SARS-CoV-2 MedDRA version: 23.0 Level: LLT Classification code 10084272 Term: SARS-CoV-2 infection System Organ Class: 100000004862
Conditions
Sponsors
HIPRA SCIENTIFIC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part A: - Male or female, by birth, = 18 years old at Screening. - Willing and able to comply with scheduled visits, laboratory tests, complete diaries, and other study procedures. - Body Mass Index (BMI) between 18 to 40 kg/m2. - Has received a complete COVID-19 vaccination programme (two administrations, prime and boosting) at least 182 days and with a maximum of 365 days before Screening with Comirnaty vaccine. - Has a negative COVID-19 polymerase chain reaction (PCR) test at Screening. - Willing to avoid all other vaccines within 4 weeks before and after vaccination in this study (Day 0). Seasonal influenza vaccination is allowed if it is received at least 14 days before or after Day 0. - Willing to refrain from blood donation during the study. - Women of childbearing potential must have a negative urine pregnancy test at Screening and Day 0 (before vaccination). - Women of childbearing potential must be willing to use highly effective contraceptive methods or have practiced sexual abstinence from the screening visit until 8 weeks after the vaccination (Day 0). Highly effective contraceptive methods include oral, intravaginal, or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomised partner and sexual abstinence. - Males who are not sterilised, must be willing to avoid impregnating female partners from Screening until 8 weeks after vaccination (Day 0). - Willing and able to provide written informed consent prior the initiation of any study procedures. Part B: Adults = 18 years old at Day 0 Participant must provide consent and is willing and able to participate in this extension of the study Has received a primary vaccination of two doses of Comirnaty followed by a booster dose either with Comirnaty or PHH-1V. Last booster dose given between 6 and 12 months before Day 0 Has a negative Rapid Antigen Test (RAT) at Day 0 Participants may have underlying illnesses if are stable and well-controlled Participant is willing to avoid receiving live attenuated vaccines within 4 weeks before or after receiving study vaccine Participant agrees not to donate blood, blood products and bone marrow at least 12 weeks before and after vaccination Female participants have a negative pregnancy test on the day of vaccination Use of any acceptable contraceptive method that started at screening and until 8 weeks after vaccination Are the trial subjects under 18? no 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 802 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Part A: - Pregnant or lactating or intending to become pregnant or plans to breastfeed during the study. - Positive pregnancy test at Screening or Day 0. - Any medical disease (acute, subacute, intermittent, or chronic) or condition that in the opinion of the Investigator compromises the subject's safety, preclude vaccination or compromises interpretation of the results. - Ongoing serious psychiatric condition likely to affect participation in the study (e.g., ongoing severe depression, recent suicidal ideation, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication). - History of respiratory disease requiring daily medications currently or any treatment of respiratory disease exacerbation in the last 6 months. - History of significant cardiovascular disease or history of myocarditis or pericarditis as an adult. Controlled hypertension will be permitted at the discretion of the Investigator. - History of neurological or neurodevelopmental conditions - Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed. - Any confirmed or suspected autoimmune, immunosuppressive or immunodeficiency disease/condition (iatrogenic or congenital), including human immunodeficiency virus (HIV) infection, asplenia, or recurrent severe infections. - Acute illness within 72 hours before Day 0 - Received investigational drug within 90 days before Screening or plans to participate clinical study - History of hypersensitivity or severe allergic reactions, including anaphylaxis, generalised urticarial, angioedema and other significant reactions related to food, drugs, vaccines, or pharmaceutical agents, which are likely to be exacerbated by any component of the COVID-19 vaccine HIPRA. - Use of any immunosuppressant, glucocorticoids, or other immune-modifying drugs within 2 months before Day 0 - Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days before vaccination (Day 0). - Known bleeding disorder, blood dyscrasias, or prior history of significant bleeding or bruising following intramuscular (IM) injections or venepuncture. - Chronic liver disease. - Positive test for HIV types 1 or 2 infection, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV Abs) at Screening. - Suspected or known current alcohol abuse or any other substances abuse. - History of COVID-19 infection. - Ever been included in a trial with an experimental vaccine against COVID-19. - Close contact with anyone known to have SARS-CoV-2 infection within 15 days before Screening. - Scheduled elective surgery during the study. - Life expectancy of less than 12 months. - Any condition and/or laboratory finding that, in the Investigators opinion, would interfere with the study or put the subject at risk. Part B: History of anaphylactic shock of any kind History of COVID-19 infection 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 vaccination time-point Participant has a clinically significant acute illness or fever 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 dis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A: To determine and compare the changes of the immunogenicity measured by pseudovirus neutralisation against Wuhan strain (also known as L strain) at Baseline and Day 14, after HIPRA’s vaccine (PHH-1V) versus subjects who have received complete vaccination, including homologous booster, with the Comirnaty vaccine at least 182 days and with a maximum of 365 days before Screening. To assess the safety and tolerability of PHH-1V as a booster dose in healthy adult subjects fully vaccinated against COVID-19 with the Comirnaty vaccine. Part B: To determine and compare the changes in the immunogenicity measured by PBNA against omicron BA.1 subvariant, at Day 14 post-dose 4 of PHH-1V versus post-dose 3 in cohort 2. To assess the safety and tolerability of PHH-1V as a fourth dose in adult subjects in cohort 1 and 2;Secondary Objective: Part A: To determine and compare the changes of the immunogenicity measured by SARS-CoV-2 PBNA against the Variants of Concern (VOC) To determine and compare the changes in immunogenicity measured by wild type SARS-CoV-2 neutralisation test (VNA) To evaluate the immunogenicity measured by enzyme-linked immunosorbent assay (ELISA) to the SARS-CoV-2 spike glycoprotein. To evaluate T-cell mediated responses against the SARS-CoV-2 S glycoprotein To assess Th-1/Th-2 T-cell mediated responses against the SARS-CoV-2 S glycoprotein Part B: To determine and compare the changes of the immunogenicity measured by SARS-CoV-2 PBNA against the Variants of Concern (VOC) To evaluate the immunogenicity measured by enzyme-linked immunosorbent assay (ELISA) to the SARS-CoV-2 spike glycoprotein. To evaluate T-cell mediated responses against the SARS-CoV-2 S glycoprotein To assess Th-1/Th-2 T-cell mediated responses against the SARS-CoV-2 S glycoprotein;Primary end point(s): Part A: Efficacy: Neutralisation titre against Wuhan strain measured as inhibitory concentration 50 (IC50) by a PBNA and reported as reciprocal concentration for | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part A: · Neutralisation titre against VOC measured as IC50 by PBNA and reported as reciprocal concentration for each individual sample and GMT for treatment group comparison at Baseline and Days 14, 28, 98 (for a subset of participants), 182, and 364. · Geometric mean fold rise (GMFR) in neutralising antibodies titres for treatment group comparison at Baseline and Days 14, 28, 98 (for a subset of participants) 182, and 364. · Neutralisation titre measured as inhibitory dilution 50 (ID50) by a VNA and reported as reciprocal dilution for each individual sample, and GMT for treatment group comparison at Baseline and Days 14, 28, 182, and 364. This analysis will be performed in a subset of subjects. · Binding antibodies titre measured for each individual sample and GMT for treatment group comparison at Baseline and Days 14, 28, 98 (for a subset of participants), 182, and 364. · Geometric mean fold rise (GMFR) in binding antibodies titre from Baseline and Days 14, 28, 98 (for a subset of participants), 182, and 364. · Percentage of subjects that, after a booster dose, have a =4-fold change in binding antibodies titre from Baseline and Days 14, 28, 182, and 364. · T-cell-mediated response to the SARS-CoV-2 S protein as measured by whole peripheral blood mononuclear cell (PBMC) stimulation by enzyme-linked immune absorbent spot (ELISpot) at Baseline, Day 14 and Day 182. This analysis will be performed in a subset of subjects. · CD4+/CD8+ T-cell response to the SARS-CoV-2 S protein as measured by in vitro PBMC stimulation by cytokine staining assays at Baseline, Day 14 and Day 182. This analysis will be performed in a subset of subjects. Part B: Neutralisation titre against omicron BA.1 subvariant, measured as inhibitory concentration 50 (IC50) by PBNA and reported as log10 concentration for each individual sample and GMT, at Day 98 and 182 post-dose 4 of PHH-1V versus post-dose 3 in cohort 2 To determine the geometric mean fold rise (GMFR) in | — |
Countries
Spain
Contacts
Public ContactR&D and Regulatory Affairs Director
HIPRA SCIENTIFIC
Outcome results
None listed