Immunogenicity and safety of the Vi-CRM197 conjugate vaccine against typhoid fever in adults, children, and infants in south and southeast Asia: Results from two randomised, observer-blind, age de-escalation, phase 2 trials

The Lancet Infectious Diseases

Volumn 14, Issue 2, 2014, Pages 119-129

  Bhutta, Zulfiqar A ^a   Capeding, Maria Rosario ^b   Bavdekar, Ashish ^c   Marchetti, Elisa ^d   Ariff, Shabina ^d   Soofi, Sajid B ^a   Anemona, Alessandra ^d   Habib, Muhammad A ^a   Alberto, Edison ^b   Juvekar, Sanjay ^c   Khan, Rana M Qasim ^d   Marhaba, Rachid ^e   Ali, Noshad ^a   Malubay, Nelia ^b   Kawade, Anand ^c   Saul, Allan ^d   Martin, Laura B ^d   Podda, Audino ^d  

^a AGA KHAN UNIVERSITY   (Pakistan)

^b RESEARCH INSTITUTE FOR TROPICAL MEDICINE   (Philippines)

^c KEM HOSPITAL   (India)

^d NOVARTIS VACCINES AND DIAGNOSTICS   (Italy)

^e Novartis Vaccines and Diagnostics Human Serology Laboratories   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B HEPATITIS B VACCINE; DIPHTHERIA PERTUSSIS TETANUS HEPATITIS B VACCINE; DIPHTHERIA TOXOID CRM197; HEPATITIS B VACCINE; MEASLES VACCINE; ORAL POLIOMYELITIS VACCINE; PNEUMOCOCCUS VACCINE; TYPHOID VACCINE; BACTERIUM ANTIBODY; BIOLOGICAL MARKER; TYPHOID PARATYPHOID VACCINE; VACCINE;

ADULT; ADULT DISEASE; ANTIBODY BLOOD LEVEL; ANTIBODY TITER; ARTHRALGIA; ARTICLE; CHILD; CHILDHOOD DISEASE; CHILL; COMPUTER; CONJUGATE; CONTROLLED STUDY; DRUG SAFETY; ERYTHEMA; FATIGUE; FEMALE; FEVER; FILIPINO; HEADACHE; HEALTH CARE PERSONNEL; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; INDIA; INFANT; INFANT DISEASE; INTENTION TO TREAT ANALYSIS; IRRITABILITY; LETHARGY; LOSS OF APPETITE; MAJOR CLINICAL STUDY; MALAISE; MALE; MIDDLE AGED; MYALGIA; OUTCOME ASSESSMENT; PAIN; PAKISTAN; PHASE 2 CLINICAL TRIAL (TOPIC); PHILIPPINES; PRESCHOOL CHILD; PREVENTIVE HEALTH SERVICE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; SOUTH ASIA; SOUTHEAST ASIA; TYPHOID FEVER; UNSPECIFIED SIDE EFFECT; VACCINATION; VOMITING; WORLD HEALTH ORGANIZATION; ADOLESCENT; BLOOD; CLINICAL TRIAL; ENZYME LINKED IMMUNOSORBENT ASSAY; IMMUNOLOGY; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SINGLE BLIND PROCEDURE; YOUNG ADULT;

ADOLESCENT; ADULT; ANTIBODIES, BACTERIAL; BIOLOGICAL MARKERS; CHILD, PRESCHOOL; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMANS; INDIA; INFANT; INTENTION TO TREAT ANALYSIS; MALE; MIDDLE AGED; PAKISTAN; PHILIPPINES; SALMONELLA TYPHI; SINGLE-BLIND METHOD; TYPHOID FEVER; TYPHOID-PARATYPHOID VACCINES; VACCINES, CONJUGATE; YOUNG ADULT;

EID: 84892539966     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(13)70241-X     Document Type: Article

References (20)

1. Crump JA, Luby SP, Mintz ED The global burden of typhoid fever. Bull World Health Organ 2004, 82:346-353.
2. Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012, 380:2095-2128.
3. Murray CJL, Vos T, Lozano R, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012, 380:2197-2223.
4. Ochiai RL, Acosta CJ, Danovaro-Holliday MC, et al. A study of typhoid fever in five Asian countries: disease burden and implications for controls. Bull World Health Organ 2008, 86:260-268.
5. Sinha A, Sazawal S, Kumar R, et al. Typhoid fever in children aged less than 5 years. Lancet 1999, 354:734-737.
6. Brooks WA, Hossain A, Goswami D, et al. Bacteremic typhoid fever in children in an urban slum, Bangladesh. Emerg Infect Dis 2005, 11:326-329.
7. Siddiqui FJ, Rabbani F, Hasan R, Nizami SQ, Bhutta ZA Typhoid fever in children: some epidemiological considerations from Karachi, Pakistan. Int J Infect Dis 2006, 10:215-222.
8. Bhutta ZA, Khan MI, Soofi SB, Ochiai RL New advances in typhoid fever vaccination strategies. Adv Exp Med Biol 2011, 697:17-39.
9. Sur D, Ochiai RL, Bhattacharya SK, et al. A cluster-randomized effectiveness trial of Vi typhoid vaccine in India. N Engl J Med 2009, 361:335-344.
10. Khan MI, Soofi SB, Ochiai RL Effectiveness of Vi capsular polysaccharide typhoid vaccine among children: a cluster randomized trial in Karachi, Pakistan. Vaccine 2012, 30:5389-5395.
11. Saha SK, Baqui AH, Hanif M, et al. Typhoid fever in Bangladesh: implications for vaccination policy. Pediatr Infect Dis J 2001, 20:521-524.
12. Ghosh S, Batabyal P, Rajendran K, Palit A Typhoid fever in rural communities of West Bengal, India-an age-wise perspective. Jpn J Infect Dis 2010, 63:219-221.
13. Podda A, Saul A, Arora R, et al. Conjugate vaccines for enteric fever: proceedings of a meeting organized in New Delhi, India in 2009. J Infect Dev Ctries 2010, 4:404-411.
14. Thiem VD, Lin FY, Canh DG, et al. Vi conjugate typhoid vaccine (Vi-rEPA) is safe, elicits protective levels of IgG anti-Vi and is compatible with routine infant vaccines. Clin Vaccine Immunol 2011, 18:730-735.
15. Micoli F, Rondini S, Pisoni I, et al. Production of a conjugate vaccine for Salmonella enterica serovar Typhi from Citrobacter Vi. Vaccine 2012, 30:853-861.
16. Rondini S, Micoli F, Lanzilao L, et al. Characterization of a Citrobacter sp line as a source of Vi for a Vi-CRM197 glycoconjugate vaccine against Salmonella typhi. J Infect Dev Ctries 2012, 6:763-773.
17. Van Damme P, Kafeja F, Anemona A, et al. Safety, immunogenicity and dose ranging of a new Vi-CRM conjugate vaccine against typhoid fever: randomized clinical testing in healthy adults. PLoS One 2011, 6:e25398.
18. Naheed A, Ram PK, Brooks WA, et al. Burden of typhoid and paratyphoid fever in a densely populated urban community, Dhaka, Bangladesh. Int J Infect Dis 2010, 14(suppl 3):e93-e99.
19. Lin FY, Ho VA, Khiem HB, et al. Efficacy of a Salmonella typhi Vi conjugate vaccine (Vi-rEPA) in 2 to 5 year-old children. N Engl J Med 2001, 344:1263-1269.
20. Lahn MN, Bay BV, Ho VA, et al. Persistent efficacy of Vi conjugate vaccine against typhoid fever in young children. N Engl J Med 1999, 349:1390-1391.