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Trial record 1 of 9 for:    klh | First posted from 01/01/2011 to 02/01/2012
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A Study to Determine the Immunogenicity and Oral Tolerance to Keyhole Limpet Hemocyanin (KLH)

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ClinicalTrials.gov Identifier: NCT01489956
Recruitment Status : Terminated (Due to futility, identified after 5 subjects completed treatment in Part B)
First Posted : December 12, 2011
Results First Posted : April 12, 2016
Last Update Posted : April 12, 2016
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Autoimmune Disorders
Interventions Biological: Immucothel Alone (Part A)
Biological: Immucothel+Montanide (Part A)
Biological: Immucothel Alone or Immucothel+Montanide (Part B)
Enrollment 19
Recruitment Details One site in the United States recruited 19 healthy adult male and female participants.
Pre-assignment Details The accrual objective was 10 to 20 evaluable participants in Part A and 10 evaluable participants in Part B. The definition of an evaluable participant (measured/determined by lymphocyte proliferation assay) was provided in the protocol.
Arm/Group Title Immucothel Alone (Part A) Immucothel + Montanide (Part A) Immucothel Alone or Immucothel + Montanide (Part B)
Hide Arm/Group Description Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete. If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed. Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
Period Title: Overall Study
Started 13 [1] 0 [2] 6 [3]
Completed 12 0 5
Not Completed 1 0 1
Reason Not Completed
Lost to Follow-up             1             0             0
Withdrawal by Subject             0             0             1
[1]
Ten of the 13 participants were considered evaluable.
[2]
Nine of the 10 participants receiving Immucothel alone had a response, so Montanide was not used.
[3]
These 6 subjects had Immucothel alone since Montanide was not needed for the 10 participants dosed.
Arm/Group Title Immucothel Alone (Part A) Immucothel Alone or Immucothel + Montanide (Part B) Total
Hide Arm/Group Description Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete. Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35. Total of all reporting groups
Overall Number of Baseline Participants 13 6 19
Hide Baseline Analysis Population Description
Enrolled Sample
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 6 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
6
 100.0%
19
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 6 participants 19 participants
Female
8
  61.5%
5
  83.3%
13
  68.4%
Male
5
  38.5%
1
  16.7%
6
  31.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 6 participants 19 participants
13 6 19
1.Primary Outcome
Title Participants With a Positive Immune Response to T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part A)
Hide Description T cell stimulation index (SI) as measured by 3H-thymidine incorporation after in vitro keyhole limpet hemocyanin (KLH) stimulation of peripheral blood mononuclear cells (PBMC). An SI ≥3 on day 16 will indicate the presence of immune response. The SI is the ratio of 3H-thymidine incorporation by T cells in the presence of KLH stimulation to 3H-thymidine incorporation by T cells in the absence of stimulation. Higher values correspond with lower tolerance to KLH.
Time Frame Day 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Immucothel Alone (Part A) Immucothel + Montanide (Part A) Immucothel Alone or Immucothel + Montanide (Part B)
Hide Arm/Group Description:
Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
Overall Number of Participants Analyzed 10 0 0
Measure Type: Number
Unit of Measure: participants
9
2.Primary Outcome
Title Participants Demonstrating Tolerance to KLH Using T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part B)
Hide Description T cell stimulation index (SI) as measured by 3H-thymidine incorporation after in vitro keyhole limpet hemocyanin (KLH) stimulation of peripheral blood mononuclear cells (PBMC). An SI <3 on Day 32 indicated tolerance to KLH. The SI is the ratio of 3H-thymidine incorporation by T cells in the presence of KLH stimulation to 3H-thymidine incorporation by T cells in the absence of stimulation. Higher values correspond with lower tolerance to KLH.
Time Frame Day 32
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Immucothel Alone (Part A) Immucothel + Montanide (Part A) Immucothel Alone or Immucothel + Montanide (Part B)
Hide Arm/Group Description:
Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
Overall Number of Participants Analyzed 0 0 5
Measure Type: Number
Unit of Measure: participants
1
3.Primary Outcome
Title T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part A)
Hide Description No data available for analyses
Time Frame Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and therefore no analyses could be performed.
Arm/Group Title Immucothel Alone (Part A) Immucothel + Montanide (Part A) Immucothel Alone or Immucothel + Montanide (Part B)
Hide Arm/Group Description:
Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part A)
Hide Description No data available for analyses.
Time Frame Day 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and therefore no analyses could be performed.
Arm/Group Title Immucothel Alone (Part A) Immucothel + Montanide (Part A) Immucothel Alone or Immucothel + Montanide (Part B)
Hide Arm/Group Description:
Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Cytokine Secretion Profile of T Cells Stimulated by KLH (Part A)
Hide Description No data available for analyses.
Time Frame Days 0, 9, 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and therefore no analyses could be performed.
Arm/Group Title Immucothel Alone (Part A) Immucothel + Montanide (Part A) Immucothel Alone or Immucothel + Montanide (Part B)
Hide Arm/Group Description:
Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title T Cell Stimulation Index Measured by Carboxyfluorescein Diacetate Succinimidyl Ester (CFSE) Staining After KLH Stimulation (Part A)
Hide Description No data available for analyses.
Time Frame Days 0, 9, 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and therefore no analyses could be performed.
