Healthy Volunteers
Conditions
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.
Interventions
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody levels for pertussis | 3 weeks |
| Antibody levels for tetanus | 3 weeks |
| Antibody levels for mumps | 3 weeks |
| Antibody levels for measles | 3 weeks |
| Antibody levels for diphtheria | 3 weeks |
Countries
Canada
Contacts
Primary ContactMark Loeb, MD, MSc.
Backup ContactSasha Eskandarian, MSc
Outcome results
None listed