Phase 1 HIV and AIDS Trial, Recruiting

Written by an AI model from 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 who understand the study and are willing to go through the formal consent process
• People who are at least 18 years old at the screening appointment and no older than 55 years old on the day they enrol
• People who are able to attend all follow-up clinic visits for the full duration of the trial
• People who are willing to take part in all study procedures as scheduled
• People who agree not to join another trial of an experimental treatment while taking part in this trial (if already in another trial, approval from both that trial's sponsor and the HVTN 322 review team is needed before enrolment)
• People who are in good general health, as assessed by the trial doctor
• People whose physical examination and blood test results do not show anything that could interfere with monitoring safety, in the opinion of the trial doctor
• People who agree to discuss their personal risk of getting HIV and to receive HIV prevention counselling
• People whose haemoglobin (a measure of red blood cells) meets the minimum level — at least 11.0 g/dL for women, or at least 13.0 g/dL for men
• People whose white blood cell count falls within the range of 2,500 to 12,000 per mm³ (a count slightly above this range may still be considered with review team approval if the person is otherwise in good health)
• People whose platelet count (cells that help blood clot) falls between 125,000 and 550,000 per mm³
• People whose liver enzyme level (ALT) is below 2.5 times the upper limit of the normal reference range used by the testing laboratory
• People whose kidney function marker (creatinine) is no more than 1.1 times the upper limit of normal for their laboratory
• People whose blood calcium level is above 8.5 mg/dL
• People whose blood pressure at screening falls within the ranges of 90 to below 140 mm Hg (top number) and 50 to below 90 mm Hg (bottom number), and whose average blood pressure across the screening and enrolment visits stays below 140/90 mm Hg
• People who test negative for HIV using an approved blood or rapid test
• People who test negative for Hepatitis C antibodies, or who test negative on a follow-up Hepatitis C nucleic acid test if antibodies were detected
• People who test negative for Hepatitis B surface antigen
• Women who could become pregnant and who agree to use effective contraception starting at least 21 days before enrolment through 8 weeks after their last scheduled vaccination (women who have had a full hysterectomy, removal of both ovaries, removal of both fallopian tubes, or who have gone through menopause — defined as no periods for at least one year — are not required to meet this condition)
• Women who could become pregnant and who have a negative pregnancy test on the day of enrolment
• Women who could become pregnant and who agree not to pursue pregnancy through assisted methods (such as egg retrieval, artificial insemination, or IVF) from at least 21 days before enrolment through 8 weeks after their last scheduled vaccination

Who may not be able to join:

• Women who are pregnant or currently breastfeeding
• People with a BMI of 40 or above (enrolment of someone with a BMI of 40 or above who is otherwise in good health may be considered with review team approval)
• People with diabetes, except those whose Type 2 diabetes is controlled by diet alone with a recent HbA1c of 8% or below, or those with a history of gestational diabetes only (people with well-controlled Type 2 diabetes on medication may be considered by the review team on a case-by-case basis if their HbA1c is 8% or below within the past 6 months)
• People who have previously received, or are currently receiving, an experimental HIV vaccine (those who received a placebo or control in a previous HIV vaccine trial are not excluded)
• People who received a non-HIV experimental vaccine within the past year, unless that vaccine has since been officially approved or authorised by the FDA, WHO, or the national regulatory authority overseeing this trial
• People with a condition that weakens the immune system, whether from birth or acquired, including those who have taken immune-suppressing medications such as steroids (e.g., prednisone at 10 mg/day or more) within the past 3 months
• People who received blood products or immunoglobulin (antibody treatments) within the past 16 weeks (this may be considered with review team approval)
• People who received a live replicating vaccine, any mRNA vaccine with official approval or authorisation, or ACAM2000 vaccine with a vaccination scab still present, within the past 4 weeks
• People who received any other vaccine not covered above within the past 14 days (this includes vaccines for mpox/monkeypox)
• People with a history of inflammation of the heart muscle (myocarditis) or the lining around the heart (pericarditis)
• People who started allergy immunotherapy (antigen-based) within the past year (stable, ongoing immunotherapy is not a problem; enrolment of those who started within the past year may be considered with review team approval)
• People who received certain experimental research agents recently — those with a short half-life (7 days or fewer) within the past 4 weeks, or those with a longer or unknown half-life within the past year (the latter may be considered with review team approval)
• People who have had a serious allergic reaction (such as anaphylaxis) to any mRNA vaccine (including Comirnaty/Pfizer or Spikevax/Moderna) or to any drug delivered in a specific type of fat-based particle (lipid nanoparticle containing polyethylene glycol), such as certain chemotherapy drugs
• People with hereditary, acquired, or unexplained angioedema (a condition causing sudden swelling under the skin)
• People who have had an episode of hives (urticaria) within the past year
• People with a history of long-term (chronic) hives
• People who have had hives previously caused by a vaccination
• People with a bleeding disorder, diagnosed by a clinician, that would make study procedures unsafe
• People who have had a seizure within the past 3 years, or who have used seizure medication at any point in the past 3 years
• People who do not have a spleen, or whose spleen does not function normally
• Active duty or reserve members of the US military
• People with certain other serious ongoing health conditions, including significant substance use or alcohol use disorder, serious psychiatric conditions, a suicide attempt within the past year (an attempt between 1 and 2 years ago may be considered with review team approval), or cancer that the trial doctor considers may recur (excluding a type of minor skin cancer called basal cell carcinoma)
• People with asthma that has needed oral or injected steroids for a flare-up two or more times in the past year, or that required emergency or hospital care in the past year, or that requires use of a rescue inhaler more than 2 days per week for symptom relief, or that is managed with medium-to-high dose inhaled steroids, or that requires more than one daily maintenance medication (those on more than one maintenance medication for over 2 years may be considered with review team approval)
• People with a history of a condition classified as a potential immune-mediated condition (either currently active or in the past) — specific examples can be confirmed with the trial site; some exceptions apply, such as a past history of mild or uncomplicated conditions like Bell's palsy more than 2 years ago, mild localised psoriasis not requiring ongoing treatment, Kawasaki disease more than 10 years ago without lasting effects, or well-controlled coeliac disease managed by diet alone for at least 6 months
• People with a known allergy to local anaesthetics such as Novocaine or Lidocaine
• People for whom the trial doctor has concerns about difficulty accessing veins for blood draws, such as those with a history of intravenous drug use or significant difficulties with previous blood tests

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