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Evaluation of the Immune Response of a HIV Candidate Vaccine After Administration of One Chloroquine Dose

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00972725
First received: September 3, 2009
Last updated: January 22, 2011
Last verified: November 2010
  Purpose

The purpose of this study is to evaluate the safety and reactogenicity of one booster dose of a HIV candidate vaccine after administration of one oral dose of chloroquine.


Condition Intervention Phase
Immunologic Tests
HIV Infections
Biological: GSK Biologicals' HIV vaccine (732461)
Drug: Chloroquine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Safety and Immunogenicity of a Booster Dose of GSK Biologicals' HIV Candidate Vaccine (732461) After Administration of Chloroquine in Healthy Adults.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Cellular immune response to components of the study vaccine [ Time Frame: At Day 14 ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: During a 7-day (Day 0-6) follow-up period after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: During a 30-day (Day 0-29) follow-up period after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse event [ Time Frame: From the beginning up to the study end (Day 0-180) ] [ Designated as safety issue: No ]
  • Occurrence of adverse event of specific interest, including Immune-Mediated Disorders (IMD) [ Time Frame: From the beginning up to the study end (Day 0-180) ] [ Designated as safety issue: No ]
  • Haematological and biochemical levels [ Time Frame: At Days 0, 7, 30 and 180 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cellular and humoral immune response to components of the candidate vaccines in all subjects [ Time Frame: At Days 0, 7, 14, 30 and 180 ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: December 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: GSK Biologicals' HIV vaccine (732461)
1 dose intramuscular injection
Drug: Chloroquine
One dose of 300 mg
Other Name: Nivaquine®
Active Comparator: Group B Biological: GSK Biologicals' HIV vaccine (732461)
1 dose intramuscular injection

Detailed Description:

The Protocol Posting has been updated following Protocol amendment 1, October 2009.

  Eligibility

Ages Eligible for Study:   18 Years to 52 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female between, and including, 18 to 52 years of age at the time of vaccination.
  • Written informed consent prior to any study related procedure on the subject.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • Good general health without significant medical history or physical examination findings.
  • Negative for anti-HBc and anti-Hepatitis C Virus antibodies.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception until study completion.
  • Previous participation and completion of the study NCT00434512.
  • Cellular and humoral immune responder to vaccines administered in study NCT00434512.
  • Subjects must be willing to accept HIV test results. Individuals who elect not to receive test results will not be enrolled.

Exclusion Criteria:

  • Clinically significant laboratory value above normal range for blood urea nitrogen, creatinine, alanine aminotransferase and aspartate aminotransferase, or clinically significant laboratory value above or below normal range for Hemoglobin, as per investigator judgment.
  • Women who are pregnant or breast-feeding.
  • Receipt of live attenuated vaccines within 30 days of vaccination.
  • Receipt of medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) or allergy treatment with antigen injections (including a tuberculin skin test) within <= 21days preceding and planned <= 21 days following the study vaccine administration.
  • Receipt of blood products 120 days prior to vaccination.
  • Receipt of immunoglobulin 120 days prior to vaccination.
  • Subject has donated blood in the last 3 months.
  • Bleeding disorder that was diagnosed by a physician; e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first.
  • History of serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema and abdominal pain.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/product.
  • History of serious allergic reaction to any substance requiring hospitalization or emergency medical care.
  • History of hypersensitivity against chloroquine or any components of the drug.
  • History of hypersensitivity against aminoglycosides.
  • Ophthalmologic findings at screening.
  • Previous administration of 4-aminoquinoline in the previous year or for a duration of more than 1 year.
  • History of Glucose-6-Phosphate Dehydrogenase deficiency.
  • History of hematopoietic disease.
  • History of Myasthenia gravis.
  • History of any serious neurological disorder or seizure.
  • History of immunodeficiency or immune-mediated disorders, including active psoriasis.
  • History of type I or type II diabetes mellitus including cases controlled with diet alone.
  • Thyroid disease including history of thyroidectomy and diagnoses requiring medication.
  • Asthma requiring daily steroid or long acting β-agonist prevention.
  • Unstable asthma defined as:
  • Sudden acute attacks occurring in less than three hours without an obvious trigger.
  • Hospitalization for asthma in the last two years.
  • Food- or wine-induced asthma.
  • Known sensitivity to sulfites or aspirin.
  • History of major congenital defect.
  • History of chronic fatigue syndrome or fibromyalgia.
  • History of malignancy.
  • Splenectomy.
  • Morbid obesity.
  • Clinically relevant hypertension.
  • Subjects with a history of, or current, alcohol or substance abuse.
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Previous inclusion in a HIV vaccines trial other than study NCT00434512.
  • Subject is seropositive for HIV, as determined by the test results performed.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972725

Locations
Belgium
GSK Investigational Site
Gent, Belgium, 9000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00972725     History of Changes
Other Study ID Numbers: 113165
Study First Received: September 3, 2009
Last Updated: January 22, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by GlaxoSmithKline:
Chloroquine
Human Immunodeficiency Virus

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Chloroquine
Chloroquine diphosphate
Amebicides
Analgesics
Analgesics, Non-Narcotic
Anthelmintics
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimalarials
Antinematodal Agents
Antiparasitic Agents
Antiprotozoal Agents
Antirheumatic Agents
Central Nervous System Agents
Filaricides
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014