Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200

Learn more about:
Related Clinical Trial
Preventative Intervention for Cholera for 7 Days Impact Study of Cholera Vaccination in Endemic Areas – Clinical Surveillance Water, Sanitation, and Hygiene Mobile Health Messages as an Innovative Tool to Facilitate Behavior Change Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™ in Nepalese Safety and Immunogenicity of Peru-15 Vaccine When Given With Measles Vaccine in Healthy Indian and Bangladeshi Infants Safety and Immunogenicity of Single Dose Choleragarde® in HIV-Seropositive Adults PXVX0200 (CVD103-HgR) vs Shanchol in Mali Cholera-Hospital-Based-Intervention-for-7-days A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Adults Follow-up of Pregnant Women After a Mass Vaccination of Oral Cholera Vaccine (ShancholTM) in Nsanje Malawi Single Dose Azithromycin in the Treatment of Adult Cholera Safety and Immunogenicity of a New Formulation of Euvichol® Cholera Anti-Secretory Treatment Trial PK Study of iOWH032 in Adult Male/Female Healthy Volunteers & Adult Males With Cholera Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial Efficacy of Benefiber-Added, Reduced-Osmolarity WHO-ORS in the Treatment of Cholera in Adults Safety and Immunogenicity of Locally Manufactured New (HL-OCV) Oral Cholera Vaccine Zinc Supplementation in Cholera Patients Immunologic Responses to a Live Attenuated Oral Cholera Vaccine Pilot Introduction of Oral Cholera Vaccine in Orissa, India Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200 Immunity to Human Cholera in Bangladesh Ciprofloxacin Multiple Dose for Adult Cholera Effect of Probiotic on Immunogenicity of Oral Cholera Vaccine Effectiveness of a Bivalent Killed Whole Cell Based Oral Cholera Vaccine Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera Impact Evaluation of Urban Water Supply Improvements on Cholera and Other Diarrhoeal Diseases in Uvira, Democratic Republic of Congo Protective Immunity to Human Cholera in Bangladesh Safety and Immunogenicity of a New Formulation of a Bivalent Killed, Whole-Cell Oral Cholera Vaccine Oral Cholera Vaccine Delivery in Rural Bangladesh Study of Alternative Vaccination Schedule of Oral Cholera Vaccine Mass Oral Cholera Vaccination in Zanzibar Cholera Vaccine Investment Strategy in Bangladesh Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine Bridging Study for Killed Oral Cholera Vaccine in Ethiopia Safety and Immunogenicity of Locally Manufactured Oral Cholera Vaccine Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in Dominican Republic Introduction of Cholera Vaccine in Bangladesh Evaluation of a Pilot Program to Introduce Cholera Vaccine in Haiti as Part of Global Cholera Control Efforts Single Dose Oral Cholera Vaccine Study in Dhaka, Bangladesh Evaluation of a Boosting Regimen With Oral Cholera Vaccine Single Dose Azithromycin to Prevent Cholera in Children Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in the Philippines Randomized Controlled Trial of Killed Oral Cholera Vaccine in Kolkata

Brief Title

Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200

Official Title

A Phase 1 Randomized, Double-Blind Placebo Controlled Study to Evaluate the Safety and Immunogenicity of the LIve Oral Cholera Vaccine Candidate PXVX0200 Vibrio Cholerae Serotype 01 Inaba CVD 103-HgR Vaccine Strain

Brief Summary

      The purpose of this study is to compare the safety and immunogenicity of a single dose of the
      PXVX0200 live cholera vaccine versus placebo in volunteers (Vaccinees) and whether PXVX0200,
      which is a live attenuated bacteria, can be transmitted to other adults living in the same
      household.
    

Detailed Description

      Approximately 60 subjects and up to 120 household contacts will be enrolled in the United
      States. Vaccinees will be randomly assigned to receive either PXVX0200 or placebo in a 5:1
      ratio and will be followed for 180 days postdose.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Safety

Secondary Outcome

 Kinetics

Condition

Cholera

Intervention

PXVX0200

Study Arms / Comparison Groups

 Placebo
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

66

Start Date

April 2012

Completion Date

January 2013

Primary Completion Date

August 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Healthy Men or women, age 18 to 50 years (inclusive) without significant medical
             history, physical or clinical lab abnormalities (as per protocol defined ranges)

          -  Women of childbearing potential must have negative urine pregnancy test and must be
             willing to use adequate birth control for 2 months following vaccination and have
             additional pregnancy tests as indicated

          -  Vaccinees must live alone or have no more than two household contacts willing to sign
             informed consent and participate in the study

          -  Household contacts must be healthy (based on medical history) men or women aged 18-65
             years (inclusive)

        Exclusion Criteria:

          -  Healthcare workers who have direct contact with patients who are immunodeficient, are
             HIV-positive, have unstable medical condition or are under the age of 18

          -  Childcare workers who have direct contact with children who are 2 years of age or
             younger or those employed in the food service industry

          -  Resides with HHCs who are under the age of 18 or over the age of 65

          -  Has abnormal stool pattern defined as fewer than 3 stools per week or more than 2
             stools per day in past 6 months

          -  Has known allergy to, or known medical condition that precludes the use of both
             tetracycline or ciprofloxacin

          -  Previously received a licensed or investigational cholera vaccine

          -  Has history of cholera or enterotoxigenic E. coli infection (natural infection or
             experimental challenge)

          -  Travel to a cholera-endemic area and experienced symptoms consistent with traveler's
             diarrhea in the previous 5 years

          -  Received or plans to receive any other licensed vaccines from 14 days prior to the
             study vaccination until Day 28

          -  Received or plans to receive antibiotics (other than protocol-specified) or
             chloroquine within 14 days prior to the study vaccination through to Day 28
      

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01585181

Organization ID

PXVX-VC-0200-002


Responsible Party

Sponsor

Study Sponsor

Emergent BioSolutions


Study Sponsor

, , 


Verification Date

March 2020