Research Published: Comparison of bacille Calmette-Guérin (BCG) vaccine administration via a disposable-syringe jet injector to conventional needle and syringe
SATVI has authored "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" in the Vaccine journal.
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Our data demonstrate that BCG administration by DSJI is as safe and immunogenic as conventional Mantoux NS administration.
Introduction:Intradermal 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.
BCG Jet Injector study team, August 2014.
Method: Thirty 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.
Results: More 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.
Discussion: Our data demonstrate that BCG administration by DSJI is as safe and immunogenic as conventional Mantoux NS administration. It appears that BCG vaccination of newborn infants via DSJI is more likely to deliver an appropriate intradermal wheal, compared to NS, despite leaving more fluid on the skin surface. The significance of this finding, in terms of injection performance, needs further exploration. Follow-up research is also required to investigate the cost-effectiveness and feasibility of such devices for national vaccination programs considering multiple factors, such as reduced risk of needlestick injuries, reduced waste-management costs, and the potential for fewer staff resources due to a simplified vaccination technique. The potential application for this technology for BCG vaccination is large, given the global coverage of BCG vaccination, and further investigation is justified.
Conclusion: BCG 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.
Citation:Geldenhuys HD, Mearns H, Foster J, Saxon E, Kagina B, Saganic L, Jarrahian C, Tameris MD, Dintwe OB, Van Rooyen M, Luabeya KK, Hussey G, Scriba TJ, Hatherill M, Zehrung D. 2015. 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. Vaccine. 2015 Sep 8;33(37):4719-26. Click here.
Funding:This work was funded by grant number OPP30451 01 from the Bill and Melinda Gates Foundation.
