Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to test the safety and immune response to three different sets of HIV vaccines in healthy, HIV-uninfected adults.


Clinical Trial Description

The purpose of this study is to evaluate the safety, tolerability, and immune response to three different HIV-1 prime-boost vaccine regimens in healthy, HIV-1-uninfected adults. The regimens will differ by the type of HIV-1 envelope insert (Nat-B env, CON-S env, or Mosaic env) contained in both the DNA prime vaccine and the NYVAC boost vaccine. The study will enroll 180 healthy, HIV-1-uninfected adults in two stages (Part A and Part B). After Part A of the study is fully enrolled, study researchers will evaluate study immunogenicity data to determine whether to enroll participants into Part B. The study design and vaccination schedule for both parts of the study will be the same. Participants will be randomly assigned to one of three groups and receive either one of the experimental vaccine regimens or a placebo vaccine regimen. Participants will receive four total injections: on Day 0 and Day 28 (DNA vaccine or placebo) and on Day 84 and Day 168 (NYVAC vaccine or placebo). Group 1 participants will receive DNA Nat-B env and NYVAC Nat-B env vaccines, Group 2 participants will receive DNA CON-S env and NYVAC CON-S env vaccines, and Group 3 participants will receive DNA Mosaic env and NYVAC Mosaic env vaccines. Total study duration will be either 3 years after enrollment (for participants in the United States) or 5 years after enrollment (for participants in Switzerland). For all participants, study visits will occur on Days 0, 14, 28, 42, 84, 98, 168, 175, 182, 273, 357, and 364. After the last study visit, participants will be contacted annually by phone or e-mail for a total of 3 (U.S. participants) or 5 (Switzerland participants) years to answer questions about their health. At screening, participants will give a medical history; undergo a complete physical exam, blood collection, urine collection, and an electrocardiogram (ECG); and receive risk reduction counseling. At most follow-up visits, participants will undergo an abbreviated physical exam, blood collection, urine collection, and receive risk reduction counseling. Participants will have additional ECGs on Days 98 and 182. At all visits, female participants who were born female will be assessed for pregnancy prevention, and at select visits, will undergo a pregnancy test. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01970449
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Withdrawn
Phase Phase 1

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
Recruiting NCT06033547 - A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants Phase 1
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 NCT06072443 - AURORA Study-A Transformative Approach to Support PrEP Medication Persistence
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