Clinical trial: A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults (NCT04537949)

Eligibility criteria:
Inclusion Criteria:

          -  Have given informed consent by signing the informed consent form (ICF) before
             initiation of any trial-specific procedures.

          -  They must be willing and able to comply with scheduled visits, treatment schedule,
             laboratory tests, lifestyle restrictions (e.g., to practice social distancing and to
             follow good practices to reduce their chances of being infected or spreading
             COVID-19), and other requirements of the trial.

          -  They must be able to understand and follow trial-related instructions.

          -  For younger adult cohorts, volunteers must be aged 18 to 55 years, have a body mass
             index over 19 kg/m^2 and under 30 kg/m^2 (i.e., be neither underweight nor obese), and
             weigh at least 50 kg at Visit 0.

        OR For older adult cohorts, volunteers must be aged 56 to 85 years, have a body mass index
        over 19 kg/m^2 and under 30 kg/m^2 (i.e., be neither underweight nor obese), and weigh at
        least 50 kg at Visit 0.

          -  They must be healthy, in the clinical judgment of the investigator, based on medical
             history, physical examination, 12-lead electrocardiogram (ECG), vital signs
             (systolic/diastolic blood pressure, pulse rate, body temperature, respiratory rate),
             and clinical laboratory tests (blood chemistry, hematology, and urine chemistry) at
             Visit 0.

          -  Women of childbearing potential (WOCBP) must have a negative beta-human chorionic
             gonadotropin urine test at Visit 0 and Visit 1. Women that are postmenopausal or
             permanently sterilized will be considered as not having reproductive potential.

          -  WOCBP must agree to practice a highly effective form of contraception during the
             trial, starting after Visit 0 and continuously until 60 days after receiving the last
             immunization. WOCBP must agree to require their male partners to use condoms during
             sexual contact (unless male partners are sterilized or infertile).

          -  WOCBP must confirm that they practiced at least one highly effective form of
             contraception for the 14 days prior to Visit 0.

          -  WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted
             reproduction during trial, starting after Visit 0 and continuously until 60 days after
             receiving the last immunization.

          -  Men who are sexually active with a WOCBP and have not had a vasectomy must agree to
             practice a highly effective form of contraception with their female partner of
             childbearing potential during the trial, starting after Visit 0 and continuously until
             60 days after receiving the last immunization.

          -  Men must be willing to refrain from sperm donation, starting after Visit 0 and
             continuously until 60 days after receiving the last immunization.

          -  They must have confirmation of their health insurance coverage prior to Visit 0.

          -  They must agree to not be vaccinated during the trial, starting after Visit 0 and
             continuously until 28 days after receiving the last immunization.

        Exclusion Criteria:

          -  Have had any acute illness, as determined by the investigator, with or without fever,
             within 72 hours prior to the first immunization. An acute illness which is nearly
             resolved with only minor residual symptoms remaining is allowable if, in the opinion
             of the investigator, the residual symptoms will not compromise their well-being if
             they participate as trial subjects in the trial, or that could prevent, limit, or
             confound the protocol-specified assessments.

          -  Are breastfeeding on the day of Visit 0 or who plan to breastfeed during the trial,
             starting after Visit 0 and continuously until at least 90 days after receiving the
             last immunization.

          -  Have a known allergy, hypersensitivity, or intolerance to the planned investigational
             medicinal product (IMP) including any excipients of the IMP.

          -  Had any medical condition or any major surgery (e.g., requiring general anesthesia)
             within the past 5 years which, in the opinion of the investigator, could compromise
             their well-being if they participate as trial subjects in the trial, or that could
             prevent, limit, or confound the protocol-specified assessments.

          -  Have any surgery planned during the trial, starting after Visit 0 and continuously
             until at least 90 days after receiving the last immunization.

