Evidence map›Paper›PMID 37344265›Full record

Trial reportVaccine2023

Single Ad26.COV2.S booster dose following two doses of BBIBP-CorV vaccine against SARS-CoV-2 infection in adults: Day 28 results of a phase 1/2 open-label trial.

Sant Muangnoicharoen, Rakpong Wiangcharoen, Sira Nanthapisal, Supitcha Kamolratakul, Saranath Lawpoolsri, Anan Jongkaewwattana, Arunee Thitithanyanont, Viravarn Luvira, Pailinrut Chinwangso, Narumon Thanthamnu and 8 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase I
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 NCT05109559 (A Phase 1/2 Study to Evaluate the Safety Reactogenicity and Immunogenicity of Ad26.COV2.S Administered as a Heterologous Booster Vaccination in Adults 18 Years of Age and Older Following Single- or Two-Dose Vaccination With an Inactivated COVID-19 Vaccine), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.7field-weighted citation impact, top 16% 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.

NCT05109559 phase1 / phase2unknown statusnot on this map

A Phase 1/2 Study to Evaluate the Safety Reactogenicity and Immunogenicity of Ad26.COV2.S Administered as a Heterologous Booster Vaccination in Adults 18 Years of Age and Older Following Single- or Two-Dose Vaccination With an Inactivated COVID-19 Vaccine

TypeinterventionalSponsorMahidol UniversityRan2021 to 2024Enrolled690ConditionsSARS-CoV-2 InfectionArmsFull dose of Ad26.COV2. 5x10^10vp, Half dose of Ad26.COV2. 2.5x10^10vp
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
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  3. Review
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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

18 authors at 8 institutions in 5 countries.

Sant MuangnoicharoenVaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi, Bangkok 10400, Thailand.
Rakpong WiangcharoenPhaholpolpayuhasena Hospital, 572 Saeng Chuto Road Muang, Kanchanaburi 71000, Thailand.
Sira NanthapisalFaculty of Medicine, Thammasat University (Rangsit Campus), Pathum Thani, Thailand.
Supitcha KamolratakulVaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi, Bangkok 10400, Thailand.
Saranath LawpoolsriCenter of Excellence for Biomedical and Public Health Informatics (BIOPHICS), Bangkok, Thailand; Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Anan JongkaewwattanaNational Center for Genetic Engineering and Biotechnology (BIOTEC), National Science and Technology Development Agency (NSTDA), Pathum Thani, Thailand.
Arunee ThitithanyanontFaculty of Science, Mahidol University, Bangkok, Thailand.
Viravarn LuviraVaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi, Bangkok 10400, Thailand.
Pailinrut ChinwangsoCenter of Excellence for Biomedical and Public Health Informatics (BIOPHICS), Bangkok, Thailand.
Narumon ThanthamnuVaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi, Bangkok 10400, Thailand.
Narisara ChantratitaFaculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Jacqueline Kyungah LimInternational Vaccine Institute, Seoul, Republic of Korea.
T Anh WartelInternational Vaccine Institute, Seoul, Republic of Korea.
Jean-Louis ExclerInternational Vaccine Institute, Seoul, Republic of Korea.
Martin F RyserJanssen Global Medical Affairs, Beerse, Belgium.
Chloe LeongJanssen Asia Pacific Medical Affairs Operations, Sydney, Australia.
Tippi K MakCentre of Regulatory Excellence, Duke-NUS Medical School, Singapore; Vaccine and Infectious Disease Organization, University of Saskatchewan, Canada.
Punnee PitisuttithumVaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi, Bangkok 10400, Thailand. Electronic address: punnee.pit@mahidol.ac.th.
Mahidol University · THInternational Vaccine Institute · KRBiophics · THJanssen (Belgium) · BENational Science and Technology Development Agency · THPrapokklao Hospital · THThammasat University · THUniversity of Saskatchewan · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe inactivated COVID-19 whole-virus vaccine BBIBP-CorV has been extensively used worldwide. Heterologous boosting after primary vaccination can induce higher immune responses against SARS-CoV-2 than homologous boosting. The safety and immunogenicity after 28 days of a single Ad26.COV2.S booster dose given at different intervals after 2 doses of BBIBP-CorV are presented.

methodsThis open-label phase 1/2 trial was conducted in healthy adults in Thailand who had completed 2-dose primary vaccination with BBIBP-CorV. Participants received a single booster dose of Ad26.COV2.S (5 × 10

resultsSolicited local and systemic adverse events (AEs) on days 0-7 were mostly mild, as were unsolicited vaccine-related AEs during days 0-28, with no serious AEs. On day 28, anti-Spike binding antibodies increased from baseline by 487- and 146-fold in Groups A1 and A2, and neutralizing antibodies against ancestral SARS-CoV-2 by 55- and 37-fold, respectively. Humoral responses were strongest against ancestral SARS-CoV-2, followed by the delta, then the omicron BA.2 and BA.1 variants. T-cell-produced interferon-γ increased approximately 10-fold in both groups.

conclusionsA single heterologous Ad26.COV2.S booster dose after two BBIBP-CorV doses was well tolerated and induced robust humoral and cell-mediated immune responses measured at day 28 in both interval groups. CLINICAL TRIALS REGISTRATION: NCT05109559.

Indexed as

COVID-19VaccinesAd26COVS1AdultAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesHumansImmunogenicity, VaccineSARS-CoV-2Vaccines, InactivatedAd26COVS1Antibodies, NeutralizingAntibodies, ViralBIBP COVID-19 vaccineCOVID-19 VaccinesVaccinesVaccines, InactivatedAd26.COV2.SCOVID-19DeltaHeterologous boosterNeutralizing antibodiesOmicronSARS-CoV-2ThailandVariants of concernWhole inactivated virus vaccine

Identifiers

PMID37344265
PMCPMC10267503
OpenAlexW4380998031

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.