Deprecated: Implicit conversion from float 231.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 JAMA 2021 ; 325 (15): 1535-1544 Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
Immunogenicity of the Ad26 COV2 S Vaccine for COVID-19 #MMPMID33704352
Stephenson KE; Le Gars M; Sadoff J; de Groot AM; Heerwegh D; Truyers C; Atyeo C; Loos C; Chandrashekar A; McMahan K; Tostanoski LH; Yu J; Gebre MS; Jacob-Dolan C; Li Z; Patel S; Peter L; Liu J; Borducchi EN; Nkolola JP; Souza M; Tan CS; Zash R; Julg B; Nathavitharana RR; Shapiro RL; Azim AA; Alonso CD; Jaegle K; Ansel JL; Kanjilal DG; Guiney CJ; Bradshaw C; Tyler A; Makoni T; Yanosick KE; Seaman MS; Lauffenburger DA; Alter G; Struyf F; Douoguih M; Van Hoof J; Schuitemaker H; Barouch DH
JAMA 2021[Apr]; 325 (15): 1535-1544 PMID33704352show ga
IMPORTANCE: Control of the global COVID-19 pandemic will require the development and deployment of safe and effective vaccines. OBJECTIVE: To evaluate the immunogenicity of the Ad26.COV2.S vaccine (Janssen/Johnson & Johnson) in humans, including the kinetics, magnitude, and phenotype of SARS-CoV-2 spike-specific humoral and cellular immune responses. DESIGN, SETTING, AND PARTICIPANTS: Twenty-five participants were enrolled from July 29, 2020, to August 7, 2020, and the follow-up for this day 71 interim analysis was completed on October 3, 2020; follow-up to assess durability will continue for 2 years. This study was conducted at a single clinical site in Boston, Massachusetts, as part of a randomized, double-blind, placebo-controlled phase 1 clinical trial of Ad26.COV2.S. INTERVENTIONS: Participants were randomized to receive 1 or 2 intramuscular injections with 5 x 1010 viral particles or 1 x 1011 viral particles of Ad26.COV2.S vaccine or placebo administered on day 1 and day 57 (5 participants in each group). MAIN OUTCOMES AND MEASURES: Humoral immune responses included binding and neutralizing antibody responses at multiple time points following immunization. Cellular immune responses included immunospot-based and intracellular cytokine staining assays to measure T-cell responses. RESULTS: Twenty-five participants were randomized (median age, 42; age range, 22-52; 52% women, 44% male, 4% undifferentiated), and all completed the trial through the day 71 interim end point. Binding and neutralizing antibodies emerged rapidly by day 8 after initial immunization in 90% and 25% of vaccine recipients, respectively. By day 57, binding and neutralizing antibodies were detected in 100% of vaccine recipients after a single immunization. On day 71, the geometric mean titers of spike-specific binding antibodies were 2432 to 5729 and the geometric mean titers of neutralizing antibodies were 242 to 449 in the vaccinated groups. A variety of antibody subclasses, Fc receptor binding properties, and antiviral functions were induced. CD4+ and CD8+ T-cell responses were induced. CONCLUSION AND RELEVANCE: In this phase 1 study, a single immunization with Ad26.COV2.S induced rapid binding and neutralization antibody responses as well as cellular immune responses. Two phase 3 clinical trials are currently underway to determine the efficacy of the Ad26.COV2.S vaccine. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04436276.
free
free
free
JAMA 2021 ; 325 (15): 1535-1544
