Evidence map›Paper›PMID 42779880›Full record

ArticleResearch square2026

Relative efficacy, safety and immunogenicity of bivalent versus monovalent COVID-19 mRNA booster vaccines: a randomized trial.

Sufia Dadabhai, Taraz Samandari, Bo Zhang, Aaron Hudson, Nonhlanhla N Mkhize, Asa Tapley, Jessica Andriesen, Penny L Moore, Zvavahera Chirenje, Peter James Elyanu and 65 more

Registry-linked trialAbstract readPreprint
PubMed Full text at PMC Publisher
In one paragraph

Article in Research square, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05168813 (Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05168813 phase2 / phase3completednot on this map

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

TypeinterventionalSponsorCOVID-19 Prevention NetworkRan2021 to 2024Enrolled14,237ConditionsSARS-CoV-2 Infection, HIV Infections, COVID-19ArmsModerna mRNA-1273, Moderna mRNA-1273.222, Vaccine 3 Dose, Vaccine 2 Dose
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

75 authors.

Sufia DadabhaiJohns Hopkins Research Project, Johns Hopkins Bloomberg School of Public Health, Blantyre, Malawi.
Taraz SamandariDepartment of Microbial Pathogenesis & Immunology, College of Medicine, Texas A&M, College Station, USA.ORCID 0000-0003-4830-6108
Bo ZhangVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, USA.ORCID 0000-0002-4381-1124
Aaron HudsonVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, USA.
Nonhlanhla N MkhizeSA MRC Antibody Immunity Research Unit, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; National Institute for Communicable Diseases of the National Health Laboratory Service, Johannesburg, South Africa.ORCID 0000-0003-3037-1243
Asa TapleyDepartment of Medicine, University of Washington, Seattle, USA; The Desmond Tutu HIV Centre, University of Cape Town, South Africa; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, USA.
Jessica AndriesenVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, USA.
Penny L MooreSA MRC Antibody Immunity Research Unit, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; National Institute for Communicable Diseases of the National Health Laboratory Service, Johannesburg, South Africa; Wits Infectious Diseases and Oncology Research Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Centre for the AIDS Programme of Research in South Africa, University of Kwa-Zulu Natal, Durban, South Africa.
Zvavahera ChirenjeClinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.
Peter James ElyanuBaylor College of Medicine Children's Foundation-Uganda, Kampala, Uganda.
Joseph MakhemaBotswana Harvard AIDS Institute, Gaborone, Botswana.
Ethel KamutiCentre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia.
Harriet Nuwagaba-BiribonwohaICAP at Columbia University, Eswatini Prevention Center, Mbabane, Eswatini; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, USA.
Jia Jin KeeVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, USA.ORCID 0009-0005-1114-7862
Jiani HuVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, USA.
Katekani Baloyi-OsehHutchinson Centre Research Institute of South Africa, South Africa.
Parth ShahPublic Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, USA.ORCID 0000-0002-3536-6219
Kentse KhutoHutchinson Centre Research Institute of South Africa, South Africa.
Maurine D MinerVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, USA.ORCID 0000-0002-4637-1283
Richard LessellsKwaZulu-Natal Research Innovation & Sequencing Platform, School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa.ORCID 0000-0003-0926-710X
Sinethemba BhebheSA MRC Antibody Immunity Research Unit, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; National Institute for Communicable Diseases of the National Health Laboratory Service, Johannesburg, South Africa.
Tandile HermanusSA MRC Antibody Immunity Research Unit, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; National Institute for Communicable Diseases of the National Health Laboratory Service, Johannesburg, South Africa.
Haajira KaldineSA MRC Antibody Immunity Research Unit, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; National Institute for Communicable Diseases of the National Health Laboratory Service, Johannesburg, South Africa.ORCID 0000-0002-7946-5606
Azwidihwi TakalaniHutchinson Center Research Institute of South Africa, Chris Hani Baragwanath Academic Hospital, Soweto, South Africa.
Margaret YacovoneNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, USA.ORCID 0000-0002-6983-8560
Laura PolakowskiNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, USA.
John HuralVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, USA.
Leigh H FisherVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, USA.ORCID 0000-0001-5228-1455
