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

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Biological: ISCOMATRIX™; Biological: V950; Biological: Placebo to V950

• Registration Number: NCT00464334
• Lead Sponsor: Merck Sharp & Dohme LLC

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-04-20
• Study First Submitted QC: 2007-04-20
• Study First Posted: 2007-04-23
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2012-11-19
• Results First Submitted QC: 2012-11-19
• Results First Posted: 2012-12-18
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo to V950/IMX 0 mcg	ISCOMATRIX™	Participants receive Placebo to V950/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 0.5 mcg/IMX 16 mcg	ISCOMATRIX™	Participants receive V950 0.5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 5 mcg/IMX 16 mcg	V950	Participants receive V950 5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 50 mcg/IMX 0 mcg	ISCOMATRIX™	Participants receive V950 50 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 50 mcg/IMX 16 mcg	V950	Participants receive V950 50 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 0.5 mcg/IMX 0 mcg	ISCOMATRIX™	Participants receive V950 0.5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 0.5 mcg/IMX 16 mcg	V950	Participants receive V950 0.5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Placebo to V950/IMX 16 mcg	ISCOMATRIX™	Participants receive Placebo to V950/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Placebo to V950/IMX 16 mcg	Placebo to V950	Participants receive Placebo to V950/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 5 mcg/IMX 0 mcg	V950	Participants receive V950 5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 5 mcg/IMX 47 mcg	ISCOMATRIX™	Participants receive V950 5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 50 mcg/IMX 0 mcg	V950	Participants receive V950 50 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 5 mcg/IMX 0 mcg	ISCOMATRIX™	Participants receive V950 5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Placebo to V950/IMX 0 mcg	Placebo to V950	Participants receive Placebo to V950/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 0.5 mcg/IMX 0 mcg	V950	Participants receive V950 0.5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 0.5 mcg/IMX 47 mcg	V950	Participants receive V950 0.5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 0.5 mcg/IMX 47 mcg	ISCOMATRIX™	Participants receive V950 0.5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 0.5 mcg/IMX 94 mcg	V950	Participants receive V950 0.5 mcg/IMX 94 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 0.5 mcg/IMX 94 mcg	ISCOMATRIX™	Participants receive V950 0.5 mcg/IMX 94 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 5 mcg/IMX 16 mcg	ISCOMATRIX™	Participants receive V950 5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 5 mcg/IMX 47 mcg	V950	Participants receive V950 5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
V950 50 mcg/IMX 16 mcg	ISCOMATRIX™	Participants receive V950 50 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced at Least One Adverse Event	Up to 4 years after first dose of vaccine	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.
Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7	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).
Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies	Baseline and Month 7	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.
Number of Participants Who Discontinued Study Drug Due to an Adverse Event	Up to 6 months after first dose of vaccine	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.