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NCT02825368 Clinical Trial

Homeopathic Vaccine Trial

Healthy Volunteers Clinical Trial

— HVT  

Official title:
Homeopathic Vaccine Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02825368
Other study ID # HVT-2016
Secondary ID
Status Recruiting
Phase Phase 4
First received June 24, 2016
Last updated August 3, 2017
Start date September 2016

Study information
Verified date August 2017
Source McMaster University
Contact Mark Loeb, MD, MSc.
Phone 905-525-9140
Email loebm@mcmaster.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date August 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• MMR
0.5 mL, subcutaneous
• Tdap
0.5 mL, intramuscular
Other:
• Diphtherinum®

• Pertussinum®

• Tetanotxicum®

• Morbilinum®

• Ourlianum®

• Sterile saline
0.5 mL, intramuscular
• Sugar pellets

Locations
Country Name City State
Canada McMaster University Hamilton Ontario

Sponsors (1)
Lead Sponsor Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Antibody levels for diphtheria 3 weeks
Primary Antibody levels for pertussis 3 weeks
Primary Antibody levels for tetanus 3 weeks
Primary Antibody levels for mumps 3 weeks
Primary Antibody levels for measles 3 weeks
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