- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00972725
Evaluation of the Immune Response of a HIV Candidate Vaccine After Administration of One Chloroquine Dose
July 11, 2018 updated by: GlaxoSmithKline
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The Protocol Posting has been updated following Protocol amendment 1, October 2009.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gent, Belgium, 9000
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 52 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GSK732461+Nivaquine Group
Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
|
1 dose intramuscular injection
One dose of 300 mg
Other Names:
|
Active Comparator: GSK732461 Group
Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
|
1 dose intramuscular injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens
Time Frame: At Day 14
|
Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by intracellular cytokine staining (ICS).
|
At Day 14
|
Number of Subjects With Solicited Local Symptoms
Time Frame: During the 7 Day (Days 0-6) post-vaccination period
|
Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
|
During the 7 Day (Days 0-6) post-vaccination period
|
Number of Subjects With Solicited General Symptoms
Time Frame: During the 7 Day (Days 0-6) post-vaccination period
|
Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain] and headache.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever > 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
|
During the 7 Day (Days 0-6) post-vaccination period
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Time Frame: During the 32 Day (Days 2-29) post-chloroquine administration and during the 30 Day (Days 0-29) post-vaccine administration period
|
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
|
During the 32 Day (Days 2-29) post-chloroquine administration and during the 30 Day (Days 0-29) post-vaccine administration period
|
Number of Subjects With Serious Adverse Events (SAEs)
Time Frame: During the entire study period (from Day 0 up to Day 360)
|
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
During the entire study period (from Day 0 up to Day 360)
|
Number of Subjects With AEs of Specific Interest and Immune-Mediated Disorders (IMDs)
Time Frame: During the entire study period (from Day 0 up to Day 360)
|
Adverse events of specific interest include auto-immune diseases (AID) and immune mediated disorders such as neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events.
|
During the entire study period (from Day 0 up to Day 360)
|
Levels of Haematological and Biochemical Parameters
Time Frame: At Day 0
|
Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC].
Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.
|
At Day 0
|
Levels of Haematological and Biochemical Parameters
Time Frame: At Day 7
|
Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC].
Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.
|
At Day 7
|
Levels of Haematological and Biochemical Parameters
Time Frame: At Day 30
|
Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC].
Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.
|
At Day 30
|
Levels of Haematological and Biochemical Parameters
Time Frame: At Day 180
|
Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC].
Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - unknown, below, within and above.
|
At Day 180
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
Time Frame: At Day 0, 7, 14, 30 and 180
|
Magnitude was defined as the frequency of CD8+ T cells group-specific antigen (Gag) proteins 17, 24; negative regulatory factor (Nef); reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co).
Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).
Among the cytokines expressed were IL-2, TNF-α and INF-γ.
|
At Day 0, 7, 14, 30 and 180
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Time Frame: At Day 0, 7, 14, 30 and 180
|
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS.
|
At Day 0, 7, 14, 30 and 180
|
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Time Frame: At Day 0, 7, 14, 30 and 180
|
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
|
At Day 0, 7, 14, 30 and 180
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Time Frame: At Day 0, 7, 14, 30 and 180
|
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS.
|
At Day 0, 7, 14, 30 and 180
|
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Time Frame: At Day 0, 7, 14, 30 and 180
|
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
|
At Day 0, 7, 14, 30 and 180
|
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Time Frame: At Day 0, 7, 14, 30 and 180
|
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
|
At Day 0, 7, 14, 30 and 180
|
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Time Frame: At Day 0, 7, 14, 30 and 180
|
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
|
At Day 0, 7, 14, 30 and 180
|
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Time Frame: At Day 0, 7, 14, 30 and 180
|
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).
|
At Day 0, 7, 14, 30 and 180
|
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Time Frame: At Day 0, 7, 14, 30 and 180
|
Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).
|
At Day 0, 7, 14, 30 and 180
|
Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens
Time Frame: At Day 0, 7, 14, 30 and 180
|
Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by ICS.
|
At Day 0, 7, 14, 30 and 180
|
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
Time Frame: At Day 0, 7, 14, 30 and 180
|
Magnitude was defined as the frequency of CD4+ T cells group-specific antigen (Gag) proteins 17, 24, negative regulatory factor (Nef), reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co).
Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).
Among the cytokines expressed were IL-2, TNF-α and INF-γ.
|
At Day 0, 7, 14, 30 and 180
|
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Time Frame: At Day 0, 7, 14, 30 and 180
|
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
|
At Day 0, 7, 14, 30 and 180
|
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Time Frame: At Day 0, 7, 14, 30 and 180
|
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
|
At Day 0, 7, 14, 30 and 180
|
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Time Frame: At Day 0, 7, 14, 30 and 180
|
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
|
At Day 0, 7, 14, 30 and 180
|
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Time Frame: At Day 0, 7, 14, 30 and 180
|
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
|
At Day 0, 7, 14, 30 and 180
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Time Frame: At Day 0, 7, 14, 30 and 180
|
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est).
|
At Day 0, 7, 14, 30 and 180
|
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
Time Frame: At Day 0, 7, 14, 30 and 180
|
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est).
|
At Day 0, 7, 14, 30 and 180
|
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Time Frame: At Day 0, 7, 14, 30 and 180
|
Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.
Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est).
|
At Day 0, 7, 14, 30 and 180
|
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Time Frame: At Day 0, 7, 14, 30 and 180
|
Antibody concentrations were expressed as geometric mean concentrations (GMCs), given in milli-enzyme-linked immunosorbent assay (ELISA) units per millilitre (mEL.U/mL).
|
At Day 0, 7, 14, 30 and 180
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
October 4, 2010
Study Completion (Actual)
October 4, 2010
Study Registration Dates
First Submitted
September 3, 2009
First Submitted That Met QC Criteria
September 3, 2009
First Posted (Estimate)
September 7, 2009
Study Record Updates
Last Update Posted (Actual)
August 17, 2018
Last Update Submitted That Met QC Criteria
July 11, 2018
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 113165
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on AIDS
-
GlaxoSmithKlineCompletedAIDS | AIDS VaccinesBelgium
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
Cell Energy Life Sciences Group Co. LTDBeijing YouAn Hospital; Beijing 302 Hospital; Shenzhen Third People's Hospital; Fifth Hospital of Shijiazhuang CityRecruiting
-
ViiV HealthcarePfizerCompleted
-
University of ArizonaRecruitingHearing AidsUnited States
-
NorthShore University HealthSystemCompletedCognitive AidsUnited States
-
AIDS Malignancy ConsortiumNational Cancer Institute (NCI); University of Arkansas; The Emmes Company, LLCCompletedAIDS-related Peripheral/Systemic Lymphoma | AIDS-related Diffuse Large Cell Lymphoma | AIDS-related Diffuse Mixed Cell Lymphoma | AIDS-related Diffuse Small Cleaved Cell Lymphoma | AIDS-related Immunoblastic Large Cell Lymphoma | AIDS-related Lymphoblastic Lymphoma | AIDS-related Small Noncleaved... and other conditionsZimbabwe, Kenya
-
Sodra Alvsborgs HospitalCompleted
-
Sodra Alvsborgs HospitalCompleted
-
Beijing 302 HospitalShanghai Public Health Clinical Center; The 6th people's Hospital of Xinjiang... and other collaboratorsRecruiting
Clinical Trials on GSK Biologicals' HIV vaccine (732461)
-
GlaxoSmithKlineCompletedInfluenzaUnited States
-
GlaxoSmithKlineCompletedInfluenzaSpain, United States
-
GlaxoSmithKlineCompletedTuberculosisPhilippines
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompletedAIDSUnited States, Spain, France, Germany
-
GlaxoSmithKlineCompletedInfections, Papillomavirus | Papillomavirus VaccinesBelgium
-
Arto PalmuGlaxoSmithKlineCompletedPneumococcal InfectionsFinland
-
GlaxoSmithKlineTerminatedTuberculosisTaiwan, Estonia
-
GlaxoSmithKlineAerasCompleted
-
GlaxoSmithKlineCompleted