AIDSPhase 2NCT00434512

Dose-ranging Study to Evaluate the Safety & Immunogenicity of a HIV Vaccine 732461 in Healthy HIV Seronegative Volunteers

A Phase 2 study testing HIV vaccine 732461 in people with AIDS and HIV Infections, 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

GSK has constructed a new HIV immunogen comprised of conserved parts of the HIV virus (gag, pol and nef). The principal objectives of this study are to evaluate the reactogenicity and safety of this candidate vaccine with or without a GSK proprietary adjuvant system at three different doses and to evaluate the CD4+… Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: AIDS, HIV Infections
What is being tested?: HIV vaccine 732461
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteBelgium
Study dates: 20 Feb 2007to 13 Jun 2008
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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

A male or female between and including 18-40 years at the time of first vaccination.
Written informed consent obtained from the subject prior to any study procedure.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Good general health without significant medical history, physical examination findings, or clinically significant abnormal laboratory results.
If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Negative for antibodies against HIV-1, HIV-2 and negative for HIV p24 antigen within 56 days (8 weeks) prior to enrolment. Subjects must be willing to accept HIV test results. Individuals who elect not to receive test results will not be enrolled.
Negative for anti-HBc Ab, HBsAg and anti-HCV Ab.

Who cannot join

Women who are pregnant or breast-feeding.
Subjects with a history of, or current, alcohol or substance abuse.
The subject is at high risk of acquiring HIV according to the behavioural risk assessment questionnaire.
Morbid obesity
Previous inclusion in a HIV vaccines trial.
Receipt of live attenuated vaccines within 30 days of enrolment.

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Receipt of medically indicated subunit or killed vaccines or allergy treatment with antigen injections within 14 days of study vaccine administration.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Prior receipt of HIV-1 vaccines or placebo in a previous HIV vaccine trial.
Receipt of blood products 120 days prior to HIV screening.
Receipt of immunoglobulin 120 days prior to HIV screening.
History of serious adverse reactions including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema and abdominal pain to vaccines.
History of serious allergic reaction to any substance requiring hospitalization or emergency medical care.
History of immunodeficiency or autoimmune disease.
History of malignancy (unless there has been surgical excision followed by a sufficient observation period, of at least 5 years, to give a reasonable assurance of sustained cure and which, in the estimate of the investigator, is not likely to recur during the study period).
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination.
History of type I or type II diabetes mellitus including cases controlled with diet alone. A subject with past gestational diabetes is eligible.
Thyroid disease including history of thyroidectomy and diagnoses requiring medication. A subject not requiring thyroid medicine within the past 12 months is eligible.
Acute disease at the time of enrolment.
Asthma requiring daily steroid or long acting β agonist prevention.
Unstable asthma.
Food- or wine-induced asthma.
Known sensitivity to sulfites or aspirin.
Bleeding disorder that was diagnosed by a physician. A subject who states that he or she has easy bruising or bleeding, but does not carry a formal diagnosis and has intramuscular (IM) injections and blood draws without any adverse experience is eligible.
History of any serious neurologic disorder or seizure
History of major congenital defect
History of chronic fatigue syndrome or fibromyalgia
Splenectomy
Hypertension. A subject with hypertension is eligible if he or she is controlled on medication and the documented blood pressure is less than 150/100.
Any medical, psychiatric or social condition, or occupational or other responsibility that, in the judgement of the investigator, would interfere with or serve as a contradiction to adherence to the study protocol or ability to give informed consent.

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 Dose-ranging Study to Compare the Safety and Immunogenicity of a Candidate Human Deficiency Virus (HIV) Vaccine 732461, Adjuvanted or Not, Administered According to a 0, 1 Month Schedule to Healthy Adult HIV Seronegative Volunteers.

