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CompletedNCT00464334Updated Sep 25, 2015Results posted

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

A Phase 1 interventional study of V950 and ISCOMATRIX™ in Alzheimer Disease, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2015-09-25.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study summary

The purpose of this study is to test the safety, tolerability and the immune response to an investigational vaccine, V950, with or without ISCOMATRIX™ (IMX).

02

Conditions studied

  • Alzheimer Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's enrollment of 86 is above the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient has mild to moderate Alzheimer Disease
  • Women cannot be able to get pregnant
  • Patient has a reliable caregiver, who will attend all visits and answer questions about the patient

Exclusion criteria

Exclusion Criteria:

  • Patient lives in a nursing home or facility
  • Patient has another neurological or neurodegenerative disorder
  • Patient has a history of stroke
  • Patient uses illicit drugs or has a history of drug/alcohol abuse
  • Patient has received blood or blood derived products within 6 months
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    Placebo to V950/IMX 0 mcg

    Participants receive Placebo to V950/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

    Biological: ISCOMATRIX™ · Biological: Placebo to V950

  • Experimental
    Placebo to V950/IMX 16 mcg

    Participants receive Placebo to V950/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

    Biological: ISCOMATRIX™ · Biological: Placebo to V950

  • Experimental
    V950 0.5 mcg/IMX 0 mcg

    Participants receive V950 0.5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

    Biological: V950 · Biological: ISCOMATRIX™

  • Experimental
    V950 0.5 mcg/IMX 16 mcg

    Participants receive V950 0.5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

    Biological: V950 · Biological: ISCOMATRIX™

  • Experimental
    V950 0.5 mcg/IMX 47 mcg

    Participants receive V950 0.5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

    Biological: V950 · Biological: ISCOMATRIX™

  • Experimental
    V950 0.5 mcg/IMX 94 mcg

    Participants receive V950 0.5 mcg/IMX 94 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

    Biological: V950 · Biological: ISCOMATRIX™

  • Experimental
    V950 5 mcg/IMX 0 mcg

    Participants receive V950 5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

    Biological: V950 · Biological: ISCOMATRIX™

  • Experimental
    V950 5 mcg/IMX 16 mcg

    Participants receive V950 5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

    Biological: V950 · Biological: ISCOMATRIX™

  • Experimental
    V950 5 mcg/IMX 47 mcg

    Participants receive V950 5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

    Biological: V950 · Biological: ISCOMATRIX™

  • Experimental
    V950 50 mcg/IMX 0 mcg

    Participants receive V950 50 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

    Biological: V950 · Biological: ISCOMATRIX™

  • Experimental
    V950 50 mcg/IMX 16 mcg

    Participants receive V950 50 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

    Biological: V950 · Biological: ISCOMATRIX™

Interventions

  • BiologicalV950

    V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.

  • BiologicalISCOMATRIX™

    ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.

  • BiologicalPlacebo to V950
06

What researchers measure

Primary outcomes

  1. Number of Participants Who Experienced at Least One 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 4 years after first dose of vaccine

  2. Number of Participants Who Discontinued Study Drug Due to an Adverse Event

    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

  3. Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7

    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

  4. Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies

    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

07

Results

Posted Dec 18, 2012

Participant flow

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.

Participant flow — Overall Study
MilestonePlacebo to V950/IMX 0 mcgPlacebo to V950/IMX 16 mcgV950 0.5 mcg/IMX 0 mcgV950 0.5 mcg/IMX 16 mcgV950 0.5 mcg/IMX 47 mcgV950 0.5 mcg/IMX 94 mcgV950 5 mcg/IMX 0 mcgV950 5 mcg/IMX 16 mcgV950 5 mcg/IMX 47 mcgV950 50 mcg/IMX 0 mcgV950 50 mcg/IMX 16 mcg
Started513887798858
Completed45343367244
Not completed18544431614
Withdrew: Adverse event00011100212
Withdrew: Lack of efficacy01000000000
Withdrew: Lost to follow-up00101010002
Withdrew: Progressive disease00000100100
Withdrew: Study terminated by sponsor00010000000
Withdrew: Withdrawal by subject17422221300

