COV-COMPARE Immunogenicity of Vaccine VLA2001 Compared to AZD1222

ABSTRACT

ConditionSARS-CoV-2 Virus Infection

InterventionBiological VLA2001;Biological AZD1222;Biological VLA2001 - adolescent part;Biological Placebo

Primary outcome:Immune response measured after completion of a 2-dose immunization schedule, as determined by the geometric mean titer (GMT) ratio in adults and GMT in adolescents of SARS-CoV-2-specific neutralizing antibodies;Immune response measured after completion of a 2-dose immunization schedule, as determined by Seroconversion in adults and adolescents (definded as 4-fold increase from baseline) of SARS-CoV-2-specific neutralizing antibodies;Frequency and severity of any Adverse Events (AE)

Criteria
Inclusion Criteria

1. Participants must have read, understood, and signed the informed consent form (ICF).

2. Participants of either gender aged 12 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 (WOCBP) must be able and willing to use at least 1
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 of abuse or alcohol abuse at
screening.

8. Significant blood loss (> 450 mL) or has donated 1 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).

15. Any member of the study team or sponsor.

16. An immediate family member or household member of the study's personnel.

Booster Vaccination (Adults and Adolescents)

In addition to the above-described eligibility criteria, the following criteria must be
met

1. Participant has not received another licensed COVID-19 vaccine during the study