ISRCTN87813400Active, not recruitingPhase 1
A phase I safety, immunogenicity and dose escalation study of the candidate pan-Sarbeco Coronavirus vaccine pEVAC-PS in SARS-CoV-2 immunised UK healthy adult volunteers
niversity Hospital Southampton NHS Foundation Trust0 sites39 target enrollmentStarted: November 29, 2021Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 39
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Current participant inclusion criteria as of 24/07/2023:
- •1. Healthy males and non-pregnant females
- •2. Aged 18 - 50 years
- •3. Immunised no less than 12 weeks prior with 2 or 3 doses of SARS-CoV-2 vaccine
- •4. No history of SARS-CoV-2 infection within the past 180 days
- •Previous participant inclusion criteria:
- •1. Healthy males and non-pregnant females
- •2. Aged 18 - 50 years
- •3. Immunised no less than 12 weeks prior with 2 doses of SARS-CoV-2 vaccine
- •4. No history of serological evidence of prior SARS-CoV-2 infection (seronegative for N)
Exclusion Criteria
- •Current participant exclusion criteria as of 24/07/2023:
- •1. History of laboratory-confirmed MERS, SARS-CoV-1 or SARS-CoV-2 infection
- •2. Have an anti-SARS-CoV-2 and a SARS-CoV-1 RBD response of less than 0.5 or more than 2 AUC (Area Under the Curve) units
- •3. Planned receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination
- •4. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- •5. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting <14 days)
- •6. Any autoimmune conditions, except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy
- •7. History of allergic disease or reactions likely to be exacerbated by any component of the pEVAC-PS vaccine
- •8. Any history of angioedema
- •9. Any history of anaphylaxis
- •10. Pregnancy, lactation or willingness/intention to become pregnant for 3 months following the last personal dose of vaccine in this trial
- •Previous participant exclusion criteria:
- •1. History of laboratory-confirmed MERS, SARS-CoV-1 or SARS-CoV-2 infection
- •2. Seropositive for SARS-CoV-2 Nucleocapsid IgG at screening
- •3. Have an anti-SARS-CoV-2 and a SARS-CoV-1 RBD response of more than 2 AUC (Area Under the Curve) units
- •4. Planned receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination.
- •5. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
- •6. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting <14 days).
- •7. Any autoimmune conditions, except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy.
- •8. History of allergic disease or reactions likely to be exacerbated by any component of the pEVAC-PS vaccine
- •9. Any history of angioedema.
- •10. Any history of anaphylaxis.
- •11. Pregnancy, lactation or willingness/intention to become pregnant for 3 months following the last personal dose of vaccine in this trial.
Investigators
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