Safety and Immunogenicity of a Chimeric Recombinant Covid19 Vaccine SpiN-Tec MCTI UFMG

NCT07134725 | Completed Phase 1 DMC

• 5 other identifiers: SpiN-Tec-001U1111-1300-15265.536.1005.569.96459871822.1.1001.5149
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID - 19

Keywords

vaccine; infectious; viral disease; SARS-Cov-2; Coronavirus Infections; Coronavirus Disease 2019; Respiratory Tract Infections

Outcome Measures

Primary Outcomes (3)

• Parts A, A2 e B: safety and reactogenicity for EAG and EAIE

  A, A2 e B: the investigators expect to evaluate the safety and reactogenicity for spontaneous adverse events in the first 28 days to EAG and EAIE for the entire duration of the study after intramuscular administration of SpiN-Tec MCTI UFMG as a booster in vaccination for COVID-19 through the evaluation of the frequencies (absolute and relative) and summary measurements (such as median and interquartile range), to describe qualitative variables (requested and unsolicited clinical AEs) and quantitative (laboratory AEs, size of erythema and edema, degree of AEs ), respectively, used to verify whether the outcome occurred

  In the first 28 days to EAG and EAIE for the entire duration of the study after immunization

• Part A: define a safe and immunogenic dose of SpiN-Tec MCTI UFMG to be used in Part B

  A: the investigators expect to define a safe and immunogenic dose of SpiN-Tec MCTI UFMG to be used in Part B of the study through the results of frequencies (absolute and relative) and summary measures (such as median and interquartile range), with the aim of to describe qualitative variables (solicited and unsolicited clinical AEs) and quantitative variables (laboratory AEs, size of erythema and edema, degree of AEs), respectively; post-baseline levels of neutralizing antibodies, binding antibodies and IFNg production will be calculated for each dose; and the increment of the parameters of each arm will be compared with the other dose-arms of the study.

  At the end of visit V28 of the last randomized participant in Part A

• Parte B: prove the non-inferiority of SpiN-Tec MCTI UFMG in inducing neutralizing antibodies

  B: the investigators expect to prove the non-inferiority of SpiN-Tec MCTI UFMG in inducing neutralizing antibodies will be verified by the geometric mean ratio of the increase in neutralizing antibody titers against the ancestral strain and against relevant VOCs at the time of the study on day 28 after the booster of the SpiN-Tec MCTI UFMG vaccine compared to the active comparator by evaluating the geometric mean increase in neutralizing antibody titers on a logarithmic scale induced by SpiN-Tec MCTI UFMG will be compared to the geometric mean increase in neutralizing antibody titers (baseline change) on a logarithmic scale generated by Covishield®. A 15% non-inferiority margin will be considered a parameter for neutralizing antibody levels.

  On day 28 after the booster of the SpiN-Tec MCTI UFMG vaccine

Secondary Outcomes (4)

• Parts A and A2: identify an increase in the levels of neutralizing antibodies

  On days 14, 28, 90, 180, 270, and 360 after the booster

• Parts A and A2: observe an increase in the average levels of anti-S, anti-RBD, and anti-N IgG antibodies

  On days 14, 28, 90, 180, 270, and 360 after the booster

• Parts A and A2: observe an increase in the IFNg levels in response to S and N antigens

  On days 14, 28, 90, 180, 270, and 360 after the booster

• Part B: show an increase in the neutralizing antibody titers, in the levels of anti-S, anti-RBD, anti-N IgG, and anti-VoCs IgG antibodies, and an increase in the in IFNg levels.

  On days 14, 28, 90, 180, 270 and 360 after the booster

Study Arms (9)

Phase 1 - arm 1: 20 ug SpiN-Tec

EXPERIMENTAL

9 participants aged 18 to 54 years receiving 1 dose of the SpiN-Tec MCTI UFMG vaccine with 20 micrograms.

Biological: SpiN-Tec MCTI UFMG

Phase 1 - arm 2: 60 ug SpiN-Tec

EXPERIMENTAL

9 participants aged 18 to 54 years receive 1 dose of the SpiN-Tec MCTI UFMG vaccine with 60 micrograms.

Biological: SpiN-Tec MCTI UFMG

Phase 1

ACTIVE COMPARATOR

6 participants (3 participants in the age group of 18 to 54 years and 3 participants in the age group of 55 to 85 years ) will receive 1 dose of the active comparator

Other: Active Comparator: Covishield® vaccine

Phase 2: 60 ug SpiN-Tec

EXPERIMENTAL

reinforcement with 60 ug of SpiN-Tec MCTI UFMG, 180 individuals, 30% of whom are between 55 and 85 years old.

Biological: SpiN-Tec MCTI UFMG; Other: Active Comparator: Comirnaty® vaccine

Phase 2

ACTIVE COMPARATOR

reinforcement with active comparator, 180 individuals, 30% from the age group between 55 and 85 years old.

