A First in Human Study to Assess the Safety, Tolerability and Immunogenicity of a Single Dose of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains (sIPV) Given Intramuscularly in Healthy Adults

Phase 1 Completed 32 enrolled Janssen Vaccines & Prevention B.V.

RandomizedParallel-groupDouble-blindTreatment

Summary

The main purpose of this study is to assess the safety and tolerability of a single dose of JNJ-64152348, inactivated poliovirus vaccine produced from Sabin poliovirus strains on PER.C6 cells (sIPV) in healthy adults, using conventional inactivated poliovirus vaccine produced from Salk poliovirus strains (cIPV) as reference.

Timeline

Start: 2017-10-09
Primary completion: 2018-05-18
Completion: 2018-05-18

Publications

Leroux-Roels I, Leroux-Roels G, Shukarev G, Schuitemaker H, Cahill C, de Rooij R, Struijs M, van Zeeburg H, Jacquet JM. Safety and immunogenicity of a new Sabin inactivated poliovirus vaccine candidate produced on the PER.C6(R) cell-line: a phase 1 randomized controlled trial in adults. Hum Vaccin Immunother. 2021 May 4;17(5):1366-1373. doi: 10.1080/21645515.2020.1812315. Epub 2020 Nov 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	cIPV	Vaccine	0.5 ml	Intramuscular
Subject	sIPV	Vaccine	0.5 ml	Intramuscular

Indications

No indication recorded.