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NDV-3 vaccine with alum · 1 trial · 3 indications
The primary objective of this study is to assess the safety of a single dose of NDV-3 vaccine, administered either IM with or without alum adjuvant at one dose level or ID at a lower dose level, compared to placebo. Clinical evaluations will be assessed on each subject at selected time points up to 90 days post-vaccination.
| Arm | Type | Description |
|---|---|---|
| NDV-3 vaccine with alum IM | ACTIVE_COMPARATOR | 300 ug Als3 and 0.5 mg Al as alum in PBS per dose, one dose administered IM |
| NDV-3 vaccine without alum IM | ACTIVE_COMPARATOR | 300 ug Als3 in PBS per dose, one dose administered IM |
| Placebo IM | PLACEBO_COMPARATOR | 0.5 mg Al as alum in PBS per dose, one dose administered IM |
| NDV-3 vaccine without alum ID | ACTIVE_COMPARATOR | 30 ug Als3 in PBS per dose, one dose administered ID |
| Name | Type | Description |
|---|---|---|
| NDV-3 vaccine with alum IM | BIOLOGICAL | One dose administered IM |
| NDV-3 vaccine without alum IM | BIOLOGICAL | One dose administered IM |
| Placebo with alum IM | BIOLOGICAL | One dose administered ID |
| NDV-3 vaccine without alum ID | BIOLOGICAL | One dose administered ID |
Inclusion Criteria: 1. Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent document prior to screening. The informed consent document will be written in English, therefore the volunteer must have the ability to read and communicate in E...
NDV-3 vaccine with alum is an investigational vaccine being studied for the prevention of staphylococcal infections, including those caused by Staphylococcus aureus. It is also being evaluated for its potential to protect against yeast infections and candidiasis, as these conditions were included in the clinical trial population.
NDV-3 vaccine with alum is being developed by United Therapeutics Corporation, a biotechnology company traded on the Nasdaq under the ticker symbol UTHR. The company is conducting clinical research to evaluate the vaccine's safety and immunogenicity in healthy volunteers.
NDV-3 vaccine with alum is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine remains under evaluation for its safety and immune response profile.
NDV-3 vaccine with alum was studied in a completed Phase 1 clinical trial registered as NCT01447407. This randomized, double-blind, placebo-controlled trial enrolled 164 participants in the United States to evaluate the effect of adjuvant and route of administration on the safety and immunogenicity of the vaccine.
NDV-3 vaccine with alum is a monoclonal antibody-based vaccine designed to elicit an immune response against staphylococcal infections. The vaccine incorporates alum as an adjuvant to enhance the body's immune reaction, potentially providing protection against Staphylococcus aureus and related fungal infections such as candidiasis.