Your browser doesn't support javascript.
Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19.
Stephenson, Kathryn E; Le Gars, Mathieu; Sadoff, Jerald; de Groot, Anne Marit; Heerwegh, Dirk; Truyers, Carla; Atyeo, Caroline; Loos, Carolin; Chandrashekar, Abishek; McMahan, Katherine; Tostanoski, Lisa H; Yu, Jingyou; Gebre, Makda S; Jacob-Dolan, Catherine; Li, Zhenfeng; Patel, Shivani; Peter, Lauren; Liu, Jinyan; Borducchi, Erica N; Nkolola, Joseph P; Souza, Morgana; Tan, Chen Sabrina; Zash, Rebecca; Julg, Boris; Nathavitharana, Ruvandhi R; Shapiro, Roger L; Azim, Ahmed Abdul; Alonso, Carolyn D; Jaegle, Kate; Ansel, Jessica L; Kanjilal, Diane G; Guiney, Caitlin J; Bradshaw, Connor; Tyler, Anna; Makoni, Tatenda; Yanosick, Katherine E; Seaman, Michael S; Lauffenburger, Douglas A; Alter, Galit; Struyf, Frank; Douoguih, Macaya; Van Hoof, Johan; Schuitemaker, Hanneke; Barouch, Dan H.
  • Stephenson KE; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Le Gars M; Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts.
  • Sadoff J; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • de Groot AM; Janssen Vaccines & Prevention, Leiden, the Netherlands.
  • Heerwegh D; Janssen Vaccines & Prevention, Leiden, the Netherlands.
  • Truyers C; Janssen Vaccines & Prevention, Leiden, the Netherlands.
  • Atyeo C; Janssen Research & Development, Beerse, Belgium.
  • Loos C; Janssen Research & Development, Beerse, Belgium.
  • Chandrashekar A; Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts.
  • McMahan K; Harvard Medical School, Boston, Massachusetts.
  • Tostanoski LH; Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts.
  • Yu J; Massachusetts Institute of Technology, Cambridge.
  • Gebre MS; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Jacob-Dolan C; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Li Z; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Patel S; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Peter L; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Liu J; Harvard Medical School, Boston, Massachusetts.
  • Borducchi EN; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Nkolola JP; Harvard Medical School, Boston, Massachusetts.
  • Souza M; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Tan CS; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Zash R; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Julg B; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Nathavitharana RR; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Shapiro RL; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Azim AA; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Alonso CD; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Jaegle K; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Ansel JL; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Kanjilal DG; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Guiney CJ; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Bradshaw C; Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts.
  • Tyler A; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Makoni T; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Yanosick KE; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Seaman MS; Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Lauffenburger DA; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Alter G; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Struyf F; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Douoguih M; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Van Hoof J; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Schuitemaker H; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  • Barouch DH; Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
JAMA ; 325(15): 1535-1544, 2021 04 20.
Article in English | MEDLINE | ID: covidwho-1222577
ABSTRACT
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 × 1010 viral particles or 1 × 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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Antibodies, Neutralizing / Immunogenicity, Vaccine / COVID-19 Vaccines / COVID-19 / Immunity, Cellular / Antibodies, Viral Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Female / Humans / Male / Middle aged / Young adult Language: English Journal: JAMA Year: 2021 Document Type: Article

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: Antibodies, Neutralizing / Immunogenicity, Vaccine / COVID-19 Vaccines / COVID-19 / Immunity, Cellular / Antibodies, Viral Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Female / Humans / Male / Middle aged / Young adult Language: English Journal: JAMA Year: 2021 Document Type: Article