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A Study of V950 in People With Alzheimer Disease (V950-001 AM7)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00464334
First received: April 20, 2007
Last updated: September 24, 2015
Last verified: September 2015
History of Changes
Results First Received: November 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Diagnostic
Condition: Alzheimer Disease
Interventions: Biological: V950
Biological: ISCOMATRIX™
Biological: Placebo to V950

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 51 sites in Europe, South America and the United States. The primary treatment period was from June 2007 to August 2010, with follow up through January 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo to V950/IMX 0 mcg Participants receive Placebo to V950/ISCOMATRIX™ (IMX) 0 mcg
Placebo to V950/IMX 16 mcg Participants receive Placebo to V950/IMX 16 mcg
V950 0.5 mcg/IMX 0 mcg Participants receive V950 0.5 mcg/IMX 0 mcg
V950 0.5 mcg/IMX 16 mcg Participants receive V950 0.5 mcg/IMX 16 mcg
V950 0.5 mcg/IMX 47 mcg Participants receive V950 0.5 mcg/IMX 47 mcg
V950 0.5 mcg/IMX 94 mcg Participants receive V950 0.5 mcg/IMX 94 mcg
V950 5 mcg/IMX 0 mcg Participants receive V950 5 mcg/IMX 0 mcg
V950 5 mcg/IMX 16 mcg Participants receive V950 5 mcg/IMX 16 mcg
V950 5 mcg/IMX 47 mcg Participants receive V950 5 mcg/IMX 47 mcg
V950 50 mcg/IMX 0 mcg Participants receive V950 50 mcg/IMX 0 mcg
V950 50 mcg/IMX 16 mcg Participants receive V950 50 mcg/IMX 16 mcg

Participant Flow:   Overall Study
    Placebo to V950/IMX 0 mcg   Placebo to V950/IMX 16 mcg   V950 0.5 mcg/IMX 0 mcg   V950 0.5 mcg/IMX 16 mcg   V950 0.5 mcg/IMX 47 mcg   V950 0.5 mcg/IMX 94 mcg   V950 5 mcg/IMX 0 mcg   V950 5 mcg/IMX 16 mcg   V950 5 mcg/IMX 47 mcg   V950 50 mcg/IMX 0 mcg   V950 50 mcg/IMX 16 mcg
STARTED   5   13   8   8   7   7   9   8   8   5   8 
COMPLETED   4   5   3   4   3   3   6   7   2   4   4 
NOT COMPLETED   1   8   5   4   4   4   3   1   6   1   4 
Adverse Event                0                0                0                1                1                1                0                0                2                1                2 
Lack of Efficacy                0                1                0                0                0                0                0                0                0                0                0 
Lost to Follow-up                0                0                1                0                1                0                1                0                0                0                2 
Progressive Disease                0                0                0                0                0                1                0                0                1                0                0 
Study Terminated by Sponsor                0                0                0                1                0                0                0                0                0                0                0 
Withdrawal by Subject                1                7                4                2                2                2                2                1                3                0                0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo to V950/IMX 0 mcg Participants receive Placebo to V950/IMX 0 mcg
Placebo to V950/IMX 16 mcg Participants receive Placebo to V950/IMX 16 mcg
V950 0.5 mcg/IMX 0 mcg Participants receive V950 0.5 mcg/IMX 0 mcg
V950 0.5 mcg/IMX 16 mcg Participants receive V950 0.5 mcg/IMX 16 mcg
V950 0.5 mcg/IMX 47 mcg Participants receive V950 0.5 mcg/IMX 47 mcg
V950 0.5 mcg/IMX 94 mcg Participants receive V950 0.5 mcg/IMX 94 mcg
V950 5 mcg/IMX 0 mcg Participants receive V950 5 mcg/IMX 0 mcg
V950 5 mcg/IMX 16 mcg Participants receive V950 5 mcg/IMX 16 mcg
V950 5 mcg/IMX 47 mcg Participants receive V950 5 mcg/IMX 47 mcg
V950 50 mcg/IMX 0 mcg Participants receive V950 50 mcg/IMX 0 mcg
V950 50 mcg/IMX 16 mcg Participants receive V950 50 mcg/IMX 16 mcg
Total Total of all reporting groups

