A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of a Prophylactic SARS-CoV-2 RNA Vaccine (BNT162b3) Against COVID-19 Using Different Dosing Regimens in Healthy Adults

Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was skipped due to changes in the overall clinical development plan. The conducted Part A was a dose-finding part to investigate the optimal dose, allowing dose adjustments upwards and downwards in younger participants. Doses tested in older participants were chosen based on acceptability of dosing in younger participants.

Start Date09 Sep 2020

Sponsor / Collaborator

BioNTech SE

100 Clinical Results associated with Ganulameran

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Literatures (Medical) associated with Ganulameran

01 Dec 2021·The American Journal of Emergency MedicineQ4 · MEDICINE

Myocarditis after BNT162b2 vaccination in a healthy male

Q4 · MEDICINE

Article

Author: Gregory Griffin ; Kevin Watkins ; Erin L. Simon ; Kristen Septaric

Myocarditis following mRNA COVID-19 vaccination has recently been reported to health authorities in the United States and other countries. Cases predominately occur in young adult males within four days following the second dose of either the Moderna (mRNA-1273) or Pfizer-BioNTech (BNT162b2) vaccines. Although the number of cases reported have been small in comparison with the large number of people vaccinated, myocarditis may be a rare adverse reaction to the COVID-19 vaccination that is now only becoming apparent due to the widespread use of the vaccine. In this article, we present a case of a 20-year-old male with no prior medical history who presented to the emergency department (ED) with chest pain. He had received the BNT162b2 vaccine two days prior to his presentation to the ED. The patient had an elevated troponin at 89 ng/L which increased on repeat examination. His electrocardiogram showed diffuse concave ST segment elevations and a later MRI confirmed the diagnosis of myocarditis. Based on these findings, the patient was diagnosed with myocarditis. The patient had a previous infection with SARS-CoV-2 approximately two months prior to the onset of his symptoms, but since he had fully recovered before the time of his presentation to the ED, it is unlikely that the infection caused the myocarditis. To our knowledge, this is the first published case of myocarditis following BNT162b3 vaccination.

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Indication	Highest Phase	Country/Location	Organization	Date
Severe Acute Respiratory Syndrome	Preclinical	Germany	BioNTech SE	09 Sep 2020
COVID-19	Preclinical	Germany	Shanghai Fosun Pharmaceutical (Group) Co., Ltd.	07 Sep 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04537949 (CTgov)	Phase 1/2	COVID-19 \| Severe Acute Respiratory Syndrome	96	BNT162b3 (Part A Participants Aged 18 to 55 Years - 3 μg)	ukvswythvh(lgisetfhut) = wniflcxwkn mflejgzvkz (epzwctimtc, wlffudnrpp - tzxddrmegg) View more	-	24 Mar 2022
				BNT162b3 (Part A Participants Aged 18 to 55 Years - 10 μg)	ukvswythvh(lgisetfhut) = pboraqtjvx mflejgzvkz (epzwctimtc, fcdvioafnr - nofkowzlfm) View more

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