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HIV Vaccine + Adjuvants for HIV Prevention
Study Summary
This trial is looking at whether or not a new HIV vaccine is safe and creates an immune response in healthy people who don't have HIV.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- I don't have any major health issues that could affect the study.My general health and demographic details meet the study's requirements.My immune system is affected by certain conditions or medications.You are unlikely to contract HIV and have committed to keeping your behavior low-risk until the end of the study.You agree not to participate in any other research studies with experimental medications until after this study is finished.I am between 18 and 50 years old.I have a seizure disorder.You are willing to get the results of an HIV test.You are willing to talk about the risks of getting HIV and are open to learning how to reduce those risks.My overall health is good, as confirmed by recent medical exams and tests.You are open to talking about the risks of HIV infection and willing to receive advice on how to reduce that risk.I do not have a spleen.You can go to a medical facility that is participating in the HIV Vaccine Trials Network and are willing to be monitored for the entire study duration.You understand what the study is about and agree to participate voluntarily.I have received or am scheduled for certain vaccines within specific timeframes.My asthma is more severe than mild and not well-controlled.I meet the specific reproductive health criteria.I have had thyroid surgery or needed thyroid medication in the past year.I have been diagnosed with cancer.I have diabetes (type 1 or type 2).My overall health is good, as confirmed by recent medical exams and tests.You have a history of severe allergic reactions such as hives, swelling, or difficulty breathing.My blood pressure is under control.I have not received any blood products in the last 4 months.I am between 18 and 50 years old.You have taken experimental drugs within the last 30 days before the first vaccination.You have a mental health condition that may make it difficult for you to follow the study's instructions.You are currently pregnant or breastfeeding.I am currently on medication for tuberculosis.You are willing to find out if you have HIV.I have a bleeding disorder.You will be asked to complete a questionnaire before getting the first vaccine. If you answer any questions incorrectly, you will be asked to explain your understanding of the correct answer.
- Group 1: Part B, Group 3 (P3): Placebo
- Group 2: Part B, Group 5 (P5): Placebo
- Group 3: Part C, Group 7 (T7): BG505 SOSIP.664 gp140 + Alum
- Group 4: Part C, Group 7 (P7): Placebo
- Group 5: Part C, Group 8 (T8): Trimer 4571 + Alum
- Group 6: Part C, Group 8 (P8): Placebo
- Group 7: Part A, Group 1 (T1): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum
- Group 8: Part A, Group 2 (P2): Placebo
- Group 9: Part A, Group 1 (P1): Placebo
- Group 10: Part A, Group 2 (T2): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum
- Group 11: Part B, Group 3 (T3): BG505 SOSIP.664 gp140 + CpG 1018 + Alum
- Group 12: Part B, Group 6 (P6): Placebo
- Group 13: Part B, Group 5 (T5): BG505 SOSIP.664 gp140 + GLA-LSQ
- Group 14: Group 4 (P4): Placebo
- Group 15: Part B, Group 4 (T4): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum
- Group 16: Part B, Group 6 (T6): BG505 SOSIP.664 gp140 + Alum
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
To what conditions is BG505 SOSIP.664 gp140 typically utilized?
"BG505 SOSIP.664 gp140 is a common treatment for colic and has been demonstrated to be effective at managing the symptoms of acid regurgitation, gastroesophageal reflux disease, and other forms of colicky pain."
How many locations are carrying out this research experiment?
"Patients for this clinical trial may be recruited from multiple sites, including the University of Rochester Vaccines to Prevent HIV Infection CRS in Rochester, New york; The Hope Clinic of the Emory Vaccine Center CRS in Decatur, Georgia; and The Ponce de Leon Center CRS in Atlanta, Massachusetts. There are also 8 additional medical centres where recruitment is possible."
Has the BG505 SOSIP.664 gp140 formulation been endorsed by the FDA?
"Due to the limited available clinical data, our team at Power considers BG505 SOSIP.664 gp140's safety and efficacy to be of a moderate risk, scoring it a 1 on our scale from 1 to 3."
What are the foremost goals of this research project?
"This clinical trial, monitored for 18 months, aims to determine the Frequency of EAEs (Part B). Secondary objectives include measuring Alterations in RNAseq expression of leukocyte and/or immune cells (Part B), quantifying Alterations in blood leukocyte populations during the innate response (Part B), and assessing Percent HIV Env-specific CD4+ T cells in blood (Part A) via multiparameter flow cytometry."
Who is eligible to participate in this research endeavor?
"This investigation is accepting 105 HIV-positive participants aged 18 to 50 who are willing to discussion the risks of their infections, assessed by clinic staff as "low risk", and committed to maintaining a low-risk lifestyle until after their final study contact. Furthermore, applicants must agree not to enroll in any other research studies involving investigational agents prior to this study's conclusion."
How many participants are participating in this scientific experiment?
"This research requires 105 individuals that meet the designated criteria for participation. Patients may join from various clinical trial sites, such as University of Rochester Vaccines to Prevent HIV Infection CRS in Rochester, New york and The Hope Clinic of the Emory Vaccine Center CRS in Decatur, Georgia."
Is the age limit for enrolling in this research higher than thirty years?
"This trial is open to patients aged 18-50, and there are 109 trials for minors and 354 studies targeting those who have surpassed retirement age."
Is the research team currently enlisting participants for this experiment?
"According to the online clinicaltrials.gov database, this study is currently open for recruitment. The initial post date was January 13th 2020 with a subsequent update on July 11th 2022."
Have any prior investigations been conducted concerning BG505 SOSIP.664 gp140?
"Currently, three ongoing clinical trials for BG505 SOSIP.664 gp140 are in Phase 3 of their research. Birmingham, Alabama is the primary site hosting these studies; however, 69 other locations have joined in this medical investigation."
Is this a novel clinical trial?
"As of current, Dynavax Technologies Corporation's BG505 SOSIP.664 gp140 drug has 3 live trials across 24 cities and 11 nations. This medication was first trialled in 2020, involving 105 patients and reaching Phase 1 approval status. Since then, over 18358 studies have been completed."
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