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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Immunologic Tests; HIV Infections

Intervention: GSK Biologicals' HIV vaccine (732461) (Biological); Chloroquine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline


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.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Cellular immune response to components of the study vaccine

Occurrence of solicited local and general symptoms

Occurrence of unsolicited symptoms

Occurrence of serious adverse event

Occurrence of adverse event of specific interest, including Immune-Mediated Disorders (IMD)

Haematological and biochemical levels

Secondary outcome: Cellular and humoral immune response to components of the candidate vaccines in all subjects

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


Minimum age: 18 Years. Maximum age: 52 Years. Gender(s): Both.


Inclusion Criteria:

- A male or female between, and including, 18 to 52 years of age at the time of


- 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


- 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


- 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


- Thyroid disease including history of thyroidectomy and diagnoses requiring


- 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.

Locations and Contacts

GSK Investigational Site, Gent 9000, Belgium
Additional Information

Starting date: December 2009
Last updated: January 22, 2011

Page last updated: August 20, 2015

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