Needle adapters for intradermal administration of fractional dose of inactivated poliovirus vaccine: Evaluation of immunogenicity and programmatic feasibility in Pakistan

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 6-12months 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 28days 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 vaccinators' 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.

Keywords: Immune response; Inactivated polio vaccine; Intradermal injections; fractional dose IPV.

Fig. 1

Immune response (seroconversion or boosting of antibody titer) after one fIPV dose among children who completed all study visits and had baseline titer ≤362 [error bars: 95%CI]. * – Significant difference between Device B and BCG NS study arms (p < 0.05). n/N. PV1: HELM-31/45; Star-16/30; BCG-34/44; Total-81/119. PV2: HELM-61/83; Star-42/80; BCG-53/78; Total-156/241. PV3: HELM-56/80; Star-43/77; BCG-58/76; Total-157/233.

Fig. 2

Indicators of successful injection (from Phase I) [error bars: 95%CI]. * – Significant difference between Device B and BCG NS study arms (p < 0.05).