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Tests treatment safety and results for Human Immunodeficiency Virus
Official title Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults
ClinicalTrials.gov ID: NCT06205056
What this study is testing
What is Ad26.Mos4.HIV in CH505 TF chTrimer + ALFQ [Arm 1a]?
Ad26.Mos4.HIV in CH505 TF chTrimer + ALFQ [Arm 1a] is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for human immunodeficiency virus.
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 I, randomized, double-blind, placebo-controlled clinical study to define the safety and immunogenicity resulting from a rapid dose-escalating vaccination schedule as compared to that of a co-administered, dose-consistent vaccination schedule. Participants randomized to receive vaccines will get either dose-consistent injections of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV or rapid, dose-escalating injections of CH505 TF chTrimer+ALFQ with an Ad26.Mos4.HIV prime, followed by dose-consistent injection of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV
- Phase 1: an early, usually small safety study
- Time commitment: about 18 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 50. Healthy volunteers may be eligible.
You may be able to join if
- Participants must meet all of the following criteria to be eligible for participation:
- Male or female, aged 18 to 50 years, inclusive, at the time of enrollment
- Willing and able to read, sign, and date the informed consent form
- Demonstrates an understanding of the study with a passing score (90% or greater) on the TOU by the third attempt, before study-related procedures are...
- Willing and able to comply with study requirements and be available to attend visits for the duration of study participation
You likely can't join if
- in a participant with a normal abbreviated physical exam and vital signs. If the participant has a preexisting chronic condition not listed in the...
- first diagnosed within the 12 weeks prior to screening; or
- worsening in terms of clinical outcome in the 24 weeks prior to screening; or
- involves the need for medication that may pose a risk to the participant's safety or impede assessment of adverse events or immunogenicity if they...
- Laboratory criteria within 45 days prior to enrollment:
- Hemoglobin ≥11.0 g/dL for females; ≥12.5 g/dL for males
See the full eligibility criteria
Who can join
- Participants must meet all of the following criteria to be eligible for participation:
- Male or female, aged 18 to 50 years, inclusive, at the time of enrollment
- Willing and able to read, sign, and date the informed consent form
- Demonstrates an understanding of the study with a passing score (90% or greater) on the TOU by the third attempt, before study-related procedures are performed
- Willing and able to comply with study requirements and be available to attend visits for the duration of study participation
- Must have the means to be contacted by telephone for the duration of study participation
- Willing to have photo or fingerprint taken for identification purposes
- At low risk for HIV acquisition per investigator assessment
- Agrees to refrain from donating blood or plasma outside of this study for at least the duration of study participation
- Healthy based on the physician investigator's clinical judgment after review of past medical history, medication use, vital signs, and an abbreviated physical examination Note: Good health is defined by the absence of...
What rules you out
- in a participant with a normal abbreviated physical exam and vital signs. If the participant has a preexisting chronic condition not listed in the exclusion criteria, the condition cannot meet any of the following...
- first diagnosed within the 12 weeks prior to screening; or
- worsening in terms of clinical outcome in the 24 weeks prior to screening; or
- involves the need for medication that may pose a risk to the participant's safety or impede assessment of adverse events or immunogenicity if they participate in the study. Note: Vital signs must be normal by Adverse...
- Laboratory criteria within 45 days prior to enrollment:
- Hemoglobin ≥11.0 g/dL for females; ≥12.5 g/dL for males
- White blood cells (WBC) range: 3,500-9,000 cells/mm\^3
- Platelets between 150,000 - 450,000 cells/µL
- Normal liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤1.25x upper limit of normal
- Serum creatinine ≤1.25x upper limit of normal
- Urinalysis: blood and protein less than 1+ and negative glucose
- Negative HIV serology Note: HIV serology testing will be done via enzyme immunoassay with confirmatory testing of reactive results through a repeat enzyme immunoassay followed by an antibody differentiation immunoassay...
- Negative hepatitis B surface antigen (HbsAg)
- Negative hepatitis C serology or negative hepatitis C RNA (viral load) if antibodies are detected Note: Each laboratory screening test that is out of acceptable range can be repeated one time during the screening window...
- Biological Male-Specific Criteria:
- Must agree to refrain from donating sperm from screening until at least 12 weeks after the last study injection
- Must agree to consistently use a method of contraception from screening until at least 12 weeks after the last study injection
- Biological Female-Specific Criteria:
- Not pregnant within 12 weeks prior to screening, not pregnant or breastfeeding at screening, and not planning to become pregnant or breastfeed at any time from screening until 12 weeks after the last study injection
- Must have a negative human chorionic gonadotropin (β-HCG) pregnancy test (urine) at screening and at timepoints throughout the study, if of childbearing potential
- Must agree to consistently practice a highly effective method of contraception at least 45 days prior to enrollment and for 12 weeks after the final injection, if of childbearing potential Exclusion Criteria: Volunteers...
- Body mass index (BMI) \ 35.1 kg/m\^2
- Has a condition which affects immune function, including but not limited to:
- Known or suspected congenital or acquired immunodeficiency
- Diabetes mellitus type 1 or type 2 (including cases controlled with diet alone) Note: A history of isolated gestational diabetes is not an exclusion criterion.
- Thyroid disease
- Asplenia, defined as any condition resulting in the absence of a functional spleen
- Conditions and diagnoses defined as potential immune-mediated medical conditions
- Has a history of other chronic or clinically significant diseases or medical conditions that in the opinion of the investigator would jeopardize the safety or rights of the participant Note: Includes but is not limited...
- Has a history of malignancy other than squamous cell or basal cell skin cancer, unless there has been definitive surgical and/or medical treatment that is considered to have achieved a cure
- Had major surgery (per the physician investigator's judgment) within the 28 days prior to screening or has plans to have major surgery during the study
- Has a personal or family history of a bleeding disorder, such as factor deficiency, coagulopathy, or platelet disorder requiring special precautions
- Has a personal or family history of a blood clotting disorder, such as thrombosis with thrombocytopenia syndrome (TTS), heparin-induced thrombocytopenia and thrombosis (HITT), deep vein thrombosis, pulmonary embolism...
- Has a condition known to increase risk of blood clotting, including but not limited to autoimmune disease, connective tissue and other inflammatory conditions, immobility, recent infection, and recent head trauma...
- Hepatitis B surface antigen positive at any time in the past
- Untreated syphilis infection as confirmed by RPR or a similar quantitative nontreponemal test such as VDRL
- Prior receipt or plans to receive any of the following:
- Chronic use of therapies that may modify immune response, such as high dose inhaled and sprayed corticosteroids (\>440 µg/twice daily doses of inhaled fluticasone equivalent) and systemic corticosteroids (\>20 mg/day...
- Blood products within 120 days prior to enrollment or at any time during participation in this study
- Immunoglobulins within 90 days prior to enrollment or at any time during participation in this study
- Therapy for active tuberculosis within 90 days prior to enrollment, unless the therapy is considered to have achieved a cure, or at any time during participation in this study
- Licensed or authorized vaccine from 30 days prior to enrollment until 42 days (6 weeks) after the last study injection Note: Participants may receive inactivated seasonal influenza vaccine or COVID-19 vaccine during...
- Any investigational study products for conditions other than HIV within 90 days prior to enrollment or at any time during participation in this study
- An investigational HIV vaccine or HIV antibody at any time prior to or during participation in this study
- Medications that increase the risk of bleeding (warfarin, clopidogrel, ticagrelor, dabigatran, rivaroxaban, apixaban, heparin and other heparinoids) or blood clots (heparin in participants who have a prior history of...
- Has a known allergy or history of anaphylaxis or other serious reaction to a vaccine, vaccine component, or latex
- Current or planned participation in another study requiring blood draws or exposure to investigational or non-investigational vaccine/product (pharmaceutical or device) throughout the study period
- Has tattoos, scars, or other marks that would, in the opinion of the physician investigator, interfere with the assessment of the injection sites
- Current or history of substance abuse within 12 months prior to enrollment that, in the physician investigator's opinion, could interfere with reliable participation
- In the physician investigator's opinion, is unable to communicate reliably, is unlikely to adhere to study requirements, or has a condition that would limit completion of the study
- Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the participant or potentially impairs immune response or threatens conduct of...
- Study site employee Final evaluation of eligibility will be based on the medical judgment of the physician investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Kampala, Uganda
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 study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kampala, Uganda. 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.