Read the detailed description

This is a single center, observer-blind, randomized, dose-escalating, staggered study with 6 groups: 3 groups of 50 subjects receiving the adjuvanted candidate vaccine, at 3 different doses and 3 groups of 10 subjects receiving the non-adjuvanted candidate vaccine in water for injection, at 3 different doses. The vaccination schedule will be 0-1 month. Blood samples will be collected at 8 visits. The duration of the study will be approximately 14 months for each subject. Rationale for Protocol Posting Amendment: The third vaccination will be cancelled and the visit at Month 7 will be postponed to Month 9. The Protocol Posting has also been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions: AIDS, HIV Infections
Being tested: HIV vaccine 732461
Keywords: Gag, vaccine, adjuvant, HIV, Pol, Nef
Medical subject headings: Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

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

HIV vaccine 732461Biological

Study groups in NCT00434512
Study group	Role	What they receive
SB732461 adjuvanted_LD Group	Experimental	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30. Receives: Biological: HIV vaccine 732461
SB732461 adjuvanted_MD Group	Experimental	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30. Receives: Biological: HIV vaccine 732461
SB732461 adjuvanted_HD Group	Experimental	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30. Receives: Biological: HIV vaccine 732461
SB732461 non-adjuvanted_LD Group	Experimental	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30. Receives: Biological: HIV vaccine 732461
SB732461 non-adjuvanted_MD Group	Experimental	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30. Receives: Biological: HIV vaccine 732461
SB732461 non-adjuvanted_HD Group	Experimental	Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30. Receives: Biological: HIV vaccine 732461

What is being measured

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

Number of Subjects With Any and Grade 3 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) follow-up period after each vaccination and overall (across doses)
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, sweating, gastrointestinal symptoms(nausea, vomiting, diarrhea, and/or abdominal pain). 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) follow-up period after each vaccination and overall (across doses)
Number of Subjects With Any, Grade 3 and Related 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 outside 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 30-day (Days 0-29) follow-up period after vaccination (across doses)
Number of Subjects With Serious Adverse Events (SAEs) and Related 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 whole study period (From Month 0 up to Month 12)
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 0
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Measured: At Month 0
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Measured: At Month 1
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Measured: At Day 44
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [RBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Measured: At Month 2
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Measured: At Month 6
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Measured: At Month 9
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Measured: At Month 12
Number of Subjects With a Response in Terms of Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Cytokines Including IL-2 Equal or Above the Cut-off to at Least 1, 2, 3 Antigens and to All 4 Antigens
Antigen-specific CD4+ T-cells can express cluster of differentiation 40-ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). The frequency of antigen specific CD4+T-cells was calculated as the difference between the frequency of CD4+T-cells producing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L), upon in vitro stimulation with the peptide pools derived from the antigen minus the frequency of CD4+T-cells producing at least 2 cytokines upon in vitro stimulation in medium only.A responder was a subject with an antigen-stimulated CD4+T cells response greater than or equal to the cut-off value. The same cut-off value was used for all subjects and all antigen responses post-vaccination. It was calculated from the pre-vaccination CD4+T cell responses (the frequency of antigen-stimulated CD4+T cells expressing at least two markers; i.e. all doubles) for all subjects.
Measured: At Day 44

Secondary outcomes (3)

Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
Antigen-specific CD4+ T-cells can express CD40 ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). Frequency of CD4+ T-cells expressing markers in response to the F4co fusion protein (all antigens) was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (p17, p24, Nef, RT). Results are presented as determined by Intracellular Cytokine Staining (ICS).
Measured: At Month 0, Day 44, Month 2, Month 6 and Month 12
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
Antigen-specific CD4+ T-cells can express CD40 ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). Frequency of CD4+ T-cells expressing markers in response to the F4co fusion protein (all antigens) was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (p17, p24, Nef, RT). Results are presented as determined by Intracellular Cytokine Staining (ICS).
Measured: At Month 0, Day 44, Month 2, Month 6 and Month 12
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Anti-p17, -p24, -Nef, -RT and -F4co antibody titers were measured by Enzyme Linked Immunosorbent Assay (ELISA) and presented as geometric mean titers (GMTs).
Measured: At Month 0, Day 44, Month 2, Month 6 and Month 12

Timeline

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

20 Feb 200713 Jun 2008

First posted13 Feb 2007 (estimated)
Study start20 Feb 2007
Primary completion13 Jun 2008
Study completion13 Jun 2008

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 (3)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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00434512
Sponsor's protocol ID: 108706
Other IDs: 2006-003796-12
Status last verified: Sep 2019
First submitted: 12 Feb 2007
Last updated: 1 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below).

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
Van Braeckel E, Koutsoukos M, Bourguignon P, Clement F, McNally L, Leroux-Roels G. Vaccine-induced HIV seropositivity: a problem on the rise. J Clin Virol. 2011 Apr;50(4):334-7. doi: 10.1016/j.jcv.2011.01.003.
PubMed 21300566
Van Braeckel E, Bourguignon P, Koutsoukos M, Clement F, Janssens M, Carletti I, Collard A, Demoitie MA, Voss G, Leroux-Roels G, McNally L. An adjuvanted polyprotein HIV-1 vaccine induces polyfunctional cross-reactive CD4+ T cell responses in seronegative volunteers. Clin Infect Dis. 2011 Feb 15;52(4):522-31. doi: 10.1093/cid/ciq160. Epub 2011 Jan 5.
PubMed 21208909

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 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose-ranging Study to Compare the Safety and Immunogenicity of a Candidate Human Deficiency Virus (HIV) Vaccine 732461, Adjuvanted or Not, Administered According to a 0, 1 Month Schedule to Healthy Adult HIV Seronegative Volunteers.
ClinicalTrials.gov ID: NCT00434512
Acronym / sponsor ID: 108706
Conditions: AIDS, HIV Infections
Keywords: Gag, vaccine, adjuvant, HIV, Pol, Nef
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 20 Feb 2007 (actual)
Primary completion: 13 Jun 2008 (actual)
Study completion: 13 Jun 2008 (actual)
First posted: 13 Feb 2007 (estimated)
Results: Posted 1 Oct 2019

Clinical summary

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
SB732461 adjuvanted_LD Group	Experimental	Biological: HIV vaccine 732461Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
SB732461 adjuvanted_MD Group	Experimental	Biological: HIV vaccine 732461Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
SB732461 adjuvanted_HD Group	Experimental	Biological: HIV vaccine 732461Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
SB732461 non-adjuvanted_LD Group	Experimental	Biological: HIV vaccine 732461Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted low-antigen dose [LD] (10 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
SB732461 non-adjuvanted_MD Group	Experimental	Biological: HIV vaccine 732461Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted medium-antigen dose [MD] (30 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.
SB732461 non-adjuvanted_HD Group	Experimental	Biological: HIV vaccine 732461Healthy adult HIV seronegative subjects aged 18 to 40 years, who received two doses of the non-adjuvanted high-antigen dose [HD] (90 μg) SB732461 vaccine, intramuscularly, at Day 0 and Day 30.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

A male or female between and including 18-40 years at the time of first vaccination.
Written informed consent obtained from the subject prior to any study procedure.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Good general health without significant medical history, physical examination findings, or clinically significant abnormal laboratory results.
If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Key exclusion criteria (30 listed)

Women who are pregnant or breast-feeding.
Subjects with a history of, or current, alcohol or substance abuse.
The subject is at high risk of acquiring HIV according to the behavioural risk assessment questionnaire.
Morbid obesity
Previous inclusion in a HIV vaccines trial.

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
HIV vaccine 732461	Biological	SB732461 adjuvanted_HD Group, SB732461 adjuvanted_LD Group, SB732461 adjuvanted_MD Group, SB732461 non-adjuvanted_HD Group, SB732461 non-adjuvanted_LD Group, SB732461 non-adjuvanted_MD Group