Baseline Measures
   Placebo to V950/IMX 0 mcg   Placebo to V950/IMX 16 mcg   V950 0.5 mcg/IMX 0 mcg   V950 0.5 mcg/IMX 16 mcg   V950 0.5 mcg/IMX 47 mcg   V950 0.5 mcg/IMX 94 mcg   V950 5 mcg/IMX 0 mcg   V950 5 mcg/IMX 16 mcg   V950 5 mcg/IMX 47 mcg   V950 50 mcg/IMX 0 mcg   V950 50 mcg/IMX 16 mcg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 5   13   8   8   7   7   9   8   8   5   8   86 
Age 
[Units: Years]
Mean (Standard Deviation) 		 73.6  (10.69)   70.7  (9.6)   76.9  (4.39)   73.6  (8.07)   76.1  (8.01)   73.4  (10.89)   72.6  (9.26)   72.5  (10.10)   81.5  (5.48)   70.6  (8.38)   75.5  (10.04)   74.2  (8.85) 
Gender 
[Units: Participants]
 		                       
Female   3   7   3   5   5   6   4   5   1   3   3   45 
Male   2   6   5   3   2   1   5   3   7   2   5   41 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Number of Participants Who Experienced at Least One Adverse Event   [ Time Frame: Up to 4 years after first dose of vaccine ]

Measure Type Primary
Measure Title Number of Participants Who Experienced at Least One Adverse Event
Measure Description An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Time Frame Up to 4 years after first dose of vaccine  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Population consists of all participants who received at least one dose of vaccine.

Reporting Groups
  Description
Placebo to V950/ IMX 0 mcg Participants receive Placebo to V950/IMX 0 mcg
Placebo to V950/ IMX 16 mcg Participants receive Placebo to V950/IMX 16 mcg
V950 0.5 mcg / IMX 0 mcg Participants receive V950 0.5 mcg/IMX 0 mcg
V950 0.5 mcg / IMX 16 mcg Participants receive V950 0.5 mcg/IMX 16 mcg
V950 0.5 mcg / IMX 47 mcg Participants receive V950 0.5 mcg/IMX 47 mcg
V950 0.5 mcg / IMX 94 mcg Participants receive V950 0.5 mcg/IMX 94 mcg
V950 5 mcg / IMX 0 mcg Participants receive V950 5 mcg/IMX 0 mcg
V950 5 mcg / IMX 16 mcg Participants receive V950 5 mcg/IMX 16 mcg
V950 5 mcg / IMX 47 mcg Participants receive V950 5 mcg/IMX 47 mcg
V950 50 mcg / IMX 0 mcg Participants receive V950 50 mcg/IMX 0 mcg
V950 50 mcg / IMX 16 mcg Participants receive V950 50 mcg/IMX 16 mcg

Measured Values
   Placebo to V950/ IMX 0 mcg   Placebo to V950/ IMX 16 mcg   V950 0.5 mcg / IMX 0 mcg   V950 0.5 mcg / IMX 16 mcg   V950 0.5 mcg / IMX 47 mcg   V950 0.5 mcg / IMX 94 mcg   V950 5 mcg / IMX 0 mcg   V950 5 mcg / IMX 16 mcg   V950 5 mcg / IMX 47 mcg   V950 50 mcg / IMX 0 mcg   V950 50 mcg / IMX 16 mcg 
Participants Analyzed 
[Units: Participants]
 		 5   13   8   8   7   7   9   8   8   5   8 
Number of Participants Who Experienced at Least One Adverse Event 
[Units: Participants]
 		 4   11   7   8   6   7   9   8   8   5   8 

No statistical analysis provided for Number of Participants Who Experienced at Least One Adverse Event



2.  Primary:   Number of Participants Who Discontinued Study Drug Due to an Adverse Event   [ Time Frame: Up to 6 months after first dose of vaccine ]

Measure Type Primary
Measure Title Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Measure Description This is a measure of the number of participants who discontinued study drug because of an adverse event. An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Time Frame Up to 6 months after first dose of vaccine  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Population consists of all participants who received at least one dose of vaccine.

Reporting Groups
  Description
Placebo to V950/ IMX 0 mcg Participants receive Placebo to V950/IMX 0 mcg
Placebo to V950/ IMX 16 mcg Participants receive Placebo to V950/IMX 16 mcg
V950 0.5 mcg / IMX 0 mcg Participants receive V950 0.5 mcg/IMX 0 mcg
V950 0.5 mcg / IMX 16 mcg Participants receive V950 0.5 mcg/IMX 16 mcg
V950 0.5 mcg / IMX 47 mcg Participants receive V950 0.5 mcg/IMX 47 mcg
V950 0.5 mcg / IMX 94 mcg Participants receive V950 0.5 mcg/IMX 94 mcg
V950 5 mcg / IMX 0 mcg Participants receive V950 5 mcg/IMX 0 mcg
V950 5 mcg / IMX 16 mcg Participants receive V950 5 mcg/IMX 16 mcg
V950 5 mcg / IMX 47 mcg Participants receive V950 5 mcg/IMX 47 mcg
V950 50 mcg / IMX 0 mcg Participants receive V950 50 mcg/IMX 0 mcg
V950 50 mcg / IMX 16 mcg Participants receive V950 50 mcg/IMX 16 mcg

Measured Values
   Placebo to V950/ IMX 0 mcg   Placebo to V950/ IMX 16 mcg   V950 0.5 mcg / IMX 0 mcg   V950 0.5 mcg / IMX 16 mcg   V950 0.5 mcg / IMX 47 mcg   V950 0.5 mcg / IMX 94 mcg   V950 5 mcg / IMX 0 mcg   V950 5 mcg / IMX 16 mcg   V950 5 mcg / IMX 47 mcg   V950 50 mcg / IMX 0 mcg   V950 50 mcg / IMX 16 mcg 
Participants Analyzed 
[Units: Participants]
 		 5   13   8   8   7   7   9   8   8   5   8 
Number of Participants Who Discontinued Study Drug Due to an Adverse Event 
[Units: Participants]
 		 0   0   0   1   1   0   1   0   3   1   2 

No statistical analysis provided for Number of Participants Who Discontinued Study Drug Due to an Adverse Event



3.  Primary:   Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7   [ Time Frame: Month 7 ]

Measure Type Primary
Measure Title Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7
Measure Description The level of Aβ Peptide 1-40 specific antibodies was measured as the geometric mean titer (GMT) one month after the third dose (Month 7) of vaccine using an enzyme-linked immunosorbent assay (ELISA).
Time Frame Month 7  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.

Reporting Groups
  Description
Placebo to V950/IMX 0 mcg Participants receive Placebo to V950/IMX 0 mcg
Placebo to V950/IMX 16 mcg Participants receive Placebo to V950/IMX 16 mcg
V950 0.5 mcg/IMX 0 mcg Participants receive V950 0.5 mcg/IMX 0 mcg
V950 0.5 mcg/IMX 16 mcg Participants receive V950 0.5 mcg/IMX 16 mcg
V950 0.5 mcg/IMX 47 mcg Participants receive V950 0.5 mcg/IMX 47 mcg
V950 0.5 mcg/IMX 94 mcg Participants receive V950 0.5 mcg/IMX 94 mcg
V950 5 mcg/IMX 0 mcg Participants receive V950 5 mcg/IMX 0 mcg
V950 5 mcg/IMX 16 mcg Participants receive V950 5 mcg/IMX 16 mcg
V950 5 mcg/IMX 47 mcg Participants receive V950 5 mcg/IMX 47 mcg
V950 50 mcg/IMX 0 mcg Participants receive V950 50 mcg/IMX 0 mcg
V950 50 mcg/IMX 16 mcg Participants receive V950 50 mcg/IMX 16 mcg

