AIDSPhase 2NCT00972725

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

A Phase 2 study testing GSK Biologicals' HIV vaccine (732461) and Chloroquine in people with AIDS, run by GlaxoSmithKline at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 52 yearsHealthy volunteers can take part
Conditions the study is for: AIDS
What is being tested?: GSK Biologicals' HIV vaccine (732461) and Chloroquine
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteBelgium
Study dates: 1 Dec 2009to 4 Oct 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 52 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

GSK Investigational Site
Ghent, 9000

Other trials in Belgium

About this study

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.

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.

Read the detailed description

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

Conditions: AIDS
Being tested: GSK Biologicals' HIV vaccine (732461), Chloroquine
Keywords: Chloroquine, Human Immunodeficiency Virus
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK Biologicals' HIV vaccine (732461)Biological
1 dose intramuscular injection
ChloroquineDrug
Also called Nivaquine®
One dose of 300 mg

Study groups in NCT00972725
Study group	Role	What they receive
GSK732461+Nivaquine Group	Experimental	Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine. Receives: Biological: GSK Biologicals' HIV vaccine (732461); Drug: Chloroquine
GSK732461 Group	Active comparator	Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm. Receives: Biological: GSK Biologicals' HIV vaccine (732461)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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).
Measured: At Day 14
Number of Subjects With Solicited Local Symptoms
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.
Measured: During the 7 Day (Days 0-6) post-vaccination period
Number of Subjects With Solicited General Symptoms
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.
Measured: During the 7 Day (Days 0-6) post-vaccination period
Number of Subjects With Unsolicited Adverse Events (AEs)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: During the entire study period (from Day 0 up to Day 360)
Levels of Haematological and Biochemical Parameters
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.
Measured: At Day 0
Levels of Haematological and Biochemical Parameters
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.
Measured: At Day 7
Levels of Haematological and Biochemical Parameters
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.
Measured: At Day 30
Levels of Haematological and Biochemical Parameters
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.
Measured: At Day 180

Secondary outcomes (19)

Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
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.
Measured: At Day 0, 7, 14, 30 and 180
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
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.
Measured: At Day 0, 7, 14, 30 and 180
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
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.
Measured: At Day 0, 7, 14, 30 and 180
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
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.
Measured: At Day 0, 7, 14, 30 and 180
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
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.
Measured: At Day 0, 7, 14, 30 and 180
Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
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.
Measured: At Day 0, 7, 14, 30 and 180
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
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.
Measured: At Day 0, 7, 14, 30 and 180
Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
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).
Measured: At Day 0, 7, 14, 30 and 180
Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
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).
Measured: 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
Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by ICS.
Measured: At Day 0, 7, 14, 30 and 180
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
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.
Measured: At Day 0, 7, 14, 30 and 180
Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
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.
Measured: At Day 0, 7, 14, 30 and 180
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
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.
Measured: At Day 0, 7, 14, 30 and 180
Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
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.
Measured: At Day 0, 7, 14, 30 and 180
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
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.
Measured: At Day 0, 7, 14, 30 and 180
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
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).
Measured: At Day 0, 7, 14, 30 and 180
Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines
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).
Measured: At Day 0, 7, 14, 30 and 180
Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
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).
Measured: At Day 0, 7, 14, 30 and 180
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Antibody concentrations were expressed as geometric mean concentrations (GMCs), given in milli-enzyme-linked immunosorbent assay (ELISA) units per millilitre (mEL.U/mL).
Measured: At Day 0, 7, 14, 30 and 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20094 Oct 2010

First posted7 Sep 2009 (estimated)
Study start1 Dec 2009
Primary completion4 Oct 2010
Study completion4 Oct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AIDSStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00972725
Sponsor's protocol ID: 113165
Status last verified: Mar 2017
First submitted: 3 Sep 2009
Last updated: 17 Aug 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Leroux-Roels G, Bourguignon P, Willekens J, Janssens M, Clement F, Didierlaurent AM, Fissette L, Roman F, Boutriau D. Immunogenicity and safety of a booster dose of an investigational adjuvanted polyprotein HIV-1 vaccine in healthy adults and effect of administration of chloroquine. Clin Vaccine Immunol. 2014 Mar;21(3):302-11. doi: 10.1128/CVI.00617-13. Epub 2014 Jan 3.
PubMed 24391139

