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

NCT05007509 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-03-01

No results posted yet for this study

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.

Conditions

  • Covid19
  • SARS CoV 2 Infection

Interventions

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

Sponsors & Collaborators

  • Laboratorios Hipra, S.A.

    lead INDUSTRY

Principal Investigators

  • Elia Torroella · Laboratorios Hipra, S.A.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-16
Primary Completion
2021-09-30
Completion
2022-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05007509 on ClinicalTrials.gov