Healthy VolunteersPhase 4HVTNCT02825368
Homeopathic Vaccine Trial
A Phase 4 study testing MMR, Tdap and Diphtherinum® in people with Healthy Volunteers, run by McMaster University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MMR, Tdap and Diphtherinum®
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McMaster University
Hamilton, Ontario, L8S 4K1
Mark B Loeb, MD, MSc, 905-525-9140 ext. 26066, loebm@mcmaster.ca
Sasha Eskandarian, MSc, 905-525-9140 ext. 26672, eskand@mcmaster.ca
About this study
Official title: Homeopathic Vaccine Randomized Controlled Trial
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
- Healthy Volunteers
- Being tested
- MMR, Tdap, Diphtherinum®, Pertussinum®, Tetanotxicum®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMRBiological
0.5 mL, subcutaneous
TdapBiological
0.5 mL, intramuscular
Diphtherinum®Other
Pertussinum®Other
Tetanotxicum®Other
Morbilinum®Other
Ourlianum®Other
Sterile salineOther
0.5 mL, intramuscular
Sugar pelletsOther
| Study group | Role | What they receive |
|---|---|---|
| Homeopathic vaccine group | Experimental | * Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes.
* Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo. Receives: Other: Diphtherinum®; Other: Pertussinum®; Other: Tetanotxicum®; Other: Morbilinum®; Other: Ourlianum®; Other: Sterile saline |
| Conventional vaccine group | Active comparator | * One intramuscular dose of Tdap (tetanus, diphtheria, acellular pertussis)
* One subcutaneous dose of MMR (measles, mumps, rubella)
* Sugar pellets as placebo. Receives: Biological: MMR; Biological: Tdap; Other: Sugar pellets |
| Control group | Placebo comparator | * Sugar pellets oral dose
* Two sterile saline injections (0.5 ml each, intramuscular and subcutaneous) as placebo Receives: Other: Sterile saline; Other: Sugar pellets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody levels for diphtheria
Measured: 3 weeks
Antibody levels for pertussis
Measured: 3 weeks
Antibody levels for tetanus
Measured: 3 weeks
Antibody levels for mumps
Measured: 3 weeks
Antibody levels for measles
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825368
- Sponsor's protocol ID
- HVT-2016
- Acronym
- HVT
- Status last verified
- Aug 2017
- First submitted
- 24 Jun 2016
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homeopathic Vaccine Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02825368
- Acronym / sponsor ID
- HVT / HVT-2016
- Conditions
- Healthy Volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Aug 2017 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the immunological response of homeopathic vaccines to placebo and to conventional vaccines in healthy young adults.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Homeopathic vaccine group | Experimental | Other: Diphtherinum®, Other: Pertussinum®, Other: Tetanotxicum®, Other: Morbilinum®, Other: Ourlianum®, Other: Sterile saline* Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes. * Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo. |
| Conventional vaccine group | Active comparator | Biological: MMR, Biological: Tdap, Other: Sugar pellets* One intramuscular dose of Tdap (tetanus, diphtheria, acellular pertussis) * One subcutaneous dose of MMR (measles, mumps, rubella) * Sugar pellets as placebo. |
| Control group | Placebo comparator | Other: Sterile saline, Other: Sugar pellets* Sugar pellets oral dose * Two sterile saline injections (0.5 ml each, intramuscular and subcutaneous) as placebo |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMR0.5 mL, subcutaneous | Biological | Conventional vaccine group |
| Tdap0.5 mL, intramuscular | Biological | Conventional vaccine group |
| Diphtherinum® | Other | Homeopathic vaccine group |
| Pertussinum® | Other | Homeopathic vaccine group |
| Tetanotxicum® | Other | Homeopathic vaccine group |
| Morbilinum® | Other | Homeopathic vaccine group |
| Ourlianum® | Other | Homeopathic vaccine group |
| Sterile saline0.5 mL, intramuscular | Other | Control group, Homeopathic vaccine group |
| Sugar pellets | Other | Control group, Conventional vaccine group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MMR, Tdap and Diphtherinum® in people with Healthy Volunteers, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Loeb, MD, MSc. (905-525-9140 ext. 26066, loebm@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody levels for diphtheria (time frame: 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.