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RNActive®-Derived Therapeutic Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00906243
Recruitment Status : Terminated (Study Closed after completion of Phase I)
First Posted : May 21, 2009
Results First Posted : March 30, 2012
Last Update Posted : April 4, 2012
Sponsor:
Collaborator:
CureVac AG
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hormone Refractory Prostate Cancer
Intervention Biological: CV9103
Enrollment 6
Recruitment Details A total of 6 subjects entered Phase 1 of the study between June 2009 and December 2009.
Pre-assignment Details  
Arm/Group Title CV9103
Hide Arm/Group Description CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title CV9103
Hide Arm/Group Description CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  33.3%
>=65 years
4
  66.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
69.1  (9.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
0
   0.0%
Male
6
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Phase I: Assessment of Safety and Tolerability of the Trial Regimen
Hide Description

Dose Limiting Toxicity (DLT) is defined as the following treatment-related adverse events or laboratory abnormalities, graded according to NCI-CTCAE version 3.0:

  1. All Categories equal or greater than grade 3
  2. Allergy/autoimmunity equal or greater than grade 2
  3. Dosing delay greater than 48 hours due to toxicity All adverse events will be graded and documented according to Common Terminology Criteria for Adverse Events version 3.0.
Time Frame At Nine Weeks with Follow Up at One Year
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 1 consisted of cohort 1 with 3 subjects and cohort 2 with three subjects.
Arm/Group Title CV9103
Hide Arm/Group Description:
CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: events
6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CV9103
Hide Arm/Group Description CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
All-Cause Mortality
CV9103
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
CV9103
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CV9103
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Endocrine disorders   
Hypothyroidism  2  1/6 (16.67%)  1
Gastrointestinal disorders   
Constipation * 2  1/6 (16.67%)  1
General disorders   
Erythema * 1 [1]  6/6 (100.00%)  6
Induration * 2 [2]  6/6 (100.00%)  6
Fatigue * 2 [3]  2/6 (33.33%)  2
Influenza Like Illness * 2 [4]  1/6 (16.67%)  1
Oedema Peripheral * 2 [4]  1/6 (16.67%)  1
Infections and infestations   
Oral Fungal Infection * 2  1/6 (16.67%)  1
Rhinitis * 2  1/6 (16.67%)  1
Investigations   
Weight Decreased * 2  1/6 (16.67%)  1
Metabolism and nutrition disorders   
Anorexia * 2  1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders   
Myalgia * 2  2/6 (33.33%)  2
Arthraligia * 2  1/6 (16.67%)  1
Back Pain * 2  1/6 (16.67%)  1
Nervous system disorders   
Headache * 2  2/6 (33.33%)  2
Peripheral motorneuropathy * 2  1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders   
Cough * 2  1/6 (16.67%)  1
Ordpharyngeal pain * 2  1/6 (16.67%)  1
Skin and subcutaneous tissue disorders   
Pruitus * 2  1/6 (16.67%)  1
Rash * 2  1/6 (16.67%)  1
Surgical and medical procedures   
Skin Neopasm Excision * 2  1/6 (16.67%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 3.0
2
Term from vocabulary, CTCAE (3.0)
[1]
Injection Site Reaction.
[2]
Injection Site Reaction
[3]
Administrative Site Condition
[4]
Administrative Site Conditions
This study was terminated early by decision of the Sponsor after 6 subjects had been enrolled in the Phase I part of the study. No efficacy evaluations were planned during the Phase I part of the study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
This was a Phase 1 and Phase 2 study. The study was terminated after completion of Phase 1 under terms of a settlement agreement that restricts disclosure to limited Phase 1 results only.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Johannes Vieweg
Organization: University of Florida
Phone: 352 273-6815
EMail: j.vieweg@urology.ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00906243    
Other Study ID Numbers: CV-9103-002
First Submitted: May 14, 2009
First Posted: May 21, 2009
Results First Submitted: February 29, 2012
Results First Posted: March 30, 2012
Last Update Posted: April 4, 2012