Craig A MargaretVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, USA.ORCID 0000-0002-5056-2664
Florence AweyoKisumu CRS Clinical Research Center, Kenya.
Sharlaa Badal-FaesenClinical HIV Research Unit, Faculty of Health Sciences, University of Witwatersrand, South Africa.ORCID 0000-0002-7306-5732
William L BrumskineThe Aurum Institute NPC, Rustenburg CRS, South Africa; Vanderbilt University, Department of Medicine, Nashville, TN, USA.ORCID 0000-0002-1092-9919
Soritha CoetzerSynexus CRS, Helderberg, South Africa.
Rodney DawsonUniversity of Cape Town Lung Institute Clinical Research Site, South Africa.
Sinead Delany-MoretlweWits RHI, University of the Witwatersrand, Johannesburg, South Africa.
Katherine M GillThe Desmond Tutu HIV Centre, University of Cape Town, South Africa.ORCID 0000-0002-3372-9506
Mina C HosseinipourUniversity of North Carolina at Chapel Hill School of Medicine and UNC Project Malawi, Malawi.ORCID 0000-0003-2174-313X
Steve InnesThe Desmond Tutu HIV Centre, University of Cape Town, South Africa.ORCID 0000-0003-3969-8680
Priya KassimPerinatal HIV Research Unit Soweto Kliptown, South Africa.
Emmanuel George KafulafulaJohns Hopkins Research Project-Kamuzu University of Health Sciences, Blantyre, Malawi.
Fatima LaherPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, South Africa.ORCID 0000-0001-5231-9951
Nelly M MandonaUniversity of North Carolina, Global Projects Zambia (UNC GPZ), Zambia.
Moelo MalahlehaSynergy Biomed Research Institute, South Africa.
Vongane L MalulikeMERCLINCO, Middelburg, South Africa.
Matsontso MathebulaMeCRU (Medunsa Clinical Trial Site), South Africa.
Grace MboyaKisumu CRS Clinical Research Center, Kenya.
Essack MithaNewtown Clinical Research, Johannesburg, South Africa.
Kathryn MngadiThe Aurum Institute, South Africa.ORCID 0000-0002-7847-3671
Pamela MdaNelson Mandela Academic Clinical Research Unit CRS, Walter Sisulu University, South Africa.
Tumelo MoloantoaWits Health Consortium, PHRU-Matlosana, South Africa.
Nivashnee NaickerCAPRISA eThekwini CRS, Durban, South Africa.ORCID 0000-0002-8819-3825
Vimla NaickerTongaat CRS, South Africa Medical Research Council, South Africa.
Annet NanvubyaUVRI-IAVI HIV Vaccine Program LTD. CRS, Uganda.
Maphoshane NchabelengMeCRU, Sefako Makgatho Health Sciences University/NHLS, South Africa.
Walter OtienoUS Army Research Directorate-Africa, Kisumu, Kenya.ORCID 0000-0001-5940-1077
Elsje L PotgieterSynexus Stanza Clinical Research Centre (CRS), South Africa.ORCID 0000-0002-7865-2549
Disebo PotloaneCAPRISA Vulindlela CRS, Durban, South Africa.ORCID 0000-0001-7564-3420
Zelda PuntPHOENIX Pharma (Pty) Ltd, South Africa.
Jamil A SaidMoi University Clinical Research Center (MUCRC), Kenya.ORCID 0000-0002-7871-3401
Yashna SinghThe Desmond Tutu HIV Centre, Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, South Africa.
Mohammed S TayobMERCLINCO, South Africa.ORCID 0000-0002-3064-0629
Deo O WabwireMU-JHU Research Collaboration CRS, Kampala, Uganda.
Myron S CohenUniversity of North Carolina, Chapel Hill, USA.
M Juliana McElrathVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, USA.ORCID 0000-0003-2276-7117
Erica Andersen-NissenCape Town HVTN Immunology Laboratory, Hutchinson Centre Research Institute of South Africa, Cape Town, South Africa.ORCID 0000-0001-9213-920X
Guido FerrariDuke University Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA; Center for HIV/AIDS Vaccine Immunology, Duke University School of Medicine, Durham, NC, USA.ORCID 0000-0001-7747-3349
James G KublinVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, USA.ORCID 0000-0003-1279-3741
Linda-Gail BekkerThe Desmond Tutu HIV Centre, University of Cape Town, South Africa.ORCID 0000-0002-0755-4386
Peter B GilbertVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, USA.ORCID 0000-0002-2662-9427
Nyaradzo M MgodiClinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.
Philip L KotzeQhakaza Mbokodo Research Clinic, Ladysmith, South Africa.
Yunda HuangVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, USA.ORCID 0000-0003-1546-6172
Nigel GarrettThe Desmond Tutu HIV Centre, University of Cape Town, South Africa; Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa; Discipline of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.
Glenda E GraySouth African Medical Research Council, Cape Town, South Africa; Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Infectious Diseases and Oncology Research Institute, South Africa.
Lawrence CoreyVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center; Departments of Medicine and Laboratory Medicine & Pathology, University of Washington, Seattle, USA.ORCID 0000-0002-2179-2436