Outcome measures

PrimaryNumber of Participants Who Experienced at Least One 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 4 years after first dose of vaccine
Reported as:
Number · participants
Number of Participants Who Experienced at Least One Adverse Event
participantsPlacebo to V950/ IMX 0 mcgPlacebo to V950/ IMX 16 mcgV950 0.5 mcg / IMX 0 mcgV950 0.5 mcg / IMX 16 mcgV950 0.5 mcg / IMX 47 mcgV950 0.5 mcg / IMX 94 mcgV950 5 mcg / IMX 0 mcgV950 5 mcg / IMX 16 mcgV950 5 mcg / IMX 47 mcgV950 50 mcg / IMX 0 mcgV950 50 mcg / IMX 16 mcg
Number of Participants Who Experienced at Least One Adverse Event411786798858
PrimaryNumber of Participants Who Discontinued Study Drug Due to an Adverse Event

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
Reported as:
Number · participants
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
participantsPlacebo to V950/ IMX 0 mcgPlacebo to V950/ IMX 16 mcgV950 0.5 mcg / IMX 0 mcgV950 0.5 mcg / IMX 16 mcgV950 0.5 mcg / IMX 47 mcgV950 0.5 mcg / IMX 94 mcgV950 5 mcg / IMX 0 mcgV950 5 mcg / IMX 16 mcgV950 5 mcg / IMX 47 mcgV950 50 mcg / IMX 0 mcgV950 50 mcg / IMX 16 mcg
Number of Participants Who Discontinued Study Drug Due to an Adverse Event00011010312
PrimaryGeometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7

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
Reported as:
Geometric mean · ng/mL
Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7
ng/mLPlacebo to V950/IMX 0 mcgPlacebo to V950/IMX 16 mcgV950 0.5 mcg/IMX 0 mcgV950 0.5 mcg/IMX 16 mcgV950 0.5 mcg/IMX 47 mcgV950 0.5 mcg/IMX 94 mcgV950 5 mcg/IMX 0 mcgV950 5 mcg/IMX 16 mcgV950 5 mcg/IMX 47 mcgV950 50 mcg/IMX 0 mcgV950 50 mcg/IMX 16 mcg
Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7363 (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)
PrimaryMean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies

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
Reported as:
Geometric mean · fold change
Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies
fold changePlacebo to V950/ IMX 0 mcgPlacebo to V950/ IMX 16 mcgV950 0.5 mcg / IMX 0 mcgV950 0.5 mcg / IMX 16 mcgV950 0.5 mcg / IMX 47 mcgV950 0.5 mcg / IMX 94 mcgV950 5 mcg / IMX 0 mcgV950 5 mcg / IMX 16 mcgV950 5 mcg / IMX 47 mcgV950 50 mcg / IMX 0 mcgV950 50 mcg / IMX 16 mcg
Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies0.89 (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)

