A Phase I/IIa Study to Evaluate Safety and Immunogenicity of Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Adult Healthy Volunteers

Laboratorios Hipra, S.A.2 sites in 1 country30 target enrollmentAugust 16, 2021

ConditionsCovid19 SARS CoV 2 Infection

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Covid19
Sponsor: Laboratorios Hipra, S.A.
Enrollment: 30
Locations: 2
Primary Endpoint: Number and percentage of solicited local and systemic reactogenicity adverse events for 7 days following each vaccination.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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

Registry

clinicaltrials.gov

Start Date

August 16, 2021

End Date

September 30, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Laboratorios Hipra, S.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adults males or females between 18-39 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 PCR test and negative serum IgG binding antibody response to the SARS-CoV-2 S glycoprotein at screening or prior the first vaccination.
•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 18 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 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 (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).
•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

Number and percentage of solicited local and systemic reactogenicity adverse events for 7 days following each vaccination.

Time Frame: 7 days

Number and percentage of unsolicited local and systemic reactogenicity adverse events for 28 days following each vaccination.

Time Frame: 28 days

Secondary Outcomes

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)
Change from baseline in hematology and biochemistry laboratory values at 7 days following each vaccination(7 days)
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)
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)