safety, tolerability and immunogenicity study of 2 dose levels of trimeric glycoprotein140 (gp140) in healthy adult volunteers

Conditions: Healthy

Summary: the purpose of this study is to assess the safety and tolerability of 2 different dose levels of trimeric glycoprotein140 (gp140) administered as a 2-dosage regimen, intramuscularly (injection of a substance into a muscle), with and without aluminum phosphate as adjuvant in healthy human immunodeficiency virus (hiv)-uninfected participants.

this is a single-center, randomized (the study drug is assigned by chance), placebo-controlled (study in which the experimental treatment or procedure is compared to a pretend treatment with no drug in it to test if the drug has a real effect), and double-blind (neither physician nor participant knows the treatment that the participant receives) study. the study comprises a screening period (up to 4 weeks), a vaccination period (participants will be vaccinated on days 1 and 29), and a follow-up period (up to 48 weeks). all eligible participants will be randomly assigned to 1 of the 2 sequential cohorts (low dose cohort and high dose cohort). participants in low dose cohort will receive 1 of the following treatments: low dose (50 microgram \[mcg\]) gp140 drug product (dp), low dose gp140 dp with adjuvant (aluminum phosphate), placebo matched to low dose dp; and participants in high dose cohort will receive 1 of the following treatments: high dose (250 mcg) gp140 dp, high dose gp140 dp with adjuvant, and placebo matched to high dose dp. there will be an interim safety review of safety/tolerability from low-dose cohort before the high-dose cohort receives study treatment. total study duration will be 56 weeks per participant. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participant must be healthy on the basis of physical examination, medical history, electrocardiogram (ecg), laboratory criteria, and vital signs measurement performed at screening * participants are negative for human immunodeficiency virus (hiv) infection at screening (negative united states food and drug administration-approved hiv diagnostic blood test) * all female participants of childbearing potential must have a negative serum (beta human chorionic gonadotropin) at screening, and a negative urine pregnancy test pre-dose on day 1 and day 29 * a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction until 3 months after receiving the last dose of study vaccine. a man must agree not to donate sperm until 3 months after receiving the last dose of study vaccine * participants are assessed by the clinic staff as being at low risk for hiv infection exclusion criteria: * participant has chronic active hepatitis b or active hepatitis c, active syphilis infection, chlamydia, gonorrhea, or trichomonas. active syphilis documented by exam or serology unless positive serology is due to past treated infection * in the 12 months prior to enrollment, participant has a history of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (hsv2), chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis b * participant has any clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation (for example, history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, poorly controlled asthma, active tuberculosis or other systemic infections) * participant has had major surgery within the 4 weeks prior to study entry or planned major surgery through the course of the study * participant has had a thyroidectomy, or thyroid disease requiring medication during the last 12 months

Keywords: healthy acquired immuno-deficiency syndrome acquired immunodeficiency syndrome virus glycoprotein adjuvant vaccine placebo