Clinical trial NCT05246137: A Phase III Trial to Assess the Safety and Immunogenicity of a HIPRA's Candidate Booster Vaccination Against COVID-19.
Official title: A Phase III, Open Label, Single Arm, Multi-centre, Trial to Assess the Safety and Immunogenicity of a Booster Vaccination With a Recombinant Protein RBD Fusion Heterodimer Candidate (PHH-1V) Against SARS-CoV-2, in Adults Vaccinated Against COVID-19.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
SARS-CoV-2 Acute Respiratory Disease
Lead sponsor: Hipra Scientific, S.L.U
Sponsor class: INDUSTRY
First posted: 2022-02-18
Enrollment: 2646
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a phase III clinical study to assess the safety, tolerability and immunogenicity of PHH-1V as a booster dose in healthy adult subjects vaccinated against COVID-19 with the Comirnaty, Spikevax, Vaxevria or Janssen vaccine.

Detailed description: This is a phase III clinical study to assess the safety, tolerability and immunogenicity of PHH-1V as a booster dose in healthy adults vaccinated against COVID-19 with the Comirnaty, Spikevax, Vaxevria or Janssen vaccine at least 91 days before day 0. All the participants will receive a booster dose of the HIPRA's COVID-19 Vaccine and will be followed for 26 weeks or 52 weeks if they participate in the safety cohort, or the immunogenicity cohort, respectively.

Eligibility criteria: Inclusion Criteria:

* Male or female, ≥ 16 years old at Day 0.
* Willing to provide consent indicating that she or he understands the purpose and potential risks and is willing and able to participate in the study and comply with all the study requirements and procedures.
* Have a recognized primary vaccination scheme recognized by the authorities with Comirnaty, Spikevax, Vaxevria or Janssen at least 91 days and preferably a maximum of 240 days before Day 0.
* If having an underlying illnesses must be stable and well-controlled according to the investigator judgment.
* Participant is willing to avoid receiving live attenuated vaccines (licensed) within 4 weeks before screening or after receiving any study vaccine, or other not live vaccines (licensed) within 14 days before and after receiving any study vaccine.
* Participant agrees not to donate blood, blood products and bone marrow at least 3 months before and after vaccination.
* Female participant of childbearing potential must have a negative pregnancy test on the on Day 0 prior to vaccination.
* Female participant of childbearing potential must use any acceptable contraceptive method that should be started on day 0 and until 8 weeks after vaccination (hormonal contraception: oral, injectable or transdermal patch, intrauterine device, vasectomized partner, sexual abstinence or condom).
* Male participants must use any acceptable contraceptive method that should be started on day 0 and until 8 weeks after vaccination (vasectomized participants, condom, sexual abstinence).
* Male participants must refrain from donating sperm for at least 28 days after day 0.

Exclusion Criteria:

