Clinical Trials Logo
  1. Home
  2. HIV Infections
  3. NCT01549470

Evaluating the Safety of and Immune Response to an HIV Vaccine in Healthy, HIV-Uninfected Adults in Uganda

HIV Infections Clinical Trial

Official title:
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, in Uninfected Adult Volunteers in Uganda

Clinical Trial Summary

Currently, no vaccine prevents HIV infection. This study will test the safety and immune responses of an HIV-1 DNA vaccine in HIV-uninfected adults in a Ugandan population.

Clinical Trial Description

The global HIV/AIDS epidemic continues to increase at unacceptably high levels, and there is not yet an effective prevention method for HIV infection. This study will test the safety and immune responses of a preventive HIV vaccine, VRC-HIVDNA009-00-VP, which is a multiclade HIV-1 DNA plasmid vaccine. This study will seek to enroll 30 participants, randomly assigning 15 participants each to the study vaccine arm and the placebo vaccine arm. Three doses of the vaccine will be given by intramuscular (IM) injection using the Biojector 2000 needle-free injection management system: the first dose at Day 0 (entry), second dose at Day 28 (within 7 days before or after Day 28), and third dose at Day 56 (within 7 days before or after Day 56). Participants will attend two screening visits and visits at Days 0 (entry), 2, 14, 28, 30, 42, 56, 58, 70, 84, 168, 252, and 336. At most visits, participants will give a medical history and undergo a physical exam, blood draw, and urine collection. For women, a pregnancy test will be given at each study injection visit. Participants also will be instructed to maintain a diary of local and systemic reactions for 7 days after each injection. They also will be provided with a ruler to measure erythema, induration, or other observable reactions and a thermometer to record temperature on a daily basis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01549470
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Completion date March 2006
View Details
See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2