A fractional intradermal dose of inactivated poliovirus vaccine induced a priming immune response to poliovirus type 3 in 89.6% of infants compared to 98.1% with a full intramuscular dose (P=0.01).
RCT (n=320)
Does a fractional dose of inactivated poliovirus vaccine induce comparable priming and seroconversion compared to a full dose in infants?
A single fractional dose of IPV administered intradermally can induce priming and seroconversion in more than 90% of immunized infants, offering a potential cost-saving strategy for polio immunization.
Absolute Event Rate: 89.6% vs 98.1%
p-value: p=0.01
BACKGROUND: To reduce the costs of maintaining a poliovirus immunization base in low-income areas, we assessed the extent of priming immune responses after the administration of inactivated poliovirus vaccine (IPV). METHODS: We compared the immunogenicity and reactogenicity of a fractional dose of IPV (one fifth of a full dose) administered intradermally with a full dose administered intramuscularly in Cuban infants at the ages of 4 and 8 months. Blood was collected from infants at the ages of 4 months, 8 months, 8 months 7 days, and 8 months 30 days to assess single-dose seroconversion, single-dose priming of immune responses, and two-dose seroconversion. Specimens were tested with a neutralization assay. RESULTS: A total of 320 infants underwent randomization, and 310 infants (96.9%) fulfilled the study requirements. In the group receiving the first fractional dose of IPV, seroconversion to poliovirus types 1, 2, and 3 occurred in 16.6%, 47.1%, and 14.7% of participants, respectively, as compared with 46.6%, 62.8%, and 32.0% in the group receiving the first full dose of IPV (P<0.008 for all comparisons). A priming immune response to poliovirus types 1, 2, and 3 occurred in 90.8%, 94.0%, and 89.6% of participants, respectively, in the group receiving the fractional dose as compared with 97.6%, 98.3%, and 98.1% in the group receiving the full dose (P=0.01 for the comparison with type 3). After the administration of the second dose of IPV in the group receiving fractional doses, cumulative two-dose seroconversion to poliovirus types 1, 2, and 3 occurred in 93.6%, 98.1%, and 93.0% of participants, respectively, as compared with 100.0%, 100.0%, and 99.4% in the group receiving the full dose (P<0.006 for the comparisons of types 1 and 3). The group receiving intradermal injections had the greatest number of adverse events, most of which were minor in intensity and none of which had serious consequences. CONCLUSIONS: This evaluation shows that vaccinating infants with a single fractional dose of IPV can induce priming and seroconversion in more than 90% of immunized infants. (Funded by the World Health Organization and the Pan American Health Organization; Australian New Zealand Clinical Trials Registry number, ACTRN12610001046099.).
Resik et al. (2013) conducted an RCT in Poliovirus immunization (n=320). Inactivated poliovirus vaccine (IPV) vs. Full dose administered intramuscularly was evaluated on Priming immune response to poliovirus type 3 (p=0.01). A fractional intradermal dose of inactivated poliovirus vaccine induced a priming immune response to poliovirus type 3 in 89.6% of infants compared to 98.1% with a full intramuscular dose (P=0.01).