Q-VaxCelerate: Development of a T Cell-Based Vaccine for Q Fever

Completed

• Conditions: Q fever; Coxiellosis; 10004018

• Registration Number: NL-OMON47795
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-07-03
• Results First Posted: 2020-10-28
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 173

Inclusion Criteria

Participants in this study have been exposed to Coxiella burnetii resulting in
chronic Q fever, resolved acute Q fever, or have a strong T cell mediated
immune response to Coxiella without having any clinical symptoms. A control
group consisting of people without a Cb immune response will be recruited. In
addition, a group that was vaccinated with Q-VAX in 2011 in the RIVM/GGD
campaign for people with an increased risk of chronic Q fever will be included.

Exclusion Criteria

blood-transmissable infectious disease
known immune disease
use of immune suppressives

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Determining ex vivo the effect of Cb-derived T cell epitopes on IFN-&gamma;<br /><br>production in blood of healthy volunteers, subjects with active or resolved<br /><br>(chronic) Q fever infection, and subjects vaccinated with Q-VAX.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Comparison of T cell responses in subjects with and without acute disease.<br /><br>• Biomarker discovery to differentiate protective, non-protective, and<br /><br>reactogenic epitopes and responses.<br /><br>• Determine the role of anti-Coxiella antibody formation on T cell responses.</p><br>