Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Ad26.Mos4.HIV and CH505 TF chTrimer (Env) Combination to Mimic Acute HIV Viral Replication Kinetics in Healthy Adults
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
⁃ 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 any medical condition described in the exclusion criteria 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 criteria:
‣ 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 Event Grading Scales, local normal ranges, or determined to be a normal variant by the physician investigator.
• Note: An abbreviated physical exam differs from a complete exam in that it does not include a genitourinary and rectal exam.
⁃ 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. After the repeat enzyme immunoassay, if an antibody differentiation immunoassay cannot be done for any reason, then confirmatory testing will be done via Western Blot. HIV rapid testing will not be performed in this study.
∙ 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 if there is a possible alternative explanation for the out of range value or if the out of range value is due to a temporary condition that resolves within the screening visit window. A second screening visit may be conducted outside of the initial screening visit window for volunteers who meet certain criteria if study enrollment and/or participant replacement is ongoing.
⁃ 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