Phase I vaccine study of pEVAC-PS coronavirus vaccine

Phase 1

• Conditions: Prevention of COVID-19 and other severe beta-coronavirus infections; Infections and Infestations; COVID-19 (SARS-CoV-2 infection)

• Registration Number: ISRCTN87813400
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-29
• Last Update Posted: 26 September 2023
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified