3. The vaccine composition, dosing and participants in efficacy trials of live attenuated vaccines.
Vaccine code (Trade name) |
Item | Vaccine composition, dosing and population used in the field trials |
CVD103‐HGR (not currently available) |
Composition |
Richie 2000 Indonesia: 5 x 109 lyophilized organisms of a genetically modified V. cholerae O1 Classical Inaba (569B) Tacket 1999: 2 to 8 x 108 CFU of lyophilized organisms of a genetically modified strain of V. cholerae O1 plus buffer |
Dosing schedule | A single dose | |
Field trial Artificial challenge study |
Richie 2000 Indonesia: 67,508 participants Tacket 1999: 51 participants |
|
Population |
Richie 2000 Indonesia: Age 2 to 41 years in Jakarta, Indonesia Tacket 1999: Adults aged 18 to 40 in USA |
|
Peru15 (not currently available) |
Composition | 5 x 108 CFU of a live attenuated strain of V. cholerae O1 El Tor Inaba plus 200ml CeraVacx buffer (Cera Products, Columbia) |
Dosing schedule | A single dose | |
Artificial challenge study | Cohen 2002: 36 participants | |
Population | Volunteers aged 18 to 40 in USA | |
VC638 (not currently available) |
Composition | 1 x 109 CFU of a live attenuated strain of V. cholerae O1 El Tor Ogawa plus buffer |
Dosing schedule | A single dose | |
Artificial challenge study | García 2005: 21 participants | |
Population | Volunteer males aged 8 to 40 in Cuba |
CFU = Colony forming units