Clinical trial for HIV
Official title Phase 1 Study of CH505 HIV Vaccine Nanoparticles and mRNA Boosters in Healthy Adults
ClinicalTrials.gov ID: NCT07757802
What this study is testing
What is DV901-NP?
This is an investigational vaccine being studied to see if it can help the body build defenses against HIV. It is designed to show the immune system a specific part of the HIV virus to help it learn how to recognize and fight the infection.
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
- The study wants to find out if the CH505 vaccine and its boosters are safe, well tolerated, and can stimulate the body’s immune system against HIV.
- Who it's for
- It is looking for healthy adults who do not have HIV.
- What's involved
- Participants will get a series of protein nanoparticle vaccines and then either another protein vaccine or an mRNA booster. They will have blood tests and other immune‑response checks, and some will receive the booster in different body locations to compare effects.
- Time commitment
- The study lasts several months, with multiple clinic visits for injections and blood draws as scheduled by the research team.
- 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 and willing to be contacted 12 months after the last study product administration of...
- Willing to undergo study procedures as outlined in the schedule of procedures.
- Agrees not to enroll in another study of an investigational agent during participation in the trial.
You likely can't join if
- Woman who is 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.
- 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 and willing to be contacted 12 months after the last study product administration of ACU-026-001-1.
- Willing to undergo study procedures as outlined in the schedule of procedures.
- Agrees not to enroll in another study of an investigational agent during participation in the trial.
- 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.
- ≥11.0 g/dL for women
- ≥13.0 g/dL for men Note: If receiving exogenous hormones for more than 6 consecutive months with dosing equivalent to parenteral testosterone ≥1000 mg every 12 weeks or estradiol valerate ≥2 mg/week, determine...
- 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 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 (if the participant consented to have leukapheresis as a study procedure).
- Systolic blood pressure of 90 to \<140 mm Hg and diastolic blood pressure of 50 to \<90 mm Hg at screening visit.
- Negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA) or
- Negative results on 2 different brands of HIV rapid tests (one of which must be FDA-approved)
- Negative for anti-hepatitis C virus (HCV) antibodies (Abs) or negative HCV nucleic acid test (NAT) if anti-HCV Abs are detected.
- Negative for hepatitis B surface antigen (Ag).
- 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.
- Must have a negative beta human chorionic gonadotropin (β-HCG) pregnancy test (urine or serum) on day of enrollment.
- 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
- Woman who is 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 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.
- 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 approval.
- Live replicating vaccine
- Any mRNA-based vaccine with FDA licensure, FDA EUA, or WHO EUL
- ACAM2000 vaccine more than 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.
- 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 approval.
- Receipt of investigational research agents with a half-life of 7 or fewer days within 4 weeks prior to enrollment.
- History of serious reaction (eg, hypersensitivity, anaphylaxis) to any related vaccine, to any mRNA vaccine, including Comirnaty (Pfizer) and Spikevax (Moderna), or to any drug administered systemically as a...
- Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
- History of chronic urticaria, urticaria associated with previous vaccination, or any urticarial episode within the past year.
- Bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) diagnosed by a clinician, or current therapeutic systemic anticoagulation for any clinical indication.
- 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...
- 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 approval.
- A volunteer with a history of a potential immune-mediated medical condition (PIMMC), either active or remote. Specific examples are listed in Appendix I (AESI index).
- 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 is enrolling
- Boston, Massachusetts, 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, but 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?
This study is enrolling now at Boston, Massachusetts, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.