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Immunogenicity and Safety of a Booster Vaccination With a Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Healthy Adults Volunteers Fully Vaccinated Followed by an Extension Period to Study a Fourth Dose Administration.

NCT05142553 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 887

Last updated 2026-03-11

No results posted yet for this study

Summary

This Phase IIb clinical study aims to compare the immunogenicity and safety of a booster dose of recombinant protein RBD fusion dimer vaccine as a heterologous booster (to subjects who have received the second dose of the Pfizer-BioNTech (Comirnaty) COVID-19 vaccine at least 182 days prior to the booster dose in this study) versus a homologous booster (subjects who received the second dose of the Comirnaty COVID-19 vaccine at least 182 days prior to the booster dose in this study) will receive a third dose of the Comirnaty vaccine).

The extension part of the study aims to compare the immunogenicity and safety of a fourth dose of PHH-1V in subjects with a primovaccination with Pfizer-BioNTech (Comirnaty) COVID-19 vaccine plus either a booster dose of Comirnaty or PHH-1V versus those with three vaccinations of Comirnaty.

Conditions

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

Interventions

BIOLOGICAL

COVID-19 Vaccine HIPRA

Subjects will receive one injection of COVID-19 Vaccine HIPRA

BIOLOGICAL

Cominarty (Pfizer-BioNtech)

Subjects will receive one injection of Cominarty Vaccine

Sponsors & Collaborators

  • Laboratorios Hipra, S.A.

    collaborator INDUSTRY

  • Hipra Scientific, S.L.U

    lead INDUSTRY

Principal Investigators

  • Teresa Prat · HIPRA SCIENTIFIC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-16
Primary Completion
2023-05-29
Completion
2023-05-29

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT05142553 on ClinicalTrials.gov