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)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 629 (actual)
• Sponsor: Hipra Scientific, S.L.U · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19
• SARS-CoV-2 Acute Respiratory Disease

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 Vaccine HIPRA	Subjects will receive 2 injections of COVID-19 vaccine HIPRA administered 21 days apart
BIOLOGICAL	Cominarty (Pfizer-BioNtech)	Subjects will receive 2 injections of Cominarty administered 21 days apart

Timeline

• Start date: 2021-11-11
• Primary completion: 2021-12-27
• Completion: 2022-05-06
• First posted: 2021-12-02
• Last updated: 2024-02-26

Locations

1 site across 1 country: Vietnam