Arm/Group Title Immucothel Alone (Part A) Immucothel + Montanide (Part A) Immucothel Alone or Immucothel + Montanide (Part B)
Hide Arm/Group Description:
Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Suppression (or Non-activation) of Cytokine Secretion Profile of T Cells Stimulated by KLH Following Oral Feeding (Part B)
Hide Description No data available for analyses.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and therefore no analyses could be performed.
Arm/Group Title Immucothel Alone (Part A) Immucothel + Montanide (Part A) Immucothel Alone or Immucothel + Montanide (Part B)
Hide Arm/Group Description:
Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Suppression (or Non-activation) of T Cell Stimulation Index Measured by CFSE Staining After KLH Stimulation (Part B)
Hide Description No data available for analyses.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and therefore no analyses could be performed.
Arm/Group Title Immucothel Alone (Part A) Immucothel + Montanide (Part A) Immucothel Alone or Immucothel + Montanide (Part B)
Hide Arm/Group Description:
Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Other Mechanistic Assessments on Archived Serum Samples Like Anti-KLH Antibodies and Secreted Cytokines (Part B)
Hide Description No data available for analyses.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and therefore no analyses could be performed.
Arm/Group Title Immucothel Alone (Part A) Immucothel + Montanide (Part A) Immucothel Alone or Immucothel + Montanide (Part B)
Hide Arm/Group Description:
Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Compare the Level of KLH-specific Antibodies in the Serum (Samples From Various Time Points) Between Parts A and B
Hide Description No data available for analyses.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and therefore no analyses could be performed.
Arm/Group Title Immucothel Alone (Part A) Immucothel + Montanide (Part A) Immucothel Alone or Immucothel + Montanide (Part B)
Hide Arm/Group Description:
Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Enrollment through last study visit (up to 6 months after last immunization)
Adverse Event Reporting Description Adverse events reported for all enrolled subjects
 
Arm/Group Title Immucothel Alone (Part A) Immucothel + Montanide (Part A) Immucothel Alone or Immucothel + Montanide (Part B)
Hide Arm/Group Description Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete. If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed. Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
All-Cause Mortality
Immucothel Alone (Part A) Immucothel + Montanide (Part A) Immucothel Alone or Immucothel + Montanide (Part B)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Immucothel Alone (Part A) Immucothel + Montanide (Part A) Immucothel Alone or Immucothel + Montanide (Part B)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/0      0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Immucothel Alone (Part A) Immucothel + Montanide (Part A) Immucothel Alone or Immucothel + Montanide (Part B)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/13 (30.77%)      0/0      4/6 (66.67%)    
Gastrointestinal disorders       
Haemorrhoidal haemorrhage  1  0/13 (0.00%)  0 0/0  0 1/6 (16.67%)  1
Nausea  1  0/13 (0.00%)  0 0/0  0 1/6 (16.67%)  1
General disorders       
Injection site reaction  1  0/13 (0.00%)  0 0/0  0 1/6 (16.67%)  1
Infections and infestations       
Gingival infection  1  1/13 (7.69%)  1 0/0  0 0/6 (0.00%)  0
Investigations       
Basophil count increased  1  0/13 (0.00%)  0 0/0  0 1/6 (16.67%)  1
Basophil percentage increased  1  0/13 (0.00%)  0 0/0  0 1/6 (16.67%)  1
Blood alkaline phosphatase increased  1  1/13 (7.69%)  1 0/0  0 0/6 (0.00%)  0
Blood creatinine increased  1  1/13 (7.69%)  1 0/0  0 0/6 (0.00%)  0
Eosinophil percentage increased  1  0/13 (0.00%)  0 0/0  0 1/6 (16.67%)  2
Haematocrit decreased  1  1/13 (7.69%)  1 0/0  0 0/6 (0.00%)  0
Haematocrit increased  1  0/13 (0.00%)  0 0/0  0 1/6 (16.67%)  1
Haemoglobin decreased  1  2/13 (15.38%)  2 0/0  0 0/6 (0.00%)  0
Haemoglobin increased  1  0/13 (0.00%)  0 0/0  0 2/6 (33.33%)  3
Mean cell haemoglobin decreased  1  1/13 (7.69%)  1 0/0  0 0/6 (0.00%)  0
Red blood cell count decreased  1  1/13 (7.69%)  1 0/0  0 0/6 (0.00%)  0
White blood cell count decreased  1  1/13 (7.69%)  1 0/0  0 2/6 (33.33%)  2
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/13 (7.69%)  1 0/0  0 0/6 (0.00%)  0
Oropharyngeal pain  1  1/13 (7.69%)  1 0/0  0 0/6 (0.00%)  0
Surgical and medical procedures       
Breast reconstruction  1  1/13 (7.69%)  1 0/0  0 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Data from 4 of the 5 evaluable subjects in Part B was negative for tolerance to KLH as defined by a stimulation index <3 on day 42 after booster immunization. The study was terminated. Data were not collected and no analyses were performed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
EMail: DAITClinicalTrialsGov@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01489956    
Other Study ID Numbers: DAIT ITN047AI
First Submitted: December 1, 2011
First Posted: December 12, 2011
Results First Submitted: December 24, 2015
Results First Posted: April 12, 2016
Last Update Posted: April 12, 2016