A Study of Ad26.COV2.S in Adults (COVID-19)

Summary

The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort in healthy adults aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 years and in adults aged \>= 65 years in good health with or without stable underlying conditions. The purpose of the study is also to assess the safety and reactogenicity of Ad26.COV2.S administered as ad hoc booster vaccination in healthy adults aged \>= 18 to \<= 55 years and in adults \>= 65 years in good health with or without stable underlying conditions.

Timeline

Start

2020-07-15

Primary completion

2023-02-21

Completion

2023-02-21

Publications

• Sadoff J, Le Gars M, Brandenburg B, Cardenas V, Shukarev G, Vaissiere N, Heerwegh D, Truyers C, de Groot AM, Jongeneelen M, Kaszas K, Tolboom J, Scheper G, Hendriks J, Ruiz-Guinazu J, Struyf F, Van Hoof J, Douoguih M, Schuitemaker H. Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trials. Vaccine. 2022 Jul 30;40(32):4403-4411. doi: 10.1016/j.vaccine.2022.05.047. Epub 2022 Jun 3.
• 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. Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19. JAMA. 2021 Apr 20;325(15):1535-1544. doi: 10.1001/jama.2021.3645.
• Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot AM, Stoop J, Tete S, Van Damme W, Leroux-Roels I, Berghmans PJ, Kimmel M, Van Damme P, de Hoon J, Smith W, Stephenson KE, De Rosa SC, Cohen KW, McElrath MJ, Cormier E, Scheper G, Barouch DH, Hendriks J, Struyf F, Douoguih M, Van Hoof J, Schuitemaker H. Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine. N Engl J Med. 2021 May 13;384(19):1824-1835. doi: 10.1056/NEJMoa2034201. Epub 2021 Jan 13.
• Bos R, Rutten L, van der Lubbe JEM, Bakkers MJG, Hardenberg G, Wegmann F, Zuijdgeest D, de Wilde AH, Koornneef A, Verwilligen A, van Manen D, Kwaks T, Vogels R, Dalebout TJ, Myeni SK, Kikkert M, Snijder EJ, Li Z, Barouch DH, Vellinga J, Langedijk JPM, Zahn RC, Custers J, Schuitemaker H. Ad26 vector-based COVID-19 vaccine encoding a prefusion-stabilized SARS-CoV-2 Spike immunogen induces potent humoral and cellular immune responses. NPJ Vaccines. 2020 Sep 28;5:91. doi: 10.1038/s41541-020-00243-x. eCollection 2020.

Drugs

Indications

No indication recorded.