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

Phase 3

Completed

• Conditions: SARS CoV 2 Infection
• Interventions: Biological: PHH1-V

• Registration Number: NCT05303402
• Lead Sponsor: Hipra Scientific, S.L.U

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-03-28
• Study First Posted: 2022-03-31
• Study Start: 2022-05-12
• Primary Completion: 2023-07-29
• Study Completion: 2023-12-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: COVID-19 Vaccine HIPRA 40 mcg/dose	PHH1-V	Intramuscular injection of HIPRA's COVID-19 vaccine, consisting of 40 mcg/dose.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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).
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

Trial Locations

Locations (6)

Koc University Hospital; 🇹🇷 Istanbul, Turkey

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Hacettepe University Medical Faculty Hospitals; 🇹🇷 Ankara, Turkey

Ankara University Medical Faculty Hospitals; 🇹🇷 Ankara, Turkey

Hospital Josep Trueta; 🇪🇸 Girona, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain