Safety and Immunogenicity of Recombinant Protein RBD Fusion Dimer Vaccine Against the Virus That Cause COVID-19, Known as Severe Acute Respiratoy Syndrome Coronavirus 2 (SARS-CoV-2)

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 with grade 2 or above 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.

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.

What this study is about