Clinical trial NCT05142514: Safety and Immunogenicity of Recombinant Protein RBD Fusion Dimer Vaccine Against the Virus That Cause COVID-19, Known as Severe Acute Respiratoy Syndrome Coronavirus 2 (SARS-CoV-2)
Official title: A Phase IIb Study to Evaluate Safety and Immunogenicity of Recombinant Protein RBD Fusion Dimer Candidate Vaccine Against the Virus That Cause COVID-19, Known as Severe Acute Respiratoy Syndrome Coronavirus 2 (SARS-CoV-2) in Adult Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
SARS-CoV-2 Acute Respiratory Disease
Lead sponsor: Hipra Scientific, S.L.U
Sponsor class: INDUSTRY
Collaborators: name: Laboratorios Hipra, S.A.
name: National Institute of Hygiene and Epidemiology, Vietnam
First posted: 2021-12-02
Enrollment: 629
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
timeFrame: 7 days
measure: Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
timeFrame: 28 days
measure: Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
timeFrame: 7 days
measure: Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
timeFrame: 30 weeks
measure: Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
timeFrame: 30 weeks
measure: Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
timeFrame: 30 weeks
Secondary outcomes:
measure: Immunogenicity
timeFrame: Day 21 and 35.
measure: Immunogenicity
timeFrame: Day 21 and 35.
measure: Immunogenicity
timeFrame: Day 21 and 35.
measure: Immunogenicity at long-term
timeFrame: 24 and 48 weeks after the second dose
measure: Immunogenicity at long-term
timeFrame: 24 weeks after the second dose
measure: Immunogenicity at long-term
timeFrame: 24 weeks after the second dose
measure: Immunogenicity to the SARS-CoV-2 spike glycoprotein
timeFrame: Day 21 and 35
measure: Immunogenicity to the SARS-CoV-2 spike glycoprotein
timeFrame: Day 21 and 35
measure: Immunogenicity to the SARS-CoV-2 spike glycoprotein at long-term
timeFrame: 24 weeks after the second dose
measure: Immunogenicity to the SARS-CoV-2 spike glycoprotein at long-term
timeFrame: 24 weeks after the second dose
measure: Immunogenicity to the SARS-CoV-2 spike glycoprotein
timeFrame: Day 21 and 35.
Other outcomes:
measure: Number of participants with symptomatic SARS-CoV-2 infections in participants without evidence of infection before COVID-19 HIPRA vaccination.
timeFrame: 30 weeks
measure: Number of COVID-19 severe infections after receiving COVID-19 HIPRA vaccine.
timeFrame: 30 weeks
measure: Number of COVID-19 severe infections after receiving COVID-19 HIPRA vaccine.
timeFrame: 30 weeks
measure: Number of COVID-19 severe infections after receiving COVID-19 HIPRA vaccine.
timeFrame: 30 weeks
measure: Number of COVID-19 severe infections after receiving COVID-19 HIPRA vaccine.
timeFrame: 30 weeks
Locations:
city: Hanoi
country: Vietnam
facility: National Institute of Hygiene and Epidemiology
Study officials:
References: