G Model
ARTICLE IN PRESS
JVAC 16611 1–5
Vaccine xxx (2015) xxx–xxx
Contents lists available at ScienceDirect
Vaccine journal homepage: www.elsevier.com/locate/vaccine
Needle-free jet injector intradermal delivery of fractional dose inactivated poliovirus vaccine: Association between injection quality and immunogenicity
1
2
3
4
Q1
5 6 7
Sonia Resik a , Alina Tejeda b , Ondrej Mach c,∗ , Carolyn Sein c , Natalie Molodecky c , Courtney Jarrahian d , Laura Saganic d , Darin Zehrung d , Magile Fonseca a , Manuel Diaz a , Nilda Alemany b , Gloria Garcia b , Lai Heng Hung a , Yenisleydis Martinez a , Roland W. Sutter c a
Pedro Kouri Institute of Tropical Medicine, Havana, Cuba Centro Provincial de Higiene, Epidemiologia y Microbilogia, Camaguey, Cuba The World Health Organization, Geneva, Switzerland 10 d PATH, Seattle, WA, USA 11 Q2 8 9
b c
12
13 25
a r t i c l e
i n f o
a b s t r a c t
14 15 16 17 18 19
Article history: Received 27 April 2015 Received in revised form 12 June 2015 Accepted 17 June 2015 Available online xxx
20
24
Keywords: Poliomyelitis Needle-free injector Cuba
26
1. Introduction
21 22 23
27Q3 28 29
Introduction: The World Health Organization recommends that as part of the polio end-game strategy a dose of inactivated poliovirus vaccine (IPV) be introduced by the end of 2015 in all countries currently using only oral poliovirus vaccine (OPV). Administration of fractional dose (1/5 of full dose) IPV (fIPV) by intradermal (ID) injection may reduce costs, but its conventional administration is with Bacillus Calmette-Guerin (BCG) needle and syringe (NS), which is time consuming and technically challenging. We compared injection quality achieved with BCG NS and three needle-free jet injectors and assessed ergonomic features of the injectors. Methods: Children between 12 and 20 months of age who had previously received OPV were enrolled in the Camaguey, Cuba study. Subjects received a single fIPV dose administered intradermally with BCG NS or one of three needle-free injector devices: Bioject Biojector 2000® (B2000), Bioject ID Pen® (ID Pen), or PharmaJet Tropis® (Tropis). We measured bleb diameter and vaccine loss as indicators of ID injection quality, with desirable injection quality defined as bleb diameter ≥5 mm and vaccine loss
ARTICLE IN PRESS
JVAC 16611 1–5
Vaccine xxx (2015) xxx–xxx
Contents lists available at ScienceDirect
Vaccine journal homepage: www.elsevier.com/locate/vaccine
Needle-free jet injector intradermal delivery of fractional dose inactivated poliovirus vaccine: Association between injection quality and immunogenicity
1
2
3
4
Q1
5 6 7
Sonia Resik a , Alina Tejeda b , Ondrej Mach c,∗ , Carolyn Sein c , Natalie Molodecky c , Courtney Jarrahian d , Laura Saganic d , Darin Zehrung d , Magile Fonseca a , Manuel Diaz a , Nilda Alemany b , Gloria Garcia b , Lai Heng Hung a , Yenisleydis Martinez a , Roland W. Sutter c a
Pedro Kouri Institute of Tropical Medicine, Havana, Cuba Centro Provincial de Higiene, Epidemiologia y Microbilogia, Camaguey, Cuba The World Health Organization, Geneva, Switzerland 10 d PATH, Seattle, WA, USA 11 Q2 8 9
b c
12
13 25
a r t i c l e
i n f o
a b s t r a c t
14 15 16 17 18 19
Article history: Received 27 April 2015 Received in revised form 12 June 2015 Accepted 17 June 2015 Available online xxx
20
24
Keywords: Poliomyelitis Needle-free injector Cuba
26
1. Introduction
21 22 23
27Q3 28 29
Introduction: The World Health Organization recommends that as part of the polio end-game strategy a dose of inactivated poliovirus vaccine (IPV) be introduced by the end of 2015 in all countries currently using only oral poliovirus vaccine (OPV). Administration of fractional dose (1/5 of full dose) IPV (fIPV) by intradermal (ID) injection may reduce costs, but its conventional administration is with Bacillus Calmette-Guerin (BCG) needle and syringe (NS), which is time consuming and technically challenging. We compared injection quality achieved with BCG NS and three needle-free jet injectors and assessed ergonomic features of the injectors. Methods: Children between 12 and 20 months of age who had previously received OPV were enrolled in the Camaguey, Cuba study. Subjects received a single fIPV dose administered intradermally with BCG NS or one of three needle-free injector devices: Bioject Biojector 2000® (B2000), Bioject ID Pen® (ID Pen), or PharmaJet Tropis® (Tropis). We measured bleb diameter and vaccine loss as indicators of ID injection quality, with desirable injection quality defined as bleb diameter ≥5 mm and vaccine loss
