Determining an Effective Site (Groin Versus Arm) for Giving HIV Vaccines

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safety and immune system response to the TBC-3B HIV vaccine when it is injected either into the groin area or into the arm. The goal is to determine which injection site is better at producing a particular type of immune response. This study is not evaluating the effectiveness of the vaccine, so volunteers must maintain low risk behavior for HIV transmission throughout the study.

Clinical Trial Description

The goal of this vaccination study is to evaluate the safety and immunogenicity of the Therion Biologic Corporation (Cambridge, MA) TBC-3B vaccine. TBC-3B consists of live, recombinant vaccinia virus expressing the env and gag/pol genes of HIV-1 strain IIIB. TBC-3B will be administered by subcutaneous injection in the groin and in the deltoid region, with the aim of determining which site is better at inducing mucosal immune responses. Because the groin area drains to the inguinal lymph nodes, vaccines given there may stimulate local immunologic activity in the draining rectal mucosa as well as systemic immunologic activity in the blood.

Volunteers will be followed for 20 months. The first 2 months of the study will be an evaluation of volunteers' normal immune function. Volunteers will then be randomly selected to receive the TBC-3B experimental HIV vaccine in either the groin area or in the deltoid region. Neither volunteers nor study personnel will know which group the volunteer will be in until the day of the first immunization. All volunteers will receive TBC-3B.

During the 20 months of the study, volunteers will be asked to donate blood up to 14 times, undergo seven flexible sigmoidoscopies with biopsies, and receive three pairs of vaccine injections. For up to 36 days after each experimental vaccination, volunteers will be asked to abstain from activity that might spread the virus in the vaccine and put others at risk. Volunteers will receive specific instructions on how to avoid these risks. Volunteers will also be asked not to engage in receptive anal intercourse during the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

HIV Infections

Clinical Trial Details

NCT number	NCT00056745
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	Phase 1

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	`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
Completed	`NCT03141918` - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS	N/A
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