start end of september.
und das dauert natürlich erstmal, wenn man sieht, was die potentiellen Kanditaten nicht alles haben dürfen, bzw haben müssen.
Criteria
Inclusion Criteria:
1. Male or female between the ages of 18 to 54 years, inclusive.
2. Negative for SARS-CoV-2 infection at the time of screening
3. In generally good health, without significant medical illness
4. Demonstrates comprehension of the protocol procedures and is able to provide written informed
consent.
5. Available for all planned visits and willing to complete all protocol defined procedures and
assessments
6. Body mass index between 17 and 30 kg/m2 at screening.
7. Female subjects must have a negative pregnancy test at screening and before each vaccination
and fulfill an acceptable method of birth control (per protocol)
Exclusion Criteria:
1. Known previous exposure to SARS-CoV-2 or receipt of an investigational product for the
prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or severe acute
respiratory syndrome (SARS).
2. Is in a current occupation with high risk of exposure to SARS-CoV-2
3. Individuals with the following underlying medical conditions who are at higher risk (or might be at
higher risk) of severe illness from COVID-19 per the CDC's guidance
4. Donation or use of blood or blood products within 4 weeks prior to vaccination or planned
donation during the study period.
5. Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood
draws problematic.
6. Any condition that resulted in the absence or removal of the spleen.
7. Positive HIV, HBsAg or HCV tests at the screening visit.
24.9.2020 Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults - Full Text View - Clin…
https://clinicaltrials.gov/ct2/show/...m=vaxart&draw=2&rank=1 6/8
8. Stool sample with occult blood at screening.
9. Use of antiviral medications, including anti-retrovirals, or any prescriptive medications for the
prevention of COVID-19 within 7 days before vaccination
10. Use of antibiotics, proton pump inhibitors, H2 blockers or antacids or medications known to affect
the immune function within 7 to 14 days before vaccination
11. Regular use of nonsteroidal anti-inflammatory drugs, sulfonylureas, and angiotensin II blockers
within 7 days before vaccination
12. Acute disease within 72 hours prior to vaccination defined as the presence of a moderate or
severe illness
13. History of drug, alcohol or chemical abuse within 1 year of screening or positive urine drug
screen for drugs of abuse at screening
14. History of hypersensitivity or allergic reaction to any component of the investigational vaccine
15. Administration of any investigational vaccine, drug or device within 8 weeks preceding
vaccination
16. Any other condition that in the clinical judgment of the investigator would jeopardize the safety or
rights of a subject participating in the trial, would render the subject unable to comply with the
protocol or would interfere with the evaluation of the study endpoints.
Contacts and Locations
Information from the National Library of Medicine
United States, California
24.9.2020 Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults
|
