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

Sponsor
Hipra Scientific, S.L.U (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05303402
Collaborator
Veristat, Inc. (Other), Asphalion (Other), Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia (Other), Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (Other)
400
Enrollment
6
Locations
1
Arm
17.3
Anticipated Duration (Months)
66.7
Patients Per Site
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A phase 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

Condition or Disease Intervention/Treatment Phase
  • Biological: PHH1-V
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Phase 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
Actual Study Start Date :
May 12, 2022
Anticipated Primary Completion Date :
Jul 20, 2023
Anticipated Study Completion Date :
Oct 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: COVID-19 Vaccine HIPRA 40 mcg/dose

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

Biological: PHH1-V
COVID-19 Vaccine HIPRA, 40 mcg/dose

Outcome Measures

Primary Outcome Measures

  1. Immunogenicity against Omicron, Beta, Delta at Day 0 and Day 14 [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).

Secondary Outcome Measures

  1. Immunogenicity against Omicron, Beta, Delta at Day 91, Day 182 and Day 365 [Day 91, Day 182 and Day 365]

    1. To determine and compare the changes of the immunogenicity measured by pseudovirus (or live virus for the HIV cohort) neutralization against Omicron, Beta and Delta and any other relevant Variants of Concern (VOC) in the epidemiologic moment at Days, 91, 182 and 365, after administration of HIPRA's vaccine (PHH-1V).

  2. Total antibodies [Day 0, Day 14, Day 91, Day 182, Day 365]

    To evaluate the immunogenicity measured by means of total antibody against Receptor Binding Domain of the Spike protein of SARS-CoV-2 quantification, measured by an electrochemiluminescence immunoassay (ECLIA) at Baseline and at Days 14, 91, 182 and 365 after administration of HIPRA's vaccine (PHH-1V).

  3. Safety and tolerability of the booster vaccine [Day 0, Day 14, Day 91, Day 182, Day 365]

    To assess the safety and tolerability of PHH-1V as an additional dose in adult individuals with pre-existing immunosuppressive conditions

Other Outcome Measures

  1. Number of SARS-CoV-2 infections [Day 0, Day 14, Day 91, Day 182, Day 365]

    Number of participants with SARS-CoV-2 infections ≥14 days after PHH-1V administration.

  2. 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]

    Number of COVID-19 severe infections ≥14 days after PHH-1V administration.

  3. Celular immunity [Day 0, Day 14, Day 91, Day 182, Day 365]

    Antibody IgG subclasses titre usage and avidity of humoral immunity at Baseline and Days 14, 91, 182 and 365.

  4. T-cell cellullar immunity [Day 0, Day 14, Day 91, Day 182, Day 365]

    T-cell mediated phenotype polyclonality with potential cross-reactivity capacity and gene-expression profiles against the SARS-CoV-2 Spike & RBD proteins at Baseline and at Days 14, 91, 182 and 365 in a subset of 50% of participants.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male, female or transgender, ≥ 18 years old at Day 0.

  • Provide inform consent form

  • Participant who has:

  • 3 doses of mRNA vaccines

  • 2 doses of mRNA vaccines and previous COVID-19 infection

  • 2 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.

  • Male: Vasectomized participant, sexual abstinence, condom.

Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Germans Trias i Pujol Badalona Barcelona Spain 08916
2 Hospital Clínic de Barcelona Barcelona Spain 08036
3 Hospital Josep Trueta Girona Spain 17001
4 Hacettepe University Medical Faculty Hospitals Ankara Turkey 06230
5 Ankara University Medical Faculty Hospitals Ankara Turkey 06620
6 Koc University Hospital Istanbul Turkey 34010

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hipra Scientific, S.L.U
ClinicalTrials.gov Identifier:
NCT05303402
Other Study ID Numbers:
  • HIPRA-HH-4
First Posted:
Mar 31, 2022
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Jun 27, 2022