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Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19.
JAMA. 2021 04 20; 325(15):1535-1544.JAMA

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.

Authors+Show Affiliations

Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts. Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Janssen Vaccines & Prevention, Leiden, the Netherlands.Janssen Vaccines & Prevention, Leiden, the Netherlands.Janssen Vaccines & Prevention, Leiden, the Netherlands.Janssen Research & Development, Beerse, Belgium.Janssen Research & Development, Beerse, Belgium.Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts. Harvard Medical School, Boston, Massachusetts.Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts. Massachusetts Institute of Technology, Cambridge.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Harvard Medical School, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Harvard Medical School, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts.Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.Massachusetts Institute of Technology, Cambridge.Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts.Janssen Research & Development, Beerse, Belgium.Janssen Vaccines & Prevention, Leiden, the Netherlands.Janssen Vaccines & Prevention, Leiden, the Netherlands.Janssen Vaccines & Prevention, Leiden, the Netherlands.Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Ragon Institute of MGH, MIT and Harvard, Cambridge, Massachusetts. Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Harvard Medical School, Boston, Massachusetts. Massachusetts Consortium on Pathogen Readiness, Boston.

Pub Type(s)

Clinical Trial, Phase I
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

33704352

Citation

Stephenson, Kathryn E., et al. "Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19." JAMA, vol. 325, no. 15, 2021, pp. 1535-1544.
Stephenson KE, Le Gars M, Sadoff J, et al. Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19. JAMA. 2021;325(15):1535-1544.
Stephenson, K. E., Le Gars, M., Sadoff, J., de Groot, A. M., Heerwegh, D., Truyers, C., Atyeo, C., Loos, C., Chandrashekar, A., McMahan, K., Tostanoski, L. H., Yu, J., Gebre, M. S., Jacob-Dolan, C., Li, Z., Patel, S., Peter, L., Liu, J., Borducchi, E. N., ... Barouch, D. H. (2021). Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19. JAMA, 325(15), 1535-1544. https://doi.org/10.1001/jama.2021.3645
Stephenson KE, et al. Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19. JAMA. 2021 04 20;325(15):1535-1544. PubMed PMID: 33704352.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19. AU - Stephenson,Kathryn E, AU - Le Gars,Mathieu, AU - Sadoff,Jerald, AU - de Groot,Anne Marit, AU - Heerwegh,Dirk, AU - Truyers,Carla, AU - Atyeo,Caroline, AU - Loos,Carolin, AU - Chandrashekar,Abishek, AU - McMahan,Katherine, AU - Tostanoski,Lisa H, AU - Yu,Jingyou, AU - Gebre,Makda S, AU - Jacob-Dolan,Catherine, AU - Li,Zhenfeng, AU - Patel,Shivani, AU - Peter,Lauren, AU - Liu,Jinyan, AU - Borducchi,Erica N, AU - Nkolola,Joseph P, AU - Souza,Morgana, AU - Tan,Chen Sabrina, AU - Zash,Rebecca, AU - Julg,Boris, AU - Nathavitharana,Ruvandhi R, AU - Shapiro,Roger L, AU - Azim,Ahmed Abdul, AU - Alonso,Carolyn D, AU - Jaegle,Kate, AU - Ansel,Jessica L, AU - Kanjilal,Diane G, AU - Guiney,Caitlin J, AU - Bradshaw,Connor, AU - Tyler,Anna, AU - Makoni,Tatenda, AU - Yanosick,Katherine E, AU - Seaman,Michael S, AU - Lauffenburger,Douglas A, AU - Alter,Galit, AU - Struyf,Frank, AU - Douoguih,Macaya, AU - Van Hoof,Johan, AU - Schuitemaker,Hanneke, AU - Barouch,Dan H, PY - 2021/09/11/pmc-release PY - 2021/3/12/pubmed PY - 2021/5/4/medline PY - 2021/3/11/entrez SP - 1535 EP - 1544 JF - JAMA JO - JAMA VL - 325 IS - 15 N2 - 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. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/33704352/Immunogenicity_of_the_Ad26_COV2_S_Vaccine_for_COVID_19_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2021.3645 DB - PRIME DP - Unbound Medicine ER -