Evidence map›Paper›PMID 38762360›Full record

Trial reportVaccine2024

Interchangeability of different COVID-19 vaccine platforms as booster doses: A phase 3 study mimicking real-world practice.

Sue Ann Costa Clemens, Lily Weckx, Eveline P Milan, Igor Smolenov, Ralf Clemens

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05812586 (Covid-19 Vaccine Boosting in a Real World Setting), 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.

NCT05812586 phase3unknown statusnot on this map

Covid-19 Vaccine Boosting in a Real World Setting: Exploratory Phase 3, Cohort Randomized, Single-blind, Multi-center Study to Evaluate the Safety and Immunogenicity of a Booster Dose of Various Covid-19 Vaccines in Fully Covid-19 Vaccine-primed Subjects Regardless of the Number of Prior Booster Dose(s) Received.

TypeinterventionalSponsorD'Or Institute for Research and EducationRan2023 to 2023Enrolled760ConditionsCOVID-19ArmsSCB-2019/Clover, AstraZeneca/Fiocruz, Pfizer/Wyeth
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

5 authors.

Sue Ann Costa ClemensInstitute for Global Health, University of Siena, Siena, Italy; Department of Pediatrics, Oxford University, Oxford, UK. Electronic address: clemens.ralf@outlook.com.
Lily WeckxCRIE UNIFESP, Reference Center for Special Immunobiologicals, Federal University of São Paulo, São Paulo, Brazil.
Eveline P MilanCentro de Estudos e Pesquisa em Moléstias Infecciosas Ltda. (CEPCLIN), Natal, Brazil.
Igor SmolenovClover Biopharmaceuticals, Chengdu, China.
Ralf ClemensInternational Vaccine Institute IVI BOT, Seoul, Republic of Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe COVID-19 pandemic is over but the highly immunized or naturally exposed global population still requires booster vaccinations against newly emerging SARS-CoV-2 variants. We assessed safety and immunogenicity of booster doses of COVID-19 vaccines based on three different platforms in a setting that mimics the current routine practice in Brazil.

methodsIn this phase 3 study from 14 February 2023 to 12 June 2023 we enrolled previously immunized adults to receive an additional booster dose of one of three vaccines. Immunogenicity against ancestor SARS-CoV-2 and Omicron BF.7, BQ.1.1.3, and XBB.1.5.6 sub-lineages was measured as ELISA IgG or virus neutralizing (VNT) antibodies and safety/reactogenicity assessed using diary cards.

resultsVolunteers with a history of full primary COVID-19 immunization striated to three cohorts according to their previous booster vaccination history-0 (n = 26), 1 (n = 140) or 2 (n = 606) booster vaccinations-were randomized 2:1:1 to receive either recombinant protein (SCB-2019, Clover), adenovirus-vector (ChAdOx1-S, AstraZeneca/Fiocruz), or mRNA (BNT162b2, Pfizer/Wyeth). Baseline antibody titers were higher in individuals who had received one or two boosters and titers against both ancestor and Omicron sub-lineages increased in all groups regardless of the number of previous booster doses or the vaccine used. Day 28 geometric mean titers (GMTs) and geometric mean-fold rises (GMFR) against all variants were higher after BNT162b than SCB-2019 or ChAdOx1-S, but BNT162b groups displayed more rapid antibody waning at Day 84. Within cohorts each vaccine elicited similar GMFR against the different SARS-CoV-2 strains. All vaccines were well tolerated with similar solicited reactogenicity profiles.

conclusionsProtein, adenovirus-vector or mRNA vaccine boosters were equally well tolerated and immunogenic against ancestor SARS-CoV-2 and Omicron sub-lineages in fully primed adults with 0-2 prior boosters. BNT162b induced the highest immune responses but also the most rapid waning of antibodies 3 months after vaccination. CLINICAL

trial registrationClinicalTrials.gov, identifier NCT05812586.

Indexed as

Antibodies, NeutralizingAntibodies, ViralCOVID-19COVID-19 VaccinesImmunization, SecondaryImmunogenicity, VaccineSARS-CoV-2AdultBrazilFemaleHumansMaleMiddle AgedVaccinationYoung AdultAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesmRNA vaccineProtein vaccineSARS-CoV-2Vector vaccine

Identifiers

PMID38762360
PMCPMC11252665

What Socratic holds

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LicenceCC BY
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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 Socratic graph.