Passive Immunization Clinical Trial for HIV-Negative Adults


This study is now closed to enrollment. Thank you for your interest! We expect to have another AMP (passive immunization) study opening in the fall, so keep in touch!

A Phase I clinical trial to evaluate the safety and drug levels of a human monoclonal antibody (VRC01) administered in multiple doses intravenously and subcutaneously in different dosing schedules to healthy, HIV-uninfected adults. This strategy is called passive immunization, or antibody-mediated prevention (AMP).

HIV vaccine best hope

Purpose of the Study

Primary objective 1: To evaluate the safety and tolerability of VRC01, administered intravenously (IV) and subcutaneously (SC), at multiple timepoints.

Primary objective 2 (Groups 1-3): To evaluate the serum levels of VRC01, administered IV and SC in 3 different regimens, at Month 6.

Primary objective 3 (Groups 4 and 5): To evaluate the serum levels of VRC01 at 2 timepoints after each IV administration.

Protocol Summary

This trial is looking at the safety of a strategy that has proven successful in preventing and treating other diseases. Rather than using a vaccine to create antibodies to fight infection, passive immunization is directly giving the person antibodies through infusion or injection. HIV antibodies cannot give someone HIV. The trial in Cleveland is not asking whether the antibodies work as HIV prevention – so the people joining the trial do not have to be at risk for HIV infection.

The antibodies in this trial have been given to a small number of people in other trials. This trial is looking at the safety and dosing levels of the antibodies, as well as the best way to give the antibodies to people.

Each person will be in the trial for 8 months. There are 5 different groups that people can join, with the number of clinic visits varying between the groups from 15 to 21 visits during the trial. All clinic visits are at University Hospitals Case Medical Center in the University Circle neighborhood of Cleveland.

Compensation is provided.

Basic Eligibility Criteria

  • Healthy, HIV-negative men and women, including trans* men and trans* women
  • Ages 18 to 50
  • Weight between 116 and 253 pounds
  • Daytime flexibility for longer visits

Study Site Location

Our site is located at the Foley Medical Building, 2061 Cornell Rd, Cleveland, Ohio.

How to Contact the Study Site for More Information

For additional information about HVTN104, please call 216-844-4444 or email info@case.edu. All personal information, including your name and contact details, will be kept confidential.

More information on the study may be found here: http://www.hvtn.org/en/community/community-compass/current-issue/hvtn-104–exploring-new-pathways-to-vaccine-design.html

More information on passive immunization may be found here: http://www.avac.org/resource/busy-advocates-passive-immunization