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Varicella Zoster Vaccine · 1 trial · 3 indications
Surrogate measures of vaccine efficacy will be performed on all patients using samples collected at baseline prior to vaccination, and subsequently at 6 weeks, and one year post vaccination. These measures will include: a. Frequency of VZV-specific T cells as measured by interferon-gamma ELISPOT assay. Changes in these outcome measures will be evaluated using geometric means and percentage increases in geometric means of (a) VZV-specific reactive lymphocytes.
Surrogate measures of vaccine efficacy will be performed on all patients using samples collected at baseline prior to vaccination, and subsequently at 6 weeks, and one year post vaccination. These measures will include: b. VZVgp-specific IgG titer as measured by ELISA Changes in these outcome measures will be evaluated using geometric means and percentage increases in geometric means of (b) VZV antibody titers in vaccine recipients as compared to placebo, as well as relative to baseline measures prior to vaccination.
| Arm | Type | Description |
|---|---|---|
| Varicella Zoster Vaccine (Zostavax) | EXPERIMENTAL | Live zoster vaccine injection will be administered as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm at the baseline visit |
| Placebo Injection (Zostavax Comparator) | PLACEBO_COMPARATOR | Saline injection will be administered as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm at the baseline visit |
| Varicella Zoster Vaccine (Shingrix) | EXPERIMENTAL | Non-live zoster vaccine injection will be administered twice, 8 weeks apart, as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm at the baseline visit |
| Placebo Injection (Shingrix Comparator) | PLACEBO_COMPARATOR | Saline injection will be administered twice, 8 weeks apart, as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm at the baseline visit |
| Name | Type | Description |
|---|---|---|
| Varicella Zoster Vaccine | BIOLOGICAL | live-attenuated vaccine to prevent herpes zoster |
| Placebo Injection | OTHER | Saline solution injection |
Inclusion criteria include: * be \>= 50 years of age or older (for the Zostavax® sub-study only) * be \>= 18 years of age or older (for the Shingrix® sub-study only) * be currently treated with abatacept therapy at the time of enrollment * Eligible women must be post-menopausal (\> 1 year since las...
Varicella Zoster Vaccine is being studied for the prevention of Herpes Zoster, also known as shingles, in patients with inflammatory diseases such as rheumatoid arthritis. It is an investigational monoclonal antibody currently in Phase 2 clinical development.
Varicella Zoster Vaccine is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research to evaluate the vaccine's safety and immunogenicity in specific patient populations.
Varicella Zoster Vaccine is in Phase 2 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 2 trial has been completed to assess its effects in patients with rheumatoid arthritis and other inflammatory conditions.
Varicella Zoster Vaccine was studied in clinical trial NCT03604406, titled "The Immunogenicity and Safety of Zostavax® and Shingrix® in Rheumatoid Arthritis Patients Using Abatacept." This Phase 2, randomized, double-blind, placebo-controlled trial enrolled 154 participants in the United States and has been completed.
Varicella Zoster Vaccine is being evaluated in a biomarker-selected patient population. The completed Phase 2 trial enrolled patients with rheumatoid arthritis and other inflammatory diseases, focusing on those using abatacept, to assess the vaccine's immunogenicity and safety in this specific group.