A Phase 2 Randomized, Double-Blinded Study to Compare in Malian Adults the Immunogenicity, Clinical Acceptability and Excretion Pattern Following the Ingestion of a Single Dose of PXVX0200 (CVD 103-HgR) Live Oral Cholera Vaccine Containing Either 108 Colony Forming Units [Cfu] or 109 Cfu Using Shanchol™ Killed Whole Cell Oral Cholera Vaccine as an Immunological Comparator

NCT02145377 Phase 2 COMPLETED

To compare the ability of a single dose of PXVX0200 at two different dose levels, to placebo to elicit a significant antibody response 14 days after vaccination, compared to baseline. To compare the ability of a single dose of PXVX0200 to a comparator vaccine Shanchol, a two dose administration, to elicit antibody response by 14 days after vaccination.

Details

Lead sponsor	University of Maryland, Baltimore
Phase	Phase 2
Status	COMPLETED
Enrolment	150
Start date	2014-07
Completion	2015-03

Conditions

• Cholera

Interventions

• PXVX0200 10E8
• PXVX0200 10E9
• Placebo
• Shanchol

Primary outcomes

• To elicit a significant rise in serum Inaba vibriocidal antibody after a single vaccination — 14 days
  A comparison of the ability of a single ≥2 x10E9 cfu oral dose versus a single ≥2 x10E8 cfu oral dose of PXVX0200 (CVD 103-HgR) versus placebo to elicit a significant (\> 4-fold) rise in serum Inaba vibriocidal antibody 14 days after vaccination, compared to baseline

Countries

Mali