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00972725
Acronym / sponsor ID: 113165
Conditions: AIDS
Keywords: Chloroquine, Human Immunodeficiency Virus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Dec 2009
Primary completion: 4 Oct 2010 (actual)
Study completion: 4 Oct 2010 (actual)
First posted: 7 Sep 2009 (estimated)
Results: Posted 13 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
GSK732461+Nivaquine Group	Experimental	Biological: GSK Biologicals' HIV vaccine (732461), Drug: ChloroquineSubjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
GSK732461 Group	Active comparator	Biological: GSK Biologicals' HIV vaccine (732461)Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.

Who may qualify

Ages: 18 to 52 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

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.

Key exclusion criteria (40 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK Biologicals' HIV vaccine (732461)1 dose intramuscular injection	Biological	GSK732461 Group, GSK732461+Nivaquine Group
ChloroquineAlso: Nivaquine®One dose of 300 mg	Drug	GSK732461+Nivaquine Group

Primary outcome

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).
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.
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.
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.
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.
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.
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.
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.
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.
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.

19 secondary outcomes

Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine
Time frame: 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
Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Time frame: 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
Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Time frame: 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
Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine
Time frame: 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
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
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
Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines
Time frame: 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
Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Time frame: 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
Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines
Time frame: 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
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
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
Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations
Time frame: At Day 0, 7, 14, 30 and 180

Results and safety

Results posted to the registry on 13 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK732461+Nivaquine Group	13	13
GSK732461 Group	15	15

Primary outcome: 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. Count of participants. Unit: Participants

Measure	GSK732461+Nivaquine Group n = 13	GSK732461 Group n = 13
At least 1 antigen, Day 14	1	3
At least 2 antigens, Day 14	0	0
At least 3 antigens, Day 14	0	0
At least 4 antigens, Day 14	0	0

Population analysed: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Primary outcome: Number of Subjects With Solicited Local Symptoms

Time frame: During the 7 Day (Days 0-6) post-vaccination period. Count of participants. Unit: Participants

Measure	GSK732461+Nivaquine Group n = 13	GSK732461 Group n = 15
Any Pain	13	14
Grade 3 Pain	1	2
Any Redness	3	6
Grade 3 Redness	0	1
Any Swelling	3	5
Grade 3 Swelling	0	2

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Primary outcome: Number of Subjects With Solicited General Symptoms

Time frame: During the 7 Day (Days 0-6) post-vaccination period. Count of participants. Unit: Participants

Measure	GSK732461+Nivaquine Group n = 13	GSK732461 Group n = 15
Any Fatigue	9	14
Grade 3 Fatigue	3	3
Related Fatigue	9	11
Any Gastrointestinal	6	5
Grade 3 Gastrointestinal	1	0
Related Gastrointestinal	4	3
Any Headache	9	13
Grade 3 Headache	3	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	GSK732461+Nivaquine Group n = 13	GSK732461 Group n = 15
Any AEs	8	13
Grade 3 AEs	3	2
Related AEs	5	8

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

28 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local/general symptoms during the 7 Day (Day 0 to Day 6) post-vaccination period; Unsolicited AEs until Day 29 post-vaccination; SAEs during the entire study period (from Day 0 up to Day 360).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK732461+Nivaquine Group	0 of 13 (0%)	13 of 13 (100%)	Not reported
GSK732461 Group	0 of 15 (0%)	15 of 15 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24391139Leroux-Roels G, Bourguignon P, Willekens J, Janssens M, Clement F, Didierlaurent AM, Fissette L, Roman F, Boutriau D. Immunogenicity and safety of a booster dose of an investigational adjuvanted polyprotein HIV-1 vaccine in healthy adults and effect of administration of chloroquine. Clin Vaccine Immunol. 2014 Mar;21(3):302-11. doi: 10.1128/CVI.00617-13. Epub 2014 Jan 3.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK Biologicals' HIV vaccine (732461) and Chloroquine in people with AIDS, run by GlaxoSmithKline at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00972725, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.