Safety, Tolerability and Immunogenicity Study of 2 Dose Levels of Trimeric Glycoprotein140 (gp140) in Healthy Adult Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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gp140, 50 mcg

Group Type EXPERIMENTAL

gp140, 50 mcg

Intervention Type BIOLOGICAL

Glycoprotein 140 (gp140) vaccine containing 50 microgram (mcg) total protein will be administered intramuscularly on Day 1 and Day 29.

gp140, 50 mcg + Adjuvant

Group Type EXPERIMENTAL

gp140, 50 mcg + Adjuvant

Intervention Type BIOLOGICAL

The gp140 vaccine containing 50 mcg total protein mixed with 0.425 milligram (mg) aluminum phosphate adjuvant will be administered intramuscularly on Day 1 and Day 29.

Placebo 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matched to gp 140 vaccine drug product will be administered intramuscularly on Day 1 and Day 29.

gp140, 250 mcg

Group Type EXPERIMENTAL

gp140, 250 mcg

Intervention Type BIOLOGICAL

The gp140 vaccine containing 250 mcg total protein will be administered intramuscularly on Day 1 and Day 29.

gp140, 250 mcg + Adjuvant

Group Type EXPERIMENTAL

gp140, 250 mcg + Adjuvant

Intervention Type BIOLOGICAL

The gp140 vaccine containing 250 mcg total protein mixed with 0.425 mg aluminum phosphate adjuvant will be administered intramuscularly on Day 1 and Day 29.

Placebo 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matched to gp 140 vaccine drug product will be administered intramuscularly on Day 1 and Day 29.

Interventions

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gp140, 50 mcg

Glycoprotein 140 (gp140) vaccine containing 50 microgram (mcg) total protein will be administered intramuscularly on Day 1 and Day 29.

Intervention Type BIOLOGICAL

gp140, 50 mcg + Adjuvant

The gp140 vaccine containing 50 mcg total protein mixed with 0.425 milligram (mg) aluminum phosphate adjuvant will be administered intramuscularly on Day 1 and Day 29.

Intervention Type BIOLOGICAL

gp140, 250 mcg

The gp140 vaccine containing 250 mcg total protein will be administered intramuscularly on Day 1 and Day 29.

Intervention Type BIOLOGICAL

gp140, 250 mcg + Adjuvant

The gp140 vaccine containing 250 mcg total protein mixed with 0.425 mg aluminum phosphate adjuvant will be administered intramuscularly on Day 1 and Day 29.

Intervention Type BIOLOGICAL

Placebo

Placebo matched to gp 140 vaccine drug product will be administered intramuscularly on Day 1 and Day 29.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes