophylaxis School age Efficiency Bacteriosis Salmonellosis Child Polysaccharide Public health Fièvre typhoïde Polysaccharides, Bacterial Vacunas tifoide-paratifoide Typhoid fever Essai clinique phase II Polisacáridos bacterianos Polyosides bactériens China Placebo Placebos Fiebre tifoidea Chine Ensayos clínicos fase II Vaccin antityphoparatyphoídique Clinical trials, Phase II Typhoid-paratyphoid vaccines |
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| PublicationTitle | Bulletin of the World Health Organization |
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| References | Acharya, IL 1987; 317 Ivanoff, B 1994; 72 Gupta, A 1994; 13 Klugman, KP 1987; 2 Wang, ZG 1993; 9 Ivanoff, B 1997; 95 Wang, ZG 1997; 18 Orenstein, WA 1985; 63 Bhutta, ZA 1991; 13 |
| References_xml | – volume: 63 start-page: 1055 year: 1985 end-page: 1068 article-title: Field evaluation of vaccine efficacy publication-title: Bulletin of the World Health Organization – volume: 2 start-page: 1165 year: 1987 end-page: 1169 article-title: Protective activity of Vi capsular polysaccharide vaccine against typhoid fever publication-title: Lancet – volume: 13 start-page: 124 year: 1994 end-page: 140 article-title: Multidrug-resistant typhoid fever in children: epidemiology and therapeutic approach publication-title: Pediatric Infectious Diseases – volume: 72 start-page: 957 year: 1994 end-page: 971 article-title: Vaccination against typhoid fever: present status publication-title: Bulletin of the World Health Organization – volume: 9 start-page: 1 year: 1993 end-page: 3 article-title: Side reaction and seroconversion following immunization with typhoid Vi polysaccharide publication-title: China Public Health – volume: 13 start-page: 832 year: 1991 end-page: 836 article-title: Multidrug-resistant typhoid in children: presentation and clinical features publication-title: Review of Infectious Diseases – volume: 317 start-page: 1101 year: 1987 end-page: 1104 article-title: Prevention of typhoid fever in Nepal with the Vi capsular polysaccharide of Salmonella typhi publication-title: New England Journal of Medicine – volume: 18 start-page: 26 year: 1997 end-page: 28 article-title: Efficacy and side-effects following immunization with Salmonella typhi Vi capsular polysaccharide vaccine publication-title: Chinese Journal of Epidemiology – volume: 95 start-page: 129 year: 1997 end-page: 142 article-title: Typhoid fever: continuing challenges from a resilient bacterial foe publication-title: Bulletin de l’Institut Pasteur |
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| Snippet | To test the efficacy of locally produced Vi vaccine over a time period of longer than one year.
A double-blinded, randomized field trial was performed in... Objective To test the efficacy of locally produced Vi vaccine over a time period of longer than one year. Methods A double-blinded, randomized field trial was... Keyword Typhoid-paratyphoid vaccines/administration and dosage; Polysaccharides, Bacterial/immunology; Typhoid fever/immunology; Placebos; Clinical trials,... To test the efficacy of locally produced Vi vaccine over a time period of longer than one year. A double-blinded, randomized field trial was performed in... To test the efficacy of locally produced Vi vaccine over a time period of longer than one year.OBJECTIVETo test the efficacy of locally produced Vi vaccine... OBJECTIVE: To test the efficacy of locally produced Vi vaccine over a time period of longer than one year. METHODS: A double-blinded, randomized field trial... |
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| SubjectTerms | Adolescent Adult Antibodies, Bacterial - blood Antigens, Bacterial - administration & dosage Bacterial diseases Bacterial diseases of the digestive system and abdomen Biological and medical sciences Biological products Child Child, Preschool China Clinical trials, Phase II Developing countries Double-Blind Method Epidemics Evaluation Female Fever Health facilities Health Policy & Services Human bacterial diseases Humans Immunization Immunology Infectious diseases Laboratories LDCs Male Medical sciences Middle Aged Middle schools Pilot projects Placebos Polysaccharides, Bacterial - administration & dosage Polysaccharides, Bacterial/immunology Population Research Article Salmonella paratyphi A - isolation & purification Salmonella typhi - isolation & purification Sewage disposal Students Surveillance Treatment Outcome Typhoid Typhoid fever Typhoid Fever - immunology Typhoid Fever - microbiology Typhoid Fever - prevention & control Typhoid vaccine Typhoid-Paratyphoid Vaccines - administration & dosage Typhoid-Paratyphoid Vaccines - immunology Typhoid-paratyphoid vaccines/administration and dosage Vaccines Waterborne diseases |
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| Title | Efficacy trial of Vi polysaccharide vaccine against typhoid fever in south-western China |
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