Evidence map›Paper›PMID 37149443›Full record

Trial reportVaccine2023

Efficacy of primary series AZD1222 (ChAdOx1 nCoV-19) vaccination against SARS-CoV-2 variants of concern: Final analysis of a randomized, placebo-controlled, phase 1b/2 study in South African adults (COV005).

Anthonet L Koen, Alane Izu, Vicky Baillie, Gaurav Kwatra, Clare L Cutland, Lee Fairlie, Sherman D Padayachee, Keertan Dheda, Shaun L Barnabas, Qasim Ebrahim Bhorat and 26 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vaccine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04444674 (An Adaptive Phase I/II Randomized Placebo-controlled Trial to Determine Safety, Immunogenicity and Efficacy of Non-replicating ChAdOx1 SARS-CoV-2 Vaccine in South African Adults Living Without HIV; and Safety and Immunogenicity in Adults Living With HIV), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.2field-weighted citation impact, top 23% of its field
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.

NCT04444674 phase1 / phase2unknown statusnot on this map

An Adaptive Phase I/II Randomized Placebo-controlled Trial to Determine Safety, Immunogenicity and Efficacy of Non-replicating ChAdOx1 SARS-CoV-2 Vaccine in South African Adults Living Without HIV; and Safety and Immunogenicity in Adults Living With HIV

TypeinterventionalSponsorUniversity of OxfordRan2020 to 2021Enrolled2,130ConditionsCoronavirusArmsChAdOx1 nCoV-19, Normal saline 0.9%
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
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

36 authors at 11 institutions in 4 countries.

Anthonet L KoenSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Alane IzuSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Vicky BaillieSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Gaurav KwatraSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Clinical Microbiology, Christian Medical College, Vellore, India.
Clare L CutlandAfrican Leadership in Vaccinology Expertise (ALIVE), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Lee FairlieWits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Sherman D PadayacheeSetshaba Research Centre, Tshwane, South Africa.
Keertan DhedaCentre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and UCT Lung Institute, University of Cape Town, South Africa.
Shaun L BarnabasFamily Centre for Research with Ubuntu, Department of Paediatrics, Stellenbosch University, Cape Town, South Africa.
Qasim Ebrahim BhoratSoweto Clinical Trials Centre, Soweto, South Africa.
Carmen BrinerPerinatal HIV Research Unit, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.
Khatija AhmedSetshaba Research Centre, Tshwane, South Africa; Faculty of Health Sciences, Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa.
Sutika BhikhaSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Jinal N BhimanNational Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS), Johannesburg, South Africa; SAMRC Antibody Immunity Research Unit, School of Pathology, University of the Witwatersrand, Johannesburg, South Africa.
Jeanine du PlessisSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Aliasgar EsmailCentre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and University of Cape Town Lung Institute, Cape Town, South Africa.
Elizea HorneWits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Shi-Hsia HwaAfrica Health Research Institute, Durban, South Africa; Division of Infection and Immunity, University College London, London, UK.
Aylin Oommen-JoseSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Teresa LambeOxford Vaccine Group, Department of Paediatrics, University of Oxford, UK; Chinese Academy of Medical Science, Oxford Institute, University of Oxford, Oxford, UK.
Matt LaubscherSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Mookho MalahlehaSetshaba Research Centre, Tshwane, South Africa; Synergy Biomed Research Institute, East London, Eastern Cape, South Africa.
Gabriella BenadeWits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Shakeel McKenzieSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Suzette OelofseCentre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and University of Cape Town Lung Institute, Cape Town, South Africa.
Faeezah PatelWits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Sureshnee PillayKwaZulu-Natal Research Innovation and Sequencing Platform (KRISP), School of Laboratory Medicine & Medical Sciences, University of KwaZulu-Natal, Durban, South Africa; Centre for Epidemic Response and Innovation (CERI), Stellenbosch University, Stellenbosch, South Africa.
Sarah RheadOxford Vaccine Group, Department of Paediatrics, University of Oxford, UK.
Hylton RodelAfrica Health Research Institute, Durban, South Africa; Division of Infection and Immunity, University College London, London, UK.
Carol TaoushanisSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Houriiyah TegallyKwaZulu-Natal Research Innovation and Sequencing Platform (KRISP), School of Laboratory Medicine & Medical Sciences, University of KwaZulu-Natal, Durban, South Africa; Centre for Epidemic Response and Innovation (CERI), Stellenbosch University, Stellenbosch, South Africa.
Asha ThombrayilSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Tonya L VillafanaClinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Sarah GilbertNuffield Department of Medicine, University of Oxford, ORCRB, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
Andrew J PollardOxford Vaccine Group, Department of Paediatrics, University of Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.
Shabir A MadhiSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: shabir.madhi@wits.ac.za.
South African Medical Research Council · ZAUniversity of the Witwatersrand · ZAUniversity of Oxford · GBStellenbosch University · ZAUniversity of Cape Town · ZAAfrica Health Research Institute · ZASetshaba Research Centre · ZAAstraZeneca (United States) · USNational Health Laboratory Service · ZASoweto CTC · ZATshwane University of Technology · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

COVID-19 vaccine efficacy (VE) has been observed to vary against antigenically distinct SARS-CoV-2 variants of concern (VoC). Here we report the final analysis of VE and safety from COV005: a phase 1b/2, multicenter, double-blind, randomized, placebo-controlled study of primary series AZD1222 (ChAdOx1 nCoV-19) vaccination in South African adults aged 18-65 years. South Africa's first, second, and third waves of SARS-CoV-2 infections were respectively driven by the ancestral SARS-CoV-2 virus (wild type, WT), and SARS-CoV-2 Beta and Delta VoCs. VE against asymptomatic and symptomatic infection was 90.6% for WT, 6.7% for Beta and 77.1% for Delta. No cases of severe COVID-19 were documented ahead of unblinding. Safety was consistent with the interim analysis, with no new safety concerns identified. Notably, South Africa's Delta wave occurred ≥ 9 months after primary series vaccination, suggesting that primary series AZD1222 vaccination offers a good durability of protection, potentially due to an anamnestic response. Clinical trial identifier: CT.gov NCT04444674.

Indexed as

ChAdOx1 nCoV-19COVID-19AdultCOVID-19 VaccinesHumansSARS-CoV-2South AfricaVaccinationChAdOx1 nCoV-19COVID-19 VaccinesAZD1222ChAdOx1 nCov-19COVID-19SARS-CoV-2 variantVaccine efficacy

Identifiers

PMID37149443
PMCPMC10133888
OpenAlexW4367295044

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.