A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults
Autor: | Haranaka, Miwa, Baber, James, Ogama, Yoichiro, Yamaji, Masako, Aizawa, Masakazu, Kogawara, Osamu, Scully, Ingrid, Lagkadinou, Eleni, Türeci, Ӧzlem, Şahin, Uğur, Dormitzer, Philip R., Gruber, William C., Lockhart, Stephen |
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Jazyk: | angličtina |
Rok vydání: | 2021 |
Předmět: |
Adult
Aged 80 and over Male COVID-19 Vaccines Multidisciplinary SARS-CoV-2 Data Collection Science COVID-19 General Physics and Astronomy General Chemistry Middle Aged Injections Intramuscular Article General Biochemistry Genetics and Molecular Biology Young Adult Immunogenicity Vaccine Japan Phase I trials RNA vaccines Humans Female BNT162 Vaccine Aged |
Zdroj: | Nature Communications, Vol 12, Iss 1, Pp 1-7 (2021) Nature Communications |
ISSN: | 2041-1723 |
Popis: | We report interim safety and immunogenicity findings from an ongoing phase 1/2 study of BNT162b2 in healthy Japanese adults. Participants were randomized 3:1 to receive 2 intramuscular injections of 30 μg BNT162b2 or placebo 21 days apart. Overall, 160 individuals were randomized: 119 received BNT162b2, and 41 received placebo. Participants were stratified by age: 20–64 years (n = 130) and 65–85 years (n = 30). More than 97% of BNT162b2 recipients received 2 doses. Local reactions and systemic events were generally transient and mild to moderate. Severe adverse events were uncommon; there were no serious adverse events. One month after dose 2, SARS-CoV-2 50% serum neutralizing geometric mean titers were 571 and 366, and geometric mean fold rises were 55.8 and 36.6, in the younger and older age groups, respectively. In summary, BNT162b2 has an acceptable safety profile and produces a robust immune response, regardless of age, in Japanese adults. (ClinicalTrials.gov, NCT04588480). Here the authors provide the interim analysis of an ongoing phase 1/2 study of the BNT162b2 vaccine in healthy Japanese adults. They report mainly mild to moderate local reactions and no serious adverse events as well as good antibody induction one month after the second dose. |
Databáze: | OpenAIRE |
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