Other: Active Comparator: Comirnaty® vaccine

Phase 1 - arm 3: 100 ug SpiN-Tec

EXPERIMENTAL

9 participants aged 18 to 54 years receive 1 dose of the SpiN-Tec MCTI UFMG vaccine with 100 micrograms.

Biological: SpiN-Tec MCTI UFMG

Phase 1 - arm 1b: 20 ug SpiN-Tec

EXPERIMENTAL

9 participants aged 55 to 85 years receiving 1 dose of the SpiN-Tec MCTI UFMG vaccine with 20 micrograms.

Biological: SpiN-Tec MCTI UFMG

Phase 1 - arm 2b: 60 ug SpiN-Tec

EXPERIMENTAL

9 participants aged 55 to 85 years receive 1 dose of the SpiN-Tec MCTI UFMG vaccine with 60 micrograms.

Biological: SpiN-Tec MCTI UFMG

Phase 1 - arm 3b: 100 ug SpiN-Tec

EXPERIMENTAL

9 participants aged 55 to 85 years receive 1 dose of the SpiN-Tec MCTI UFMG vaccine with 100 micrograms.

Biological: SpiN-Tec MCTI UFMG

Interventions

SpiN-Tec MCTI UFMG BIOLOGICAL

Chimeric recombinant protein (SpiN) adjuvanted with CTVad1

Phase 1 - arm 1: 20 ug SpiN-Tec; Phase 1 - arm 1b: 20 ug SpiN-Tec; Phase 1 - arm 2: 60 ug SpiN-Tec; Phase 1 - arm 2b: 60 ug SpiN-Tec; Phase 1 - arm 3: 100 ug SpiN-Tec; Phase 1 - arm 3b: 100 ug SpiN-Tec; Phase 2: 60 ug SpiN-Tec

Active Comparator: Covishield® vaccine OTHER

active comparator using vaccine approved by ANVISA (Brazilian Health Regulatory Agency)

Phase 1

Active Comparator: Comirnaty® vaccine OTHER

active comparator using vaccine approved by ANVISA (Brazilian Health Regulatory Agency)

Phase 2; Phase 2: 60 ug SpiN-Tec

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 is the only partner. Intrauterine device (with or without hormones) implanted. Birth control medications (oral, topical, injectable, or implantable). True sexual abstinence is in line with the patient's preferred and usual lifestyle. Note: periodic abstinence, such as calendar, ovulation, symptothermal, post-ovulation, or coitus interruptus methods, will not be considered a valid method.

You may not qualify if:

• Part A:
• No previous history or acute infection with SARS-CoV-2. Previous records will be considered self-declaration by the participant.
• The presence of comorbidities or any condition that, in the study investigator's assessment, could put the participant at risk or create a confounding factor in the study, including clinically stable chronic diseases.
• Part A2:
• Vaccination booster for COVID-19 less than six months ago.
• The presence of comorbidities or any condition that, in the study investigator's assessment, could put the participant at risk or create a confounding factor in the study, including clinically stable chronic diseases.
• Part B:
• Vaccination booster for COVID-19 less than six months ago.
• All Parties:
• Have received primary vaccination with Janssen or Comirnaty® vaccine.
• Have received a booster vaccine with the Janssen or CoronaVac® vaccine.
• History of SAE after administration of a COVID-19 vaccine.
• History of thrombophilia.
• Being on anticoagulant therapy or having a bleeding disorder that contraindicates intramuscular injection.
• Positive serology for HIV, HBV (HBsAg) or HCV.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Oswaldo Cruz Foundation: collaborator
• The Ministry of Science, Technology and Innovation, Brazil: collaborator
• Prefeitura de Belo Horizonte (PBH): collaborator

Study Sites (1)

Faculdade de Medicina da UFMG - Unidade de Pesquisa Clínica em Vacinas (UPqVac)

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Related Publications (1)

• Hojo-Souza NS, de Castro JT, Rivelli GG, Azevedo PO, Oliveira ER, Faustino LP, Salazar N, Bagno FF, Carvalho AF, Rattis B, Lourenco KL, Gomes IP, Assis BRD, Piccin M, Fonseca FG, Durigon E, Silva JS, de Souza RP, Goulart GAC, Santiago H, Fernandes APS, Teixeira SR, Gazzinelli RT. SpiN-Tec: A T cell-based recombinant vaccine that is safe, immunogenic, and shows high efficacy in experimental models challenged with SARS-CoV-2 variants of concern. Vaccine. 2024 Dec 2;42(26):126394. doi: 10.1016/j.vaccine.2024.126394. Epub 2024 Oct 4.

  PMID: 39368129 BACKGROUND

MeSH Terms

Conditions

COVID-19; Communicable Diseases; Virus Diseases; Coronavirus Infections; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ricardo T Gazzinelli, DVM, PhD

  Vaccine Technology Center (CT Vacinas)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 21, 2025
• Study Start: November 23, 2022
• Primary Completion: May 22, 2023
• Study Completion: May 7, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

BR (1)