SARS-CoV-2 MedDRA version: 23.0 Level: LLT Classification code 10084272 Term: SARS-CoV-2 infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: PHH-1V
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: PHH-1V
Other descriptive name: PHH-1V
Concentration unit: µg microgram(s)
Concentration type: range
Concentration
Sponsors
LABORATORIOS HIPRA, S.A.
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
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). 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1.1 Number and percentage of solicited local and systemic reactogenicity adverse events for 7 days following each vaccination. 1.2 Number and percentage of unsolicited local and systemic reactogenicity adverse events for 28 days following each vaccination. Local solicited reactions will be collected as pain, tenderness, erythema/redness, and induration/swelling. Systemic solicited events will be collected as fever, nausea/vomiting, diarrhoea, headache, fatigue and myalgia;Timepoint(s) of evaluation of this end point: 7 and 28 days;Main Objective: To assess safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers. Safety will be measured by solicited and unsolicited reactions (local and systemic) following each dose vaccination.;Secondary Objective: 1.Overall safety of COVID-19 HIPRA vaccine. 2.Immunogenicity measured by wild-type and pseudovirus neutralization at baseline and 3-weeks after the first dose and 2-weeks after the second dose of vaccine. 3.Immunogenicity measured by wild-type and pseudovirus neutralization at long-term, i.e. 12, 24 and 48 weeks after the second dose of vaccine. 4.Immunogenicity measured by enzyme-linked immunosorbent assay (ELISA) to the SARS-CoV-2 spike glycoprotein at baseline and 3-weeks after the first dose and 2-weeks after the second dose of vaccine. 5.Immunogenicity measured by enzyme-linked immunosorbent assay (ELISA) to the SARS-CoV-2 spike glycoprotein at long-term, i.e. 12, 24 and 48 weeks after the second dose of vaccine. 6.T-cell mediated responses against the SARS-CoV-2 S glycoprotein at baseline and 2-weeks after the second dose of vaccine. 7.Th-1/Th-2 T-cell mediated responses against the SARS-CoV-2 S glycoprotein at baseline and 2-weeks after the second dose of vaccine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.1 Change from baseline in safety laboratory parameters at 7 days following each vaccination. 1.2 Number and percentage of serious adverse events throughout the study duration. 1.3 Number and percentage of adverse events of special interest (AESI) throughout the study duration. 1.4 Number and percentage of medically attended adverse events (MAAE) related to study vaccine throughout the study duration. 2.1 Neutralization titer measured as ID50 or IC50 and reported as reciprocal dilution/concentration for each individual sample, and GMT for group comparison at Day 21 and 35. ID50 measured by VNA and IC50 measured by PBNA. 2.2 Geometric mean fold rise (GMFR) in neutralizing antibodies titers from baseline at Day 21 and 35. 3.1 Neutralization titer measured as ID50 or IC50 and reported as reciprocal dilution/concentration for each individual sample, and GMT for group comparison at 12, 24 and 48 weeks after the second dose. ID50 measured by VNA and IC50 measured by PBNA. 3.2 GMFR in neutralizing antibodies titers from baseline at 12, 24 and 48 weeks after the second dose. 4.1 Binding antibody titer measured for each individual sample and GMT for group comparison at Day 21 and 35. 4.2 GMFR in binding antibody titer from baseline at Day 21 and 35. 5.1 Binding antibody titer measured for each individual sample and GMT for group comparison at 12, 24 and 48 weeks after the second dose. 5.2 GMFR in binding antibody titer from baseline at 12, 24 and 48 weeks after the second dose. 6.1 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. 7.1 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.;Timepoint(s) of evaluation of this end point: Days 21, 28 and 35. 12, 24 and 48 weeks after the second dose. | — |
Countries
Spain
Contacts
Public ContactR&D and Regulatory Affairs Director
LABORATORIOS HIPRA, S.A.
Outcome results
None listed