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Homeopathic Vaccine Trial (HVT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02825368
Recruitment Status : Unknown
Verified August 2017 by McMaster University.
Recruitment status was:  Recruiting
First Posted : July 7, 2016
Last Update Posted : August 4, 2017
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date  ICMJE June 24, 2016
First Posted Date  ICMJE July 7, 2016
Last Update Posted Date August 4, 2017
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July¬†4,¬†2016)
  • Antibody levels for diphtheria [ Time Frame: 3 weeks ]
  • Antibody levels for pertussis [ Time Frame: 3 weeks ]
  • Antibody levels for tetanus [ Time Frame: 3 weeks ]
  • Antibody levels for mumps [ Time Frame: 3 weeks ]
  • Antibody levels for measles [ Time Frame: 3 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Homeopathic Vaccine Trial
Official Title  ICMJE Homeopathic Vaccine Randomized Controlled Trial
Brief Summary The purpose of the study is to compare the immunological response of homeopathic vaccines to placebo and to conventional vaccines in healthy young adults.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Biological: MMR
    0.5 mL, subcutaneous
  • Biological: Tdap
    0.5 mL, intramuscular
  • Other: Diphtherinum®
  • Other: Pertussinum®
  • Other: Tetanotxicum®
  • Other: Morbilinum®
  • Other: Ourlianum®
  • Other: Sterile saline
    0.5 mL, intramuscular
  • Other: Sugar pellets
Study Arms  ICMJE
  • Experimental: Homeopathic vaccine group
    • Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes.
    • Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo.
    • Other: Diphtherinum®
    • Other: Pertussinum®
    • Other: Tetanotxicum®
    • Other: Morbilinum®
    • Other: Ourlianum®
    • Other: Sterile saline
  • Active Comparator: Conventional vaccine group
    • One intramuscular dose of Tdap (tetanus, diphtheria, acellular pertussis)
    • One subcutaneous dose of MMR (measles, mumps, rubella)
    • Sugar pellets as placebo.
    • Biological: MMR
    • Biological: Tdap
    • Other: Sugar pellets
  • Placebo Comparator: Control group
    • Sugar pellets oral dose
    • Two sterile saline injections (0.5 ml each, intramuscular and subcutaneous) as placebo
    • Other: Sterile saline
    • Other: Sugar pellets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Between the ages of 18 and 24 years
  • Has received primary childhood DTaP and MMR vaccinations
  • Available for a follow up visit (3 weeks after initial visit)

Exclusion Criteria:

  • Received a live vaccine in the past 4 weeks
  • Has had a serious allergic reaction to a previous vaccination
  • Has allergies to one or more of the components of the vaccines to be used (Neomycin, egg protein)
  • Has a history of encephalopathy within 7 days of receiving DTP/DTap
  • Has received nosodes for Diphtheria, Tetanus, Pertussis, Measles and Mumps
  • Has received an adult booster dose of conventional vaccines of diphtheria, pertussis, tetanus, mumps, and measles (Tdap or MMR)
  • Has received immunosuppressive doses of steroids or anti-cancer drugs in the past 3 months
  • Is pregnant or if there is a chance they could become pregnant during the next month
  • Has a moderate to severe acute illness at the time of enrolment
  • Has cancer, leukemia, HIV/AIDS, or any other serious immune health condition
  • Has a history of Guillaume Barre Syndrome
  • Has received blood transfusion, blood products, or immune globulin within the past year
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 24 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02825368
Other Study ID Numbers  ICMJE HVT-2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account McMaster University
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP