PXVX0200 (CVD103-HgR) vs Shanchol in Mali

NCT02145377 | Completed Phase 2

• 1 other identifier: HP-00059690
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholera

Keywords

Cholera; Vaccine; Mali

Outcome Measures

Primary Outcomes (1)

• To elicit a significant rise in serum Inaba vibriocidal antibody after a single vaccination

  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

  14 days

Secondary Outcomes (4)

• To measure antibody response for a 10E8 dose and 10E9 dose of PXVX0200 oral vaccine

  14 days

• To plot the kinetics of the serum Inaba Vibriocidal antibody response

  Baseline and post-vaccination time point.

• Assess fecal shedding of PXVX0200

  Day 1-3, day 7 and day 14

• Compare rate of diarrhea

  7 days

Other Outcomes (2)

• Plot seroconversion

  Day 7, 14, 21, 28, 35 and 42

• Assess reactogenicity

  For seven days after each dose of PXVX0200

Study Arms (5)

PXVX0200 10E8 then placebo

EXPERIMENTAL

PXVX0200 10E8 on day 0; Placebo on day 14

Biological: PXVX0200 10E8; Biological: Placebo

Placebo, then PXVX0200 10E8

EXPERIMENTAL

Placebo on day 0; PXVX0200 10E8 on day 14

Biological: PXVX0200 10E8; Biological: Placebo

PXVX0200 10E9 then Placebo

EXPERIMENTAL

PXVX0200 10E9 on day 0; Placebo on day 14

Biological: PXVX0200 10E9; Biological: Placebo

Placebo then PXVX0200 10E9

EXPERIMENTAL

Placebo on day 0; PXVX0200 10E9 on day 14

Biological: PXVX0200 10E9; Biological: Placebo

Shanchol

ACTIVE COMPARATOR

Two doses of Shanchol, on day 0 and day 14

Biological: Shanchol

Interventions

PXVX0200 10E8 BIOLOGICAL

Oral dose of PXVX0200 10E8

PXVX0200 10E8 then placebo; Placebo, then PXVX0200 10E8

PXVX0200 10E9 BIOLOGICAL

Oral dose of PXVX0200 10E9

PXVX0200 10E9 then Placebo; Placebo then PXVX0200 10E9

Placebo BIOLOGICAL

Oral dose of sodium bicarbonate buffer

PXVX0200 10E8 then placebo; PXVX0200 10E9 then Placebo; Placebo then PXVX0200 10E9; Placebo, then PXVX0200 10E8

Shanchol BIOLOGICAL

Licensed comparator

Shanchol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to understand the study and give consent (either written or through a process that involves audio tapes explaining all aspects of the study and the consent form in local languages \[Bambara and French\] followed by making a mark and signature by a literate witness)
• Healthy men or women, age 18 to 45 years (inclusive) without significant medical history
• Women of child-bearing potential must have negative urine pregnancy test at baseline, prior to vaccination. They must also be willing to use adequate birth control for the duration of the 28-day study and have additional pregnancy tests if indicated. Effective methods of birth control for this study include abstinence, intrauterine device (IUD), oral or depot contraceptive, or barrier plus spermicide
• Willingness to remain in the study area until at least 42 days after receipt of the first vaccine dose

You may not qualify if:

• Health care workers who have direct contact with patients who are immune deficient, HIV-positive, or have an unstable medical condition
• Clinically significant history of immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurologic illness, psychiatric disorder requiring hospitalization, current drug or alcohol abuse
• History of an abnormal stool pattern or regular use of laxatives
• Previously received a licensed or investigational cholera vaccine
• History of cholera illness

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Emergent BioSolutions: collaborator
• Shantha Biotechnics Limited: collaborator

Study Sites (1)

Centre pour le Développement des Vaccins, Mali (CVD-Mali)

Bamako, Mali

Location

Related Publications (1)

• Sow SO, Tapia MD, Chen WH, Haidara FC, Kotloff KL, Pasetti MF, Blackwelder WC, Traore A, Tamboura B, Doumbia M, Diallo F, Coulibaly F, Onwuchekwa U, Kodio M, Tennant SM, Reymann M, Lam DF, Gurwith M, Lock M, Yonker T, Smith J, Simon JK, Levine MM. Randomized, Placebo-Controlled, Double-Blind Phase 2 Trial Comparing the Reactogenicity and Immunogenicity of a Single Standard Dose to Those of a High Dose of CVD 103-HgR Live Attenuated Oral Cholera Vaccine, with Shanchol Inactivated Oral Vaccine as an Open-Label Immunologic Comparator. Clin Vaccine Immunol. 2017 Dec 5;24(12):e00265-17. doi: 10.1128/CVI.00265-17. Print 2017 Dec.

  PMID: 29021299 DERIVED

MeSH Terms

Conditions

Cholera

Interventions

shanchol

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Milagritos D Tapia, MD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

• Samba O Sow, MD, MS

  Centre pour le Developpement des Vaccins - Mali

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 22, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

MA (1)