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Published on: April 20, 2011
Fractional doses of inactivated poliovirus vaccine in Oman
Ali Jafer Mohammed1, Salah AlAwaidy, Shyam Bawikar
1Ministry of Health, Oman.
Insights
Fractional doses of inactivated poliovirus vaccine (IPV) given intradermally achieved similar seroconversion rates but lower antibody titers compared to full intramuscular doses. This strategy may enhance vaccine affordability in developing countries.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- Evaluating strategies to make inactivated poliovirus vaccine (IPV) affordable for developing countries.
- Clinical trial conducted in Oman to assess fractional IPV doses in infants.
Purpose of the Study:
- To compare immunogenicity and reactogenicity of fractional IPV doses versus full IPV doses.
- To assess the feasibility of using fractional IPV doses for cost-effective vaccination programs.
Main Methods:
- Infants randomly assigned to receive fractional (0.1 ml, intradermal, jet injector) or full (intramuscular) IPV doses at 2, 4, and 6 months.
- Seroconversion rates and antibody titers measured 30 days post-vaccination.
- Oral poliovirus vaccine challenge administered at 7 months with stool sample analysis.
Main Results:
- Similar seroconversion rates observed for fractional vs. full IPV doses (97.3-97.9% vs. 100%).
- Significantly lower median antibody titers in the fractional-dose group (P<0.001).
- Higher poliovirus type 1 excretion in the fractional-dose group post-challenge (74.8% vs. 63.1%, P=0.03).
Conclusions:
- Fractional IPV doses induce comparable seroconversion but lower antibody titers than full doses.
- Intradermal fractional IPV administration is a potential strategy for increasing vaccine affordability.
- Further evaluation needed to confirm long-term efficacy and safety in diverse populations.
Background:
We conducted a clinical trial of fractional doses of inactivated poliovirus vaccine administered to infants in Oman, in order to evaluate strategies for making the vaccine affordable for use in developing countries.
Methods:
We compared fractional doses of inactivated poliovirus vaccine (0.1 ml, representing one fifth of a full dose) given intradermally with the use of a needle-free jet injector device, with full doses of vaccine given intramuscularly, with respect to immunogenicity and reactogenicity. Infants were randomly assigned at birth to receive either a fractional dose or a full dose of inactivated poliovirus vaccine at 2, 4, and 6 months. We also administered a challenge dose of monovalent type 1 oral poliovirus vaccine at 7 months and collected stool samples before and 7 days after administration of the challenge dose.
Results:
A total of 400 infants were randomized, of whom 373 (93.2%) fulfilled the study requirements. No significant baseline differences between the groups were detected. Thirty days after completion of the three-dose schedule, the rates of seroconversion to types 1, 2, and 3 poliovirus were 97.3%, 95.7%, and 97.9%, respectively, in the fractional-dose group, as compared with 100% seroconversion to all serotypes in the full-dose group (P=0.01 for the comparison with respect to type 2 poliovirus; results with respect to types 1 and 3 poliovirus were not significant). The median titers were significantly lower in the fractional-dose group than in the full-dose group (P<0.001 for all three poliovirus serotypes). At 7 months, 74.8% of the infants in the fractional-dose group and 63.1% of those in full-dose group excreted type 1 poliovirus (P=0.03). Between birth and 7 months, 42 hospitalizations were reported, all related to infectious causes, anemia, or falls, with no significant difference between vaccination groups.
Conclusions:
These data show that fractional doses of inactivated poliovirus vaccine administered intradermally at 2, 4, and 6 months, as compared with full doses of inactivated poliovirus vaccine given intramuscularly on the same schedule, induce similar levels of seroconversion but significantly lower titers. (Current Controlled Trials number, ISRCTN17418767.)
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