Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern

Summary

The study will evaluate the clinical efficacy of different dosing regimens of the Moderna COVID-19 mRNA vaccine (100 mcg) in preventing COVID-19 disease in people who are living with HIV or have comorbidities associated with elevated risk of severe COVID-19, with the different vaccine regimens assessed determined by whether the participant had evidence of prior SARS-CoV-2 infection at enrollment.

Timeline

Start

2021-12-01

Primary completion

2024-04-19

Completion

2024-04-19

Publications

• Results Garrett N, Tapley A, Hudson A, Dadabhai S, Zhang B, Mgodi NM, Andriesen J, Takalani A, Fisher LH, Kee JJ, Magaret CA, Villaran M, Hural J, Andersen-Nissen E, Ferarri G, Miner MD, Le Roux B, Wilkinson E, Lessells R, de Oliveira T, Odhiambo J, Shah P, Polakowski L, Yacovone M, Samandari T, Chirenje Z, Elyanu PJ, Makhema J, Kamuti E, Nuwagaba-Biribonwoha H, Badal-Faesen S, Brumskine W, Coetzer S, Dawson R, Delany-Moretlwe S, Diacon AH, Fry S, Gill KM, Ebrahim Hoosain ZA, Hosseinipour MC, Inambao M, Innes C, Innes S, Kalonji D, Kasaro M, Kassim P, Kayange N, Kilembe W, Laher F, Malahleha M, Maluleke VL, Mboya G, McHarry K, Mitha E, Mngadi K, Mda P, Moloantoa T, Mutuluuza CK, Naicker N, Naicker V, Nana A, Nanvubya A, Nchabeleng M, Otieno W, Potgieter EL, Potloane D, Punt Z, Said J, Singh Y, Tayob MS, Vahed Y, Wabwire DO, McElrath MJ, Kublin JG, Bekker LG, Gilbert PB, Corey L, Gray GE, Huang Y, Kotze P; CoVPN 3008 Ubuntu Study Team. Hybrid versus vaccine immunity of mRNA-1273 among people living with HIV in East and Southern Africa: a prospective cohort analysis from the multicentre CoVPN 3008 (Ubuntu) study. EClinicalMedicine. 2025 Jan 20;80:103054. doi: 10.1016/j.eclinm.2024.103054. eCollection 2025 Feb.

Drugs

Indications