Evidence map›Paper›PMID 38512394›Full record

Trial reportHuman vaccines & immunotherapeutics2024

Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults.

Prasad S Kulkarni, Chandrasekaran Padmapriyadarsini, Johan Vekemans, Ashish Bavdekar, Madhu Gupta, Praveen Kulkarni, B S Garg, Nithya J Gogtay, Muralidhar Tambe, Sanjay Lalwani and 22 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIClinical Trial, Phase III
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. 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

32 authors.

Prasad S KulkarniSerum Institute of India Pvt Ltd, Pune, India.
Chandrasekaran PadmapriyadarsiniIndian Council of Medical Research, Delhi, India.
Johan VekemansFormerly of: Clinical Development, Infection, Late-stage Development, Respiratory and Immunology (R&I), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Ashish BavdekarKEM Hospital Research Centre, Pune, India.
Madhu GuptaDepartment of Community Medicine and School of Public Health, Post Graduate Institute of Medical Education & Research, Chandigarh, India.
Praveen KulkarniDepartment of Community Medicine, JSS Academy of Higher Education and Research, Mysore, India.
B S GargDepartment of Community Medicine and Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Wardha, India.
Nithya J GogtayDepartment of Clinical Pharmacology, Seth G S Medical College & KEM Hospital, Mumbai, India.
Muralidhar TambeDepartment of Community Medicine, B J Government Medical College and Sassoon General Hospitals, Pune, India.
Sanjay LalwaniDepartment of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune, India.
Kiranjit SinghJehangir Clinical Development Centre Pvt Ltd, Pune, India.
Renuka MunshiDepartment of Clinical Pharmacology, TN Medical College & BYL Nair Hospital, Mumbai, India.
Sushant MeshramDepartment of Pulmonary Medicine, Government Medical College, Nagpur, India.
T S SelvavinayagamDirectorate of Public Health and Preventive Medicine, Chennai, India.
Krishna PandeyRajendra Memorial Research Institute of Medical Sciences, Patna, India.
Devi Madhavi BhimarasettyDepartment of Community Medicine, Andhra Medical College, Visakhapatnam, India.
S R RamakrishnanDepartment of Clinical Research, Sri Ramchandra Institute of Higher Education and Research, Chennai, India.
Chetanraj BhamareSerum Institute of India Pvt Ltd, Pune, India.
Abhijeet DharmadhikariSerum Institute of India Pvt Ltd, Pune, India.
Chandrashekhar BudhawantBiostatistics, PPD India Pvt Ltd, Mumbai, India.
Cyrille J BonhommeLaboratory Services, Vaccines Sciences Lab, Clinical Research, PPD, Part of Thermo Fisher Scientific, Richmond, VA, USA.
Madhuri ThakarIndian Council of Medical Research, Delhi, India.
Swarali N KurleIndian Council of Medical Research, Delhi, India.
Elizabeth J KellyFormerly of: Translational Medicine, Vaccines and Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Manish GautamSerum Institute of India Pvt Ltd, Pune, India.
Nivedita GuptaIndian Council of Medical Research, Delhi, India.
Samiran PandaIndian Council of Medical Research, Delhi, India.
Balram BhargavaIndian Council of Medical Research, Delhi, India.
Cyrus S PoonawallaSerum Institute of India Pvt Ltd, Pune, India.
Umesh ShaligramSerum Institute of India Pvt Ltd, Pune, India.
Dhananjay KapseSerum Institute of India Pvt Ltd, Pune, India.
Bhagwat GunaleSerum Institute of India Pvt Ltd, Pune, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1 nCoV-19 with AZD1222 was previously demonstrated in an observer-blind, phase 2/3 immuno-bridging study (trial registration: CTRI/2020/08/027170). In this analysis of immunogenicity and safety data 6 months post first vaccination (Day 180), 1,601 participants were randomized 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (immunogenicity/reactogenicity cohort

Indexed as

ChAdOx1 nCoV-19COVID-19AdultAntibodies, ViralCOVID-19 VaccinesFollow-Up StudiesHumansImmunogenicity, VaccineImmunoglobulin GAntibodies, ViralChAdOx1 nCoV-19COVID-19 VaccinesImmunoglobulin GAZD1222 (ChAdOx1 nCoV-19)COVID-19 vaccineimmunogenicitysafetySARS-CoV-2SII-ChAdOx1 nCoV-19

Identifiers

PMID38512394
PMCPMC10962622

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Registered trials

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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.