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI Sinead Delany-Moretlwe, RAPHAEL J LANDOVITZ · 2011 to 2026
$779.5M
LC: HIV Vaccine Trials NetworkUM1AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Margaret Juliana McElrath · 2011 to 2026
$483.6M
SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
HOST DEFENSE TRAINING IN ALLERGY AND INFECTIOUS DISEASEST32AI007044 · NIAID · UNIVERSITY OF WASHINGTON · PI DAVID Neal FREDRICKS · 1985 to 2026
$14.6M
NIAID NIH HHS T32 AI007044NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI068635
6 · The paper itself

Abstract

The relative efficacy, safety, and immunogenicity of monovalent mRNA-1273 (ancestral WA1) versus bivalent mRNA-1273.222 (ancestral plus omicron BA.4/BA.5) boosting have not been studied prospectively where HIV and SARS-CoV-2 seroprevalence are high. CoVPN 3008 (NCT05168813) was a randomized, double-blinded trial in seven African countries during omicron waves, enrolling people with HIV (PWH) or comorbidities associated with severe COVID-19 who had previously received mRNA-1273. Participants were randomized 1:1 to intramuscular monovalent or bivalent booster and routinely PCR-tested for SARS-CoV-2. Between 10/2022 and 03/2023, 3,988 participants (3,086 PWH) received bivalent (n=2012) or monovalent (n=1976) booster. By month 12, 293 COVID-19 cases and 221 asymptomatic infections occurred, including one severe case. COVID-19 rates did not differ between arms (hazard ratio [HR] 0.92, 95% CI 0.73-1.15, P=0.45). Combined COVID-19 and asymptomatic infection was 15% lower with the bivalent (239 vs. 275; HR 0.85, 0.71-1.01, P=0.07), and asymptomatic infection alone was 24% lower (HR 0.76, 0.59-1.00, P=0.05). Neutralizing antibody titers to BA.4/5 and XBB.1.5, measured in 100 PWH per arm, boosted higher in bivalent recipients (P=0.026 and 0.002). Adverse events were similar. In predominantly PWH, the bivalent booster was well tolerated, elicited superior immunogenicity against omicron variants, and appeared to protect against asymptomatic infection but not COVID-19.

Identifiers

PMID42779880
PMCPMC13596654

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Registered trials

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