SARS-CoV-2 infection 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: 1. Male, female or transgender, = 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 one of the following SARS-CoV-2 vaccination schemes : • Three doses of mRNA vaccines (Comirnaty and/or Spikevax) with or without past history of positive test for COVID-19, provided that last vaccination and diagnose of COVID-19 is at least 91 days before day 0, and if hospitalization was required, participant was discharged from hospital at least 30 days before day 0. • Two doses of mRNA vaccines (Comirnaty and/or Spikevax) and previous history of positive test for COVID-19, provided that last vaccination and diagnose of COVID-19 is at least 91 days before day 0, and if hospitalization was required, participant was discharged from hospital at least 30 days before day 0. For sites in Turkey were vaccination with Coronavac was started, the following vaccinations schemes will be allowed: • A combination of 2 doses of Coronavac and 1 Comirnaty, or 1 Coronavac and 2 Comirnaty without past history of a positive test for COVID-19, provided that last vaccination is at least 91 days before day 0 4. Participant who has any of the following underlying immunosuppressive conditions*: • Confirmed HIV infection with CD4 T cell counts 1 year and with last anti-CD20/anti-CD3 biological treatment given at least >1 year prior to Day0 and on maintenance triple immunosuppressive therapy based on tacrolimus, glucocorticoids and mycophenolate or everolimus/sirolimus; • Auto-immune disease (AID**) on treatment with rituximab (RTX) during at least 14 days within the last 6 months prior to Day0 *approximately 60 participants per condition will be included and approximately 50% of individuals in each condition will have past history of COVID-19 ** AID includes: vasculitis, myositis, SLE/Sjögren, rheumatoid arthritis and multiple sclerosis. 5. 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]: • Have a negative pregnancy test on the day of vaccination. • Use of any acceptable contraceptive method that should be started on day 0 and until 8 weeks after vaccination, except hormonal contraception. Acceptable contraceptive methods are: o Hormonal contraception (progestogen-only or combined): oral, injectable or transdermal (patch) started at least 28 days before day 0 and until 8 weeks after vaccination o Intrauterine device. o Vasectomized partner (the vasectomized partner should be the sole partner for that participant). o Sexual abstinence, as a form of contraception, is acceptable if in line with the participant’s lifestyle. o Condom b. Male participants: • Vasectomized participants. • Re
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded from the study: 6. History of anaphylaxis to any prior vaccine. 7. Participant received or plans to receive: • Live attenuated vaccines (licensed) within 4 weeks before or after receiving any study vaccine. • Other not live vaccines (licensed) within 14 days before and after receiving any study vaccine • Viral-vectored COVID-19 vaccines, such as Vaxzevria (AstraZenca) or Ad26.CoV2.S from Janssen 8. Pregnancy or breast-feeding at screening or Day 0 (vaccination time-point) or willingness/intention to become pregnant during the entire length of the study for female participants. For male participants, willingness/intention that your parent becomes pregnant during the entire length of the study. Medical conditions 9. A confirmed COVID-19 diagnose (by RT-PCR or RAT, asymptomatic or symptomatic) 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. 12.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) 13. 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. 14. 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. 15. Participant suffering from post-acute COVID-19 syndrome / long-covid Prior/Concomitant Therapy and Clinical Study Experience. 16. Participant received any immunotherapy (monoclonal antibodies, plasma) aimed to prevent or treat COVID-19 within 90 days preceding the planned administration of study vaccine (180 days in case of Evusheld) 17. Participation in any research involving an investigational product (drug, biologic, device) within 12 weeks prior to vaccination and during the study. 18. Participant has donated = 450ml of blood products within 12 weeks before screening. 19. 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 determine and compare the changes of the immunogenicity 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 Objective: - 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). - 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). - To assess the safety and tolerability of PHH-1V as an additional dose in adult individuals with pre-existing immunosuppressive conditions.;Primary end point(s): 1.1 Neutralization titer against Omicron, Beta and Delta strains, and any other relevant VOC in the epidemiologic moment, measured as inhibitory concentration 50 (IC50) by a pseudovirion-based neutralization assay (PBNA) and reported as reciprocal concentration for each individual sample and geometric mean titer (GMT) for descriptive statistics analysis at Baseline and at Day 14. For the HIV cohort, ID50 (the reciprocal dilution inhibiting 50% of the infection) will be reported using a live virus assay (VNA) to measure cytophatic effect in Vero E6 cells. 1.2 The geometric mean fold rise (GMFR) in neutralizing antibody titer from baseline to Day 14.;Timepoint(s) of evaluation of this end point: Day 0 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.1 Neutralization titer against Omicron, Beta and Delta strains, and any other relevant VOC in the epidemiologic moment, measured as inhibitory concentration 50 (IC50) by a pseudovirion-based neutralization assay (PBNA) and reported as reciprocal concentration for each individual sample and geometric mean titer (GMT) for descriptive statistics analysis at Days 91, 182 and 365. For the HIV cohort, ID50 (the reciprocal dilution inhibiting 50% of the infection) will be reported using a live virus assay (VNA) to measure cytophatic effect in Vero E6 cells. 2.1 Binding antibodies titer measured for each individual sample and GMT for descriptive statistics analysis at Baseline and Days 14, 91, 182 and 365. 2.2 The geometric mean fold rise (GMFR) in binding antibody titer from baseline to Day 14. 2.3 The percentage of individuals that after PHH-1V vaccine have a =2-fold and 4-fold change in binding antibodies titer from Baseline to Day 14. 3.1. Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination. 3.2. Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through Day 28 after vaccination. 3.3. Number and percentage of serious adverse events (SAEs) through the end of the study. 3.4. Number and percentage of adverse event of special interest (AESI) through the end of the study. 3.5. Number and percentage of medically attended adverse events (MAAE) related to study vaccine through the end of the study. 3.6. Grade 3 and 4 changes from baseline in safety laboratory parameters at Days 14, 91, 182 and 365 after vaccination.;Timepoint(s) of evaluation of this end point: Day 0, Day 14, Day 91, Day 182 and Day 365 | — |
Countries
Spain, Turkey
Contacts
Public ContactRegulatory Affairs Director
HIPRA SCIENTIFIC
Outcome results
None listed