COVID-19, SARS-CoV-2 Acute Respiratory Disease
Conditions
Brief summary
This is a Phase IIb, randomized, controlled, observer-blinded, clinical trial to evaluate safety and immunogenicity of COVID-19 Vaccine HIPRA in adult healthy volunteers in Vietnam
Detailed description
The study population includes 256 healthy adults aged 18-60 which will be randomized in a ratio 1:1 test:commercial vaccine. Each participant will receive 2 immunisations separated by 21 days and will be followed for 24 weeks after the second dose.
Interventions
BIOLOGICALCOVID-19 Vaccine HIPRA
Subjects will receive 2 injections of COVID-19 vaccine HIPRA administered 21 days apart
BIOLOGICALCominarty (Pfizer-BioNtech)
Subjects will receive 2 injections of Cominarty administered 21 days apart
Sponsors
Laboratorios Hipra, S.A.
National Institute of Hygiene and Epidemiology, Vietnam
Hipra Scientific, S.L.U
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults males or females between 18-60 years of age at the day of screening. * Willing and able to comply with scheduled visits, laboratory test, complete diaries and other study procedures. * Body Mass Index 18 to 40 Kg/m2 at screening. * COVID19 negative quick test or PCR test and negative serum IgG binding antibody response to the SARS-CoV-2 S glycoprotein at screening or prior the first vaccination. If an enrolled subject has neutralizing antibodies at baseline, he or she will be excluded from final analysis. * 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. * Women of childbearing potential must have a negative pregnancy test in urine before the inclusion of the study and prior to each vaccination. * 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. * If male and not sterilized, willing to avoid impregnating female partners from screening until 8 weeks after last injection. * Willing and able to provide written informed consent prior the initiation of any study procedures.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers | 7 days | Number and percentage of solicited local and systemic reactogenicity adverse events for 7 days following each vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | Day 21 and 35. | Neutralization titer for each individual sample and GMT for group comparison at Day 21 and 35. |
| Immunogenicity at long-term | 24 and 48 weeks after the second dose | Neutralization titer for each individual sample and GMT for group comparison at 24 and 48 weeks after the second dose. |
| Immunogenicity to the SARS-CoV-2 spike glycoprotein | Day 21 and 35 | Total binding antibody titer and GMT for group comparison at Day 21 and 35. |
| Immunogenicity to the SARS-CoV-2 spike glycoprotein at long-term | 24 weeks after the second dose | Total Binding antibody titer and GMT for group comparison at 24 weeks after the second dose. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with symptomatic SARS-CoV-2 infections in participants without evidence of infection before COVID-19 HIPRA vaccination. | 30 weeks | Number and percentage of subjects with symptomatic SARS-CoV-2 infections according to COVID-19 infection criteria. |
| Number of COVID-19 severe infections after receiving COVID-19 HIPRA vaccine. | 30 weeks | Number and percentage of COVID-19 severe infections throughout the study duration. |
Countries
Vietnam
Outcome results
None listed