NCT05007509

Safety and Immunogenicity Study of Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Adult Healthy Volunteers (COVID-19)

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Laboratorios Hipra, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Covid19
• SARS CoV 2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 vaccine HIPRA 10	One sentinel subject and 4 additional subjects will be assigned to COVID-19 vaccine HIPRA 10 µg
BIOLOGICAL	COVID-19 vaccine HIPRA 20	One sentinel subject and 9 additional subjects will be assigned to COVID-19 vaccine HIPRA 20 µg
BIOLOGICAL	COVID-19 vaccine HIPRA 40	One sentinel subject and 9 additional subjects will be assigned to COVID-19 vaccine HIPRA 40 µg
BIOLOGICAL	Commercial COVID-19 vaccine	One subject in cohort 1 and 2 subjects in Cohort 2 and 3 will be assigned to Commercial COVID-19 vaccine

Timeline

• Start date: 2021-08-16
• Primary completion: 2021-09-30
• Completion: 2022-09-30
• First posted: 2021-08-16
• Last updated: 2023-03-01

Locations

2 sites across 1 country: Spain