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Wits RHI

IAVI C100 Study

Infectious Diseases
Sexual and Reproductive Health

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 increased access to HIV prevention and antiretroviral therapy (ART) in South Africa, the country continues to face high HIV incidence, with an estimated 220,000 new infections each year. There is an urgent need to develop new, longer-lasting interventions beyond the current daily oral pre-exposure prophylaxis (PrEP). The IAVI C100 study focuses on the potential of combining two potent broadly neutralizing antibodies (bNAbs)—3BNC117-LS-J and 10-1074-LS-J. These antibodies target non-overlapping regions of the HIV-1 envelope glycoprotein (gp120), offering a higher potency and broader range of protection than either antibody alone.

Primary Objectives

  1. Safety and Tolerability: To evaluate the safety and tolerability of two bNAbs, 3BNC117-LS-J and 10-1074-LS-J, both individually and in combination, administered intravenously (IV) or subcutaneously (SC) to HIV-uninfected adults.
  2. Pharmacokinetic Profile: To assess the pharmacokinetics of these bNAbs, alone and in combination, via IV or SC administration to HIV-uninfected individuals.
  3. Long-Acting Regimen: To identify a regimen for administering the antibodies subcutaneously every 3 months that maintains a trough level of >10 µg/ml for each antibody in more than 80% of participants.

Study Design

This multi-site, multi-country, randomized, double-blind, placebo-controlled Phase 1/2 study evaluates the safety, tolerability, and pharmacokinetics of the two bNAbs in HIV-uninfected adults.

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 Kim Comline, Sub-investigator
  • Dr Jenny Omony, Sub-investigator
  • Dr Nicole Poovan, Sub – Investigator

Latest Update

April 2024

For more information, please contact the study team at rhicomms@wrhi.ac.za

Research Brief

IAVI C‐100 Study