AtherosclerosisPhase 3V6NCT03042741
Vaccine Against Atherosclerosis in Patients With Overweight Problems or Obesity
A Phase 3 study testing atherosclerosis vaccine in people with Atherosclerosis, run by Immunitor LLC at 1 site in Mongolia.
Trial summary
Atherosclerosis vaccine, V6, has been through two small-scale Phase II open label clinical trials. It has shown significant improvement in lipid profile in patients with overweight or obesity Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- atherosclerosis vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteMongolia
- Study dates
- 1 Feb 2017to 18 Dec 2019
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Baseline waist diameter over 90 and 80 cm for men and women, respectively
Who cannot join
- Pregnant and lactating women
- Individuals with clinical symptoms or diseases who in opinion of study investigators are not eligible to participate
Trial locations and contacts
1 site in 1 country.
Mongolia1 site, 1 recruiting
- Recruiting
Immunitor LLC
Ulaanbaatar, CA, 13838
aldar bourinbaiar, 3014760930, aldar@immunitor.com
About this study
Official title: Phase II Trial of Daily Dose of Oral Vaccine Against Atherosclerosis
Atherosclerosis vaccine, V6, has been through two small-scale Phase II open label clinical trials. It has shown significant improvement in lipid profile in patients with overweight or obesity
Read the detailed description
The proposed study will evaluate daily dose of one V6 pill administered for one month in placebo-controlled, randomized, double-blind phase 3 trial in men and women with baseline waist diameter over 90 and 80 cm respectively. The effect of V6 will be assessed by changes in lipid profile, i.e., LDL, HDL, TG and TC; anthropomorphic indices, i.e., circumference of waist, mid-arm, and hips; arterial blood pressure and fasting glucose levels at baseline versus post-treatment timepoint.
- Conditions
- Atherosclerosis
- Being tested
- atherosclerosis vaccine, Placebo pills
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atherosclerosis vaccineBiological
Atherosclerosis vaccine, V6, formulated as an oral pill made from from pooled antigens derived from adipose tissue
Placebo pillsBiological
Half of the patients will be randomly assigned to receive placebo pill
| Study group | Role | What they receive |
|---|---|---|
| V6 recipients | Experimental | Arm will comprise 150 individuals with overweight problem or obesity randomly assigned to receive V6 - oral atherosclerosis vaccine administered once per day for one month Receives: Biological: atherosclerosis vaccine |
| Placebo recipients | Placebo comparator | Arm will comprise 150 individuals with overweight problem or obesity randomly assigned to receive placebo pills given once per day as a single pill for one month Receives: Biological: Placebo pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunotherapy of atherosclerosis
Effect on lipid profile as measured by changes in LDL, HDL, triglycerides and total cholesterol
Measured: 1 month
Secondary outcomes (3)
Effect on anthropomorphic indices of obesity
Effect on diameter of waist, mid-arm and hip after one month of treatment versus baseline measurements
Measured: 1 month
Effect on hypertension
The systolic and diastolic blood pressures measured one month apart
Measured: 1 month
Effect on glucose levels
Changes in fasting glucose levels from baseline to post-treatment time-point
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Feb 2017
- Primary completion18 Dec 2019 (estimated)
- Study completion18 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group on experimental drug compared against group receiving placebo in randomized, blinded phase III study to evaluate effect on lipid profile, i.e., LDL, HDL, triglycerides and total cholesterol
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunitor LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
- Responsible party
- Sponsor
- Investigators
- Allen Bain, PhD, Study chair, Immunitor Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042741
- Sponsor's protocol ID
- V6
- Acronym
- V6
- Status last verified
- Aug 2018
- First submitted
- 1 Feb 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared without identification of participants
Publications
Bourinbaiar AS, Jirathitikal V. Effect of oral immunization with pooled antigens derived from adipose tissue on atherosclerosis and obesity indices. Vaccine. 2010 Mar 24;28(15):2763-8. doi: 10.1016/j.vaccine.2010.01.032. Epub 2010 Jan 29.