Primary outcome

Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses)
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 Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses)
Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, sweating, gastrointestinal symptoms(nausea, vomiting, diarrhea, and/or abdominal pain). 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 Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: During the 30-day (Days 0-29) follow-up period after vaccination (across doses)
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 outside 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) and Related SAEs
Time frame: During the whole study period (From Month 0 up to Month 12)
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 Abnormal Haematological and Biochemical Levels at Month 0
Time frame: At Month 0
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 1
Time frame: At Month 1
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Number of Subjects With Abnormal Haematological and Biochemical Levels at Day 44
Time frame: At Day 44
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 2
Time frame: At Month 2
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [RBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 6
Time frame: At Month 6
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 9
Time frame: At Month 9
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Number of Subjects With Abnormal Haematological and Biochemical Levels at Month 12
Time frame: At Month 12
The frequency distribution of values below, within and above normal ranges, were tabulated per treatment group at each scheduled time point for the following biochemical or haematological parameters: red blood cells [RBC] count, haemoglobin, haematocrit, white blood cell [WBC] count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, sodium, potassium, urea nitrogen, creatinine, alanine aminotransferase [ALT] and aspartate aminotransferase [AST].
Number of Subjects With a Response in Terms of Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Cytokines Including IL-2 Equal or Above the Cut-off to at Least 1, 2, 3 Antigens and to All 4 Antigens
Time frame: At Day 44
Antigen-specific CD4+ T-cells can express cluster of differentiation 40-ligand (CD40-L) and produce the cytokines Interleukin 2 (IL-2) and/or Tumor Necrosis Factor alpha (TNF-α) and/or Interferon-gamma (IFN-γ). The frequency of antigen specific CD4+T-cells was calculated as the difference between the frequency of CD4+T-cells producing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L), upon in vitro stimulation with the peptide pools derived from the antigen minus the frequency of CD4+T-cells producing at least 2 cytokines upon in vitro stimulation in medium only.A responder was a subject with an antigen-stimulated CD4+T cells response greater than or equal to the cut-off value. The same cut-off value was used for all subjects and all antigen responses post-vaccination. It was calculated from the pre-vaccination CD4+T cell responses (the frequency of antigen-stimulated CD4+T cells expressing at least two markers; i.e. all doubles) for all subjects.

3 secondary outcomes

Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing IL-2 and at Least Another Marker
Time frame: At Month 0, Day 44, Month 2, Month 6 and Month 12
Frequency of p17, p24, Nef and RT-specific CD4+ T-cells Expressing at Least 2 Immune Markers
Time frame: At Month 0, Day 44, Month 2, Month 6 and Month 12
Antibody Titers Against p17, p24, Nef, RT and F4co Antigens
Time frame: At Month 0, Day 44, Month 2, Month 6 and Month 12

Results and safety

Results posted to the registry on 1 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SB732461 Non-adjuvanted_LD Group	10	10
SB732461 Non-adjuvanted_MD Group	10	9
SB732461 Non-adjuvanted_HD Group	10	10
SB732461 adjuvanted_LD Group	50	49
SB732461 adjuvanted_MD Group	50	49
SB732461 adjuvanted_HD Group	50	49

Primary outcome: Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Time frame: During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses). Count of participants. Unit: Participants

Measure	SB732461 Non-adjuvanted_LD Group n = 10	SB732461 Non-adjuvanted_MD Group n = 10	SB732461 Non-adjuvanted_HD Group n = 10	SB732461 adjuvanted_LD Group n = 50	SB732461 adjuvanted_MD Group n = 50	SB732461 adjuvanted_HD Group n = 50
Any Pain, Dose 1	2	0	2	49	49	49
Grade 3 Pain, Dose 1	0	0	0	4	1	4
Any Redness, Dose 1	0	0	0	5	18	9
Grade 3 Redness, Dose 1	0	0	0	3	9	2
Any Swelling, Dose 1	0	0	0	9	12	5
Grade 3 Swelling, Dose 1	0	0	0	5	2	1
Any Pain, Dose 2	3	2	4	47	49	48
Grade 3 Pain, Dose 2	0	0	0	6	4	6

Population analysed: The analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects with at least one vaccine administration documented for whom data were available and who had their symptom sheets filled in.

