Safety, Effectiveness and Immunogenicity of heterologous mRNA-1273 Boost
South Africa
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SafetyEffectivenessandImmunogenicityofheterologousmRNA-1273Boost
Safety, Effectiveness and Immunogenicity of heterologous mRNA-1273 Boost
| Name | Country code |
|---|---|
| South Africa | ZAR |
77% (95%CI 9-94%) in the one-Ad26.COV2.S dose group and 52% (95%CI 13-73%) in the two-dose group. Severe COVID-19 was identified in 148 unboosted participants, and only one SHERPA participant with severe HIV-related immunosuppression. Of 11798 participants in the safety analysis, 271 (2.3%) reported a reactogenicity event or unsolicited AE, more among those with prior SARS-CoV-2 infections (adjusted odds ratio [aOR] 2.03, 95%CI 1.59-2.59) and less among people living with HIV (PLWH) (aOR 0.49, 95%CI 0.34-0.69). No related serious AEs were reported. In an immunogenicity sub-study, mRNA-1273 increased antibody functions and T-cell responses 4 weeks after boosting regardless of the number of prior Ad26.COV2.S doses, or HIV status, and generated Omicron spike-specific crossreactive responses. mRNA-1273 boosters after one or two Ad26.COV2.S doses were well-tolerated, safe and effective against Omicron SARS-CoV-2 infections among HCWs and PLWH.
Producers and sponsors
| Name | Affiliation |
|---|---|
| Nigel Garrett | Centre for the AIDS Programme of Research in South Africa, Durban, South Africa |
| Tarylee Reddy | Biostatistics Research Unit, South African Medical Research Council (SAMRC), Durban, South Africa |
| Nonhlanhla Yende-Zuma | Biostatistics Research Unit, South African Medical Research Council (SAMRC), Durban, South Africa |
| Azwidhwi Takalani | Hutchinson Center Research Institute of South Africa, Cape Town, South Africa |
| Kubashni Woeber | Grants, Innovation and Product Development Unit, SAMRC, Durban, South Africa |
| Annie Bodenstein | Right to Care, Johannesburg, Gauteng, South Africa |
| Phumeza Jonas | Right to Care, Johannesburg, Gauteng, South Africa |
| Imke Engelbrecht | Right to Care, Johannesburg, Gauteng, South Africa |
| Waasila Jassat | Division of Public Health Surveillance and Response, National Institute for Communicable Diseases (NICD) of the National Health Laboratory Services (NHLS), Johannesburg, South Africa |
| Harry Moultrie | Division of Public Health Surveillance and Response, National Institute for Communicable Diseases (NICD) of the National Health Laboratory Services (NHLS), Johannesburg, South Africa |
| Debbie Bradshaw | Burden of Disease Research Unit, SAMRC, Tygerberg, South Africa |
| Ishen Seocharan | Biostatistics Research Unit, South African Medical Research Council (SAMRC), Durban, South Africa |
| Jackline Odhiambo | Hutchinson Center Research Institute of South Africa, Cape Town, South Africa |
| Kentse Khuto | Hutchinson Center Research Institute of South Africa, Cape Town, South Africa |
| Simone I. Richardson | SAMRC Antibody Immunity Research Unit, School of 28 Pathology, University of the Witwatersrand, Johannesburg, South Africa. |
| Millicent A. Omondi | Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, Department of Pathology, University of Cape Town, Cape Town, South Africa |
| Rofhiwa Nesamari | Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, Department of Pathology, University of Cape Town, Cape Town, South Africa |
| Roanne S. Keeton | Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, Department of Pathology, University of Cape Town, Cape Town, South Africa |
| Catherine Riou | Wellcome Centre for Infectious Diseases Research in Africa, University of Cape Town, Cape Town, South Africa |
| Thandeka Moyo-Gwete | SAMRC Antibody Immunity Research Unit, School of 28 Pathology, University of the Witwatersrand, Johannesburg, South Africa. |
| Penny L. Moore | SAMRC Antibody Immunity Research Unit, School of 28 Pathology, University of the Witwatersrand, Johannesburg, South Africa. |
| Wendy A. Burgers | Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, Department of Pathology, University of Cape Town, Cape Town, South Africa |
| Kate Anteyi | Moderna Inc., Cambridge, MA, USA |
| Brett Leav | Moderna Inc., Cambridge, MA, USA |
| Linda-Gail Bekker | Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa |
| Glenda E Gray | Office of the President and CEO, SAMRC, Cape Town, South Africa |
| Ameena Goga | HIV and other Infectious Diseases Research Unit, SAMRC, Durban, South Africa |
| SHERPA study team |