- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05542693
Safety and Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine
September 13, 2022 updated by: Azidus Brasil
Phase IIb, Randomized, Double-blind, Non-inferior, Multicenter Study to Evaluate the Safety and Immunogenicity of the Self-replicating Nanoparticle Carrier Replicon RNA Carrier (repRNA) Vaccine in Adults 18 to 65 Years of Age
A multicenter, randomized, double-blind, active comparator, non-inferiority, multicenter IIb clinical trial to compare the safety and immunogenicity of two dose levels of the MCTI CIMATEC HDT RNA Vaccine against two authorized COVID-19 vaccines in Brazil (Comirnaty - Pfizer and Covishield - Oxford/AstraZeneca) in 300 participants.
Each vaccine will be provided as a single booster vaccine in adults aged 18 to 65 years previously immunized with both vaccines (Comirnaty - Pfizer and Covishield - Oxford/Astrazen).
The investigational product MCTI C HDT will be administered in one of the two doses evaluated (5µg and 10 µg).
The comparator products will be Comirnaty - Pfizer and Covishield - Oxford/AstraZeneca.
The primary outcomes will be the number of participants with a 2-fold increase or more on average by titers of neutralizing D64G pseudovirus strain (pNT50) and comparison of titers generated by 5µg and 10µg doses of MCTI-CIMATEC-HDT RNA Vaccine.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 18 years
- Complete primary vaccination with Cominarty (Pfizer) or Covishield (Oxford/Astrazeneca) vaccines, and at least one booster dose with Cominarty (Pfizer) or Covishield (Oxford/Astrazeneca) vaccines. The last duration being at least 4 before the study duration.
- Adult in a healthy condition or with a stable health status if pre-existing medical history.
- Sign informed consent, be able and willing to make the assessment, be accessible by telephone or in person by the local study team and willing to remain in the study area for the duration of the study
- For women of childbearing age: a highly negative sensitive urinary pregnancy test during the inclusion visit AND use an effective contraceptive method.
Exclusion Criteria:
- History of COVID-19 in the 30 days before study enrollment.
- Participation in other clinical studies in the last 12 (two) months.
- Receive or plan any immunization during the study, except the seasonal influenza vaccine, within 30 days of enrollment.
- Receive a blood or immunoglobulin transfusion within 90 days before study enrollment;
- Blood donation up to 30 days before inclusion in the study;
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immunomodulatory drugs.
- History of autoimmune disease or immunosuppression.
- Rash, tattoos, or any other skin condition that could adversely affect the vaccine injection site.
- Body mass index (BMI) > 35.
- Known or suspected drug or alcohol abuse in the last 6 months;
- History of previous anaphylaxis or severe allergic reactions to the vaccine, products known to contain polyethene glycol (PEG) or unknown allergens.
- History of myocarditis or carditis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RNA MCTI CIMATEC HDT 5µg
Intramuscular injections of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (VACCINE RNA MCTI CIMATEC HDT) at a dose of 5 µg of single-dose administration on day 1.
|
Adults previously immunized will be randomized to receive a single booster vaccine: experimental (MCTI-CIMATEC-HDT RNA)
|
Experimental: RNA MCTI CIMATEC HDT 10µg
Intramuscular injections of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (VACCINE RNA MCTI CIMATEC HDT) at a dose of 10 µg of single-dose administration on day 1.
|
Adults previously immunized will be randomized to receive a single booster vaccine: experimental (MCTI-CIMATEC-HDT RNA)
|
Active Comparator: Covishield® - AstraZeneca
Intramuscular injections of vaccine Covishield® - AstraZeneca at a usual dose of single-dose administration on day 1.
|
Adults previously immunized will be randomized to receive a single booster vaccine comparator (Comirnaty - Pfizer)
|
Active Comparator: Comirnaty® - Pfizer
Intramuscular injections of vaccine Comirnaty® - Pfizer at a usual dose of single-dose administration on day 1.
|
Adults previously immunized will be randomized to receive a single booster vaccine comparator (Comirnaty - Pfizer and (Covishield - Oxford/Astrazen).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine (Non-inferiority)
Time Frame: Day 29 after vaccination until day 181.
|
Proportion of participants with a 2-fold or greater increase in geometric mean neutralizing antibody titers against D614G pseudovirus strain (pNT50).
|
Day 29 after vaccination until day 181.
|
Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine (Dose determination)
Time Frame: Day 29 after vaccination until day 181.
|
Comparison of antibody titers generated by 5µg and 10µg doses of the MCTI-CIMATEC-HDT RNA Vaccine
|
Day 29 after vaccination until day 181.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2023
Primary Completion (Anticipated)
March 1, 2023
Study Completion (Anticipated)
September 1, 2023
Study Registration Dates
First Submitted
August 26, 2022
First Submitted That Met QC Criteria
September 13, 2022
First Posted (Actual)
September 15, 2022
Study Record Updates
Last Update Posted (Actual)
September 15, 2022
Last Update Submitted That Met QC Criteria
September 13, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNA-MCTI-CIMATEC-HDT-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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