A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults

Bavarian Nordic

Status and phase: Completed; Phase 3

Conditions: Cholera

Treatments: Biological: PXVX0200 Lot C; Biological: PXVX0200 Lot A; Biological: PXVX0200 Lot B; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02094586

PXVX-VC-200-004

Details and patient eligibility

About

The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.

Full description

The primary goal of this Phase III study is to compare three lots for consistency of manufacture.

Enrollment: 3,146 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy men or women,
• age 18 to 45 years inclusive;
• normal medical history and physical examination
• Women must have a negative pregnancy test.

Exclusion criteria

• travel to a cholera endemic area in the previous 5 years;
• abnormal stool pattern or regular use of laxatives;
• Currently active unstable or undiagnosed medical conditions
• current or recent antibiotic use;
• pregnancy or nursing;
• Previously received a licensed or investigational cholera vaccine
• History of cholera or enterotoxigenic E. coli infection
• History of Guillain-Barré Syndrome
• Received or plans to receive any other licensed vaccines, except for seasonal influenza
• Recipient of bone marrow or solid organ transplant
• Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders diagnosed or treated during the past 5 years
• Use of systemic chemotherapy in the previous 5 years prior to the study
• any immunosuppressive medical condition

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,146 participants in 4 patient groups, including a placebo group

PXVX0200 Lot A

Experimental group

Description:

PXVX0200 (Lot P700-1CA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension

Treatment:

Biological: PXVX0200 Lot A

PXVX0200 Lot B

Experimental group

Description:

PXVX0200 (Lot P700-3CA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension

Treatment:

Biological: PXVX0200 Lot B

PXVX0200 Lot C

Experimental group

Description:

PXVX0200 (Lot P700-6BA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension

Treatment:

Biological: PXVX0200 Lot C

Placebo

Placebo Comparator group

Description:

Placebo physiological saline

Treatment:

Biological: Placebo