NCT00464334

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P75+ for phase_1 alzheimer-disease

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_1 alzheimer-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2007

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 18, 2012

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

4.8 years

First QC Date

April 20, 2007

Results QC Date

November 19, 2012

Last Update Submit

September 24, 2015

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (4)

  • 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.

    Up to 4 years after first dose of vaccine

  • 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.

    Up to 6 months after first dose of vaccine

  • 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).

    Month 7

  • 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.

    Baseline and Month 7

Study Arms (11)

Placebo to V950/IMX 0 mcg

EXPERIMENTAL

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

Placebo to V950/IMX 16 mcg

EXPERIMENTAL

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

V950 0.5 mcg/IMX 0 mcg

EXPERIMENTAL

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

Biological: V950Biological: ISCOMATRIX™

V950 0.5 mcg/IMX 16 mcg

EXPERIMENTAL

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

Biological: V950Biological: ISCOMATRIX™

V950 0.5 mcg/IMX 47 mcg

EXPERIMENTAL

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

Biological: V950Biological: ISCOMATRIX™

V950 0.5 mcg/IMX 94 mcg

EXPERIMENTAL

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

Biological: V950Biological: ISCOMATRIX™

V950 5 mcg/IMX 0 mcg

EXPERIMENTAL

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

Biological: V950Biological: ISCOMATRIX™

V950 5 mcg/IMX 16 mcg

EXPERIMENTAL

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

Biological: V950Biological: ISCOMATRIX™

V950 5 mcg/IMX 47 mcg

EXPERIMENTAL

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

Biological: V950Biological: ISCOMATRIX™

V950 50 mcg/IMX 0 mcg

EXPERIMENTAL

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

Biological: V950Biological: ISCOMATRIX™

V950 50 mcg/IMX 16 mcg

EXPERIMENTAL

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

Biological: V950Biological: ISCOMATRIX™

Interventions

V950BIOLOGICAL

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

V950 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
ISCOMATRIX™BIOLOGICAL

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

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 mcg
Placebo to V950BIOLOGICAL
Placebo to V950/IMX 0 mcgPlacebo to V950/IMX 16 mcg

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer Disease

Interventions

ISCOMATRIX

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2007

First Posted

April 23, 2007

Study Start

March 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

September 25, 2015

Results First Posted

December 18, 2012

Record last verified: 2015-09