A Safety and Immunogenicity Trial of IHV01

NCT02756208 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: HP-00065547
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the safety of the FLSC vaccine and will be a randomized, placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult volunteers (Human Immunodeficiency Virus-1 uninfected).

Conditions

HIV Infection

Keywords

vaccine; healthy volunteer

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Local and Systemic Reactogenicity Signs and Symptoms

  Signs and symptoms include pain, tenderness, maximum severity of pain and/or tenderness, erythema, induration, fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and maximum severity of systemic symptoms.

  48 weeks

• Number of Participants With Related Adverse Events

  Treatment emergent adverse events assessed by investigator to be either possibly, probably, or definitely related to study treatment. Medical Dictionary for Regulatory Activities (MedDRA) preferred term, severity, and assessed relationship to study products.

  48 weeks

• Number of Participants With Sustained Decrease in CD4 Count and CD4%.

  CD4 count was monitored from baseline and at each study visit through study completion. Baseline CD4 and CD4% levels were calculated by taking the average of the screening and first vaccination visits. The number of individuals who had sustained (2 consecutive time points) 30% decrease in CD4 cell/ul and CD4% from baseline were counted.

  48 weeks

Secondary Outcomes (3)

• Binding Antibody Response Rates to FLSC

  2 weeks after 4th (last) vaccination.

• Binding Antibody Response Rates to BaL-gp120

  2 weeks after 4th (last) vaccination

• Competitive Antibody Rates to CD4i Epitopes

  2 weeks after 4th (last) vaccination

Study Arms (4)

300 ug FLSC vaccine

EXPERIMENTAL

Subjects will be vaccinated with 300 ug FLSC vaccine (highest vaccine dose) on study days 0, 28, 56 and 168.

Biological: 300 ug FLSC vaccine

150 ug FLSC vaccine

EXPERIMENTAL

Subjects will be vaccinated with 150 ug FLSC vaccine (middle vaccine dose) on study days 0, 28, 56 and 168.

Biological: 150 ug FLSC vaccine

75 ug FLSC vaccine

EXPERIMENTAL

Subjects will be vaccinated with 75 ug FLSC vaccine (lowest vaccine dose) on study days 0, 28, 56 and 168.

Biological: 75 ug FLSC vaccine

Placebo

PLACEBO COMPARATOR

Subjects will be vaccinated with placebo (control group) on study days 0, 28, 56 and 168.

Biological: Placebo

Interventions

300 ug FLSC vaccine BIOLOGICAL

FLSC vaccine 300 ug (1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168

Also known as: Full length single chain gp120-CD4 complex vaccine

300 ug FLSC vaccine

150 ug FLSC vaccine BIOLOGICAL

FLSC vaccine 150 ug (0.5 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168

Also known as: Full length single chain gp120-CD4 complex vaccine

150 ug FLSC vaccine

75 ug FLSC vaccine BIOLOGICAL

FLSC vaccine 75 ug (0.25 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168

Also known as: Full length single chain gp120-CD4 complex vaccine

75 ug FLSC vaccine

Placebo BIOLOGICAL

Placebo sterile saline (0.25 - 1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168

Also known as: sterile saline

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 to 45 years of age.
• Sex: Male or Female (female volunteers of child bearing potential must have a negative serum beta human chorionic gonadotropin (b-HCG or pregnancy) test at time of screening and entry into the study and provide assurance of the use of effective(as judged by the investigator) birth control methods or abstinence beginning at least 60 days prior to the study and during the study
• Documented HIV-1 negative by ELISA

You may not qualify if:

• No identifiable risk factor for acquisition of HIV infection (i.e., intravenous drug use/needle sharing, unprotected sex with multiple partners)
• Negative b-HCG pregnancy test on the day of initial vaccination.
• Negative screen for Hepatitis B surface antigen (HBsAg);
• Negative screen for antibodies to Hepatitis C virus (Patient may enroll if patient can provide documentation of negative hepatitis C viral load.)
• Participant must have a CD4 count ( a type of white blood cells) within the normal range of the clinical laboratory utilized for the study and a CD4 percentage within 20% of the normal range of the clinical laboratory
• Volunteers must be willing and able to provide written informed consent to participate in the study.
• Available for at least 48 weeks of follow-up.
• High risk behavior for acquisition of HIV within 24 weeks of study entry(i.e., intravenous drug use/needle sharing, unprotected sex with multiple partners)
• Volunteers with an acute and clinically significant medical event (as determined by the investigator) within the past 30 days of screening.
• Have active tuberculosis or other systemic infectious process by review of systems and physical examination
• Have a history of immunodeficiency, autoimmune disease, or use of immunosuppressive medications
• Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
• Is pregnant
• History of any chronic illness that would interfere with conduct or completion of study(as determined by the investigator)
• Have evidence of psychiatric, medical and/or substance abuse problems during the past 24 weeks that the investigator believes would adversely affect the volunteer's ability to participate in the trial

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Bill and Melinda Gates Foundation: collaborator
• Auro Vaccines LLC: collaborator

Study Sites (1)

University of Maryland, Institute of Human Virology

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Mohammad Sajadi
• Organization: Institute of Human Virology

msajadi@ihv.umaryland.edu

410-7061779

Study Officials

• Charles E Davis, M.D.

  Institute of Human Virology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 17, 2016
• First Posted: April 29, 2016
• Study Start: November 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 16, 2021
• Results First Posted: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)