Adverse events

Collected over Up to 4 years after first dose of vaccine. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo to V950/ IMX 0 mcg—1/5 (20%)4/5 (80%)
Placebo to V950/ IMX 16 mcg—0/13 (0%)11/13 (84.6%)
V950 0.5 mcg / IMX 0 mcg—2/8 (25%)7/8 (87.5%)
V950 0.5 mcg / IMX 16 mcg—2/8 (25%)8/8 (100%)
V950 0.5 mcg / IMX 47 mcg—3/7 (42.9%)6/7 (85.7%)
V950 0.5 mcg / IMX 94 mcg—1/7 (14.3%)7/7 (100%)
V950 5 mcg / IMX 0 mcg—4/9 (44.4%)9/9 (100%)
V950 5 mcg / IMX 16 mcg—1/8 (12.5%)8/8 (100%)
V950 5 mcg / IMX 47 mcg—2/8 (25%)8/8 (100%)
V950 50 mcg / IMX 0 mcg—1/5 (20%)5/5 (100%)
V950 50 mcg / IMX 16 mcg—0/8 (0%)8/8 (100%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventPlacebo to V950/ IMX 0 mcgPlacebo to V950/ IMX 16 mcgV950 0.5 mcg / IMX 0 mcgV950 0.5 mcg / IMX 16 mcgV950 0.5 mcg / IMX 47 mcgV950 0.5 mcg / IMX 94 mcgV950 5 mcg / IMX 0 mcgV950 5 mcg / IMX 16 mcgV950 5 mcg / IMX 47 mcgV950 50 mcg / IMX 0 mcgV950 50 mcg / IMX 16 mcg
ArrhythmiaCardiac disorders0/50/132/80/80/70/70/90/80/80/50/8
ContusionInjury, poisoning and procedural complications1/50/130/80/80/70/70/90/80/80/50/8
DepressionPsychiatric disorders0/50/130/80/80/70/70/90/80/81/50/8
Orthostatic hypotensionVascular disorders1/50/130/80/80/70/70/90/80/80/50/8
Cardiac arrestCardiac disorders0/50/130/80/81/70/70/90/80/80/50/8
DysphagiaGastrointestinal disorders0/50/130/80/81/70/70/90/80/80/50/8
Urinary tract infectionInfections and infestations0/50/130/80/81/70/70/90/80/80/50/8
Bladder cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/50/130/80/81/70/70/90/80/80/50/8
Cerebrovascular accidentNervous system disorders0/50/130/80/80/71/70/90/80/80/50/8
HaematuriaRenal and urinary disorders0/50/130/80/81/70/70/90/80/80/50/8
Most frequent other events
Showing 10 of 190
Most frequent other events
EventPlacebo to V950/ IMX 0 mcgPlacebo to V950/ IMX 16 mcgV950 0.5 mcg / IMX 0 mcgV950 0.5 mcg / IMX 16 mcgV950 0.5 mcg / IMX 47 mcgV950 0.5 mcg / IMX 94 mcgV950 5 mcg / IMX 0 mcgV950 5 mcg / IMX 16 mcgV950 5 mcg / IMX 47 mcgV950 50 mcg / IMX 0 mcgV950 50 mcg / IMX 16 mcg
Injection site painGeneral disorders1/53/131/84/81/77/74/93/84/85/55/8
Injection site erythemaGeneral disorders1/52/130/81/82/73/72/92/83/82/56/8
Injection site swellingGeneral disorders1/52/131/83/82/72/70/92/83/83/55/8
HeadacheNervous system disorders0/50/131/81/81/73/73/90/80/83/50/8
FallInjury, poisoning and procedural complications2/51/130/81/80/71/71/90/81/80/50/8
Mental status changesPsychiatric disorders1/50/131/81/80/70/70/90/80/82/50/8
PyrexiaGeneral disorders0/51/133/81/81/70/71/90/80/80/50/8
DiarrhoeaGastrointestinal disorders0/53/131/81/82/70/72/90/80/81/50/8
NauseaGastrointestinal disorders0/50/130/80/81/72/72/90/80/80/50/8
Upper respiratory tract infectionInfections and infestations1/51/131/80/82/71/71/90/80/80/50/8

Baseline characteristics

Age, Continuous
Age, Continuous(years)Placebo to V950/IMX 0 mcgPlacebo to V950/IMX 16 mcgV950 0.5 mcg/IMX 0 mcgV950 0.5 mcg/IMX 16 mcgV950 0.5 mcg/IMX 47 mcgV950 0.5 mcg/IMX 94 mcgV950 5 mcg/IMX 0 mcgV950 5 mcg/IMX 16 mcgV950 5 mcg/IMX 47 mcgV950 50 mcg/IMX 0 mcgV950 50 mcg/IMX 16 mcgTotal
Mean73.6 ± 10.6970.7 ± 9.676.9 ± 4.3973.6 ± 8.0776.1 ± 8.0173.4 ± 10.8972.6 ± 9.2672.5 ± 10.1081.5 ± 5.4870.6 ± 8.3875.5 ± 10.0474.2 ± 8.85
Sex: Female, Male
Sex: Female, Male(Participants)Placebo to V950/IMX 0 mcgPlacebo to V950/IMX 16 mcgV950 0.5 mcg/IMX 0 mcgV950 0.5 mcg/IMX 16 mcgV950 0.5 mcg/IMX 47 mcgV950 0.5 mcg/IMX 94 mcgV950 5 mcg/IMX 0 mcgV950 5 mcg/IMX 16 mcgV950 5 mcg/IMX 47 mcgV950 50 mcg/IMX 0 mcgV950 50 mcg/IMX 16 mcgTotal
Female3735564513345
Male2653215372541
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00464334
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Apr 23, 2007
Start date
Mar 2007
Primary completion
Jan 2012
Completion
Jan 2012
Results posted
Dec 18, 2012
Last update
Sep 25, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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