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Needle adapters for intradermal administration of fractional dose of inactivated poliovirus vaccine: Evaluation of immunogenicity and programmatic feasibility in Pakistan
Ali Faisal Saleema, , ,
a Aga Khan University, Karachi, Pakistan
b Polio Eradication Department, World Health Organization, Geneva, Switzerland
c Polio and Picornavirus Laboratory Branch, Centers for Disease Control and Prevention, Atlanta, USA
Received 6 November 2016, Revised 27 March 2017, Accepted 25 April 2017, Available online 4 May 2017
https://doi.org/10.1016/j.vaccine.2017.04.075
Under a Creative Commons license
Open Access
Excerpts below. Full text is at http://www.sciencedirect.com/science/article/pii/S0264410X17305765
Vaccine, Volume 35, Issue 24, 31 May 2017, Pages 3209–3214
Abstract
Administration of 1/5th dose of Inactivated poliovirus vaccine intradermally (fIPV) provides similar immune response as full-dose intramuscular IPV, however, fIPV administration with BCG needle and syringe (BCG NS) is technically difficult. We compared immune response after one fIPV dose administered with BCG NS to administration with intradermal devices, referred to as Device A and B; and assessed feasibility of conducting a door-to-door vaccination campaign with fIPV. In Phase I, 452 children 6–12 months old from Karachi were randomized to receive one fIPV dose either with BCG NS, Device A or Device B in a health facility. Immune response was defined as seroconversion or fourfold rise in polio neutralizing antibody titer 28 days after fIPV among children whose baseline titer ≤362. In Phase II, fIPV was administered during one-day door-to-door campaign to assess programmatic feasibility by evaluating vaccinator experience. For all three poliovirus (PV) serotypes, the immune response after BCG NS and Device A was similar, however it was lower with Device B (34/44 (77%), 31/45 (69%), 16/30 (53%) respectively for PV1; 53/78 (68%), 61/83 (74%), 42/80 (53%) for PV2; and; 58/76 (76%), 56/80 (70%), 43/77 (56%) for PV3; p < 0.05 for all three serotypes). Vaccinators reported problems filling Device B in both Phases; no other operational challenges were reported during Phase II. Use of fIPV offers a dose-saving alternative to full-dose IPV.
1. Background
The Global Polio Eradication Initiative (GPEI) is getting ever closer to reaching its goal, with only 34 cases of polio caused by wild poliovirus (WPV) reported from 3 endemic countries (Afghanistan, Pakistan and Nigeria) as of December 20, 2016 [1]. Complete poliovirus eradication, however, requires the disappearance of not only WPVs but of all polioviruses from human populations: including those resulting from use of oral poliovirus vaccine (OPV). The Polio Eradication & Endgame Strategic Plan 2013–2018 provides a framework for interruption of WPV transmission in remaining endemic foci and lays out plans for the new polio endgame, which includes the withdrawal of Sabin strains contained in OPV vaccine, starting with type 2, and the introduction of inactivated poliovirus vaccine (IPV), for risk mitigation purposes [2]. The last case of poliomyelitis caused by type 2 wild poliovirus was reported in 1999 and this serotype is now considered to be eradicated [3].
The switch from trivalent OPV (tOPV) to bivalent OPV (bOPV) without type 2 poliovirus has been conducted in a globally synchronized manner in April 2016. As of December 2016, there were no countries still using type 2 containing OPV, except for outbreak control: in case of outbreaks of type 2 circulating vaccine derived poliovirus (cVDPV2) or wild poliovirus in the post switch era, WHO maintains a stock of monovalent type 2 OPV (mOPV2) reserved for outbreak response [4].
At least one dose of inactivated poliovirus vaccine (IPV) has been planned to be introduced globally in routine immunization of all countries in 2015 and 2016 to provide immunity against type 2 polioviruses. In addition to IPV use in routine immunization, IPV, together with mOPV2, are tools to be used in campaigns as a response to cVDPV 2 outbreaks [5]. However, as of June 2016, there was acute IPV shortage that affected 43 countries and caused either delayed IPV introduction or stock-outs in countries that had already introduced IPV [6] ; [7]. This global shortage is likely to last at least until end 2018.
Intradermal administration of 1/5th of full IPV dose (0.1 mL instead of 0.5 mL), referred to as fractional IPV (fIPV) has demonstrated good safety and immunogenicity [8]; [9]; [10]; [11]; [12]; [13]; [14] ; [15]; and can be considered as an alternative to full-dose, intramuscular IPV in routine immunizations, and in outbreak response IPV campaigns [16].
Use of full-dose IPV in campaigns (combined with OPV) has been successfully demonstrated in Kenya, Nigeria and in high risk areas of Pakistan and Afghanistan to accelerate eradication or to control polio outbreaks [17]. The fIPV intradermal administration in campaigns is however, technically difficult with BCG needles and syringes (considered a “classical” intradermal administration performed by insertion of a 26–27 gauge needle nearly parallel to and solely into the skin to raise a visible bleb), requires additional training, and may result in poor intradermal injection. Therefore, new intradermal administration methods are being explored. Needle-free jet injectors, various needle adaptors, or intradermal syringes have been developed to ease intradermal administration and improve injection quality [7].
This study was conducted in two phases; in Phase I, we assessed the usability and immune response following fIPV administration with two novel ID adaptors (Device A: Intradermal Adapter by HELM/West Pharmaceutical Services Inc., Exton, USA and Device B: Star Intradermal Syringe by Star Syringe Ltd, East Sussex, UK) and compared this response with the one achieved with traditional BCG syringe which served as a reference. In Phase II we evaluated the feasibility of conducting a door-to-door campaign with intradermal fIPV administered using BCG NS and the two novel devices.