Evidence map›Paper›PMID 25862299›Full record

Trial reportVaccine2015

A randomized clinical trial in adults and newborns in South Africa to compare the safety and immunogenicity of bacille Calmette-Guérin (BCG) vaccine administration via a disposable-syringe jet injector to conventional technique with needle and syringe.

Hennie D Geldenhuys, Helen Mearns, Jennifer Foster, Eugene Saxon, Benjamin Kagina, Laura Saganic, Courtney Jarrahian, Michele D Tameris, One B Dintwe, Michele Van Rooyen and 5 more

Open access · hybridAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vaccine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 18% 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.

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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Immunogenicity of Fractional Dose Inactivated Poliovirus Vaccine in India.Journal of the Pediatric Infectious Diseases Society · 2022
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  3. Trial
  4. Article
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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

15 authors at 3 institutions in 2 countries.

Hennie D GeldenhuysSouth African Tuberculosis Vaccine Initiative (SATVI), Institute of Infectious Disease and Molecular Medicine (IDM) and Department of Paediatrics and Child Health, University of Cape Town, Brewelskloof Hospital, Haarlem Street, Worcester 6850, South Africa. Electronic address: hennie.geldenhuys@uct.ac.za.
Helen MearnsSouth African Tuberculosis Vaccine Initiative (SATVI), Institute of Infectious Disease and Molecular Medicine (IDM) and Department of Paediatrics and Child Health, University of Cape Town, Brewelskloof Hospital, Haarlem Street, Worcester 6850, South Africa.
Jennifer FosterPATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98109, USA.
Eugene SaxonPATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98109, USA.
Benjamin KaginaVaccine for Africa Initiative (VACFA), Institute of Infectious Disease and Molecular Medicine (IDM), University of Cape Town, Anzio Road, Observatory 7925, Cape Town, South Africa.
Laura SaganicPATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98109, USA.
Courtney JarrahianPATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98109, USA.
Michele D TamerisSouth African Tuberculosis Vaccine Initiative (SATVI), Institute of Infectious Disease and Molecular Medicine (IDM) and Department of Paediatrics and Child Health, University of Cape Town, Brewelskloof Hospital, Haarlem Street, Worcester 6850, South Africa.
One B DintweSouth African Tuberculosis Vaccine Initiative (SATVI), Institute of Infectious Disease and Molecular Medicine (IDM) and Department of Paediatrics and Child Health, University of Cape Town, Brewelskloof Hospital, Haarlem Street, Worcester 6850, South Africa.
Michele Van RooyenSouth African Tuberculosis Vaccine Initiative (SATVI), Institute of Infectious Disease and Molecular Medicine (IDM) and Department of Paediatrics and Child Health, University of Cape Town, Brewelskloof Hospital, Haarlem Street, Worcester 6850, South Africa.
Kany-Kany A LuabeyaSouth African Tuberculosis Vaccine Initiative (SATVI), Institute of Infectious Disease and Molecular Medicine (IDM) and Department of Paediatrics and Child Health, University of Cape Town, Brewelskloof Hospital, Haarlem Street, Worcester 6850, South Africa.
Gregory HusseyVaccine for Africa Initiative (VACFA), Institute of Infectious Disease and Molecular Medicine (IDM), University of Cape Town, Anzio Road, Observatory 7925, Cape Town, South Africa.
Thomas J ScribaSouth African Tuberculosis Vaccine Initiative (SATVI), Institute of Infectious Disease and Molecular Medicine (IDM) and Department of Paediatrics and Child Health, University of Cape Town, Brewelskloof Hospital, Haarlem Street, Worcester 6850, South Africa.
Mark HatherillSouth African Tuberculosis Vaccine Initiative (SATVI), Institute of Infectious Disease and Molecular Medicine (IDM) and Department of Paediatrics and Child Health, University of Cape Town, Brewelskloof Hospital, Haarlem Street, Worcester 6850, South Africa.
Darin ZehrungPATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98109, USA.
University of Cape Town · ZAProgram for Appropriate Technology in Health · USSouth African Tuberculosis Vaccine Initiative · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIntradermal bacille Calmette-Guérin (BCG) vaccination by needle-free, disposable-syringe jet injectors (DSJI) is an alternative to the Mantoux method using needle and syringe (NS). We compared the safety and immunogenicity of BCG administration via the DSJI and NS techniques in adults and newborn infants at the South African Tuberculosis Vaccine Initiative (SATVI) research site in South Africa.

methodThirty adults and 66 newborn infants were randomized 1:1 to receive intradermal BCG vaccine (0.1 mL in adults; 0.05 mL in infants) via DSJI or NS. Wheal diameter (mm) and skin fluid deposition at the site of injection (SOI) were measured immediately post-vaccination. Adverse events and SOI reactogenicity data were collected 30 min and 1, 2, 4, and 12 weeks after vaccination for adults and at 30 min and 4, 10, and 14 weeks for infants. Blood was collected in infants at 10 and 14 weeks to assess BCG-specific T-cell immune responses.

resultsMore infant BCG vaccinations by DSJI deposited >5 μL fluid on the skin surface, compared to NS (49% versus 9%, p=0.001). However, all 12 infant vaccinations that did not produce any SOI wheal occurred in the NS group (36%, p<0.001). Median wheal diameter, in participants for which an SOI wheal formed, did not differ significantly between groups in infants (combined 3.0mm IQR 2.0 to 4.0, p=0.59) or in adults (combined 9.0mm IQR 7.0 to 10.0, p=0.13). Adverse events were similar between study arms. Proportion of participants with BCG scars after three months did not differ in adults (combined 97%, p=0.67) or infants (combined 62%, p=0.13). Frequencies of BCG-specific clusters of differentiation 4 (CD4) and clusters of differentiation 8 (CD8) T-cells co-expressing IFN-γ, TNF-α, IL-2, and/or IL-17 were not different in the DSJI and NS groups.

conclusionBCG vaccination of newborn infants via DSJI was more likely to deliver an appropriate intradermal wheal at the SOI as compared to NS, despite leaving more fluid on the surface of the skin. Safety, reactogenicity, and antigen-specific T-cell immune responses did not differ between DSJI and NS techniques.

Indexed as

AdolescentAdultBCG VaccineCytokinesDrug-Related Side Effects and Adverse ReactionsFemaleHumansInfant, NewbornInjections, IntradermalInjections, JetMaleMiddle AgedSouth AfricaT-LymphocytesYoung AdultBCG VaccineCytokinesBCGIntradermal vaccineJet injectorMantouxVaccine administration

Identifiers

PMID25862299
PMCPMC4564069
OpenAlexW1964314307

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.