C100

Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117- LS-J and 10-1074- LS-J, in Healthy American and African Adults (IAVI C100)

Rationale

Despite all efforts to increase access to HIV prevention and ART in South Africa, incidence of HIV infection continues to be unacceptably high with an estimated 220 000 new infections per year. There is an urgent need to develop new interventions with a longer duration of action than the currently available pre-exposure prophylaxis (PrEP) which is based on a daily oral regimen. The 3BNC117 and 10-1074 are two of the most potent broadly neutralizing antibodies (bNAbs) available. The combination of these two antibodies, which target two nonoverlapping epitopes on HIV-1 gp 120 provides higher breadth and potency than either antibody alone.

Primary Objectives

  • To evaluate the safety and tolerability of two broadly neutralizing monoclonal human antibodies, 3BNC117-LS-J and 10-1074-LS-J, alone and in combination, intravenously (IV) or subcutaneously (SC) to Healthy American and African adults.
  • To evaluate the pharmacokinetic profile of two broadly neutralizing monoclonal human antibodies, 3BNC117-LS-J and 10-1074-LS-J, when given alone or in combination, IV or SC to Healthy Ameriacan and African Adults.
  • To identify a regimen of the two antibodies that, when given SC every 3 months, will maintain a serum trough level of > 10 µg/ml for each antibody in >80% of the study population.

Study population

Healthy African adults, ages 18-45 years residing in Johannesburg.

Investigators

Prof Sinead Delany-Moretlwe, Principal Investigator

Dr Carrie – Ann Matthew Sub-investigator

Dr KimComline Sub-investigator

Dr Jenny Omony Sub-investigator

Dr Nicole Poovan Sub - Investigator

Latest Update: 15 February 2021

For more about C100 please email rhicomms@wrhi.ac.za