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

Primary Purpose

SARS CoV 2 Infection

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PHH1-V
Sponsored by
Hipra Scientific, S.L.U
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS CoV 2 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Germans Trias i PujolRecruiting
  • Hospital Clínic de BarcelonaRecruiting
  • Hospital Josep TruetaRecruiting
  • Hacettepe University Medical Faculty Hospitals
  • Ankara University Medical Faculty Hospitals
  • Koc University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: COVID-19 Vaccine HIPRA 40 mcg/dose

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Immunogenicity against Omicron, Beta, Delta at 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).
Total antibodies
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).
Safety and tolerability of the booster vaccine
To assess the safety and tolerability of PHH-1V as an additional dose in adult individuals with pre-existing immunosuppressive conditions

Full Information

First Posted
March 28, 2022
Last Updated
June 21, 2022
Sponsor
Hipra Scientific, S.L.U
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT05303402
Brief Title
A Phase III Clinical Trial to Assess Safety and Immunogenicity of a COVID-19 Vaccine Booster Dose in Immunosupressed Adults.
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
July 20, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hipra Scientific, S.L.U
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS CoV 2 Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: COVID-19 Vaccine HIPRA 40 mcg/dose
Arm Type
Experimental
Arm Description
Intramuscular injection of HIPRA's COVID-19 vaccine, consisting of 40 mcg/dose.
Intervention Type
Biological
Intervention Name(s)
PHH1-V
Intervention Description
COVID-19 Vaccine HIPRA, 40 mcg/dose
Primary Outcome Measure Information:
Title
Immunogenicity against Omicron, Beta, Delta at Day 0 and Day 14
Description
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).
Time Frame
Day 0 and Day 14
Secondary Outcome Measure Information:
Title
Immunogenicity against Omicron, Beta, Delta at Day 91, Day 182 and Day 365
Description
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).
Time Frame
Day 91, Day 182 and Day 365
Title
Total antibodies
Description
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).
Time Frame
Day 0, Day 14, Day 91, Day 182, Day 365
Title
Safety and tolerability of the booster vaccine
Description
To assess the safety and tolerability of PHH-1V as an additional dose in adult individuals with pre-existing immunosuppressive conditions
Time Frame
Day 0, Day 14, Day 91, Day 182, Day 365
Other Pre-specified Outcome Measures:
Title
Number of SARS-CoV-2 infections
Description
Number of participants with SARS-CoV-2 infections ≥14 days after PHH-1V administration.
Time Frame
Day 0, Day 14, Day 91, Day 182, Day 365
Title
Number of SARS-CoV-2 severe infections (Severe cases are considered as any episode of COVID-19 requiring ≥ 24hrs of hospitalization.)
Description
Number of COVID-19 severe infections ≥14 days after PHH-1V administration.
Time Frame
Day 0, Day 14, Day 91, Day 182, Day 365
Title
Celular immunity
Description
Antibody IgG subclasses titre usage and avidity of humoral immunity at Baseline and Days 14, 91, 182 and 365.
Time Frame
Day 0, Day 14, Day 91, Day 182, Day 365
Title
T-cell cellullar immunity
Description
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.
Time Frame
Day 0, Day 14, Day 91, Day 182, Day 365

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Prat, Dr.
Phone
+34 972 430660
Email
teresa.prat@hipra.com
Facility Information:
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatriz Mothe, Dr.
Email
bmothe@irsicaixa.es
First Name & Middle Initial & Last Name & Degree
Beatriz Mothe, Dr.
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Soriano, Dr.
Email
asoriano@clinic.cat
First Name & Middle Initial & Last Name & Degree
Alex Soriano, Dr.
Facility Name
Hospital Josep Trueta
City
Girona
ZIP/Postal Code
17001
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoni Castro, Dr
Email
acastro.girona.ics@gencat.cat
First Name & Middle Initial & Last Name & Degree
Antoni Castro, Dr.
Facility Name
Hacettepe University Medical Faculty Hospitals
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serhat Ünal, Dr.
First Name & Middle Initial & Last Name & Degree
Serhat Ünal, Dr.
Facility Name
Ankara University Medical Faculty Hospitals
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alpay Azap, Dr.
First Name & Middle Initial & Last Name & Degree
Alpay Azap, Dr.
Facility Name
Koc University Hospital
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Önder Ergönül, Dr.
First Name & Middle Initial & Last Name & Degree
Önder Ergönül, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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