* History of anaphylaxis to any prior vaccine.
* Previous severe SARS-CoV-2 infections that required \>24 hous of hospitalisation.
* Participant received or plans to receive live attenuated vaccines within 4 weeks before and after day 0; or other not live vaccines within 14 days before and after day 0.
* Pregnancy or breast-feeding at screening or Day 0 or willingness/intention to become pregnant during the study.
* Having a clinically significant acute illness or fever (temperature ≥38º C (100.4ºF)) at screening or within 48 hours prior to Day 0.
* Participant had a surgery requiring hospitalization before vaccination and he/she has not received the hospital discharge at day 0; or has a surgery requiring hospitalization planned within 12 weeks after study vaccine administration.
* Having any active malignancy even if under treatment except for non-melanoma skin cancer, uterine cervical carcinoma, anal carcinoma, localized prostate cancer.
* Having ongoing severe and non-stable psychiatric condition likely to affect participation in the study.
* Having problematic or risk use of substances including alcohol that can compromise the study follow-up.
* Having a bleeding disorder or has any condition that in the opinion of the investigator contraindicates intramuscular injections.
* Having abnormal function of the immune system, except stable clinical conditions like controlled HIV.
* Having clinically significant and unstable cardiovascular, respiratory, hepatic, neurological, gastrointestinal, renal, or any other medical disorder judged by the investigator within 3 months before screening.
* Chronic or recurrent administration of systemic immunosuppressant medication.
* Having received immunoglobulins and/or blood-derived products 12 weeks prior vaccination (Day 0) or expects to receive them during the study.
* Having received any immunotherapy (monoclonal antibodies, plasma) aimed to prevent or treat COVID-19 within 90 days before day 0.
* Participation in any research involving an investigational product (drug, biologic, device) within 12 weeks prior to vaccination and during the study.
* Participant has donated ≥ 450ml of blood products within 12 weeks before screening.
* Participant has any medical condition and/or finding that in the investigator opinion might increase participant risks, interfere with the study or impair interpretation of study data.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
timeFrame: Day 7
measure: Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (AEs)
timeFrame: Day 28
measure: Incidence of Serious Adverse Events (Safety and tolerability) (SAE)
timeFrame: Day 365
measure: Incidence of Special Interest Adverse Events (Safety and tolerability) (AESI).
timeFrame: Day 365
measure: Incidence of Medically Attended Adverse Events (Safety and tolerability) (MAAEs)
timeFrame: Day 365
measure: Incidence of Adverse Events in laboratory parameters (Safety and tolerability)
timeFrame: Day 365
Secondary outcomes:
measure: Changes in the immunogenicity measured by pseudovirus neutralisation
timeFrame: Day 365
measure: Changes in the immunogenicity measured by pseudovirus neutralisation
timeFrame: Day 14
measure: Changes in the immunogenicity measured by means of total antibody against RBD
timeFrame: Day 365
measure: Changes in the immunogenicity measured by means of total antibody against RBD.
timeFrame: Day 14
measure: Changes in the immunogenicity measured by means of total antibody against RBD
timeFrame: Day 14
Other outcomes:
measure: To assess number of subjects with SARS-CoV-2 infections ≥14 days after PHH-1V booster.
timeFrame: Day 365
measure: To assess number of COVID-19 severe infections ≥14 days after receiving PHH-1V. SARS-CoV-2 infections ≥14 days after PHH-1V booster.
timeFrame: Day 365
measure: To assess number of COVID-19 severe infections ≥14 days after receiving PHH-1V and hospital admissions SARS-CoV-2 infections ≥14 days after PHH-1V booster.
timeFrame: Day 365
measure: To assess number of COVID-19 severe infections ≥14 days after receiving PHH-1V in ICU. SARS-CoV-2 infections ≥14 days after PHH-1V booster.
timeFrame: Day 365
measure: To assess number of COVID-19 severe infections ≥14 days after receiving PHH-1V receiving noninvasive ventilation. SARS-CoV-2 infections ≥14 days after PHH-1V booster.
timeFrame: Day 365
measure: To assess number of COVID-19 severe infections ≥14 days after receiving PHH-1V causing death.
timeFrame: Day 365
measure: To evaluate T-cell mediated responses against the SARS-CoV-2 S glycoprotein at Baseline and Day 14 in subjects who have received two doses of Vaxzevria vaccine and PHH-1V as a booster..
timeFrame: Day 14
measure: To assess Th-1/Th-2 T-cell mediated responses against S protein at Baseline and Day 14 in subjects who have received two doses of Vaxzevria vaccine and PHH-1V as a booster.
timeFrame: Day 14
Locations:
city: Milano
country: Italy
facility: Hospital de Niguarda
city: Badalona
country: Spain
facility: Hospital Germans Trias I Pujol
state: Barcelona
city: Mollet Del Vallès
country: Spain
facility: Hospital de Mollet
state: Barcelona
city: Meco
country: Spain
facility: Hospital Principe de Asturias
state: Madrid
city: Móstoles
country: Spain
facility: Hospital HM Puerta del Sur
state: Madrid
city: Barakaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital HM Delfos
city: Barcelona
country: Spain
facility: Hospital Quironsalud Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Girona
country: Spain
facility: Hospital Universitari Dr. Josep Trueta
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital HM Sanchinarro
city: Madrid
country: Spain
facility: Hospital Quironsalud Madrid
city: Madrid
country: Spain
facility: Hospital HM Montepríncipe
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
Study officials:
References: