Phase II Tularemia Vaccine Comparison

Summary

The purpose of this study is to compare 2 experimental vaccines that could provide protection from the disease, tularemia. This research will compare the ability of the vaccines to cause the body to develop an immune (protective) response and obtain more information on side effects of the vaccines. About 220 male and non-pregnant female volunteers 18 to 45 years will participate. Volunteers will be assigned to 1 of 2 vaccine groups by chance. About half of the volunteers will be placed in the DVC-LVS vaccine group and half of volunteers will be placed in the USAMRIID-LVS vaccine group. Additionally, both groups will receive an injection of placebo (inactive salt water). Study procedures include physical exam and blood and urine samples. Evaluation of the vaccination sites will be performed as well as blood samples to measure the body's response to the vaccine. Participants will be involved in the study for about 6 months.

Timeline

Start

2010-09

Primary completion

2012-01

Completion

2012-01

Publications

• Goll JB, Bosinger SE, Jensen TL, Walum H, Grimes T, Tharp GK, Natrajan MS, Blazevic A, Head RD, Gelber CE, Steenbergen KJ, Patel NB, Sanz P, Rouphael NG, Anderson EJ, Mulligan MJ, Hoft DF. The Vacc-SeqQC project: Benchmarking RNA-Seq for clinical vaccine studies. Front Immunol. 2023 Jan 19;13:1093242. doi: 10.3389/fimmu.2022.1093242. eCollection 2022.
• Mulligan MJ, Stapleton JT, Keitel WA, Frey SE, Chen WH, Rouphael N, Edupuganti S, Beck A, Winokur PL, El Sahly HM, Patel SM, Atmar RL, Graham I, Anderson E, El-Kamary SS, Pasetti MF, Sztein MB, Hill H, Goll JB; DMID 08-0006 Tularemia Vaccine Study Group. Tularemia vaccine: Safety, reactogenicity, "Take" skin reactions, and antibody responses following vaccination with a new lot of the Francisella tularensis live vaccine strain - A phase 2 randomized clinical Trial. Vaccine. 2017 Aug 24;35(36):4730-4737. doi: 10.1016/j.vaccine.2017.07.024. Epub 2017 Jul 24.

Drugs

Indications