Immunogenicity and safety of an adjuvanted inactivated polio vaccine, IPV-Al, compared to standard IPV: A phase 3 observer-blinded, randomised, controlled trial in infants vaccinated at 6, 10, 14 weeks and 9 months of age.

Autor: Bravo LC; University of the Philippines Manila, Manila, Philippines., Carlos JC; University of the East-Ramon Magsaysay Memorial Medical Center Incorporated, Manila, Philippines., Gatchalian SR; UP CM University of the Philippines, Manila, Department of Pediatrics. Philippine General Hospital, Philippines., Montellano MEB; Mary Chiles General Hospital, Sampaloc, Manila, Philippines., Tabora CFCB; Research Institute for Tropical Medicine, Muntinlupa City, Metro Manila, Philippines., Thierry-Carstensen B; Statens Serum Institut, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: BTC@ssi.dk., Tingskov PN; Statens Serum Institut, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: PNT@ssi.dk., Sørensen C; AJ Vaccines, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: CHS@ajvaccines.com., Wachmann H; Larix A/S, Lyskær 8b, 2730 Herlev, Denmark. Electronic address: HEW@larixcro.com., Bandyopadhyay AS; Bill & Melinda Gates Foundation, Seattle, WA, USA. Electronic address: Ananda.bandyopadhyay@gatesfoundation.org., Nielsen PI; AJ Vaccines, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: PXN@ajvaccines.com., Kusk MV; AJ Vaccines, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: MHK@ajvaccines.com.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2020 Jan 16; Vol. 38 (3), pp. 530-538. Date of Electronic Publication: 2019 Nov 05.
DOI: 10.1016/j.vaccine.2019.10.064
Abstrakt: Background: A dose-sparing inactivated polio vaccine (IPV-Al), obtained by adsorption of inactivated virus to an aluminium hydroxide adjuvant, can help mitigate global supply and the cost constraints of IPV. The objective of this trial was to demonstrate the non-inferiority of IPV-Al to standard IPV.
Methods: This phase 3, observer-blinded, randomised, controlled trial was conducted at 5 investigational sites in the Philippines. Infants not previously vaccinated with any polio vaccines were randomised to receive three IPV-Al (n = 502) or IPV vaccinations (n = 500) at 6, 10 and 14 weeks of age plus a booster vaccination at 9 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.
Results: Seroconversion rates following primary vaccination with IPV-Al (483 infants in the per-protocol analysis set) or IPV (478 infants) were: polio type 1, 97.1% versus 99.0%; type 2, 94.2% versus 99.0%; and type 3, 98.3% versus 99.6%. IPV-Al was non-inferior to IPV, as the lower 95% confidence limits of the treatment differences were above the predefined -10%-point limit: type 1, -1.85% (-3.85; -0.05); type 2, -4.75% (-7.28; -2.52); type 3, -1.24 (-2.84; 0.13). The booster effect (geometric mean titre (GMT) post-booster / GMT pre-booster) was: type 1, 63 versus 43; type 2, 54 versus 47; type 3, 112 versus 80. IPV-Al was well tolerated with a safety profile comparable to that of IPV. Serious adverse events were recorded for 29 infants (5.8%, 37 events) in the IPV-Al group compared to 28 (5.6%, 48 events) in the IPV group.
Conclusion: Non-inferiority of IPV-Al to IPV with respect to seroconversion was confirmed and a robust booster response was demonstrated. Both vaccines had a similar safety profile. ClinicalTrials.gov identifier: NCT03032419.
(Copyright © 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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