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.