PXVX0200 (CVD103-HgR) vs Shanchol in Mali

NCT ID: NCT02145377

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-03-31

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.

Detailed Description

Currently there are two licensed inactivated vibrio oral vaccines (Dukoral® [Crucell; Leiden, The Netherlands] and Shanchol™ [Shantha Biotechnics; Hyderabad, India]) that are pre-qualified by the World Health Organization (WHO) for procurement by United Nations (UN) agencies. Each of these vaccines requires a two-dose regimen which is difficult to implement in the face of explosive outbreaks of cholera in unsettled situations in developing countries. For this reason there is great interest in identifying a cholera vaccine that can provide rapid onset of protection following the ingestion of just a single oral dose.

This Phase 2 randomized, observer-blinded and subject-blinded clinical trial to be conducted in Bamako, Mali will assess the immunogenicity of the 10^8 cfu versus the 10^9 cfu formulation of PaxVax-manufactured CVD 103-HgR.

Conditions

Cholera

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

PXVX0200 10E8 then placebo

PXVX0200 10E8 on day 0; Placebo on day 14

Group Type: EXPERIMENTAL

PXVX0200 10E8

Intervention Type: BIOLOGICAL

Oral dose of PXVX0200 10E8

Placebo

Intervention Type: BIOLOGICAL

Oral dose of sodium bicarbonate buffer

Placebo, then PXVX0200 10E8

Placebo on day 0; PXVX0200 10E8 on day 14

Group Type: EXPERIMENTAL

PXVX0200 10E8

Intervention Type: BIOLOGICAL

Oral dose of PXVX0200 10E8

Placebo

Intervention Type: BIOLOGICAL

Oral dose of sodium bicarbonate buffer

PXVX0200 10E9 then Placebo

PXVX0200 10E9 on day 0; Placebo on day 14

Group Type: EXPERIMENTAL

PXVX0200 10E9

Intervention Type: BIOLOGICAL

Oral dose of PXVX0200 10E9

Placebo

Intervention Type: BIOLOGICAL

Oral dose of sodium bicarbonate buffer

Placebo then PXVX0200 10E9

Placebo on day 0; PXVX0200 10E9 on day 14

Group Type: EXPERIMENTAL

PXVX0200 10E9

Intervention Type: BIOLOGICAL

Oral dose of PXVX0200 10E9

Placebo

Intervention Type: BIOLOGICAL

Oral dose of sodium bicarbonate buffer

Shanchol

Two doses of Shanchol, on day 0 and day 14

Group Type: ACTIVE_COMPARATOR

Shanchol

Intervention Type: BIOLOGICAL

Licensed comparator

Interventions

PXVX0200 10E8

Oral dose of PXVX0200 10E8

Intervention Type: BIOLOGICAL

PXVX0200 10E9

Oral dose of PXVX0200 10E9

Intervention Type: BIOLOGICAL

Placebo

Oral dose of sodium bicarbonate buffer

Intervention Type: BIOLOGICAL

Shanchol

Licensed comparator

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emergent BioSolutions

INDUSTRY

Sponsor Role: collaborator

Shantha Biotechnics Limited

INDUSTRY

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Milagritos Tapia

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Milagritos D Tapia, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Samba O Sow, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Centre pour le Developpement des Vaccins - Mali

Locations

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

Bamako, , Mali

Countries

Mali

References

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.

Reference Type: DERIVED

PMID: 29021299 (View on PubMed)

Other Identifiers

HP-00059690

Identifier Type: -

Identifier Source: org_study_id