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DNA Vaccine
DNA/gp120 HIV Vaccine for Human Immunodeficiency Virus Infection
Phase 1
Waitlist Available
Research Sponsored by Worcester HIV Vaccine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured through participants' last study visit, at month 20 to 24, depending on which part of the study participants are enrolled in
Awards & highlights
Study Summary
This trial is looking at whether a new HIV vaccine is safe and effective.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured through participants' last study visit, at month 20 to 24, depending on which part of the study participants are enrolled in
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured through participants' last study visit, at month 20 to 24, depending on which part of the study participants are enrolled in
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of adverse events (AEs)
Frequency of local injection site (including DTH) reactogenicity signs and symptoms
Frequency of systemic reactogenicity signs and symptoms
+4 moreSecondary outcome measures
Breadth of gp70-V1V2 IgG and gp120 IgA
Frequency of HIV-1 specific CD4+ and CD8+ T-cell responses
Genes, env
+1 moreSide effects data
From 2020 Phase 1 trial • 60 Patients • NCT0340927630%
Any Event in SOC
20%
Upper respiratory tract infection
20%
Blood creatinine increased
10%
Tongue ulceration
10%
Respiratory tract infection viral
10%
Aspartate aminotransferase increased
10%
Blood glucose increased
10%
Arthralgia
10%
Panic attack
10%
Ecchymosis
10%
Eczema
10%
Muscle strain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: Placebo
Part A: Vaccine
Part B: Placebo
Part B: Vaccine 1
Part B: Vaccine 2
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 2 (Treatment): Admixture of DNA Vaccine and Protein VaccineExperimental Treatment2 Interventions
Participants will receive admixture of 2 mg of env (A,B,C,A/E)/gag (C) DNA vaccine and 400 mcg of gp120 (A,B,C,A/E) protein vaccine (no adjuvant) at Day 0, and Months 1, 3, 6, and 8.
Group II: Group 1 (Treatment): DNA Vaccine + Protein Vaccine/GLA-SEExperimental Treatment3 Interventions
Participants will receive 2 mg of env (A,B,C,A/E)/gag (C) DNA vaccine and 400 mcg of gp120 (A,B,C,A/E) protein vaccine admixed with GLA-SE adjuvant at Day 0, and Months 3, 6, and 12.
Group III: Group 1 (Control)Placebo Group1 Intervention
Participants will receive placebo at Day 0, Months 3, 6, and 12.
Interventions:
Group IV: Group 2 (Control)Placebo Group1 Intervention
Participants will receive placebo at Day 0, and Months 1, 3, 6, and 8.
Interventions:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GLA-SE adjuvant
2018
Completed Phase 1
~220
gp120 (A,B,C,A/E) Protein Vaccine
2018
Completed Phase 1
~110
env (A,B,C,A/E)/gag (C) DNA Vaccine
2018
Completed Phase 1
~110
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Access to Advanced Health Institute (AAHI)OTHER
28 Previous Clinical Trials
1,624 Total Patients Enrolled
Worcester HIV VaccineLead Sponsor
Brigham and Women's HospitalOTHER
1,608 Previous Clinical Trials
11,469,835 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to come to the study site and commit to participating for the entire study duration.You understand what the study is about and agree to take part in it.You received any non-live vaccines within 14 days before the first dose of the study vaccine.You have an autoimmune disease, a connective tissue disease, or have had vasculitis in the past.You have a weakened immune system.You have a mental health condition that could prevent you from following the study instructions.You have cancer.You have a history of swelling in the body without an apparent cause.You cannot have received any experimental drugs within 30 days prior to the first vaccine.You are currently pregnant or breastfeeding.You participated in a previous HIV vaccine trial and received an HIV vaccine.You agree to find out the results of an HIV test.You are between 18 and 50 years old.You cannot have received live vaccines (except for flu vaccine) within the past 30 days or have one scheduled within 14 days after study injection.You have received or are scheduled to receive allergy shots within 30 days before the first vaccine, or within 14 days after the first vaccine.You had a seizure within the last three years.You don't have a working spleen.You are open to talking about the risks of HIV infection and willing to receive counseling about ways to reduce your risk.Your blood test results must fall within a certain range.Before getting the first vaccine, you will take a questionnaire to show that you understand the study. If you answer any questions incorrectly, you will be asked to explain them verbally.You are in good overall health based on your medical history, physical examination, and lab tests.You have a medical condition that may affect your ability to safely participate in the study.Your asthma is not mild and well-controlled.You have received an experimental vaccine in a previous study within the last 5 years, unless that vaccine has been approved by regulatory agencies.You have diabetes, whether it is type 1 or type 2, even if it is controlled by diet only.You are planning to join another study that involves testing experimental drugs or requires HIV antibody testing that is not part of this study.You promise not to participate in any other experimental drug studies while taking part in this one.You are at a low risk of getting HIV and are committed to maintaining behaviors that reduce the risk of HIV exposure throughout the study. The study will follow guidelines for defining low risk.You are willing to talk about the risk of getting HIV and open to learning ways to reduce that risk.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2 (Treatment): Admixture of DNA Vaccine and Protein Vaccine
- Group 2: Group 1 (Treatment): DNA Vaccine + Protein Vaccine/GLA-SE
- Group 3: Group 1 (Control)
- Group 4: Group 2 (Control)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the env (A,B,C,A/E)/gag (C) DNA Vaccine been authorized by the US Food and Drug Administration?
"Our team at Power calculated a safety rating of 1 for env (A,B,C,A/E)/gag (C) DNA Vaccine because this is an early-stage trial with limited data on efficacy and even fewer studies concerning its security."
Answered by AI
Are individuals being sought for this experiment at present?
"According to clinicaltrials.gov's records, this medical trial is not currently recruiting participants, as it was last updated on June 8th 2022. However, there are presently 484 additional studies actively looking for volunteers."
Answered by AI
Are the requirements for this medical study limited to individuals aged 65 and over?
"The terms of inclusion for this medical study limit participants to those between 18 and 50 years old. For minors or seniors, there are respectively 108 trials and 352 trials that could be more suitable."
Answered by AI
What are the eligibility requirements for participation in this experiment?
"Eligibility for this research includes HIV-positive patients between ages 18 to 50. Currently, 42 participants are being enrolled."
Answered by AI
Can you elucidate the primary aims of this investigation?
"This clinical trial aims to measure the reactogenicity of local injection sites through participants' last visit, which will occur between Months 20 and 24. Secondary outcomes include Frequency of HIV-1 specific CD4+ and CD8+ T-cell responses (Assessed by intracellular cytokine staining), Serum neutralizing antibody responses against Tier 1A, Tier 1B, and selected Tier 2 viruses (Assessed by TZM-bl assay) Breadth of gp70-V1V2 IgG and gp120 IgA (Assessed by ELISA or Binding Antibody Multiplex Assay), and ADCC"
Answered by AI
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