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

NCT05303402 | Completed Phase 2 DMC

• 1 other identifier: HIPRA-HH-4
• Study Type: interventional
• Target: 241
• Locations: 2 countries
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• Immunogenicity against Omicron, Beta, Delta at Day 0 and Day 14

  Changes in neutralising antibodies measured by pseudovirus (or live virus for the HIV cohort\*) neutralization against Omicron, Beta and Delta any other relevant Variants of Concern (VOC) in the epidemiologic moment, at Baseline and at Day 14 after administration of HIPRA's vaccine (PHH-1V).

  Day 0 and Day 14

Secondary Outcomes (3)

• Immunogenicity against Omicron, Beta, Delta at Day 91, Day 182 and Day 365

  Day 91, Day 182 and Day 365

• Total antibodies

  Day 0, Day 14, Day 91, Day 182, Day 365

• Safety and tolerability of the booster vaccine

  Day 0, Day 14, Day 91, Day 182, Day 365

Other Outcomes (4)

• Number of SARS-CoV-2 infections

  Day 0, Day 14, Day 91, Day 182, Day 365

• Number of SARS-CoV-2 severe infections (Severe cases are considered as any episode of COVID-19 requiring ≥ 24hrs of hospitalization.)

  Day 0, Day 14, Day 91, Day 182, Day 365

• Celular immunity

  Day 0, Day 14, Day 91, Day 182, Day 365

Study Arms (1)

Experimental: COVID-19 Vaccine HIPRA 40 mcg/dose

EXPERIMENTAL

Intramuscular injection of HIPRA's COVID-19 vaccine, consisting of 40 mcg/dose.

Biological: PHH-1V

Interventions

PHH-1V BIOLOGICAL

COVID-19 Vaccine HIPRA, 40 mcg/dose

Experimental: COVID-19 Vaccine HIPRA 40 mcg/dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, female or transgender, ≥ 18 years old at Day 0.
• Provide inform consent form
• Participant who has:
• doses of mRNA vaccines
• doses of mRNA vaccines and previous COVID-19 infection
• doses of Coronavac and 1 Comirnaty, or, 1 Coronavac and 2 Comirnaty
• Participant who has:
• HIV infection with CD4 Tcells counts \<400
• Primary antibody deficiency disorders
• Kidney disease on dialysis
• Kidney transplant at least \>1 year
• Auto Immune Disease (AID) in treatment with rituximab
• For a female of childbearing potential, to have a negative pregnancy test at Day 0
• Use of any of these contraception:
• Female: hormonal contraception, intrauterine device, vasectomized partner, sexual abstinence, condom.

You may not qualify if:

• History of anaphylaxis to any prior vaccine
• Participants has received or plans to receive live attenuated vaccines, other not live vaccines, or Vaxzevria or Janssen vaccines.
• Pregnant or breast-feeding at Day 0.
• A confirmed COVID-19 diagnose \<90 days prior to vaccination day 0.
• A clinically significant acute illness or fever at screening or 48h before day 0.
• Participant had a surgery requiring hospitalisation and has not received the hospital discharge.
• Participant has an ongoing severe and non-stable psychiatric condition
• Participant has a problematic or risky use of substances including alcohol
• Participant has a bleeding disorder that contraindicates intramuscular injection
• Participant suffering from post-acute COVID-19 syndrome / long COVID
• Participant received any immunotherapy to prevent/treat COVID-19 in the last 90 days
• Participant is already participating in another research involving drug, biologics or device
• Participant has donated ≥450 ml of blood products within 12 weeks before screening
• Participant has any medical condition and/or finding that in the investigator opinion might increase participant risk, interfere with the study or impair interpretation of study data.

Sponsors & Collaborators

• Hipra Scientific, S.L.U: lead
• Veristat, Inc.: collaborator
• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: collaborator
• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: collaborator
• Asphalion: collaborator

Study Sites (6)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Josep Trueta

Girona, Girona, 17001, Spain

Location

Hacettepe University Medical Faculty Hospitals

Ankara, Ankara, 06230, Turkey (Türkiye)

Location

Ankara University Medical Faculty Hospitals

Ankara, Ankara, 06620, Turkey (Türkiye)

Location

Koc University Hospital

Istanbul, Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

HIPRA COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: March 31, 2022
• Study Start: May 12, 2022
• Primary Completion: July 29, 2023
• Study Completion: December 1, 2023
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); TU (3)