Immunogenicity, Vaccine
Conditions
Interventions
SpiN-Tec-001 is a multicenter, double-blind, randomized, controlled with active comparator (Covishield®), escalating dose study to verify the safety and immunogenicity of the investigational product,
Sponsors
Centro de Tecnologia em Vacinas (CT Vacinas) da Universidade Federal de Minas Gerais
Fundação Oswaldo Cruz (FIOCRUZ)
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
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. 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. Agree not to donate blood while participating in the study. 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.
Exclusion criteria
Exclusion criteria: Part A: No previous history or acute infection with SARS-CoV-2. Previous records will be considered self-declaration by the participant. Vaccination booster for COVID-19 less than nine months ago and more than 15 months after inclusion in the study. 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: Acute SARS-CoV-2 infection or less than six months from the date of inclusion in the study. 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: Acute or SARS-CoV-2 infection or less than six months from the date of inclusion. Vaccination booster for COVID-19 less than six months ago. Any condition that, in the assessment of the study investigator, could put the participant at risk or create a confounding factor in the study. Diseases such as diabetes, hypertension, and clinically stable neuralgia may not constitute an exclusion criterion as determined by the medical investigator. 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. Laboratory abnormality in blood count, biochemistry, or urine tests. Exception will be defined by the clinical investigator when evaluated together with the participant's medical history. Women who are pregnant, breastfeeding, or intend to become pregnant/breastfeed within three months of inclusion in the study. Evidence of clinically active disease such as, but not limited to: neurological, renal, cardiovascular, endocrine, pulmonary, hepatic, hematological, immunological (including autoimmunities and immunodeficiencies), neoplastic or infectious disease. Psychiatric illness or cognitive impairment that, in the investigator's judgment, may affect the participant's ability to engage in the clinical trial following the established agenda. Alcohol abuse or use of illicit drugs in the last 12 months before recruitment has caused any family, medical, or professional problems. History of severe allergic reaction or anaphylaxis to any component of the vaccine. History of asplenia. Have participated in any other experimental clinical trial in the 12 months before inclusion or intend to participate in any experimental clinical trial in the 12 months following participation. Plans to participate in other clinical studies concurrently with this one. Use of some immunosuppressive therapy three months before recruitment or planning its use within three months after vaccination, including use of corticosteroids or other immunosuppressive medication (note: the immunosuppressive dose of corticosteroids is equivalent to 20 mg/day of prednisone per more than a week (topical or nasal corticosteroids are not considered immunosuppressive). Use of blood products (blood or immunoglobulins) within three months before inclusion or indication of their use during the study. Suspected active infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A, A2 e B: We expect to evaluate the safety and reactogenicity for spontaneous adverse events in the first 28 days and of 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;A: We 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.;B: We 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 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| A and A2: We expect to identify an increase in the levels of neutralizing antibodies induced by SpiN-Tec MCTI UFMG measured by the geometric mean of neutralizing antibody titers on days 14, 28, 90, 180, 270, and 360 after the booster with the SpiN- Tec MCTI UFMG against time 0, measured by post-baseline levels of neutralizing antibodies to the ancestral strain and each relevant VoCs.;A and A2: We expect to observe an increase in the average levels of anti-S, anti-RBD, and anti-N IgG antibodies, measured by the geometric mean (in U/mL), on days 14, 28, 90, 180, 270, and 360 after the booster with the SpiN-Tec MCTI UFMG vaccine compared to time 0 measured by post-baseline antibody levels will be calculated for each participant and each evaluated antigen.;A and A2: We expect to observe an increase in the geometric mean of IFNg levels (in pg/mL) produced by PBMCs in response to S and N antigens on days 14, 28, 90, 180, 270, and 360 after the SpiN-Tec vaccine booster MCTI UFMG compared to time 0 measured by post-baseline levels of antibodies calculated for each participant and for each evaluated antigen.;B: The SpiN-Tec MCTI UFMG vaccine is expected to show a Geometric Mean increase in neutralizing antibody titers, an increase in the levels of anti-S, anti-RBD, and anti-N IgG antibodies, and anti-VoCs IgG antibodies, and an increase in the geometric mean of the rise in IFNg levels produced by PBMCs stimulated with S and N antigens on days 14, 28, 90, 180, 270 and 360 after boosting with the SpiN-Tec MCTI UFMG vaccine compared to time 0 measured by ELISA assay. | — |
Countries
Brazil
Contacts
Public ContactHelton Santiago
Universidade Federal de Minas Gerais
Outcome results
None listed