Safety and Immunogenicity Study of Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Adult Healthy Volunteers (COVID-19)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: COVID-19 vaccine HIPRA Subjects will receive 2 injections of COVID-19 vaccine HIPRA administered 21 days apart. |
Biological: COVID-19 vaccine HIPRA 10
One sentinel subject and 4 additional subjects will be assigned to COVID-19 vaccine HIPRA 10 µg
Other Names:
Biological: COVID-19 vaccine HIPRA 20
One sentinel subject and 9 additional subjects will be assigned to COVID-19 vaccine HIPRA 20 µg
Other Names:
Biological: COVID-19 vaccine HIPRA 40
One sentinel subject and 9 additional subjects will be assigned to COVID-19 vaccine HIPRA 40 µg
Other Names:
|
| Active Comparator: Commercial COVID-19 vaccine Subjects will receive 2 injections of commercial COVID-19 vaccine administered 21 days apart. |
Biological: Commercial COVID-19 vaccine
One subject in cohort 1 and 2 subjects in Cohort 2 and 3 will be assigned to Commercial COVID-19 vaccine
|
Outcome Measures
Primary Outcome Measures
- Number and percentage of solicited local and systemic reactogenicity adverse events for 7 days following each vaccination. [7 days]
- Number and percentage of unsolicited local and systemic reactogenicity adverse events for 28 days following each vaccination. [28 days]
Secondary Outcome Measures
- Change from baseline in hematology and biochemistry laboratory values at 7 days following each vaccination [7 days]
- Number and percentage of serious adverse events throughout the study duration. [357 days]
- Number and percentage of adverse events of special interest (AESI) throughout the study [357 days]
- Number and percentage of medically attended adverse events (MAAE) related to study vaccine throughout the study duration [357 days]
- Neutralization titer measured as Inhibitory concentration 50 (IC50) for each individual sample and geometric mean titer (GMT) for group comparison at Day 21 and 35 [Day 21 and 35]
- Geometric mean fold rise (GMFR) in neutralizing antibodies titers from baseline at Day 21 and 35. [Day 21 and 35]
- Neutralization titer measured as IC50 for each individual sample and GMT for group comparison at 24 and 48 weeks after the second dose [week 27 and week 51]
- GMFR in neutralizing antibodies titers from baseline at 24 and 48 weeks after the second dose. [week 27 and week 51]
- Binding antibody IgG titer measured for each individual sample and GMT for group comparison at Day 21 and 35 [Day 21 and 35]
- GMFR in IgG titer from baseline at Day 21 and 35 [Day 21 and 35]
- Binding antibody IgG titer measured for each individual sample and GMT for group comparison at 24 and 48 weeks after the second dose. [week 27 and week 51]
- GMFR in IgG titer from baseline at 24 and 48 weeks after the second dose [week 27 and week 51]
- T-cell-mediated response to the SARS-CoV-2 S protein as measured by whole PBMC stimulation by ELISpot at baseline and at Day 35. [Day 35]
- CD4+/CD8+ T-cell response to the SARS-CoV-2 S protein as measured by in vitro PBMC stimulation by cytokine staining assays at baseline and at Day 35 [Day 35]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults males or females between 18-39 years of age at the day of screening.
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Willing and able to comply with scheduled visits, laboratory test, complete diaries and other study procedures.
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Body Mass Index 18 to 40 Kg/m2 at screening.
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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.
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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.
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Women of childbearing potential must have a negative pregnancy test in urine before the inclusion of the study and prior to each vaccination.
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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.
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If male and not sterilized, willing to avoid impregnating female partners from screening until 18 weeks after last injection.
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Willing and able to provide written informed consent prior the initiation of any study procedures.
Exclusion Criteria:
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Pregnant or lactating or intending to become pregnant or plans to breastfeed during the study.
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Positive pregnancy test at screening or prior to each vaccination.
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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.
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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).
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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.
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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.
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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).
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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.
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Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections.
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Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital).
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Acute illness within 72 hours prior each vaccination that in the opinion of the investigator may interfere the evaluation of safety parameters.
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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.
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History of hypersensitivity or severe allergic reaction including anaphylaxis, generalized urticarial, angioedema and other significant reactions related to food, drugs, vaccines or pharmaceutical agents.
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History of allergic disease or reactions likely to be exacerbated by any component of the COVID-19 vaccine HIPRA.
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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.
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Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination.
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Known disturbance of coagulation (iatrogenic or congenital) or blood dyscrasias.
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Known bleeding disorder (e-g- factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
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Chronic liver disease.
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Positive test for HIV types 1 or 2 infection, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV Abs) at screening.
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Suspected or known current alcohol abuse or any other substances abuse (except tobacco).
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History of COVID-19 infection.
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Receipt of medications intended to prevent COVID-19.
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Ever received an experimental vaccine against COVID-19.
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Close contact of anyone known to have SARS-CoV-2 infection within 15 days prior to screening visit.
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Being directly involved in the conduct of the study.
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Any condition and/or laboratory finding that at the investigator consideration would interfere with the study or put at risk the participant.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clínic de Barcelona | Barcelona | Spain | 08036 | |
| 2 | Hospital Universitari Dr. Josep Trueta | Girona | Spain | 17007 |
Sponsors and Collaborators
- Laboratorios Hipra, S.A.
Investigators
- Study Chair: Elia Torroella, Laboratorios Hipra, S.A.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HIPRA-HH-1
- 2021-001411-82