Homeopathic Vaccine Trial (HVT)

McMaster University

Status and phase: Unknown; Phase 4

Conditions: Healthy Volunteers

Treatments: Other: Morbilinum®; Other: Sugar pellets; Biological: Tdap; Biological: MMR; Other: Tetanotxicum®; Other: Diphtherinum®; Other: Pertussinum®; Other: Sterile saline; Other: Ourlianum®

Study type: Interventional

Funder types: Other

Identifiers

NCT02825368

HVT-2016

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

0 participants in 3 patient groups, including a placebo group

Homeopathic vaccine group

Experimental group

Description:

* Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes. * Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo.

Treatment:

Other: Morbilinum®

Other: Tetanotxicum®

Other: Pertussinum®

Other: Sterile saline

Other: Ourlianum®

Other: Diphtherinum®

Conventional vaccine group

Active Comparator group

Description:

* One intramuscular dose of Tdap (tetanus, diphtheria, acellular pertussis) * One subcutaneous dose of MMR (measles, mumps, rubella) * Sugar pellets as placebo.

Treatment:

Biological: MMR

Other: Sugar pellets

Biological: Tdap

Control group

Placebo Comparator group

Description:

* Sugar pellets oral dose * Two sterile saline injections (0.5 ml each, intramuscular and subcutaneous) as placebo

Treatment:

Other: Sugar pellets

Other: Sterile saline