Clinical trial NCT05303402: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: SARS CoV 2 Infection
Lead sponsor: Hipra Scientific, S.L.U
Sponsor class: INDUSTRY
Collaborators: name: Veristat, Inc.
name: Asphalion
name: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
name: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
First posted: 2022-03-31
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Immunogenicity against Omicron, Beta, Delta at Day 0 and Day 14
timeFrame: Day 0 and Day 14
Secondary outcomes:
measure: Immunogenicity against Omicron, Beta, Delta at Day 91, Day 182 and Day 365
timeFrame: Day 91, Day 182 and Day 365
measure: Total antibodies
timeFrame: Day 0, Day 14, Day 91, Day 182, Day 365
measure: Safety and tolerability of the booster vaccine
timeFrame: Day 0, Day 14, Day 91, Day 182, Day 365
Other outcomes:
measure: Number of SARS-CoV-2 infections
timeFrame: Day 0, Day 14, Day 91, Day 182, Day 365
measure: Number of SARS-CoV-2 severe infections (Severe cases are considered as any episode of COVID-19 requiring ≥ 24hrs of hospitalization.)
timeFrame: Day 0, Day 14, Day 91, Day 182, Day 365
measure: Celular immunity
timeFrame: Day 0, Day 14, Day 91, Day 182, Day 365
measure: T-cell cellullar immunity
timeFrame: Day 0, Day 14, Day 91, Day 182, Day 365
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Girona
country: Spain
facility: Hospital Josep Trueta
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty Hospitals
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty Hospitals
city: Istanbul
country: Turkey
facility: Koc University Hospital
Study officials:
References: