Safety Evaluation of a Q-fever Vaccine, NDBR 105
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
|Official Title:||Continued Evaluation of the Safety of Q Fever Vaccine, Phase I, Inactivated, Freeze Dried, NDBR 105, in Those at Risk of Exposure to Coxiella Burnetii, A Phase 2 Study|
- The Adverse Reaction and Occupational Illness Endpoint Measurements in This Q Fever NDBR 105 Vaccine Study Will be Evaluated for All Intent-to-treat Volunteers. [ Time Frame: AEs recorded through day 28 after vaccination; SAEs recorded through duration of study; Confirmed occupational illness recorded through duration of study ]Observe adverse reactions and occupational illness endpoint measurements 7 days follow-up after receipt of skin test antigen and 12 months of follow-up after receipt of vaccine
|Study Start Date:||February 2006|
|Study Completion Date:||June 2014|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Experimental: Q Fever Vaccine (NDBR 105)
Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.
Biological: Q Fever Vaccine (NDBR 105
Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study.
1. Continue to collect and assess safety data on Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105, and 2) Provide vaccine that potentially protects personnel at risk for occupational exposure to Q Fever and collect data on incidence of occupational Q Fever infection (subclinical and clinical) in immunized personnel.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584454
|United States, Maryland|
|U.S. Army Medical Research Institute of Infectious Diseases|
|Fort Detrick, Maryland, United States, 21702|
|Principal Investigator:||Mark Goldberg, MD||USAMRIID Medical Division|