SARS-CoV-2 MedDRA version: 23.0 Level: LLT Classification code 10084272 Term: SARS-CoV-2 infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: PHH-1V
Product Code: [PHH-1V]
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: PHH-1V
Current Sponsor code: PHH-1V
Concentration unit: µg microgram(s)
Concentration type:
Sponsors
HIPRA SCIENTIFIC S.L.U
Eligibility
Sex/Gender
All
Inclusion 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. - Participants may have underlying illnesses if are 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 participants of childbearing potential must have a negative pregnancy test on the on Day 0 prior to vaccination. - Female participants 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. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2940 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - History of anaphylaxis to any prior vaccine. - Previous severe SARS-CoV-2 infections are not permitted (ote: Severity explained as any episode of COVID-19 requiring = 24hrs of hospitalization). - 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. - Participant has 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. - Participant has any active malignancy even if under treatment except for non-melanoma skin cancer, uterine cervical carcinoma, anal carcinoma, localized prostate cancer. - Participant has ongoing severe and non-stable psychiatric condition likely to affect participation in the study. - Participant has a problematic or risk use of substances including alcohol that can compromise the study follow-up. - Participant has a bleeding disorder or has any condition that in the opinion of the investigator contraindicates intramuscular injections. - Participant has abnormal function of the immune system, except stable clinical conditions like controlled HIV. - Participants have clinically significant and unstable cardiovascular, respiratory, hepatic, neurological, gastrointestinal, renal, or any other medical disorder judged by the investigator clinically significant and unstable within 3 months before screening. - Chronic or recurrent administration of systemic immunosuppressant medication. - Subject has received immunoglobulins and/or blood-derived products 12 weeks prior vaccination (Day 0) or expects to receive them during the study. - Participant 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of PHH-1V as a booster dose in healthy adult subjects vaccinated against COVID-19 with the Comirnaty, Spikevax, Vaxevria or Janssen vaccine;Secondary Objective: 1. To determine and compare the changes of the immunogenicity measured by pseudovirus neutralisation against Wuhan strain (also known as L strain) and against Omicron, and any other relevant Variants of Concern (VOC) in the epidemiologic moment, at Baseline and at Days 14, 91, 182 and 365, after booster of HIPRA’s vaccine (PHH-1V) in a subset of participants. 2. 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 booster of HIPRA’s vaccine (PHH-1V) in a subset of participants.;Primary end point(s): Number, percentage, and characteristics of solicited local reactions through Day 7 after vaccination. Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through Day 28 after vaccination. Number and percentage of serious adverse events (SAEs) through the end of the study. Number and percentage of adverse event of special interest (AESI) through the end of the study. Number and percentage of medically attended adverse events (MAAE) related to study vaccine through the end of the study. Grade 3 and 4 change from baseline in safety laboratory parameters at Days 14, 91 and 182 after vaccination;Timepoint(s) of evaluation of this end point: D0, D14, D91, D182. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Neutralisation titre against Wuhan and Omicron strains, and any other relevant VOC in the epidemiologic moment, measured as inhibitory concentration 50 (IC50) by a pseudovirion-based neutralisation assay (PBNA) and reported as reciprocal concentration for each individual sample and geometric mean titre (GMT) for descriptive analysis at Baseline and at Days 14, 91, 182 and 365. The geometric mean fold rise (GMFR) in neutralising antibody titre from baseline to Day 14. Binding antibodies titre measured for each individual sample and GMT for descriptive analysis at Baseline and Days 14, 91, 182 and 365. The geometric mean fold rise (GMFR) in binding antibody titre from baseline to Day 14. The percentage of subjects that after the booster dose have a =4-fold change in binding antibodies titre from Baseline to Day 14. ;Timepoint(s) of evaluation of this end point: D0, D14, D91, D182, D365. | — |
Countries
Italy, Portugal, Spain
Contacts
Public ContactR&D and Regulatory Affairs Director
HIPRA SCIENTIFIC S.L.U.
Outcome results
None listed