Safety of an HIV DNA Vaccine Given to HIV Uninfected Adults

Status Completed

Clinical Trial Summary

The purpose of this study is to see if the experimental HIV vaccine pGA2/JS2 is safe and is well tolerated at two different doses. Another important purpose of this study is to observe how the immune system responds to the vaccine at different dose levels. Vaccines are given to people to help their bodies fight infection. The vaccine being tested in this study is a DNA vaccine. The pGA2/JS2 plasmid DNA vaccine instructs the body to make some HIV proteins. These HIV proteins may trigger an immune response. Because only a few of the many proteins HIV needs are made through DNA vaccination, there is no risk of getting HIV from the vaccination. This and other similar DNA vaccines have been tested for safety in mice, rabbits, and monkeys. The vaccine has been well tolerated at doses to be used in this study.

Clinical Trial Description

DNA vaccination has induced immune responses in animals to a number of viral, bacterial, and parasite derived antigens. Early clinical experiences with HIV DNA vaccines in humans indicate: 1) the tolerability and short-term safety of DNA at doses up to 5000 mcg in humans are excellent; and 2) there is potential for immunogenicity. The pGA2/JS2 DNA vaccine is part of a planned prime/boost regimen of a DNA vaccine prime followed by a modified vaccinia Ankara (MVA) vaccine boost. In studies in monkeys, a combination of a DNA vaccine and an MVA vaccine protected the monkeys against disease caused by a monkey virus similar to HIV. The current study is an initial investigation of the safety and immunogenicity of the DNA vaccine given alone. The pGA2/JS2 DNA vaccine expresses gag, protease, reverse transcriptase, env, tat, vpu, and rev. Participants are randomized to 1 of 2 groups. People in Group A receive either 2 injections of a lower dose (300 mcg) of the DNA plasmid vaccine or the placebo control. People in Group B receive either 2 injections of a higher dose (3000 mcg) of the DNA plasmid vaccine or the control. Group B will be enrolled only if the vaccine is found to be safe and well-tolerated during the initial 2-week evaluation of all participants in Group A. Participants receive vaccinations administered at Months 0 and 2. All vaccinations are administered by intramuscular (IM) injection in an outpatient setting. Participants have about 10 clinic visits during this study, including the screening and injection visits. Participants give blood and urine samples at study visits. They are tested for HIV before entering the study and 4 more times during the study. Women who can become pregnant may undergo up to 3 pregnancy tests during the study period. ;

Study Design

Related Conditions & MeSH terms

HIV Infections

Clinical Trial Details

NCT number	NCT00043511
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	Phase 1
Completion date	April 2003

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