Homeopathic Vaccine Trial (HVT)

August 3, 2017 updated by: McMaster University

Homeopathic Vaccine Randomized Controlled Trial

The purpose of the study is to compare the immunological response of homeopathic vaccines to placebo and to conventional vaccines in healthy young adults.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • Recruiting
        • McMaster University
        • Contact:
        • Principal Investigator:
          • Mark B Loeb, MD, MSc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Antibody levels for diphtheria
Time Frame: 3 weeks
3 weeks
Antibody levels for pertussis
Time Frame: 3 weeks
3 weeks
Antibody levels for tetanus
Time Frame: 3 weeks
3 weeks
Antibody levels for mumps
Time Frame: 3 weeks
3 weeks
Antibody levels for measles
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

June 24, 2016

First Submitted That Met QC Criteria

July 4, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • HVT-2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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