Measured Values
   Placebo to V950/IMX 0 mcg   Placebo to V950/IMX 16 mcg   V950 0.5 mcg/IMX 0 mcg   V950 0.5 mcg/IMX 16 mcg   V950 0.5 mcg/IMX 47 mcg   V950 0.5 mcg/IMX 94 mcg   V950 5 mcg/IMX 0 mcg   V950 5 mcg/IMX 16 mcg   V950 5 mcg/IMX 47 mcg   V950 50 mcg/IMX 0 mcg   V950 50 mcg/IMX 16 mcg 
Participants Analyzed 
[Units: Participants]
 		 4   4   8   7   1   6   9   1   6   0   5 
Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7 
[Units: ng/mL]
Geometric Mean (95% Confidence Interval) 		 363 
 (161 to 729)  		 542.08 
 (310.16 to 818.02)  		 855 
 (575 to 1275)  		 443 
 (345 to 560)  		 990 
 (990 to 990)  		 2208.02 
 (628.53 to 12105)  		 725 
 (378 to 1385)  		 3835 
 (3835 to 3835)  		 1277.38 
 (604.83 to 2453.4)  		    935.55 
 (447.14 to 1728.0) 

No statistical analysis provided for Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7



4.  Primary:   Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies   [ Time Frame: Baseline and Month 7 ]

Measure Type Primary
Measure Title Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies
Measure Description The Aβ Peptide 1-40 specific immunogenicity of 3-dose regimen of V950 was measured one month after the third dose (Month 7) of vaccine by the GMT fold change of Aβ 1-40 specific antibodies compared to Baseline (Month 0) using ELISA.
Time Frame Baseline and Month 7  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.

Reporting Groups
  Description
Placebo to V950/ IMX 0 mcg Participants receive Placebo to V950/IMX 0 mcg
Placebo to V950/ IMX 16 mcg Participants receive Placebo to V950/IMX 16 mcg
V950 0.5 mcg / IMX 0 mcg Participants receive V950 0.5 mcg/IMX 0 mcg
V950 0.5 mcg / IMX 16 mcg Participants receive V950 0.5 mcg/IMX 16 mcg
V950 0.5 mcg / IMX 47 mcg Participants receive V950 0.5 mcg/IMX 47 mcg
V950 0.5 mcg / IMX 94 mcg Participants receive V950 0.5 mcg/IMX 94 mcg
V950 5 mcg / IMX 0 mcg Participants receive V950 5 mcg/IMX 0 mcg
V950 5 mcg / IMX 16 mcg Participants receive V950 5 mcg/IMX 16 mcg
V950 5 mcg / IMX 47 mcg Participants receive V950 5 mcg/IMX 47 mcg
V950 50 mcg / IMX 0 mcg Participants receive V950 50 mcg/IMX 0 mcg
V950 50 mcg / IMX 16 mcg Participants receive V950 50 mcg/IMX 16 mcg

Measured Values
   Placebo to V950/ IMX 0 mcg   Placebo to V950/ IMX 16 mcg   V950 0.5 mcg / IMX 0 mcg   V950 0.5 mcg / IMX 16 mcg   V950 0.5 mcg / IMX 47 mcg   V950 0.5 mcg / IMX 94 mcg   V950 5 mcg / IMX 0 mcg   V950 5 mcg / IMX 16 mcg   V950 5 mcg / IMX 47 mcg   V950 50 mcg / IMX 0 mcg   V950 50 mcg / IMX 16 mcg 
Participants Analyzed 
[Units: Participants]
 		 4   4   8   7   1   6   9   1   5   0   5 
Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies 
[Units: Fold change]
Geometric Mean (95% Confidence Interval) 		 0.89 
 (0.70 to 1.16)  		 0.76 
 (0.49 to 1.06)  		 0.98 
 (0.79 to 1.17)  		 1.02 
 (0.82 to 1.27)  		 0.15 
 (0.15 to 0.15)  		 2.68 
 (1.03 to 8.66)  		 0.74 
 (0.18 to 1.80)  		 2.27 
 (2.27 to 2.27)  		 1.38 
 (0.84 to 2.78)  		    1.84 
 (1.29 to 2.67) 

No statistical analysis provided for Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies




  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00464334     History of Changes
Other Study ID Numbers: V950-001
2007_518 ( Other Identifier: Merck Registration ID )
Study First Received: April 20, 2007
Results First Received: November 19, 2012
Last Updated: September 24, 2015