PMID- 36064670 OWN - NLM STAT- MEDLINE DCOM- 20220913 LR - 20221222 IS - 1873-2518 (Electronic) IS - 0264-410X (Print) IS - 0264-410X (Linking) VI - 40 IP - 40 DP - 2022 Sep 22 TI - Persistence of protective anti-poliovirus antibody levels in 4-year-old children previously primed with Picovax(R), a trivalent, aluminium-adjuvanted reduced dose inactivated polio vaccine. PG - 5835-5841 LID - S0264-410X(22)00858-1 [pii] LID - 10.1016/j.vaccine.2022.06.084 [doi] AB - BACKGROUND: To meet the demand for effective and affordable inactivated polio vaccines (IPVs), a reduced dose, aluminium hydroxide (Al(OH)(3))-adjuvanted IPV vaccine was developed (IPV-Al, Picovax(R)) and evaluated in clinical trials. The present trial is an extension of two previous trials (a primary and a booster trial). The aim was to evaluate the persistence of seroprotective antibodies (poliovirus type-specific antibody titre >/= 8) in 4-year-old children who previously received IPV-Al as primary and booster vaccine doses and to determine the potential booster response and safety profile of an additional dose of IPV-Al. METHODS: Children participating in the two previous trials were invited to receive one additional dose of IPV-Al at 4 years of age (2.5 years after the booster dose) and to have their blood samples collected to measure the pre- and post-vaccination antibody titres. Systemic adverse events (AEs) and local reactogenicity were recorded. RESULTS: At study entry, the seroprotection rates were 89.2%, 100% and 91.1% against poliovirus type 1, 2 and 3, respectively. The additional vaccination with IPV-Al boosted the level of poliovirus type 1, 2 and 3 antibodies to above the seroprotection threshold for all but one subject, i.e., 99.4% for type 1 and 100% for types 2 and 3. The additional dose induced a robust booster response of a 26.3-, 13.9- and 30.9-fold increase in titre for poliovirus types 1, 2 and 3, respectively. The vaccine was well tolerated, with only mild and transient AEs reported. CONCLUSIONS: The present trial demonstrated that the primary vaccination with an aluminium-adjuvanted reduced dose IPV induced a persistent immune memory as evidenced by the robust anamnestic response when the subjects were re-exposed to the antigen 2.5 years after the last dose. Thus, the IPV-Al is an efficient and safe addition to increase the availability of inactivated polio vaccines globally. (ClinicalTrials.gov reg no. NCT04448132). CI - Copyright (c) 2022. Published by Elsevier Ltd. FAU - Saez-Llorens, Xavier AU - Saez-Llorens X AD - Hospital del Nino, Panama City, Panama; Cevaxin, Avenida Mexico Calle 33, Local 4, Panama City, Panama; Sistema Nacional de Investigacion, Senacyt, Panama. FAU - Chan, Milagros AU - Chan M AD - Cevaxin, Avenida Mexico Calle 33, Local 4, Panama City, Panama. FAU - DeAntonio, Rodrigo AU - DeAntonio R AD - Cevaxin, Avenida Mexico Calle 33, Local 4, Panama City, Panama; Sistema Nacional de Investigacion, Senacyt, Panama. FAU - Petersen, Torben AU - Petersen T AD - Larix A/S, Lyskaer 8b, 2730 Herlev, Denmark. FAU - Olesen, Charlotte AU - Olesen C AD - Larix A/S, Lyskaer 8b, 2730 Herlev, Denmark. FAU - Jensen, Jens Sondergaard AU - Jensen JS AD - Larix A/S, Lyskaer 8b, 2730 Herlev, Denmark. FAU - Sorensen, Charlotte AU - Sorensen C AD - AJ Vaccines A/S, Artillerivej 5, 2300 Copenhagen S, Denmark. FAU - Ekstrand, Lena Messerschmidt AU - Ekstrand LM AD - AJ Vaccines A/S, Artillerivej 5, 2300 Copenhagen S, Denmark. Electronic address: lmek@ajvaccines.com. FAU - Czort, Michaela Katrine AU - Czort MK AD - AJ Vaccines A/S, Artillerivej 5, 2300 Copenhagen S, Denmark. FAU - Kristensen, Hans-Henrik AU - Kristensen HH AD - AJ Vaccines A/S, Artillerivej 5, 2300 Copenhagen S, Denmark. FAU - Thulstrup, Niels AU - Thulstrup N AD - AJ Vaccines A/S, Artillerivej 5, 2300 Copenhagen S, Denmark. FAU - Christoffersen, Dorte Birk AU - Christoffersen DB AD - AJ Vaccines A/S, Artillerivej 5, 2300 Copenhagen S, Denmark. LA - eng SI - ClinicalTrials.gov/NCT04448132 PT - Clinical Trial PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220903 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Adjuvants, Immunologic) RN - 0 (Antibodies, Viral) RN - 0 (Poliovirus Vaccine, Inactivated) RN - CPD4NFA903 (Aluminum) SB - IM MH - Adjuvants, Immunologic MH - Aluminum MH - Antibodies, Viral MH - Child, Preschool MH - Humans MH - Immunization, Secondary/adverse effects MH - Infant MH - *Poliomyelitis/etiology/prevention & control MH - *Poliovirus MH - Poliovirus Vaccine, Inactivated PMC - PMC9488130 OTO - NOTNLM OT - Affordable inactivated polio vaccine OT - Aluminium hydroxide adjuvant OT - Immunogenicity OT - Oral polio vaccine OT - Polio OT - Reduced dose COIS- Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2022/09/06 06:00 MHDA- 2022/09/14 06:00 PMCR- 2022/09/22 CRDT- 2022/09/05 23:55 PHST- 2022/06/10 00:00 [received] PHST- 2022/06/28 00:00 [accepted] PHST- 2022/09/06 06:00 [pubmed] PHST- 2022/09/14 06:00 [medline] PHST- 2022/09/05 23:55 [entrez] PHST- 2022/09/22 00:00 [pmc-release] AID - S0264-410X(22)00858-1 [pii] AID - 10.1016/j.vaccine.2022.06.084 [doi] PST - ppublish SO - Vaccine. 2022 Sep 22;40(40):5835-5841. doi: 10.1016/j.vaccine.2022.06.084. Epub 2022 Sep 3.