Primary outcome: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Time frame: During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses). Count of participants. Unit: Participants

Measure	SB732461 Non-adjuvanted_LD Group n = 10	SB732461 Non-adjuvanted_MD Group n = 10	SB732461 Non-adjuvanted_HD Group n = 10	SB732461 adjuvanted_LD Group n = 50	SB732461 adjuvanted_MD Group n = 50	SB732461 adjuvanted_HD Group n = 50
Any Fatigue, Dose 1	3	5	5	27	28	33
Grade 3 Fatigue, Dose 1	0	0	0	2	0	1
Related Fatigue, Dose 1	2	4	3	26	24	32
Any Fever, Dose 1	0	0	0	3	3	3
Grade 3 Fever, Dose 1	0	0	0	0	0	0
Related Fever, Dose 1	0	0	0	3	3	3
Any Gastrointestinal, Dose 1	1	1	1	9	9	8
Grade 3 Gastrointestinal, Dose 1	0	0	0	0	0	0

Primary outcome: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

Time frame: During the 30-day (Days 0-29) follow-up period after vaccination (across doses). Count of participants. Unit: Participants

Measure	SB732461 Non-adjuvanted_LD Group n = 10	SB732461 Non-adjuvanted_MD Group n = 10	SB732461 Non-adjuvanted_HD Group n = 10	SB732461 adjuvanted_LD Group n = 50	SB732461 adjuvanted_MD Group n = 50	SB732461 adjuvanted_HD Group n = 50
Any AE(s)	5	6	7	42	30	33
Grade 3 AE(s)	0	1	0	9	5	6
Related AE(s)	0	0	1	22	15	15

Primary outcome: Number of Subjects With Serious Adverse Events (SAEs) and Related SAEs

Time frame: During the whole study period (From Month 0 up to Month 12). Count of participants. Unit: Participants

Measure	SB732461 Non-adjuvanted_LD Group n = 10	SB732461 Non-adjuvanted_MD Group n = 10	SB732461 Non-adjuvanted_HD Group n = 10	SB732461 adjuvanted_LD Group n = 50	SB732461 adjuvanted_MD Group n = 50	SB732461 adjuvanted_HD Group n = 50
SAEs: SAEs	0	0	0	2	2	2
Related SAEs: SAEs	0	0	0	0	0	0

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (from Month 0 up to Month 12).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SB732461 Non-adjuvanted_LD Group	0 of 10 (0%)	8 of 10 (80%)	0 of 10
SB732461 Non-adjuvanted_MD Group	0 of 10 (0%)	7 of 10 (70%)	0 of 10
SB732461 Non-adjuvanted_HD Group	0 of 10 (0%)	9 of 10 (90%)	0 of 10
SB732461 adjuvanted_LD Group	2 of 50 (4%)	50 of 50 (100%)	0 of 50
SB732461 adjuvanted_MD Group	2 of 50 (4%)	50 of 50 (100%)	0 of 50
SB732461 adjuvanted_HD Group	2 of 50 (4%)	50 of 50 (100%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
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.
Derived from this study: PubMed 21300566Van Braeckel E, Koutsoukos M, Bourguignon P, Clement F, McNally L, Leroux-Roels G. Vaccine-induced HIV seropositivity: a problem on the rise. J Clin Virol. 2011 Apr;50(4):334-7. doi: 10.1016/j.jcv.2011.01.003.
Derived from this study: PubMed 21208909Van Braeckel E, Bourguignon P, Koutsoukos M, Clement F, Janssens M, Carletti I, Collard A, Demoitie MA, Voss G, Leroux-Roels G, McNally L. An adjuvanted polyprotein HIV-1 vaccine induces polyfunctional cross-reactive CD4+ T cell responses in seronegative volunteers. Clin Infect Dis. 2011 Feb 15;52(4):522-31. doi: 10.1093/cid/ciq160. Epub 2011 Jan 5.
Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below).

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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 HIV vaccine 732461 in people with AIDS and HIV Infections, 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 7 inclusion and 30 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 1 Oct 2019. 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 1 Oct 2019). 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 Any and Grade 3 Solicited Local Symptoms (time frame: During the 7-day (Days 0-6) follow-up period after each vaccination and overall (across doses)). The study lists 12 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 NCT00434512, which also lists 3 linked publications.

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 1 Oct 2019; AzTrials last refreshed its copy on 1 Nov 2026.