The Approach

The Approach

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.