A phase I study to evaluate safety and immunogenicity of recombinant protein candidate vaccine against SARS-CoV-2 in healthy volunteers.
- Conditions
- SARS-CoV-2MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-001411-82-ES
- Lead Sponsor
- ABORATORIOS HIPRA, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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).
NOTE: Mild psoriasis, well controlled autoimmune thyroid disease, vitiligo, stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy and any stable endocrine disorders that have a confirmed autoimmune aetiology (e.g., thyroid, pancreatic), including stable diet-controlled diabetes will be permitted at the discretion of the investigator.
11. Acute illness within 72 hours prior each vaccination that in the opinion of the investigator may interfere the evaluation of safety parameters.
12. 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.
13. History of hypersensitivity or severe allergic reaction including anaphylaxis, generalized urticarial, angioedema and other significant reactions related to food, drugs, vaccines or pharmaceutical agents.
14. History of allergic disease or reactions likely to be exacerbated by any component of the COVID-19 vaccine HIPRA (including the oil in water adjuvant ).
15. 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.
NOTE: The use of topical, inhaled, and nasal routes are not permitted.
16. Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination.
17. Known disturbance of coagulation (iatrogenic or congenital) or blood dyscrasias.
18. Known bleeding disorder
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method