Study of Immune Responses Induced by a HIV Vaccine

NCT01933685 | Unknown Phase 2

• 3 other identifiers: RV 3281939S-11-0005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to define the immune responses induced by a HIV vaccine, AIDSVAX B/E. Blood and mucosal samples will be collected to assess immune responses.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• Change in Immune Response

  Characterization of vaccine-induced immune responses in the systemic and mucosal compartments by intracellular cytokine staining (ICS) and IFN-gamma ELISPOT at Baseline, Weeks 4, 6, 24, 26, 48, 50 and 72.

  Through Week 72

• Change in Humoral Response

  Characterization of vaccine-induced humoral immune response in the systemic and mucosal compartments by binding and neutralizing antibodies at Baseline, Weeks 4, 6, 24, 26, 48, 50 and 72.

  Through Week 72

Secondary Outcomes (1)

• Safety Monitoring

  Through Week 49

Study Arms (2)

AIDSVAX B/E

EXPERIMENTAL

AIDSVAX B/E at Weeks 0, 4, 24 and 48

Biological: AIDSVAX B/E

AIDSVAX B/E Placebo

PLACEBO COMPARATOR

AIDSVAX B/E Placebo at Weeks 0, 4, 24 and 48

Biological: AIDSVAX B/E Placebo

Interventions

AIDSVAX B/E BIOLOGICAL

1 mL per injection (300 ug dose/antigen for a total of 600 ug/dose administered)

AIDSVAX B/E

AIDSVAX B/E Placebo BIOLOGICAL

1 mL per injection

AIDSVAX B/E Placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female volunteers between age 20 and 40, available for follow up in Bangkok for a period of 18 months and having a Thai identification card.
• Must be at low risk for HIV infection per investigator assessment.
• Can read and write Thai language and must be able to understand and complete the informed consent process.
• Must successfully complete a Test of Understanding (TOU) prior to enrollment.
• Must be in good general health without clinically significant medical history.
• HIV-uninfected per diagnostic algorithm within 45 days of enrollment.
• Laboratory screening analysis (within normal institutional range):
• Hemoglobin: Women \>/= 12.0 g/dL, Men \>/= 12.5 g/dL
• White cell count: 4,000 to 11,000 cells/mm\^3
• Platelets: 150,000 to 450,000/mm\^3
• ALT and AST \</= 1.25 institutional upper limit of reference range
• Creatinine: \</= 1.25 institutional upper limit of reference range
• Urinalysis (dipstick) for blood and protein no greater than 1+, glucose negative
• Female-Specific Criteria:
• Negative human choriogonadotropin (β-HCG) urine pregnancy test for women at screening and prior to each vaccination (same day), and prior to invasive procedures.

You may not qualify if:

• Active, untreated syphilis
• Asplenia: any condition resulting in the absence of a functional spleen
• Bleeding disorder diagnosed by a medical doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), therapeutic anticoagulation resulting in an abnormal prothrombin (PT) / international normalized ration (INR) of partial prothrombin time (PTT)
• Women breast-feeding or pregnant (positive pregnancy test) or planning to become pregnant during the window between study enrollment and 3 months after the last vaccination visit.
• Male or female who has exchanged money or goods for sex in the last 12 months.
• An intravenous drug user in the last 12 months.
• History of anaphylaxis or other serious adverse reaction to vaccines any time in the past, or allergies or reactions likely to be exacerbated by any component of the vaccine or placebo, including streptomycin or neomycin.
• Subject has received any of the following substances:
• Chronic use of therapies that may modify immune response, such as IV immune globulin and systemic corticosteroids (in doses of \>/= 20 mg/day prednisone equivalent for periods exceeding 10 days). The following exceptions are permitted and will not exclude study participation: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on investigator clinical judgment) at least 2 weeks prior to enrollment in this study.
• Blood products within 120 days prior to HIV screening.
• Immunoglobulins within 30 days prior to HIV screening.
• Any licensed vaccine within 14 days prior to initial study vaccine administration in the present study.
• Receipt of any investigational HIV vaccine.
• Investigational research agents or vaccine within 30 days prior to initial study vaccine administration in the present study.
• Use of anti-tuberculosis prophylaxis or therapy during the past 90 days.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

HIV Infections

Interventions

AIDSVAX B-E

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

Study Officials

• Nittaya Phanuphak,, MD, PhD

  Thai Red Cross AIDS Research Centre

  PRINCIPAL INVESTIGATOR

• Jintanat Ananworanich, MD, PhD

  US Military HIV Research Program

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: September 2, 2013
• Study Start: July 3, 2014
• Primary Completion: May 24, 2016
• Study Completion: May 1, 2020
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

TH (1)