BridgeMD
Tests treatment safety and results for HIV
Official title Clinical Trial to Evaluate the Safety and Immunogenicity of the V2 Apex-Directed Immunogens DV201P-RNA and DV202B1-RNA in Adult Participants Without HIV
ClinicalTrials.gov ID: NCT07390474
What this study is testing
What is DV201P-RNA?
DV201P-RNA is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for hiv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 1, multicenter, open-label, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of DV201P-RNA and DV202B1-RNA, immunogens designed to induce HIV-1 envelope (Env) V2 apex-specific broadly neutralizing antibodies (V2 apex bnAbs). Both vaccines consist of a modified mRNA encapsulated in lipid nanoparticles (LNP) that when translated in cells produces HIV-1 Env gp150 transmembrane trimers.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Demonstrates an understanding of the study and is able and willing to complete the informed consent process.
- At least 18 years old at screening and up to 55 years old on day of enrollment.
- Available for clinic follow-up through the last clinic visit.
- Willing to undergo study procedures as outlined in the schedule of procedures (Appendix A).
- Agrees not to enroll in another study of an investigational agent during participation in the trial. If a potential participant is already enrolled...
You likely can't join if
- Women who are breastfeeding or pregnant.
- Body mass index (BMI) ≥40. Enrollment of individuals with BMI ≥40 who are in good health, as assessed by the site investigator, may be considered by...
- Diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c ≤8% within the last 6 months) or a history of isolated...
- Previous or current recipient of an investigational HIV vaccine (previous placebo/control recipients are not excluded).
- Receipt of non-HIV investigational vaccine(s) received within the last 1 year. Exceptions include vaccines that have subsequently undergone licensure...
- Congenital or acquired immunodeficiency, including systemic medication use likely to impair immune response to vaccine in the opinion of the site...
See the full eligibility criteria
Who can join
- Demonstrates an understanding of the study and is able and willing to complete the informed consent process.
- At least 18 years old at screening and up to 55 years old on day of enrollment.
- Available for clinic follow-up through the last clinic visit.
- Willing to undergo study procedures as outlined in the schedule of procedures (Appendix A).
- Agrees not to enroll in another study of an investigational agent during participation in the trial. If a potential participant is already enrolled in another clinical trial, approvals from the other trial sponsor and...
- In good general health according to the clinical judgment of the site investigator.
- Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgment of the site investigator.
- Agrees to discuss their potential for HIV acquisition and agrees to HIV prevention counseling.
- Hemoglobin (Hgb):
- 11.0 g/dL for women
- 13.0 g/dL for men
- White blood cell (WBC) count of 2,500 to 12,000/mm3. WBC over 12,000/mm3 is not exclusionary if further evaluation shows general good health and if PSRT approval is granted.
- Platelet count of 125,000 to 550,000/mm3.
- Alanine aminotransferase (ALT) \<2.5× the upper limit of institutional reference range.
- Serum creatinine ≤1.1× the upper limit of normal (ULN) based on the institutional normal range.
- Total measured serum calcium level \>8.5 mg/dL.
- Systolic blood pressure of 90 to \<140 mm Hg and diastolic blood pressure of 50 to \<90 mm Hg at screening visit. The average blood pressure between the screening visit and the enrollment visit must be below 140 mm Hg...
- HIV test results by one of the following options:
- Negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA) or
- Negative results on two different brands of HIV rapid tests (one of which must be FDA-approved)
- Negative for anti-Hepatitis C virus (HCV) Abs or negative HCV nucleic acid test (NAT) if anti-HCV Abs are detected.
- Negative for Hepatitis B surface antigen (Ag).
- For women of pregnancy potential:
- Must agree to use effective means of contraception from at least 21 days prior to enrollment through 8 weeks after their last scheduled vaccination timepoint (see Appendix D).
- Must have a negative beta human chorionic gonadotropin (β-HCG) pregnancy test (urine or serum) on day of enrollment. Note: Women who have had a total hysterectomy, bilateral oophorectomy, or bilateral salpingectomy...
- Women of pregnancy potential must agree to not seek pregnancy through alternative methods, such as oocyte retrieval, artificial insemination, or in vitro fertilization from at least 21 days prior to enrollment through 8...
What rules you out
- Women who are breastfeeding or pregnant.
- Body mass index (BMI) ≥40. Enrollment of individuals with BMI ≥40 who are in good health, as assessed by the site investigator, may be considered by PSRT approval.
- Diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c ≤8% within the last 6 months) or a history of isolated gestational diabetes are not exclusionary. Enrollment of individuals with type...
- Previous or current recipient of an investigational HIV vaccine (previous placebo/control recipients are not excluded).
- Receipt of non-HIV investigational vaccine(s) received within the last 1 year. Exceptions include vaccines that have subsequently undergone licensure or Emergency Use Authorization (EUA) by the FDA or World Health...
- Congenital or acquired immunodeficiency, including systemic medication use likely to impair immune response to vaccine in the opinion of the site investigator, such as glucocorticoid use or prednisone dose of ≥10...
- Blood products or immunoglobulin within 16 weeks prior to enrollment; receipt of immunoglobulin within 16 weeks prior to enrollment requires PSRT approval.
- Receipt of any of the following within 4 weeks prior to enrollment:
- Live replicating vaccine
- Any mRNA-based vaccine with FDA licensure, FDA EUA, or WHO EUL
- ACAM2000 vaccine \>28 days prior with a vaccination scab still present
- Receipt of any vaccine that is not covered in exclusion criterion #8 within 14 days prior to enrollment. Please note this includes replication-incompetent vaccines such as the Jynneos vaccine for the prevention of mpox...
- History of myocarditis and/or pericarditis.
- Initiation of Ag-based immunotherapy for allergies within the past year (stable immunotherapy is not exclusionary); inclusion of participants who initiated immunotherapy within the previous year requires PSRT approval.
- Receipt of investigational research agents with a half-life of 7 or fewer days within 4 weeks prior to enrollment. (Receipt of an investigational research agent with a half-life of 7 or fewer days more than 4 weeks...
- History of serious reaction (eg, hypersensitivity, anaphylaxis) to any mRNA vaccine, including Comirnaty (Pfizer) and Spikevax (Moderna), or to any drug administered systemically as a polyethylene glycol containing LNP...
- Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
- Urticarial episode (idiopathic or known etiology) within the past year.
- History of chronic urticaria.
- History of urticaria previously associated with immunization.
- Bleeding disorder diagnosed by a clinician that would make study procedures a contraindication.
- History of seizure(s) within the past 3 years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
- Asplenia or functional asplenia.
- Active duty and reserve US military personnel.
- Any other chronic or clinically significant condition that, in the clinical judgment of the investigator, would jeopardize the safety or rights of the study participant, including but not limited to clinically...
- Asthma is excluded if the participant meets any of the following criteria:
- Required either oral or parenteral corticosteroids for an exacerbation 2 or more times within the past year
- Needed emergency care, urgent care, hospitalization, or intubation for an acute asthma exacerbation within the past year (eg, would not exclude individuals with asthma who meet all other criteria but sought...
- Uses a short-acting rescue inhaler more than 2 days per week for acute asthma symptoms (ie, not for preventive treatment prior to athletic activity)
- Uses medium- to high-dose inhaled corticosteroids (\>250 mcg fluticasone or therapeutic equivalent per day), whether in single-therapy or dual-therapy inhalers (ie, with a long-acting beta agonist [LABA])
- Uses more than 1 medication for maintenance therapy daily. Inclusion of anyone on a stable dose of more than 1 medication for maintenance therapy daily for greater than 2 years requires PSRT approval.
- A participant with a history of a PIMMC, either active or remote. Specific examples are listed in Appendix E (AESI index). Not exclusionary: (1) remote history of Bell's palsy (\>2 years ago) not associated with other...
- History of allergy to local anesthetic (Novocaine, Lidocaine).
- Investigator concern for difficulty with venous access based on clinical history and physical examination. For example, persons with a history of intravenous drug use or substantial difficulty with previous blood draws.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Rochester, New York, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Decatur, Georgia, United States; Boston, Massachusetts, United States; New York, New York, United States; Rochester, New York, United States; Philadelphia, Pennsylvania, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.