Status unknownNCT02825368HVTUpdated Aug 4, 2017

Homeopathic Vaccine Trial

A Phase 4 interventional study of MMR and Tdap in Healthy Volunteers, sponsored by McMaster University. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-04.

Sponsored by McMaster University · Phase 4 and Interventional

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Ages: 18 Years to 24 Years
Sex: All

Study 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.

Conditions studied

Healthy Volunteers

In context

Lead sponsor

McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 24 Years
Sexes eligible: All
Accepts 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

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

Phase: Phase 4
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)

Study arms

Experimental
Homeopathic vaccine group
* 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® · Other: Pertussinum® · Other: Tetanotxicum® · Other: Morbilinum® · Other: Ourlianum® · Other: Sterile saline
Active comparator
Conventional vaccine group
* One intramuscular dose of Tdap (tetanus, diphtheria, acellular pertussis) * One subcutaneous dose of MMR (measles, mumps, rubella) * Sugar pellets as placebo.
Biological: MMR · Biological: Tdap · Other: Sugar pellets
Placebo comparator
Control group
* Sugar pellets oral dose * Two sterile saline injections (0.5 ml each, intramuscular and subcutaneous) as placebo
Other: Sterile saline · Other: Sugar pellets

Interventions

BiologicalMMR
0.5 mL, subcutaneous
BiologicalTdap
0.5 mL, intramuscular
OtherDiphtherinum®
OtherPertussinum®
OtherTetanotxicum®
OtherMorbilinum®
OtherOurlianum®
OtherSterile saline
0.5 mL, intramuscular
OtherSugar pellets

What researchers measure

Primary outcomes

Antibody levels for diphtheria
Time frame: 3 weeks
Antibody levels for pertussis
Time frame: 3 weeks
Antibody levels for tetanus
Time frame: 3 weeks
Antibody levels for mumps
Time frame: 3 weeks
Antibody levels for measles
Time frame: 3 weeks

Study locations

1 of 1 sites recruiting

McMaster University
Hamilton, Ontario L8S 4K1, Canada
- Mark B Loeb, MD, MSc · Contact · loebm@mcmaster.ca · 905-525-9140
- Sasha Eskandarian, MSc · Contact · eskand@mcmaster.ca · 905-525-9140
- Mark B Loeb, MD, MSc · Principal investigator
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02825368
Lead sponsor: McMaster University
Responsible party: Sponsor
First posted: Jul 7, 2016
Start date: Sep 2016
Primary completion: Aug 2017 (estimated)
Last update: Aug 4, 2017

Study contacts

Mark Loeb, MD, MSc.

Contact

loebm@mcmaster.ca

905-525-9140 ext. 26066

Sasha Eskandarian, MSc

Contact

eskand@mcmaster.ca

905-525-9140 ext. 26672

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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