Journal article
Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19
JAMA : the journal of the American Medical Association, Vol.325(15), pp.1535-1544
04/20/2021
DOI: 10.1001/jama.2021.3645
PMCID: PMC7953339
PMID: 33704352
Abstract
Control of the global COVID-19 pandemic will require the development and deployment of safe and effective vaccines.
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.
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.
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).
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.
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.
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.
ClinicalTrials.gov Identifier: NCT04436276.
Details
- Title: Subtitle
- Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19
- Creators
- Kathryn E Stephenson - Beth Israel Deaconess Medical CenterMathieu Le Gars - Janssen Vaccines and Prevention, Leiden, the NetherlandsJerald Sadoff - Janssen Vaccines and Prevention, Leiden, the NetherlandsAnne Marit de Groot - Janssen Vaccines & Prevention, Leiden, the NetherlandsDirk Heerwegh - JanssenCarla Truyers - JanssenCaroline Atyeo - Harvard UniversityCarolin Loos - Massachusetts Institute of TechnologyAbishek Chandrashekar - Beth Israel Deaconess Medical CenterKatherine McMahan - Beth Israel Deaconess Medical CenterLisa H Tostanoski - Beth Israel Deaconess Medical CenterJingyou Yu - Beth Israel Deaconess Medical CenterMakda S Gebre - Beth Israel Deaconess Medical CenterCatherine Jacob-Dolan - Beth Israel Deaconess Medical CenterZhenfeng Li - Beth Israel Deaconess Medical CenterShivani Patel - Beth Israel Deaconess Medical CenterLauren Peter - Beth Israel Deaconess Medical CenterJinyan Liu - Beth Israel Deaconess Medical CenterErica N Borducchi - Beth Israel Deaconess Medical CenterJoseph P Nkolola - Beth Israel Deaconess Medical CenterMorgana Souza - Beth Israel Deaconess Medical CenterChen Sabrina Tan - Beth Israel Deaconess Medical CenterRebecca Zash - Beth Israel Deaconess Medical CenterBoris Julg - Beth Israel Deaconess Medical CenterRuvandhi R Nathavitharana - Beth Israel Deaconess Medical CenterRoger L Shapiro - Beth Israel Deaconess Medical CenterAhmed Abdul Azim - Beth Israel Deaconess Medical CenterCarolyn D Alonso - Beth Israel Deaconess Medical CenterKate Jaegle - Beth Israel Deaconess Medical CenterJessica L Ansel - Beth Israel Deaconess Medical CenterDiane G Kanjilal - Beth Israel Deaconess Medical CenterCaitlin J Guiney - Beth Israel Deaconess Medical CenterConnor Bradshaw - Beth Israel Deaconess Medical CenterAnna Tyler - Beth Israel Deaconess Medical CenterTatenda Makoni - Beth Israel Deaconess Medical CenterKatherine E Yanosick - Beth Israel Deaconess Medical CenterMichael S Seaman - Beth Israel Deaconess Medical CenterDouglas A Lauffenburger - Massachusetts Institute of TechnologyGalit Alter - Ragon Institute of MGH, MIT and HarvardFrank Struyf - Janssen (Netherlands)Macaya Douoguih - Janssen Vaccines and Prevention, Leiden, the NetherlandsJohan Van Hoof - Janssen Vaccines and Prevention, Leiden, the NetherlandsHanneke Schuitemaker - Janssen Vaccines and Prevention, Leiden, the NetherlandsDan H Barouch - Beth Israel Deaconess Medical Center
- Resource Type
- Journal article
- Publication Details
- JAMA : the journal of the American Medical Association, Vol.325(15), pp.1535-1544
- DOI
- 10.1001/jama.2021.3645
- PMID
- 33704352
- PMCID
- PMC7953339
- NLM abbreviation
- JAMA
- ISSN
- 0098-7484
- eISSN
- 1538-3598
- Grant note
- U01 CA260476 / NCI NIH HHS
- Language
- English
- Date published
- 04/20/2021
- Academic Unit
- Iowa Neuroscience Institute; Internal Medicine
- Record Identifier
- 9984366288102771
Metrics
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