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A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
PaxVax, Inc.
ClinicalTrials.gov Identifier:
NCT02094586
First received: March 20, 2014
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Cholera
Biological: PXVX0200
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase III Randomized, Double-blind, Placebo-Controlled Three-Lot Consistency Study in Healthy Adult Volunteers to Assess Immunogenicity, and Clinical Acceptability of a Single-dose of the Live Oral Cholera Vaccine Candidate PXVX0200, Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR

Resource links provided by NLM:


Further study details as provided by PaxVax, Inc.:

Primary Outcome Measures:
  • The geometric mean antibody titer (GMT) of each lot must be within ± 50% of each other lot with 95% confidence. [ Time Frame: Measured 10 days following vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of vaccinees with at least a 4-fold rise vibriocidal antibody [ Time Frame: Measured 10 days after vaccination ] [ Designated as safety issue: No ]
  • tolerability of vaccine [ Time Frame: following vaccination through 180 days ] [ Designated as safety issue: Yes ]
    Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, and fever Incidence and severity of unsolicited adverse events


Estimated Enrollment: 2964
Study Start Date: May 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PXVX0200
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; > 2x108 CFU in a liquid suspension
Biological: PXVX0200
comparing 3 lots of PXVX0200
Placebo Comparator: Placebo
Placebo physiological saline
Biological: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02094586

  Show 25 Study Locations
Sponsors and Collaborators
PaxVax, Inc.
  More Information

No publications provided

Responsible Party: PaxVax, Inc.
ClinicalTrials.gov Identifier: NCT02094586     History of Changes
Other Study ID Numbers: PXVX-VC-200-004
Study First Received: March 20, 2014
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cholera
Bacterial Infections
Gram-Negative Bacterial Infections
Vibrio Infections

ClinicalTrials.gov processed this record on November 19, 2014