Homeopathic Vaccine Trial
Phase 4
- Conditions
- Healthy Volunteers
- 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
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)
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the immunological response to homeopathic vaccines like Tetanotxicum and Pertussinum compared to conventional vaccines?
How do antibody titers and cytokine profiles in NCT02825368 compare between homeopathic vaccines (Morbilinum, Diphtherinum) and standard-of-care MMR/Tdap vaccines?
Are there predictive biomarkers for differential immune response to homeopathic vs conventional vaccines in healthy young adults?
What adverse event profiles are reported for homeopathic vaccines (e.g., Ourlianum) versus sterile saline placebo in Phase 4 trials?
How do combination approaches of homeopathic vaccines with conventional immunizations (MMR, Tdap) affect immunogenicity in Phase 4 studies?
Trial Locations
- Locations (1)
McMaster University
🇨🇦Hamilton, Ontario, Canada
McMaster University🇨🇦Hamilton, Ontario, CanadaMark B Loeb, MD, MScPrincipal InvestigatorSasha Eskandarian, MScContact905-525-9140eskand@mcmaster.ca