A phase II study to evaluate safety and immunogenicity of recombinant proteincandidate vaccine against SARS-CoV-2 in adults fully vaccinated against COVID-19 with extension period to evaluate a fourth dose
- Conditions
- SARS-CoV-2MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-005226-26-ES
- Lead Sponsor
- HIPRA SCIENTIFIC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 802
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method