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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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SARS CoV 2 Infection

Intervention / Treatment
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* Biological: PHH1-V


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: COVID-19 Vaccine HIPRA 40 mcg/dose<br>Intramuscular injection of HIPRA's COVID-19 vaccine, consisting of 40 mcg/dose. | Biological: PHH1-V<br>* COVID-19 Vaccine HIPRA, 40 mcg/dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Day 91, Day 182 and Day 365 | 
| 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). | Day 0, Day 14, Day 91, Day 182, Day 365 | 
| 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 | Day 0, Day 14, Day 91, Day 182, Day 365 |