Dose Escalation Trial of CD40.Pan.CoV Vaccine, Adjuvanted or Not, as a Booster in Adult Healthy Volunteers

Exclusion Criteria34

• Acute febrile infection (body temperature ≥ 38.0°C) within the previous 72 hours and/or presenting symptoms suggestive of COVID-19 or SARS-CoV-2 infection within the previous 28 days or having been in contact with an infected individual for the last 14 days before the inclusion visit.
• Immunosuppressive medications received within the last three months before IMP administration or within 6 months for chemotherapies. (Not excluded: \[1\] corticosteroid nasal spray; \[2\] topical corticosteroids for mild, uncomplicated dermatitis; or \[3\] a single course of oral/parenteral corticosteroids at doses < 2 mg/kg/day and length of therapy < 11 days with completion at least 30 days prior to enrolment). The scheduled use of these treatments up to 6 months after the injection also represents a contraindication.
• Immunoglobulins and/or monoclonal antibodies within 90 days before IMP administration. The scheduled use of these treatments up to 6 months after the injection also represents a contraindication.
• Blood products, including convalescent plasma, within 120 days before IMP administration. The scheduled use of these treatments up to 6 months after the injection also represents a contraindication.
• Any medical condition that could impair the immune response: clinically significant medical condition (like cancer), clinical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
• A process that would affect the immune response;
• A process that would require medication that affects the immune response;
• Any contraindication to repeated injections or blood draws;
• A condition that requires active medical intervention or monitoring to avert grave danger to the participant's health or well-being during the trial period;
• A condition or process for which signs or symptoms could be confused with reactions to vaccine;
• Intent to participate in another trial of an investigational research agent within 4 weeks prior to the enrolment visit or until the end of follow-up.
• Under tutorship, guardianship, or deprived of liberty by a juridical or administrative decision.
• Pregnancy or breastfeeding that is currently ongoing, or positive pregnancy test at screening visit and the day of the vaccination.
• History of severe adverse events following vaccine administration including anaphylactic reaction and associated symptoms such as rash, breathing problems, angioedema, and abdominal pain, or a history of allergic reaction that could be triggered by a component of the SARS-CoV-2 vaccine at the time of the vaccine injection (Not excluded: a participant who had a non-anaphylactic adverse reaction to pertussis vaccine as a child).
• Any bleeding disorder considered as a contraindication to an intramuscular injection, previous phlebotomy, or receipt of anticoagulants.
• A condition that requires active medical intervention or monitoring to avert grave danger to asthma other than mild, well-controlled asthma (symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report). Exclude a subject who:
• Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
• Uses moderate/high dose inhaled corticosteroids, or
• In the past year has either of the following: (i) Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids or (ii) Needed emergency care, urgent care, hospitalization, or intubation for asthma.
• Hypertension:
• If a person has been diagnosed with hypertension, exclude for blood pressure that is not well controlled (well-controlled blood pressure is defined as consistently ≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤ 150 mm Hg systolic and ≤ 100 mm Hg diastolic). For these participants, blood pressure must be ≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic at enrolment
• If a person has NOT been diagnosed with hypertension, exclude for systolic blood pressure ≥ 150 mm Hg at enrolment or diastolic blood pressure ≥ 100 mm Hg at enrolment (the measurement must be performed on a person who has been lying down for at least 5 minutes and repeated at the end of the consultation, if appropriated). Tension must be confirmed outside the clinical site to rule hypertension.
• BMI ≥ 40 kg/m2; ≤ 18 kg/m2; or BMI ≥ 35 kg/m2 with 2 or more of the following: age > 45, current smoker, known hyperlipidemia, blood pressure is defined as consistently ≥ 140 mm Hg systolic and ≥ 90 mm Hg diastolic.
• Malignancy (Not excluded: participant who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the trial).
• Asplenia: any condition resulting in the absence of a functional spleen.
• Seizure disorder: History of seizure(s) within the past three years. Also exclude if Participants have used medications to prevent or treat seizure(s) at any time within the past 3 years.
• History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
• History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including arrhythmia requiring medication, treatment, or clinical follow-up).
• History of autoimmune disease.
• Any medical, occupational, or other condition that, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence, assessment of safety or reactogenicity, or a participant's ability to give informed consent.
• Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
• Any vaccination received within 30 days before IMP administration.
• Allergy treatment with antigen injections within 30 days before IMP administration. The scheduled use of these treatments up to 6 months after the injection also represents a contraindication.
• Other prohibited medications: Corticosteroids > 10 mg prednisone equivalent/day (not excluded: topical preparations), Immunomodulators (such as cytokines or interferons) and anti-tuberculosis drugs within 3 months before IMP administration. The scheduled use of these treatments up to 6 months after the injection also represents a contraindication.