Vaccine Product Profile
Target product profile of a prophylactic onchocerciasis vaccine
Item | Desired target |
---|---|
Indication | A vaccine to protect against infection with infective (L3) larvae and to reduce adult worm burden and microfiladermia for the purpose of reducing morbidity and transmission. |
Target Population | Children < 5 years. |
Route of Administration | Intramuscular injection. |
Product Presentation | Single-dose vials; 0.5 ml volume of delivery. |
Dosage Schedule | Maximum of 3 immunizations given 4 weeks apart. |
Warnings and Precautions/Pregnancy and Lactation | Mild to moderate local injection site reactions such as erythema, edema and pain, the character, frequency, and severity of which is similar to licensed recombinant protein vaccines. Less than 0.01% risk of urticaria and other systemic allergic reactions. Incidence of serious adverse reactions no more than licens ed comparator vaccines. |
Expected Efficacy | >50% efficacy at preventing establishment of incoming worms; >90% reduction of microfilariae (based on current animal model results). |
Co-administration | All doses may be co-administered and/or used with other infant immunization programmes. |
Shelf-Life | 4 Years. |
Storage | Refrigeration between 2 to 8 degrees Celsius. Cannot be frozen. Can be out of refrigeration (at temperatures up to 25 degrees) for up to 72 hours. |
Product Registration | Licensure by the Food and Drug Administration and/or the European Medicine Agency. |
Target price | Less than $10 per dose for use in low- and middle-income countries. |