PubMed 20117273Bourinbaiar AS, Jirathitikal V. Safety and efficacy trial of adipose-tissue derived oral preparation V-6 Immunitor (V-6): results of open-label, two-month, follow-up study. Lipids Health Dis. 2010 Feb 2;9:14. doi: 10.1186/1476-511X-9-14.
PubMed 20122177
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Daily Dose of Oral Vaccine Against Atherosclerosis
- ClinicalTrials.gov ID
- NCT03042741
- Acronym / sponsor ID
- V6 / V6
- Conditions
- Atherosclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Immunitor LLCIndustry (pharma, biotech, devices)
- Collaborators
- Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 18 Dec 2019 (estimated)
- Study completion
- 18 Dec 2019 (estimated)
- First posted
- 3 Feb 2017 (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.
Atherosclerosis vaccine, V6, has been through two small-scale Phase II open label clinical trials. It has shown significant improvement in lipid profile in patients with overweight or obesity
Detailed description
The proposed study will evaluate daily dose of one V6 pill administered for one month in placebo-controlled, randomized, double-blind phase 3 trial in men and women with baseline waist diameter over 90 and 80 cm respectively. The effect of V6 will be assessed by changes in lipid profile, i.e., LDL, HDL, TG and TC; anthropomorphic indices, i.e., circumference of waist, mid-arm, and hips; arterial blood pressure and fasting glucose levels at baseline versus post-treatment timepoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Group on experimental drug compared against group receiving placebo in randomized, blinded phase III study to evaluate effect on lipid profile, i.e., LDL, HDL, triglycerides and total cholesterol
| Arm | Type | Receives |
|---|---|---|
| V6 recipients | Experimental | Biological: atherosclerosis vaccineArm will comprise 150 individuals with overweight problem or obesity randomly assigned to receive V6 - oral atherosclerosis vaccine administered once per day for one month |
| Placebo recipients | Placebo comparator | Biological: Placebo pillsArm will comprise 150 individuals with overweight problem or obesity randomly assigned to receive placebo pills given once per day as a single pill for one month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Baseline waist diameter over 90 and 80 cm for men and women, respectively
Key exclusion criteria (2 listed)
- Pregnant and lactating women
- Individuals with clinical symptoms or diseases who in opinion of study investigators are not eligible to participate
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 |
|---|---|---|
| atherosclerosis vaccineAtherosclerosis vaccine, V6, formulated as an oral pill made from from pooled antigens derived from adipose tissue | Biological | V6 recipients |
| Placebo pillsHalf of the patients will be randomly assigned to receive placebo pill | Biological | Placebo recipients |
Primary outcome
Immunotherapy of atherosclerosis
Time frame: 1 month
Effect on lipid profile as measured by changes in LDL, HDL, triglycerides and total cholesterol
3 secondary outcomes
Effect on anthropomorphic indices of obesity
Time frame: 1 month
Effect on hypertension
Time frame: 1 month
Effect on glucose levels
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Background: PubMed 20117273Bourinbaiar AS, Jirathitikal V. Effect of oral immunization with pooled antigens derived from adipose tissue on atherosclerosis and obesity indices. Vaccine. 2010 Mar 24;28(15):2763-8. doi: 10.1016/j.vaccine.2010.01.032. Epub 2010 Jan 29.
- Background: PubMed 20122177Bourinbaiar AS, Jirathitikal V. Safety and efficacy trial of adipose-tissue derived oral preparation V-6 Immunitor (V-6): results of open-label, two-month, follow-up study. Lipids Health Dis. 2010 Feb 2;9:14. doi: 10.1186/1476-511X-9-14.
- Individual participant dataSharing planned: Undecided. Data will be shared without identification of participants
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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.
Allen Bain, PhD study chair
Immunitor Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing atherosclerosis vaccine in people with Atherosclerosis, run by Immunitor LLC at 1 site in Mongolia.
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 1 inclusion and 2 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 16 Apr 2019. 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 Mongolia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 aldar bourinbayar, PhD, MD/PhD (3014760930, IMMUNITOR@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunotherapy of atherosclerosis (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03042741, which also lists 2 linked publications.
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 16 Apr 2019.