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

Study Overview
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Brief Summary
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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).

Official Title
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A Double-Blind, Randomized, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety, Tolerability, and Immunogenicity of V950 Formulated on Aluminum-Containing Adjuvant With or Without ISCOMATRIX™ in Patients With Alzheimer Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Biological: V950
* Biological: ISCOMATRIX™
* Biological: Placebo to V950


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo to V950/IMX 0 mcg<br>Participants receive Placebo to V950/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. | Biological: ISCOMATRIX™<br>* ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.<br>Biological: Placebo to V950<br> <br> |
| Experimental: Placebo to V950/IMX 16 mcg<br>Participants receive Placebo to V950/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. | Biological: ISCOMATRIX™<br>* ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.<br>Biological: Placebo to V950<br> <br> |
| Experimental: V950 0.5 mcg/IMX 0 mcg<br>Participants receive V950 0.5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. | Biological: V950<br>* V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.<br>Biological: ISCOMATRIX™<br>* ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.<br>|
| Experimental: V950 0.5 mcg/IMX 16 mcg<br>Participants receive V950 0.5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. | Biological: V950<br>* V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.<br>Biological: ISCOMATRIX™<br>* ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.<br>|
| Experimental: V950 0.5 mcg/IMX 47 mcg<br>Participants receive V950 0.5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. | Biological: V950<br>* V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.<br>Biological: ISCOMATRIX™<br>* ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.<br>|
| Experimental: V950 0.5 mcg/IMX 94 mcg<br>Participants receive V950 0.5 mcg/IMX 94 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. | Biological: V950<br>* V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.<br>Biological: ISCOMATRIX™<br>* ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.<br>|
| Experimental: V950 5 mcg/IMX 0 mcg<br>Participants receive V950 5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. | Biological: V950<br>* V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.<br>Biological: ISCOMATRIX™<br>* ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.<br>|
| Experimental: V950 5 mcg/IMX 16 mcg<br>Participants receive V950 5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. | Biological: V950<br>* V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.<br>Biological: ISCOMATRIX™<br>* ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.<br>|
| Experimental: V950 5 mcg/IMX 47 mcg<br>Participants receive V950 5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. | Biological: V950<br>* V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.<br>Biological: ISCOMATRIX™<br>* ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.<br>|
| Experimental: V950 50 mcg/IMX 0 mcg<br>Participants receive V950 50 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. | Biological: V950<br>* V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.<br>Biological: ISCOMATRIX™<br>* ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.<br>|
| Experimental: V950 50 mcg/IMX 16 mcg<br>Participants receive V950 50 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. | Biological: V950<br>* V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.<br>Biological: ISCOMATRIX™<br>* ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |