title: Immunogenicity and safety of measles-mumps-rubella vaccine delivered by disposable-syringe jet injector in healthy Brazilian infants: a randomized non-inferiority study.
abstract: This study aimed to determine if immunogenicity to measles-mumps-rubella vaccine delivered to infants via a disposable-syringe jet injector (DSJI) was non-inferior to that administered by needle and syringe (NS). Vaccination safety was evaluated, as were the use, performance, and acceptability of each delivery method. The DSJI was the PharmaJet 2009 generation-1 device (G1) and the vaccine was measles-mumps-rubella vaccine from Bio-Manguinhos. Five hundred eighty-two healthy Brazilian infants were randomized to receive vaccine via G1 or NS. Seroconversion rates against measles and mumps viruses in the G1 treatment group did not meet non-inferiority criteria when compared with the NS group; however, responses in the G1 group to rubella virus were non-inferior to those of NS vaccinees. Most adverse events were mild or moderate. Crying after injection was more frequent in the NS group, and local skin reactions were more common in the G1 group. Five serious adverse events were judged causally unrelated to treatment and all resolved. Parents/guardians expressed a strong preference for G1 over NS for their children. Vaccinators found the G1 easy to use but noted incomplete vaccine delivery in some cases. Although the G1 has been superseded by an updated device, our results are important for the continued improvement and evaluation of DSJIs, which have the potential to overcome many of the challenges and risks associated with needle-based injections worldwide. Recommendations for future DSJI clinical studies include rigorous training of vaccinators, quantitative measurement of wetness on the skin following injection, and regular monitoring of device and vaccinator performance.
authors.affiliation: Bio-Manguinhos/Fiocruz, Manguinhos, Rio de Janeiro, Brazil. Electronic address: Rmenezes@bio.fiocruz.br.
authors.forename: Reinaldo
authors.initials: R
authors.lastname: de Menezes Martins
authors.affiliation: PATH, 2201 Westlake Avenue North, Suite 200, Seattle, WA, USA. Electronic address: birutecurran@comcast.net.
authors.forename: Birute
authors.initials: B
authors.lastname: Curran
authors.affiliation: Bio-Manguinhos/Fiocruz, Manguinhos, Rio de Janeiro, Brazil. Electronic address: lourdes.maia@bio.fiocruz.br.
authors.forename: Maria de Lourdes Sousa
authors.initials: Mde L
authors.lastname: Maia
authors.affiliation: Bio-Manguinhos/Fiocruz, Manguinhos, Rio de Janeiro, Brazil.
authors.forename: Maria das Graças Tavares
authors.initials: Md
authors.lastname: Ribeiro
authors.affiliation: National School of Public Health/Fiocruz, Manguinhos, Rio de Janeiro, Brazil.
authors.forename: Luiz Antonio Bastos
authors.initials: LA
authors.lastname: Camacho
authors.affiliation: Bio-Manguinhos/Fiocruz, Manguinhos, Rio de Janeiro, Brazil.
authors.forename: Marcos
authors.initials: M
authors.lastname: da Silva Freire
authors.affiliation: Bio-Manguinhos/Fiocruz, Manguinhos, Rio de Janeiro, Brazil.
authors.forename: Anna Maya Yoshida
authors.initials: AM
authors.lastname: Yamamura
authors.affiliation: Oswaldo Cruz Institute/Fiocruz, Manguinhos, Rio de Janeiro, Brazil.
authors.forename: Marilda Mendonça
authors.initials: MM
authors.lastname: Siqueira
authors.affiliation: Municipal Health Secretary of Rio de Janeiro, Brazil.
authors.forename: Maria Cristina F
authors.initials: MC
authors.lastname: Lemos
authors.affiliation: Bio-Manguinhos/Fiocruz, Manguinhos, Rio de Janeiro, Brazil.
authors.forename: Elizabeth Maciel
authors.initials: EM
authors.lastname: de Albuquerque
authors.affiliation: Bio-Manguinhos/Fiocruz, Manguinhos, Rio de Janeiro, Brazil.
authors.forename: Vanessa dos Reis
authors.initials: Vdos R
authors.lastname: von Doellinger
authors.affiliation: Bio-Manguinhos/Fiocruz, Manguinhos, Rio de Janeiro, Brazil. Electronic address: Akira@bio.fiocruz.br.
authors.forename: Akira
authors.initials: A
authors.lastname: Homma
authors.affiliation: PATH, 2201 Westlake Avenue North, Suite 200, Seattle, WA, USA. Electronic address: laurasag@gmail.com.
authors.forename: Laura
authors.initials: L
authors.lastname: Saganic
authors.affiliation: PATH, 2201 Westlake Avenue North, Suite 200, Seattle, WA, USA. Electronic address: cjarrahian@path.org.
authors.forename: Courtney
authors.initials: C
authors.lastname: Jarrahian
authors.affiliation: PharmaJet, 400 Corporate Circle, Suite N, Golden, CO, USA. Electronic address: michael@cedarindustriesinc.com.
authors.forename: Michael
authors.initials: M
authors.lastname: Royals
authors.affiliation: PATH, 2201 Westlake Avenue North, Suite 200, Seattle, WA, USA. Electronic address: dzehrung@path.org.
authors.forename: Darin
authors.initials: D
authors.lastname: Zehrung
mesh_terms: D057134:Antibodies, Neutralizing / Q000276:immunology; D000914:Antibodies, Viral / Q000276:immunology; D001938:Brazil; D004209:Disposable Equipment; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000276:immunology; D007223:Infant; D007279:Injections, Subcutaneous / Q000295:instrumentation*; D008297:Male; D008457:Measles / Q000276:immunology / Q000517:prevention & control*; D022542:Measles-Mumps-Rubella Vaccine / Q000008:administration & dosage* / Q000276:immunology / Q000627:therapeutic use; D009107:Mumps / Q000276:immunology / Q000517:prevention & control*; D010342:Patient Acceptance of Health Care; D012409:Rubella / Q000276:immunology / Q000517:prevention & control*; D013594:Syringes
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D007074:Immunoglobulin G; D022542:Measles-Mumps-Rubella Vaccine
keywords: Acceptability; Disposable-syringe jet injector (DSJI); Immunogenicity; Measles–mumps–rubella vaccine; Needle-free; Vaccination