HIV Infections Clinical Trial
Official title:
A Phase 1b Clinical Trial to Evaluate the Safety and Immunogenicity of Different Combinations of DNAHIV-PT123, NYVAC-HIV-PT1 and NYVAC-HIV-PT4, and AIDSVAX® B/E in Healthy, HIV Uninfected Adult Participants
This study will evaluate the safety and immune response to five different combinations of three HIV vaccines in healthy, HIV-uninfected adults.
This study will evaluate the safety, tolerability, and immune response to five different combinations of three HIV vaccines-a DNA vaccine (DNA-HIV-PT123), a NYVAC vaccine (NYVAC-HIV-PT1 and NYVAC-HIV-PT4 injections), and the AIDSVAX® B/E vaccine-in healthy, HIV-uninfected adult participants. The study will enroll 180 healthy, HIV-uninfected participants aged 18 to 50 years. The participants will be randomly assigned to one of five groups. All participants will receive injections according to their assigned group schedule at study entry (Month 0) and Months 1, 3, and 6. The immune response of different prime and boost vaccine strategies will be tested in Groups 1 through 4, and the immune response of the co-administration of the DNA and AIDSVAX® B/E vaccine will be tested in Group 5. Group 1 participants will receive AIDSVAX® B/E as a prime followed by NYVAC as a boost; Group 2 participants will receive NYVAC as a prime followed by an AIDSVAX® B/E boost; Group 3 participants will receive AIDSVAX® B/E as a prime followed by a DNA boost; Group 4 participants will receive a DNA prime followed by an AIDSVAX® B/E boost; and Group 5 participants will receive both the DNA and AIDSVAX® B/E vaccines at each of the 4 vaccination visits. Total study duration will be approximately 42 months and will involve 12 months of scheduled clinic visits at screening, study entry [Month 0], and Months 0.5, 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12) followed by annual health contacts via e-mail or phone to a total of 3 years following initial study injection. All study visits will include a physical exam, HIV risk reduction counseling, and an interview and/or questionnaire. Select study visits will include blood collection, urine collection, an electrocardiogram (ECG), and a pregnancy test for participants who were born female. For participants in Groups 1 and 2, select study visits will also include an assessment of cardiac symptoms. Participants will remain in the clinic for 30 minutes after receiving the vaccines for observation and monitoring. For 7 days after receiving the vaccines, participants will record their symptoms and report them to study researchers. ;
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 |
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 |
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 |