Prevention of COVID-19 and other severe beta-coronavirus infections Infections and Infestations COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
Current interventions as of 24/07/2023:
Investigational product: pEVAC-PS
Doses: 1.2mg Intradermal (ID), 0.8mg ID, 0.4mg ID, 0.2mg ID
Total: 36 volunteers
Group 1: 9 volunteers
2 doses of pEVAC-PS at 0.2mg intradermally
Group 2: 9 volunteers
2 doses of pEVAC-PS at 0.4mg intradermally
Group 3: 9 volunteers
2 doses of pEVAC-PS at 0.8mg intradermally
Group 4: 9 volunteers
2 doses of pEVAC-PS at 1.2mg intradermally
Previous interventions:
Investigational product: pEVAC-PS
Doses: 1.2mg Intradermal (ID), 0.8mg ID, 0.4mg ID, 0.2mg ID
Total: 36 volunteers
Stage 1
Group 1:
2 doses of pEVAC-PS at 0.2mg (lowest dose) intradermally
Stage 2 subject to safety and immunogenicity analysis from stage 1 after 4 weeks post 2nd dose
- Primary immunogenicity target met
Expanded gr
2 doses of pEVAC-PS at 0.2mg intradermally
Review for plan of reduced dose formulation and testing if continued safety and immunogenicity targets met in expanded group
- Primary immunogenicity target
2 doses of pEVAC-PS at 0.4mg intradermally PLUS
Group 2b: 9 volunteers
2 doses of pEVAC-PS at 0.8mg intradermally
- Very Poor/No response
Group 2a: 9 volunteers
2 doses of pEVAC-PS at 0.8mg intradermally PLUS
Group 2b: 9 volunteers
2 doses of pEVAC-PS at 1.2mg intradermally
Stage 3 subject to safety and immunogenicity analysis from stage 2 after 4 weeks post 2nd dose
- Primary immunogenicity target met
Group 3: 12 volunteers, 2
2 doses of pEVAC-PS at 1.2mg intradermally
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and reactogenicity measured as: 1. Solicited local reactogenicity signs and symptoms for 7 days following vaccination measured using participant symptom diary entries 2. Solicited systemic reactogenicity signs and symptoms for 7 days following vaccination measured using participant symptom diary entries 3. Unsolicited adverse events (AEs) for 28 days following vaccination measured using participant symptom diary entries 4. Safety laboratory measures measured using routine Haematology and Biochemistry at day 0, 3, 7 and 42 5. Occurrence of disease enhancement episodes measured using surveillance for COVID-19 hospitalisations during the whole study period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Humoral immunogenicity of pEVAC-PS through the analysis of SARS-CoV and SARS-CoV-2 RBD antibody titres at 28 days (4 weeks) after 2 doses of pEVAC-PS have been administered 28 days apart, measured as serology: receptor binding domain (RBD) responses in the majority of vaccinees per group for SARS-CoV and SARS-CoV-2 2. Dose tolerability at 28 days (4 weeks) after the second dose of vaccine measured using participant symptom diary entries 3. Results of immunogenicity at 28 days (4 weeks) after the second dose of vaccine measured using ELISpot 3. Long term (up to 12 months) humoral immunogenicity measured as serology: receptor binding domain (RBD) for SARS-CoV and SARS- CoV-2 RBD pre and post- immunisation. | — |
Countries
England, United Kingdom
Outcome results
None listed