Homeopathic Vaccine Trial

Phase 4

• Conditions: Healthy Volunteers
• Interventions: Other: Sterile saline; Other: Diphtherinum®; Biological: MMR; Other: Sugar pellets; Other: Pertussinum®; Biological: Tdap; Other: Tetanotxicum®; Other: Morbilinum®; Other: Ourlianum®

• Registration Number: NCT02825368
• Lead Sponsor: McMaster University

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-07-04
• Study First Posted: 2016-07-07
• Study Start: 2016-09
• Status Verified: 2017-08
• Primary Completion: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Sugar pellets	* Sugar pellets oral dose * Two sterile saline injections (0.5 ml each, intramuscular and subcutaneous) as placebo
Homeopathic vaccine group	Tetanotxicum®	* Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes. * Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo.
Homeopathic vaccine group	Ourlianum®	* Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes. * Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo.
Control group	Sterile saline	* Sugar pellets oral dose * Two sterile saline injections (0.5 ml each, intramuscular and subcutaneous) as placebo
Homeopathic vaccine group	Pertussinum®	* Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes. * Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo.
Homeopathic vaccine group	Morbilinum®	* Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes. * Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo.
Homeopathic vaccine group	Diphtherinum®	* Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes. * Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo.
Conventional vaccine group	MMR	* One intramuscular dose of Tdap (tetanus, diphtheria, acellular pertussis) * One subcutaneous dose of MMR (measles, mumps, rubella) * Sugar pellets as placebo.
Homeopathic vaccine group	Sterile saline	* Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes. * Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo.
Conventional vaccine group	Sugar pellets	* One intramuscular dose of Tdap (tetanus, diphtheria, acellular pertussis) * One subcutaneous dose of MMR (measles, mumps, rubella) * Sugar pellets as placebo.
Conventional vaccine group	Tdap	* One intramuscular dose of Tdap (tetanus, diphtheria, acellular pertussis) * One subcutaneous dose of MMR (measles, mumps, rubella) * Sugar pellets as placebo.

Primary Outcome Measures

Name	Time	Method
Antibody levels for tetanus	3 weeks
Antibody levels for mumps	3 weeks
Antibody levels for diphtheria	3 weeks
Antibody levels for pertussis	3 weeks
Antibody levels for measles	3 weeks

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada