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A Phase IIb/III Clinical Trial to Assess Safety and Immunogenicity of a COVID-19 Vaccine Booster Dose in Immunosupressed Adults.

NCT05303402 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2025-09-16

No results posted yet for this study

Summary

A phase IIb/III, open label, single arm, multi-centre, trial to assess the immunogenicity and safety of an additional dose vaccination with a recombinant protein RBD fusion heterodimer candidate (PHH-1V) against SARS-CoV-2, in adults with pre-existing immunosuppressive conditions vaccinated against COVID-19

Conditions

  • SARS CoV 2 Infection

Interventions

BIOLOGICAL

PHH-1V

COVID-19 Vaccine HIPRA, 40 mcg/dose

Sponsors & Collaborators

  • Veristat, Inc.

    collaborator OTHER

  • Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

    collaborator OTHER

  • Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

    collaborator OTHER

  • Asphalion

    collaborator UNKNOWN

  • Hipra Scientific, S.L.U

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2023-07-29
Completion
2023-12-01

Countries

  • Spain
  • Turkey (Türkiye)

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 NCT05303402 on ClinicalTrials.gov