COV-COMPARE: A study to compare the VLA2001 and AZD1222 vaccines against COVID-19 in adults

Phase 3

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations

• Registration Number: ISRCTN79815558
• Lead Sponsor: Valneva (Austria)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-27
• Last Update Posted: 21 June 2021
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

1. Participants must have read, understood, and signed the informed consent form (ICF)
2. Participants of either gender aged 18 years and older at screening
3. Medically stable
4. Must be able to attend all visits of the study and comply with all study procedures
5. Women of childbearing potential (WOCBPs) must be able and willing to use at least one highly effective method of contraception for a minimum of 3 months after the last dose of study vaccine
6. WOCBPs must have a negative pregnancy test prior to each vaccination

Exclusion Criteria

1. Participant is pregnant or planning to become pregnant within 3 months after study vaccine administration
2. History of allergy to any component of the vaccine
3. Significant infection (e.g. positive SARS-CoV-2 RT-PCR) or other acute illness, including fever >100 °F (>37.8 °C) 48 hours before vaccination
4. Participant has a known or suspected defect of the immune system
5. Participant has a history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome
6. Participant has a history of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there has been surgical excision or treatment more than 5 years ago that is considered to have achieved a cure, the participant may be enrolled. A history of hematologic malignancy is a permanent exclusion. Participants with a history of skin cancer must not be vaccinated at the previous tumour site
7. History of drug dependency or current use of drug abuse or alcohol abuse at screening
8. Significant blood loss (> 450 ml) or has donated one or more units of blood or plasma within 6 weeks prior to the expected day of randomization (Visit 1)
9. History of clinically significant bleeding disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture
10. Severe and uncontrolled ongoing autoimmune or inflammatory disease History of Guillain-Barre syndrome or any other demyelinating condition
11. Any other significant disease, disorder or finding which in the opinion of the investigator may significantly increase the risk to the volunteer

Prior/concomitant therapy:
12. Receipt of immunoglobulin or another blood product within the 3 months before expected day of randomization (visit 1) in this study or those who expect to receive immunoglobulin or another blood product during this study
13. Receipt of medications and or vaccinations intended to prevent COVID-19
14. Receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine, within 28 days prior to the expected day of randomization (Visit 1)

Others:
15. Any member of the study team or sponsor
16. An immediate family member or household member of the study’s personnel

Study & Design

• Study Type: Interventional
• Study Design: Not specified