          -  Had any chronic use (more than 21 continuous days) of any systemic medications,
             including immunosuppressants or other immune-modifying drugs, within the 6 months
             prior to Visit 0 unless in the opinion of the investigator, the medication would not
             prevent, limit, or confound the protocol-specified assessments or could compromise
             subject safety.

          -  Received any vaccination within the 28 days prior to Visit 0.

          -  Had administration of any immunoglobulins and/or any blood products within the 3
             months prior to Visit 0.

          -  Had administration of another IMP including vaccines within 60 days or 5 half-lives
             (whichever is longer), prior to Visit 0.

          -  Have a known history or a positive test of any of human immunodeficiency virus (HIV) 1
             or 2, Hepatitis B, or Hepatitis C, within the 30 days prior to Visit 0.

          -  Have a positive polymerase chain reaction (PCR)-based test for severe acute
             respiratory syndrome coronavirus 2 (SARS-CoV-2) within the 30 days prior to Visit 1.

          -  Have a positive drugs of abuse (for amphetamines, benzodiazepines, barbiturates,
             cocaine, cannabinoids, opiates, methadone, methamphetamines, phencyclidine, and
             tricyclic antidepressants) result at Visit 0 or Visit 1.

          -  Have a positive breath alcohol test at Visit 0 or Visit 1.

          -  Previously participated in an investigational trial involving lipid nanoparticles.

          -  Are subject to exclusion periods from other investigational trials or simultaneous
             participation in another clinical trial.

          -  Have any affiliation with the trial site (e.g., are close relative of the investigator
             or dependent person, such as an employee or student of the trial site).

          -  Have a history (within the past 5 years) of substance abuse or known medical,
             psychological, or social conditions which, in the opinion of the investigator, could
             compromise their well-being if they participate as trial subjects in the trial, or
             that could prevent, limit, or confound the protocol-specified assessments.

          -  Have a history of hypersensitivity or serious reactions to previous vaccinations.

          -  Have a history of Guillain-Barré Syndrome within 6 weeks following a previous
             vaccination.

          -  Have a history of narcolepsy.

          -  Have history of alcohol abuse or drug addiction within 1 year before Visit 0.

          -  Have a history of or suspected immunosuppressive condition, acquired or congenital, as
             determined by medical history and/or physical examination at Visit 0.

          -  Have any abnormality or permanent body art (e.g., tattoo) that, in the opinion of the
             investigator, would obstruct the ability to observe local reactions at the injection
             site.

          -  Have had any blood loss >450 mL, e.g., due to donation of blood or blood products or
             injury, within the 7 days prior to Visit 0 or plan to donate blood during the trial,
             starting after Visit 0 and continuously until at least 7 days after receiving the last
             immunization.

          -  Symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath
             and breathing difficulties.

          -  Have had contact with persons diagnosed with COVID-19 or who tested positive for
             SARS-CoV-2 by any diagnostic test within the 30 days prior to Visit 1.

          -  Are soldiers, subjects in detention, contract research organization (CRO) or sponsor
             staff or their family members.

          -  Regular receipt of inhaled/nebulized corticosteroids.

          -  Have a condition known to put them at high risk for severe COVID-19, including those
             with any of the following risk factors:

               -  Cancer

               -  COPD (chronic obstructive pulmonary disease)

               -  Immunocompromised state (weakened immune system) from solid organ transplant

               -  Obesity (BMI of 30 or higher)

               -  Serious heart conditions, such as heart failure, coronary artery disease, or
                  cardiomyopathies

               -  Sickle cell disease

               -  Diabetes mellitus

               -  Hypertension

               -  Asthma

               -  Chronic liver disease

               -  Known Stage 3 or worse chronic kidney disease (glomerular filtration rate <60
                  mL/min/1.73 m^2)

               -  Anticipating the need for immunosuppressive treatment within the next 6 months

               -  Resident in a long-term facility

               -  Current vaping or smoking (occasional smoking is acceptable)

               -  History of chronic smoking within the prior year
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 85 Years

Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Contradiction