safety and immunogenicity study of recombinant protein rbd candidate vaccine against sars-cov-2 in adult healthy volunteers (covid-19)

Conditions: Covid19; SARS CoV 2 Infection

Summary: this is a first-in-human, phase i/iia, randomized, controlled, observer-blinded, dose-escalation, multicentre clinical trial to evaluate safety and immunogenicity of covid-19 hipra vaccine in adult healthy volunteers.

the study population includes 30 healthy adults aged 18-39 which will be distributed in 3 cohorts, receiving three different doses of antigen, 10 µg, 20 µg and 40 µg. in each cohort, patients will be randomized in ratio of 10:2 test:commercial vaccine, following an staggered enrolment with a sentinel subject in each cohort. each participant will receive 2 immunisations separated by 21 days, and will be followed for 48 weeks after the second dose

Eligibility criteria:
inclusion criteria: * adults males or females between 18-39 years of age at the day of screening. * willing and able to comply with scheduled visits, laboratory test, complete diaries and other study procedures. * body mass index 18 to 40 kg/m2 at screening. * covid19 negative pcr test and negative serum igg binding antibody response to the sars-cov-2 s glycoprotein at screening or prior the first vaccination. * willing to avoid all other vaccines within 4 weeks before and after each injection. seasonal influenza vaccination is allowed if it is received at least 14 days before or after the vaccination. * women of childbearing potential must have a negative pregnancy test in urine before the inclusion of the study and prior to each vaccination. * if female of childbearing potential, willing to use highly effective contraceptive methods or have practiced sexual abstinence from the screening visit until 8 weeks after the last injection. * if male and not sterilized, willing to avoid impregnating female partners from screening until 18 weeks after last injection. * willing and able to provide written informed consent prior the initiation of any study procedures. exclusion criteria: * pregnant or lactating or intending to become pregnant or plans to breastfeed during the study. * positive pregnancy test at screening or prior to each vaccination. * any medical disease (acute, subacute, intermittent or chronic) or condition that in the opinion of the investigator compromise the volunteer's safety, preclude vaccination or compromise interpretation of the results. * history of serious psychiatric condition likely to affect participation in the study (e-g- ongoing severe depression, history of admission to an in-patient psychiatric facility, recent suicidal ideation, history of suicide attempt, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication). * history of respiratory disease (e.g., chronic obstructive pulmonary disease (copd) and asthma) requiring any daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years. * history of significant cardiovascular disease including hypertension (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult. * history of neurological or neurodevelopmental conditions (e.g., migraines, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, guillain-barré syndrome, encephalomyelitis or transverse myelitis). * ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed. * any confirmed or suspected immunosuppressive or immunodeficient state, including hiv infection; asplenia; recurrent severe infections. * any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital). * acute illness within 72 hours prior each vaccination that in the opinion of the investigator may interfere the evaluation of safety parameters. * usage of any investigational drug ≤ 90 days prior to study entry or plan to participate in another research involving an investigational product (drug/biologic/device) within 12 months after the first study vaccination. * history of hypersensitivity or severe allergic reaction including anaphylaxis, generalized urticarial, angioedema and other significant reactions related to food, drugs, vaccines or pharmaceutical agents. * history of allergic disease or reactions likely to be exacerbated by any component of the covid-19 vaccine hipra. * use of any immunosuppressant, glucocorticoids, or other immune-modifying drugs within 2 months prior to first study vaccination; or anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. * received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination. * known disturbance of coagulation (iatrogenic or congenital) or blood dyscrasias. * known bleeding disorder (e-g- factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following im injections or venepuncture. * chronic liver disease. * positive test for hiv types 1 or 2 infection, hepatitis b surface antigen (hbsag), or hepatitis c virus antibodies (hcv abs) at screening. * suspected or known current alcohol abuse or any other substances abuse (except tobacco). * history of covid-19 infection. * receipt of medications intended to prevent covid-19. * ever received an experimental vaccine against covid-19. * close contact of anyone known to have sars-cov-2 infection within 15 days prior to screening visit. * being directly involved in the conduct of the study. * any condition and/or laboratory finding that at the investigator consideration would interfere with the study or put at risk the participant.