Homeopathic Vaccine Trial

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

Official Title
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Homeopathic Vaccine Randomized Controlled Trial

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Biological: MMR
* Biological: Tdap
* Other: Diphtherinum®
* Other: Pertussinum®
* Other: Tetanotxicum®
* Other: Morbilinum®
* Other: Ourlianum®
* Other: Sterile saline
* Other: Sugar pellets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homeopathic vaccine group<br>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®<br> <br> Other: Pertussinum®<br> <br> Other: Tetanotxicum®<br> <br> Other: Morbilinum®<br> <br> Other: Ourlianum®<br> <br> Other: Sterile saline<br>* 0.5 mL, intramuscular<br>|
| Active Comparator: Conventional vaccine group<br>One intramuscular dose of Tdap (tetanus, diphtheria, acellular pertussis) One subcutaneous dose of MMR (measles, mumps, rubella) Sugar pellets as placebo. | Biological: MMR<br>* 0.5 mL, subcutaneous<br>Biological: Tdap<br>* 0.5 mL, intramuscular<br>Other: Sugar pellets<br> <br> |
| Placebo Comparator: Control group<br>Sugar pellets oral dose Two sterile saline injections (0.5 ml each, intramuscular and subcutaneous) as placebo | Other: Sterile saline<br>* 0.5 mL, intramuscular<br>Other: Sugar pellets<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody levels for diphtheria |  | 3 weeks | 
| Antibody levels for pertussis |  | 3 weeks | 
| Antibody levels for tetanus |  | 3 weeks | 
| Antibody levels for mumps |  | 3 weeks | 
| Antibody levels for measles |  | 3 weeks |