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CholeraPhase 2NCT02145377

PXVX0200 (CVD103-HgR) vs Shanchol in Mali

A Phase 2 study testing PXVX0200 10E8, PXVX0200 10E9 and Shanchol in people with Cholera, run by University of Maryland, Baltimore at 1 site in Mali.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Cholera
What is being tested?
PXVX0200 10E8, PXVX0200 10E9 and Shanchol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteMali
Study dates
Jul 2014to Mar 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Mali1 site

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

    Bamako

Other trials in Mali

About this study

Official title: 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

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.

Read the 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
Being tested
PXVX0200 10E8, PXVX0200 10E9, Placebo, Shanchol
Keywords
Cholera, Vaccine, Mali
Medical subject headings
Cholera

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PXVX0200 10E8Biological

    Oral dose of PXVX0200 10E8

  • PXVX0200 10E9Biological

    Oral dose of PXVX0200 10E9

  • PlaceboBiological

    Oral dose of sodium bicarbonate buffer

  • ShancholBiological

    Licensed comparator

Study groups in NCT02145377
Study groupRoleWhat they receive
PXVX0200 10E8 then placeboExperimentalPXVX0200 10E8 on day 0; Placebo on day 14
Receives: Biological: PXVX0200 10E8; Biological: Placebo
Placebo, then PXVX0200 10E8ExperimentalPlacebo on day 0; PXVX0200 10E8 on day 14
Receives: Biological: PXVX0200 10E8; Biological: Placebo
PXVX0200 10E9 then PlaceboExperimentalPXVX0200 10E9 on day 0; Placebo on day 14
Receives: Biological: PXVX0200 10E9; Biological: Placebo
Placebo then PXVX0200 10E9ExperimentalPlacebo on day 0; PXVX0200 10E9 on day 14
Receives: Biological: PXVX0200 10E9; Biological: Placebo
ShancholActive comparatorTwo doses of Shanchol, on day 0 and day 14
Receives: Biological: Shanchol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 14 days

Secondary outcomes (4)

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

    To compare the ability of a single ≥2 x108 cfu dose of PXVX0200 (CVD 103-HgR) or ≥2 x109 oral dose of PXVX0200 (CVD 103-HgR) versus Shanchol™ to elicit serum Inaba vibriocidal antibody mean fold rise (compared to baseline titer) and GMT

    Measured: 14 days

  2. To plot the kinetics of the serum Inaba Vibriocidal antibody response

    To plot the kinetics of the serum Inaba vibriocidal antibody response after ingestion of a single oral dose of PXVX0200 (CVD 103-HgR) containing ≥2 x10E8 cfu or ≥2 x10E9 cfu versus Shanchol™. (With GMT on the Y axis and time points on the X axis, the GMTs at baseline and at each post-vaccination time point will be connected as a line graph).

    Measured: Baseline and post-vaccination time point.

  3. Assess fecal shedding of PXVX0200

    Shedding of CVD 103-HgR in stool as determined by stool culture (whole specimen or rectal swab)

    Measured: Day 1-3, day 7 and day 14

  4. Compare rate of diarrhea

    To compare the rate of diarrhea (≥ 4 loose stools within 24 hours) following administration of each vaccine regimen versus placebo over 7 days of follow-up

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02145377
Sponsor's protocol ID
HP-00059690
Status last verified
Sep 2019
First submitted
20 May 2014
Last updated
26 Sep 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29021299

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PXVX0200 10E8, PXVX0200 10E9 and Shanchol in people with Cholera, run by University of Maryland, Baltimore at 1 site in Mali.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To elicit a significant rise in serum Inaba vibriocidal antibody after a single vaccination (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02145377, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.

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