SARS CoV 2 Infection
Conditions
Brief summary
A phase IIb/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
Interventions
BIOLOGICALPHH-1V
COVID-19 Vaccine HIPRA, 40 mcg/dose
Sponsors
Veristat, Inc.
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
Asphalion
Hipra Scientific, S.L.U
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Spain, Turkey (Türkiye)
Outcome results
None listed