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Homeopathic Vaccine Trial (HVT)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by McMaster University
Sponsor:
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT02825368
First received: June 24, 2016
Last updated: August 3, 2017
Last verified: August 2017
  Purpose
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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Homeopathic Vaccine Randomized Controlled Trial

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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 ]

Study Start Date: September 2016
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02825368

Contacts
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
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

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02825368     History of Changes
Other Study ID Numbers: HVT-2016
Study First Received: June 24, 2016
Last Updated: August 3, 2017

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 22, 2017