COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN87813400

Not reported

Not reported

2021-11-29

Recruiting

nonRCT

Non-randomized

Single group assignment

Open label

single-center

Prevention

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)

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.

1

University Hospital Southampton NHS Foundation Trust

18

50

United Kingdom

Healthy volunteers

N/A

36

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

Phase 1

[{"arm_notes": "", "treatment_id": 2554, "treatment_name": "Pevac-ps", "treatment_type": "Pan-sarbecovirus vaccine", "pharmacological_treatment": "Vaccine"}]