Safety and Immunogenicity of a Chimeric Recombinant Covid19 Vaccine SpiN-Tec MCTI UFMG (NCT07134725) | Clinical Trial Compass
CompletedPhase 1/2
Safety and Immunogenicity of a Chimeric Recombinant Covid19 Vaccine SpiN-Tec MCTI UFMG
Brazil432 participantsStarted 2022-11-23
Plain-language summary
SpiN-Tec MCTI UFMG will be used as a vaccine booster against COVID-19 and will be evaluated using the active comparator, a vaccine approved by ANVISA (Brazilian Health Regulatory Agency). The study will consist of two parts: Part A) a Phase 1 dose-escalation clinical trial to assess safety and reactogenicity; followed by Part B) a Phase 2 clinical trial to assess the safety and immunogenicity of SpiN-Tec. The study will include healthy participants of both sexes, aged 18 to 85, who have already received the full COVID-19 vaccination schedule with CoronaVac® (Butantan) or Covishield® (AstraZeneca) and who have received one or two booster doses of Covishield® or Comirnaty® (Pfizer's RNA-based vaccine) at least 6 months ago. Participants may or may not have had natural SARS-CoV-2 infection.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Part A: Healthy individuals aged 18 to 54 with completed primary vaccination schedule for COVID-19 with CoronaVac®. Have received a booster dose with Comirnaty® between 9 and 15 months before inclusion in the study.
Part A2: Healthy individuals aged 55 to 85 with a completed vaccination schedule for COVID-19 with CoronaVac® or Covishield® for at least six months from inclusion in the study. Have received at least one booster dose with Comirnaty® or Covishield® at least six months ago.
Part B: Healthy individuals aged 18 to 85 who completed the vaccination schedule for COVID-19 with CoronaVac® or Covishield® for at least six months from inclusion in the study. Have received at least one booster dose with Comirnaty® or Covishield® at least six months ago.
All Parties:
* Consent to the study and its procedures, documented by signing the Free and Informed Consent Form (TCLE).
* Present good general health as determined by medical examination.
* Agree not to donate blood while participating in the study.
* Women of childbearing potential must agree to use acceptable contraception\* for at least 30 days before initiation of vaccination and at least 90 days following the use of the investigational product or active comparator.
* Acceptable contraceptive methods: Barrier methods, including condoms or cervical caps. Surgically sterile partner/participant (including those undergoing vasectomy, hysterectomy, bilateral oophorectomy, and or tubal ligation) who …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Parts A, A2 e B: safety and reactogenicity for EAG and EAIE
Timeframe: In the first 28 days to EAG and EAIE for the entire duration of the study after immunization
2
Part A: define a safe and immunogenic dose of SpiN-Tec MCTI UFMG to be used in Part B
Timeframe: At the end of visit V28 of the last randomized participant in Part A
3
Parte B: prove the non-inferiority of SpiN-Tec MCTI UFMG in inducing neutralizing antibodies
Timeframe: On day 28 after the booster of the SpiN-Tec MCTI UFMG vaccine