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

Hipra Scientific, S.L.U1 site in 1 country629 target enrollmentNovember 11, 2021

ConditionsCOVID-19 SARS-CoV-2 Acute Respiratory Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: COVID-19
Sponsor: Hipra Scientific, S.L.U
Enrollment: 629
Locations: 1
Primary Endpoint: Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 11, 2021

End Date

May 6, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hipra Scientific, S.L.U

Responsible Party

Sponsor

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).

Outcomes

Primary Outcomes

Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers

Time Frame: 30 weeks

Number and percentage of medically attended adverse events (MAAE) related to study vaccine throughout the study duration.

Secondary Outcomes

Immunogenicity to the SARS-CoV-2 spike glycoprotein at long-term(24 weeks after the second dose)
Immunogenicity(Day 21 and 35.)
Immunogenicity at long-term(24 weeks after the second dose)
Immunogenicity to the SARS-CoV-2 spike glycoprotein(Day 21 and 35.)