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Clinical Immunogenicity of Measles, Mumps, and Rubella Vaccine (MMRII) delivered by the INJEX™ Needle-free device: comparison with standard syringe injection.

Investigators – Mark J. Sarno, B.A.; Erich Blasé, B.A.; Neely Galindo, R.N.; Roberto Ramirez, M.D.; Carl L. Schirmer, M.S.; and Daniel F. Trujillo-Juarez, M.D.

Forty adolescent subjects were injected bilaterally via needle syringe and the Injex 30 Needle Free Injector with MMR vaccine and reconstitution buffer. Subjects were then followed longitudinally for 12 weeks post-immunization and titers to Measles, Mumps, and Rubella immunogens were determined by enzyme immunoassays.

Results – Adverse events were mild in intensity and included injection site soreness, injection site bleeding, malaise, and fever. These adverse events were more frequent in subjects receiving injections via the syringe/needle. All subjects displayed measles titers significantly above baseline during the longitudinal follow-up. Ninety-five percent (95%) of subjects displayed titers above baseline for the mumps and rubella antigens. No significant difference in immunogenicity were found between groups receiving the vaccine via the Injex 30 Needle Free Injector or the needle syringe at any time during follow up.

Conclusion – We conclude that the Injex 30 Needle Free Injector can safely and effectively deliver mumps and rubella virus the MMR vaccine for immunity to measles, mumps and rubella virus. This device therefore provides an alternative to standard needle injection and a methodology that may reduce the high incidence of needle-stick accidents.

Source: Ped Infect Dis J, 19:9:839-42