3 Adjuvated Reduced Dose IPV-Al SSI Vaccines and Non-adjuvated Full Dose IPV SSI, as Booster Vaccination to Adolescents

Summary

The background of the clinical trial is the overall aim of the World Health Organization (WHO) to obtain eradication of polio in the world. As part of this overall plan, inactivated polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price, needs to become available in low resource third World countries. The primary objective of the phase I/II clinical trial is to provide proof of concept (POC) that up to 10 times dose reduction of IPV SSI does not decrease the immunogenicity clinically significantly compared to full dose IPV SSI, by demonstrating the non-inferiority of the booster effects of each of 3 Al(OH)3 adjuvated reduced dose IPV formulations (1/3 IPV-Al SSI, 1/5 IPV-Al SSI and 1/10 IPV-Al SSI) compared to non-adjuvated full dose IPV SSI. A total of 240 healthy adolescents with a history of IPV SSI vaccination at 3, 5, 12 months and 5 years of age according to the Danish vaccination program will be included in the trial.

Timeline

Start

2014-11-13

Primary completion

2015-03

Completion

2015-03-05

Outcome

Missed primary endpoint

paper Thus, the three IPV-Al formulations were highly immunogenic, but inferior to IPV Vaccine SSI, in this booster vaccination trial. PMID 28027810 ↗

Publications

• Lindgren LM, Tingskov PN, Justesen AH, Nedergaard BS, Olsen KJ, Andreasen LV, Kromann I, Sorensen C, Dietrich J, Thierry-Carstensen B. First-in-human safety and immunogenicity investigations of three adjuvanted reduced dose inactivated poliovirus vaccines (IPV-Al SSI) compared to full dose IPV Vaccine SSI when given as a booster vaccination to adolescents with a history of IPV vaccination at 3, 5, 12months and 5years of age. Vaccine. 2017 Jan 23;35(4):596-604. doi: 10.1016/j.vaccine.2016.12.027. Epub 2016 Dec 24.

Drugs

Indications

No indication recorded.