A phase I/IIa study to evaluate safety and immunogenicity of recombinant protein RBD fusion dimer candidate vaccine against SARS-CoV-2 in adult healthy volunteers.

ABORATORIOS HIPRA, S.A.0 sites30 target enrollmentJune 22, 2021

ConditionsSARS-CoV-2 MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862 Therapeutic area: Diseases [C] - Virus Diseases [C02]

DrugsComirnaty

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: SARS-CoV-2
Sponsor: ABORATORIOS HIPRA, S.A.
Enrollment: 30
Status: Active, Not Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 22, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ABORATORIOS HIPRA, S.A.

Eligibility Criteria

Inclusion Criteria

•1\. Adults males or females between 18\-39 years of age at the day of screening.
•2\. Willing and able to comply with scheduled visits, laboratory test, complete diaries and other study procedures.
•3\. Body Mass Index 18 to 40 Kg/m2 at screening.
•4\. 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.
•5\. 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.
•6\. Women of childbearing potential must have a negative pregnancy test in urine before the inclusion of the study and prior to each vaccination.
•7\. 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. Highly effective contraceptive methods will include: oral, intravaginal or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable or implantable progestogen\-only hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone\-releasing system; bilateral tubal occlusion; vasectomized partner and sexual abstinence.
•8\. If male and not sterilized, willing to avoid impregnating female partners from screening until 8 weeks after last injection.
•9\. Willing and able to provide written informed consent prior the initiation of any study procedures.
•Are the trial subjects under 18? no

Exclusion Criteria

•1\. Pregnant or lactating or intending to become pregnant or plans to breastfeed during the study.
•2\. Positive pregnancy test at screening or prior to each vaccination.
•3\. 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.
•4\. 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).
•5\. 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.
•6\. 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.
•7\. 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).
•8\. 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.
•9\. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections.
•10\. Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital).