Phase 1 HIV and AIDS Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 50 years old at the time of joining the trial
• People who are willing and able to read, sign, and date a consent form
• People who can demonstrate an understanding of the study by passing a short quiz with a score of 90% or higher (within three attempts) before any study procedures begin
• People who are able and willing to follow all study requirements and attend all required visits for the full duration of the trial
• People who can be reached by phone throughout the study
• People who are willing to have a photo or fingerprint taken for identification
• People assessed by the trial doctor as being at low risk of acquiring HIV
• People who agree not to donate blood or plasma outside of this study for the entire time they are participating
• People considered healthy by the trial doctor, based on medical history, current medications, vital signs, and a basic physical examination — any pre-existing conditions must not have been first diagnosed within 12 weeks before the screening visit, must not have gotten worse in the 24 weeks before screening, and must not require medications that could affect safety or study results
• People whose recent blood test results (taken within 45 days before joining) fall within the required ranges, including normal levels for red blood cells, white blood cells, platelets, liver function, kidney function, and urine, and who test negative for HIV, hepatitis B, and hepatitis C
• People assigned male at birth who agree to avoid donating sperm and to use contraception from the screening visit until at least 12 weeks after the last study injection
• People assigned female at birth who are not pregnant, have not been pregnant in the 12 weeks before screening, are not breastfeeding, and do not plan to become pregnant or breastfeed from screening until at least 12 weeks after the last study injection — and who, if capable of becoming pregnant, agree to use a highly effective method of contraception starting at least 45 days before joining and continuing for 12 weeks after the final injection, and who test negative on a pregnancy test at screening and at required points during the study

Who may not be able to join:

• People with a body mass index (BMI) below 18.0 or above 35.1 (a measure of body weight relative to height)
• People with conditions that affect immune system function, including known or suspected immune deficiency, type 1 or type 2 diabetes (even if managed by diet alone), thyroid disease, absence of a functioning spleen, or other conditions that may affect immune response — note that a past history of gestational diabetes alone is not an exclusion
• People with a history of other serious ongoing health conditions that the trial doctor believes could put them at risk, including (but not limited to) sickle cell anaemia, chronic liver disease, chronic hives, heart disease, uncontrolled high blood pressure, severe asthma, chronic lung disease, kidney failure, or lymphatic filariasis
• People with a history of cancer, unless it was limited to certain types of skin cancer or has been fully treated and considered cured
• People who have had major surgery in the 28 days before screening, or who plan to have major surgery during the trial
• People with a personal or family history of a bleeding disorder, such as a clotting factor deficiency or platelet disorder requiring special precautions
• People with a personal or family history of blood clotting disorders, including thrombosis with low platelets (TTS), heparin-induced clotting (HITT), deep vein thrombosis, pulmonary embolism, heart attack, or stroke
• People with conditions known to increase the risk of blood clots, including autoimmune disease, inflammatory conditions, prolonged immobility, recent infection, or recent head injury or stroke
• People who have ever tested positive for hepatitis B surface antigen
• People with an untreated syphilis infection confirmed by standard blood tests
• People who have recently received, or plan to receive, certain medications or treatments, including: high-dose steroids (within 14 days before joining or at any point during the study); blood products (within 120 days before joining); immunoglobulins (within 90 days before joining); active tuberculosis treatment (within 90 days before joining); most vaccines (within 30 days before joining or within 6 weeks after the last study injection — with limited exceptions for flu and COVID-19 vaccines); other experimental study products within 90 days before joining; any previous or planned HIV vaccine or HIV antibody treatment; or blood-thinning or clot-promoting medications within 30 days before joining
• People with a known allergy to any vaccine, vaccine ingredient, or latex, or who have had a severe allergic reaction (anaphylaxis) to any of these
• People who are currently participating in, or planning to join, another study that involves blood draws or exposure to an experimental or non-experimental product during the same period
• People with tattoos, scars, or other marks at the injection site area that the trial doctor believes would make it difficult to assess the injection sites
• People with a current or recent history (within the past 12 months) of substance misuse that, in the trial doctor's view, could interfere with reliable participation
• People who the trial doctor believes may have difficulty communicating reliably, following study requirements, or completing the study
• People with any other serious medical condition that, in the trial doctor's view, could affect safety, immune response, or the conduct of the study
• Current employees of the trial site

Important: Always verify eligibility with the trial site directly before applying.