Key result
IPV-Al was noninferior to standard IPV for seroconversion across all three poliovirus serotypes (e.g., type 1 difference 3.94%, 95% CI -6.51 to -2.01, against a -10% margin).
Why the study?
Availability of affordable inactivated polio vaccines is of major importance to meet increasing global supply needs.
Does a reduced-dose, adjuvanted inactivated polio vaccine (IPV-Al) provide non-inferior seroconversion compared to standard IPV in infants?
RCT (n=800)
observer-blinded
randomised
Does a reduced-dose, adjuvanted inactivated polio vaccine (IPV-Al) provide non-inferior seroconversion compared to standard IPV in infants?
A reduced-dose, adjuvanted inactivated polio vaccine demonstrated non-inferior immunogenicity to standard IPV in infants, supporting its use to meet global supply needs.
Supports reduced-dose IPV-Al use in infants to address global supply needs; extends RCT evidence for dose-sparing polio vaccination.
BACKGROUND: Availability of affordable inactivated polio vaccines (IPV) is of major importance to meet the increasing global supply needs. The results presented here demonstrate non-inferiority of a reduced-dose, aluminium hydroxide-adjuvanted IPV (IPV-Al) to standard IPV. METHODS: A phase 3, observer-blinded, randomised, clinical trial was conducted in Panama in infants who received either IPV-Al (n = 400) or standard IPV (n = 400) at age 2, 4 and 6 months. In the booster trial, subjects received a single dose of IPV-Al at age 15-18 months. The primary endpoint was type-specific seroconversion, defined as an antibody titre ≥4-fold higher than the estimated maternal antibody titre and a titre ≥8, one month after the primary vaccination series. In the booster trial, the primary endpoint was the type-specific booster effects (geometric mean titre (GMT) post-booster (Day 28)/GMT pre-booster (Day 0). RESULTS: Seroconversion rates following primary vaccination with IPV-Al vs IPV were: 96.1% vs 100% (type 1); 100% vs 100% (type 2); and 99.2% vs 100% (type 3) respectively. IPV-Al was non-inferior to IPV, as the lower 95% confidence limits of the treatment differences were above the pre-defined -10%-point limit: 3.94% (-6.51; -2.01) for type 1; 0.0% (-1.30; -1.37) for type 2; -0.85 (-2.46; 0.40) for type 3. The booster effects for the group primed with IPV-Al versus the group primed with IPV were 25.3 vs 9.2 (type 1), 19.1 vs 6.5 (type 2) and 50.4 vs 12.5 (type 3). IPV-Al had a comparable safety profile to that of IPV. CONCLUSIONS: Non-inferiority of IPV-Al to standard IPV with respect to seroconversion after vaccination at 2, 4 and 6 months was confirmed for all three poliovirus serotypes. A robust booster response was demonstrated following vaccination with IPV-Al, regardless of the primary vaccine received. Both vaccines were well tolerated. ClinicalTrials.gov identifiers: NCT03025750 and NCT03671616.
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Sáez‐Llorens et al. (2020) conducted an RCT in Poliovirus immunization (n=800). IPV-Al (reduced-dose, aluminium hydroxide-adjuvanted IPV) vs. Standard IPV was evaluated on Type-specific seroconversion one month after the primary vaccination series (Difference 3.94%, 95% CI -6.51 to -2.01). IPV-Al was noninferior to standard IPV for seroconversion across all three poliovirus serotypes (e.g., type 1 difference 3.94%, 95% CI -6.51 to -2.01, against a -10% margin).
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