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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
McMaster University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: MMR Biological: Tdap Other: Diphtherinum® Other: Pertussinum® Other: Tetanotxicum® Other: Morbilinum® Other: Ourlianum® Other: Sterile saline Other: Sugar pellets Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Homeopathic Vaccine Randomized Controlled Trial
Study Start Date : September 2016
Estimated Primary Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
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
0.5 mL, intramuscular
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
0.5 mL, subcutaneous

Biological: Tdap
0.5 mL, intramuscular

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
0.5 mL, intramuscular

Other: Sugar pellets


Outcome Measures
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Primary Outcome Measures :
  1. Antibody levels for diphtheria [ Time Frame: 3 weeks ]
  2. Antibody levels for pertussis [ Time Frame: 3 weeks ]
  3. Antibody levels for tetanus [ Time Frame: 3 weeks ]
  4. Antibody levels for mumps [ Time Frame: 3 weeks ]
  5. Antibody levels for measles [ Time Frame: 3 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825368


Contacts
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Contact: Mark Loeb, MD, MSc. 905-525-9140 ext 26066 loebm@mcmaster.ca
Contact: Sasha Eskandarian, MSc 905-525-9140 ext 26672 eskand@mcmaster.ca

Locations
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Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Mark B Loeb, MD, MSc    905-525-9140 ext 26066    loebm@mcmaster.ca   
Contact: Sasha Eskandarian, MSc    905-525-9140 ext 26672    eskand@mcmaster.ca   
Principal Investigator: Mark B Loeb, MD, MSc         
Sponsors and Collaborators
McMaster University
More Information
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02825368    
Other Study ID Numbers: HVT-2016
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017