M&M Study
University of North Carolina at Chapel Hill
Description
We are conducting this study to find out: • If it is safe for HIV-infected people to receive injections of two investigational HIV vaccines, called MVAtHIVconsv3 and MVAtHIVconsv4. • If giving participants these vaccine doses will increase their immune system's ability to kill HIV virus.
Keywords:
HIV/AIDS
Category:
Drug or Biologic
Qualifications
Age
18 - 65 years
Gender
Any
Study Population
HIV-infected men and women between 18 and 60 years of age with viral suppression on ART as measured on standard HIV RNA assays. Eligible participants must have a CD4 cell count ≥ 350 cells/mm3 at screening.
Investigator
Cindy Gay
Clinical Associate Professor
Medicine-Infectious Diseases
Recruitment Period End
March 31, 2020
Location
Primary Location
Clinical & Translational Research Center (CTRC)
Secondary Location
UNC Hospital Apheresis lab
Study Qualifications
Age Range 18 - 65 years
Participant qualification(s) Men and women age 18-65 with HIV-1 infection who are on a stable, continuous ART regimen for at least 3 months and are able to continue ART during the study. Must be able to commit to all study visits and procedures and agree to stay in contact with the study team. Must be able to receive shots in the upper arm and ability to give blood with no problems. Willing to delay a flu shot until 1 month after the first study vaccine. Willing to use strict birth control to prevent pregnancy during study.
Not eligible if: Conditions such as: anemia, syphilis, bleeding disorders, other auto immune disorders, seizures or fainting spells, abnormal or removed spleen, latex or egg allergy, history of severe reaction to vaccines, unstable asthma, chronic skin problems (ex. eczema, psoriasis), hepatitis C treatment within 6 months. Cannot have extensive tattoos on upper arms or have received any HIV or experimental vaccine.
Number of Visits
- » 10 In person visit(s)
Clinic visits with 2 blood procedures. Option to participate in additional lymph node procedures (completely optional)
» 2 Remote visit(s)Phone calls
Participation Period
Just over 8 months (32.5 weeks)
