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

NCT02304185 | Completed Phase 1 DMC

• 3 other identifiers: CR104488HIV-V-A003IPCAVD008
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Healthy; Acquired Immuno-Deficiency Syndrome; Acquired Immunodeficiency Syndrome Virus; Glycoprotein; Adjuvant; Vaccine; Placebo

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Local and Systemic Reactogenicity Events Over 8 Days After First Vaccination

  Participants will be asked to note occurrences of local reactions: erythema, induration, swelling, pain/tenderness, itching, or warmth at the injection site, and systemic events: daily temperature, fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, rashes, and general itching daily for 8 days post-vaccination. These occurrences will be recorded through the memory aid provided to serve as a reminder to the participants for the next clinic visit.

  Day 8

• Number of Participants With Local and Systemic Reactogenicity Events Over 8 Days After Second Vaccination

  Participants will be asked to note occurrences of local reactions: erythema, induration, swelling, pain/tenderness, itching, or warmth at the injection site, and systemic events: daily temperature, fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, rashes, and general itching daily for 8 days post-vaccination. These occurrences will be recorded through the memory aid provided to serve as a reminder to the participants for the next clinic visit.

  Day 36

• Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

  An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Week 52 or early withdrawal

Secondary Outcomes (1)

• Envelop (Env) Binding Antibody Titer at Week 8

  Week 8

Study Arms (6)

gp140, 50 mcg

EXPERIMENTAL

Biological: gp140, 50 mcg

gp140, 50 mcg + Adjuvant

EXPERIMENTAL

Biological: gp140, 50 mcg + Adjuvant

Placebo 1

PLACEBO COMPARATOR

Drug: Placebo

gp140, 250 mcg

EXPERIMENTAL

Biological: gp140, 250 mcg

gp140, 250 mcg + Adjuvant

EXPERIMENTAL

Biological: gp140, 250 mcg + Adjuvant

Placebo 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

gp140, 50 mcg BIOLOGICAL

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

gp140, 50 mcg

gp140, 50 mcg + Adjuvant 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.

gp140, 50 mcg + Adjuvant

gp140, 250 mcg BIOLOGICAL

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

gp140, 250 mcg

gp140, 250 mcg + Adjuvant 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.

gp140, 250 mcg + Adjuvant

Placebo DRUG

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

Placebo 1; Placebo 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Crucell Holland BV: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Unknown Facility

Miami, Florida, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

GP 140; Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Crucell Holland BV Clinical Trials

  Crucell Holland BV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 1, 2014
• Study Start: December 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 6, 2016

Record last verified: 2016-06

Locations

US (1)