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: Subjects must meet all the following criteria to be considered eligible for the study: 1. Male or female, = 18 years old at Day 0. 2. Participant must 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 (scheduled visits, laboratory tests, complete diaries, etc). 3. Participant who has been vaccinated with two doses of Vaxzevria at least 91 days before Day 0 and a maximum of 365 days of the second dose. 4. Has a negative Rapid Antigen Test (RAT) at Day 0 5. Participants may have underlying illnesses if are stable and well-controlled according to the investigator judgment. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to screening and for which neither a significant change in treatment or hospitalization for worsening is expected in the near future. 6. Participant agrees not to donate blood, blood products and bone marrow at least 12 weeks before and after vaccination. 7. Contraceptive use should be consistent with local regulation for participants in clinical trials. A. Female participants of childbearing potential [defined as any female who has experienced menarche and until becoming postmenopausal* (defined as having = 12 months amenorrhea prior to screening without an alternative cause) unless is surgically sterile]: i. Have a negative pregnancy test on the day of vaccination. ii. Use of any acceptable contraceptive method that should be started at screening and until 8 weeks after vaccination except hormonal contraception. Acceptable contraceptive methods are: 1) Hormonal contraception (progestogen-only or combined): oral, injectable or transdermal (patch) at least 30 days before Day 0 and until 8 weeks after vaccination. 2) Intrauterine device. 3)Vasectomized partner (the vasectomized partner should be the sole partner for that participant). 4) Sexual abstinence **, as a form of contraception, is acceptable if in line with the participant’s lifestyle. 5)Condom B. Male participants: i. Vasectomized participants. ii. Refrain from donating sperm for at least 28 days after day 0. iii. Agree to use a male condom may be considered in women of childbearing potential partners, from screening and for at least 28 days after day 0. iv. Sexual abstinence**, as a form of contraception, is acceptable if in line with the participant’s lifestyle. 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 263 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - 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 screening or Day 0 (vaccination time-point) or willingness/intention to become pregnant during the study. - Participant has a clinically significant acute illness (this does not include minor self-limited illness such as mild diarrhoea) or fever (temperature =38º C (100.4ºF) at screening or within 48 hours prior to the planned vaccination (Day 0). - Participant had a surgery requiring hospitalization (defined as inpatient stay for > 24 hours) 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. Minor surgical procedures not requiring hospitalization are accepted. - Participant has any active malignancy even if under treatment except for (at the discretion of the investigator): Non-melanoma adequately treated skin cancer without evidence of disease, or, adequately treated uterine cervical carcinoma in situ without evidence of disease, or, adequately treated anal carcinoma in situ without evidence of disease, or, localized prostate cancer. - Participant has ongoing severe and non-stable psychiatric condition likely to affect participation in the study (e.g., ongoing and non-stable severe depression, recent suicidal ideation, severe eating disorder, psychosis). - Participant has a problematic or risk use of substances including alcohol (except tobacco) that can compromise the study follow-up. Problematic or risk use of psychoactive substances is understood as the one that causes evident damage, whether it is dependence or any other physical, psychological, or social problem or that carries a high risk of suffering these damages. The negative consequences that consumption causes to third parties could be included. - Participant has a bleeding disorder (e.g., factor deficiency, platelet disorder), blood dyscrasia, or continuous use of anticoagulants or has any condition that in the opinion of the investigator contraindicates intramuscular injections or frequent phlebotomy. The use of = 325mg of aspirin or = 75mg of clopidogrel per day as prophylaxis is permitted but not combined. - Participant has abnormal function of the immune system as in autoimmune diseases, asplenia, recurrent infections or congenital/acquired immunodeficiency. Participants under immune-modifying treatment for any cause. Permitted: participants with stable clinical conditions (e.g., autoimmune thyroiditis, celiac disease, type 1- diabetes) and participants living with HIV with CD4 T cell count = 400 cells/mm3 under stable antiretroviral treatment with a fully suppressed viral load = 1 year are permitted [one or two non-consecutives blips (HIV viral load = 500 viral copies)]. - Participants have clinically significant and unstable cardiovascular, respiratory, hepatic, neurological, gastrointestinal, renal, or any other medical disorder as judged by the investigator and defined as disease requiring hospitalization or addition of new treatments or major dose adjustments within 3 months before screening. - Chronic or recurrent administration (during at least 14 days) of systemic immunosuppressant medication (defined as given by oral or parenteral routes) within 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.To determine and compare the changes of the immunogenicity measured by pseudovirus neutralisation against Omicron strain at Baseline and Day 14, in subjects who have received two doses of Vaxzevria vaccine and PHH-1V as a booster, versus subjects who have received two doses of Vaxzevria and Comirnaty as a booster, at least 91 days and with a maximum of 365 days before day 0. 2.To assess the safety and tolerability of PHH-1V as a booster dose in healthy adult subjects fully vaccinated against COVID-19 with the Vaxzevria vaccine.;Secondary Objective: 1.To determine and compare the changes of the immunogenicity (PBNA) against VOCs Beta and Delta, at Baseline and at Day 14, 98 and 182 in subjects of both arms. 2.To determine and compare the changes of the immunogenicity measured by SARS-CoV-2 PBNA against Omicron at Day 98 and 182 in subjects of both arms. 3.To determine and compare the changes of the immunogenicity measured by wild type SARS-CoV-2 neutralisation test (VNA) against Omicron at Baseline and Days 14, 98 and 182 in subjects of both arms. Wild type neutralisation assay will be performed only in a subset of approximately 20% of the total subjects included in the study. 4. To evaluate the immunogenicity measured by means of total antibody against RBD of the Spike protein of SARS-CoV-2 quantification, measured by an electrochemiluminescence immunoassay (ECLIA) at Baseline and at Days 14, 98 and 182 in subjects of both arms.;Primary end point(s): 1.1.Neutralisation titre against Omicron strain 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 treatment group comparison at Baseline and Day 14 2.1Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination. 2.2Number, percentage, and characteristics of unsolicited local and systemic adverse | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.1. Neutralisation titre against VOCs (Beta and Delta) 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, 98 and 182. 1.2. Geometric mean fold rise (GMFR) in neutralising antibodies titres against Omicron and VOCs (Beta and Delta) for treatment group comparison at Baseline and Day 14. 1.3. Neutralisation titre against Omicron measured as IC50 by PBNA and reported as reciprocal concentration for each individual sample and GMT for treatment group comparison at Days 98 and 182. 1.4. Neutralisation titre measured as inhibitory dilution 50 (ID50) against Omicron by a VNA and reported as reciprocal dilution for each individual sample, and GMT for treatment group comparison at Baseline and Day 14, 98 and 182. This analysis will only be performed in a subset of participants. 4.1 Binding antibodies titre measured for each individual sample and GMT for treatment group comparison at Baseline and Days 14, 98 and 182. 4.2 Geometric mean fold rise (GMFR) in binding antibodies titre from Baseline and Days 14. 4.3 Percentage of subjects that, after a booster dose, have a =4-fold change in binding antibodies titre from Baseline and Days 14, 98 and 182.;Timepoint(s) of evaluation of this end point: D0, D14, D98, D182 | — |
Countries
Spain
Contacts
Public ContactRegulatory Affairs HH Director
HIPRA SCIENTIFIC
Outcome results
None listed