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

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ClinicalTrials.gov Identifier: NCT02304185
Recruitment Status : Completed
First Posted : December 1, 2014
Last Update Posted : June 6, 2016
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Crucell Holland BV

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.

Condition or disease Intervention/treatment Phase
Healthy Biological: gp140, 50 mcg Biological: gp140, 50 mcg + Adjuvant Biological: gp140, 250 mcg Biological: gp140, 250 mcg + Adjuvant Drug: Placebo Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A First in Human Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Dose Levels of Trimeric gp140 Protein in Healthy Adult Volunteers
Study Start Date : December 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: gp140, 50 mcg Biological: gp140, 50 mcg
Glycoprotein 140 (gp140) vaccine containing 50 microgram (mcg) total protein will be administered intramuscularly on Day 1 and Day 29.

Experimental: gp140, 50 mcg + Adjuvant 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.

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

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

Experimental: gp140, 250 mcg + Adjuvant 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.

Placebo Comparator: Placebo 2 Drug: Placebo
Placebo matched to gp 140 vaccine drug product will be administered intramuscularly on Day 1 and Day 29.




Primary Outcome Measures :
  1. Number of Participants With Local and Systemic Reactogenicity Events Over 8 Days After First Vaccination [ Time Frame: Day 8 ]
    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.

  2. Number of Participants With Local and Systemic Reactogenicity Events Over 8 Days After Second Vaccination [ Time Frame: Day 36 ]
    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.

  3. Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Week 52 or early withdrawal ]
    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.


Secondary Outcome Measures :
  1. Envelop (Env) Binding Antibody Titer at Week 8 [ Time Frame: Week 8 ]
    The humoral immune response will be assessed by Env Clade C-specific enzyme-linked immunosorbent assay (ELISA) binding antibody titer at Week 8.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304185


Locations
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United States, Florida
Miami, Florida, United States
Sponsors and Collaborators
Crucell Holland BV
National Institute of Allergy and Infectious Diseases (NIAID)
Beth Israel Deaconess Medical Center
Investigators
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Study Director: Crucell Holland BV Clinical Trials Crucell Holland BV

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Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT02304185     History of Changes
Other Study ID Numbers: CR104488
HIV-V-A003 ( Other Identifier: Crucell Holland BV )
IPCAVD008 ( Other Identifier: Crucell Holland BV )
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016

Keywords provided by Crucell Holland BV:
Healthy
Acquired Immuno-Deficiency Syndrome
Acquired Immunodeficiency Syndrome Virus
Glycoprotein
Adjuvant
Vaccine
Placebo

Additional relevant MeSH terms:
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polysaccharide-K
Aluminum phosphate
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antibiotics, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Protective Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents