AIDSPhase 1NCT00814762

Safety of the HIV Vaccine 732462 in HIV Infected Subjects Aged 18 to 55 Years Old

A Phase 1 study testing HIV Vaccine 732462 in people with AIDS, run by GlaxoSmithKline at 6 sites in Germany.

Completed

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

Trial summary

The purpose of this research study is to evaluate the safety of GSK Biologicals' investigational HIV vaccine 732462, administered as two doses approximately 1 month apart, in a small group of HIV infected people. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: AIDS
What is being tested?: HIV Vaccine 732462
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 41 participants
Where: 6 sitesGermany
Study dates: 3 Feb 2009to 18 Aug 2010
Phase: Phase 1
Are there results?: None posted in the registry

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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

All subjects must satisfy the following criteria at screening and before vaccination:
A male or female, aged between and including 18-55 years at the time of first vaccination.
Known to be HIV-1 infected and under care of an HIV physician for a minimum of 6 months. However, subjects who initially presented with primary HIV infection need to have been diagnosed and under care for 12 months.
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.
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 throughout the duration of the study.

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CD4 count ≥ 450 cells per mm³
Additional inclusion criteria for subjects enrolled in the first cohort (HIV-infected subjects receiving HAART):
Stable on highly active antiretroviral therapy (HAART) for at least one year.
Undetectable viral load
Additional inclusion criteria for subjects enrolled in second cohort (treatment-naïve HIV-infected subjects):
HAART-naïve (never received anti-retrovirals after HIV diagnosis)
VL 5000-80000 copies/mL at screening
Commencement of HAART is not expected based on current assessment within next year.

Who cannot join

The following criteria should be checked at the time of screening and before vaccination. If any apply, the subject must not be included in the study:
Infection with HIV-2
Had an AIDS defining illness (CDC Classification).
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine/placebo, or planned use of any investigational or non-registered product other than the study vaccine during the study period.
Drug therapy with immunomodulators or steroids within the three months preceding the first dose of study vaccine/placebo or planned administration during the study period
Administration of immunoglobulins and/ or any blood products within the three months preceding the first dose of study vaccine/placebo or planned administration during the study period.

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Planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the first dose of study vaccine/placebo and ending at Month 4 It is recommended that the vaccination history of all subjects has been reviewed with their health care provider and that they have been encouraged to be fully vaccinated according to their country vaccination schedule for HIV- infected persons before enrolment into this study.
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).
Any previous vaccination or immunotherapy against HIV.
History of immune reconstitution disease when commencing antiretroviral therapy (for HIV-infected subjects receiving HAART)
A family history of hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Acute or chronic infective hepatitis (A past history of hepatitis B or C is not an exclusion criterion).
Acute or chronic, clinically relevant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Any condition (including alcohol and drug abuse) which, in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol
History of medically confirmed autoimmune disease
History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure
Asthma requiring daily steroid or long acting ß agonist prevention
Unstable asthma defined as:
Sudden acute attacks occurring in less than three hours without an obvious trigger.
Hospitalisation for asthma in the last two years
Food or wine induced asthma
Known sensitivity to sulfites or aspirin
Known sensitivity to aminoglycoside antibiotics

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Germany6 sites

GSK Investigational Site
Berlin, 12157
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50937
GSK Investigational Site
Erlangen, Bavaria, 91054
GSK Investigational Site
Hamburg, 20099
GSK Investigational Site
Hamburg, 20246
GSK Investigational Site
Munich, Bavaria, 80335

Other trials in Germany

About this study

Official title: Study to Evaluate the Safety and Reactogenicity of the HIV Vaccine SB732462 in HIV Infected Subjects Aged 18 to 55 Years Old

Read the detailed description

This multicenter observer-blind study will determine the safety and reactogenicity of GSK Biologicals' investigational HIV vaccine 732462 in two sequentially enrolling cohorts of HIV-infected subjects treated with HAART (highly active antiretroviral therapy) and HIV infected treatment naïve subjects, respectively.

Conditions: AIDS
Being tested: HIV Vaccine 732462, Placebo vaccine
Keywords: immunogenicity, HIV, reactogenicity, safety, vaccine, HIV Infections
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 732462Biological
Two doses reconstituted adjuvanted vaccine, injected intramuscularly, at an interval of approximately one month.
Placebo vaccineBiological
Two doses of placebo, injected intramuscularly, at an interval of approximately one month

Study groups in NCT00814762
Study group	Role	What they receive
HIV 732462 Group	Experimental	Subjects received 2 doses of the HIV Vaccine 732462 into the deltoid muscle of the dominant arm, on a 0, 1 Month schedule. Receives: Biological: HIV Vaccine 732462
Placebo Group	Placebo comparator	Subjects received 2 doses of the placebo vaccine into the deltoid muscle of the dominant arm, on a 0, 1 Month schedule. Receives: Biological: Placebo vaccine

What is being measured

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

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 causing inability to perform usual social and functional activities. Grade 1 redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) of injection site.
Measured: During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)
Number of subjects with solicited general symptoms
Assessed solicited general symptoms were abdominal pain, anorexia, diarrhoea, fatigue, headache, myalgia, nausea, sweating, vomiting and temperature [oral temperature equal to or above (≥) 37.7 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms causing inability to perform usual social and functional activities. Grade 3 anorexia = loss of appetite associated with significant weight loss. Grade 3 diarrhoea = bloody diarrhoea or increase of ≥7 stools per 24 hour period, or IV fluid replacement. Grade 3 nausea/vomiting = persistent nausea/vomiting resulting in minimal oral intake for more (>) than 48 hours/in orthostatic hypotension or aggressive rehydration indicated. Grade 3 temperature = temperature between 39.4- 40.5 °C
Measured: During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)
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 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: Day 0-Day 29 after each vaccination
Number of subjects with Serious Adverse Events (SAEs) and medically attended visits
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. Medically attended visits include any kind of medical attention such as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
Measured: From Screening at Day -42 and up to the additional visit post study end, Month 12
Number of subjects with study pre-defined Human Immunodeficiency Virus (HIV)-related adverse events
Study pre-defined HIV-related AEs included: cluster of differentiation-4 (CD4) count decrease [(≥)25% post vaccination], viral load increase [(≥)50 copies per (/) milliliter (mL) of HIV ribonucleic acid (RNA) post-vaccination, for cohort A and at least 0.5 log post-vaccination for cohort B], initiation of Highly Active Anti-Retroviral Therapy (HAART) for cohort B, or changes in HAART for cohort A, abnormal biochemistry and haematology parameters.
Measured: From Day 0 to study end at Month 12
Number of subjects presenting abnormal biochemical and haematological values (any and grade ≥ 3)
Assessed biochemical and haematological parameters included: Absolute neutrophil count (ANC), Haemoglobin (Hgb), Partial Thromboplastin Time (PTT), Platelets decreased (PLT/D), WBC decreased (WBC/D), Albumin serum low (ALB/SL), Alkaline Phosphatase (ALP), Alanine aminotransferase (SGPT), Aspartate aminotransferase (SGOT), Bilirubin Total (BL/T), Creatinine (CRT), Potassium serum high (K/SH), Potassium serum low (K/SL), Sodium serum high (Na/SH), Sodium serum low (NA/SL), Uric acid (UA).
Measured: From Day 0 to study end at Month 12
Time to initiation of HAART therapy (for treatment-naïve HIV-infected subjects) or change in HAART therapy (for HIV-infected subjects receiving HAART)
Time to HAART initiation and/or HAART changes was expressed in days from administration of first dose.
Measured: From Day 0 to Month 12

Secondary outcomes (3)

CD4 count and change of CD4 count from baseline
Baseline was defined as the value measured in the pre-vaccination blood sample obtained at Day 0 prior to the administration of the first dose.
Measured: From Day 0 to Month 12
Viral load and change in viral load from baseline
Baseline was defined as the value measured in the pre-vaccination blood sample obtained at Day 0 prior to the administration of the first dose.
Measured: From Day 0 to Month 12
Cluster of differentiation 40 ligand (CD40L+) CD4+ T-cell-mediated immune response (as measured by ICS)
CD40L+ and CD4+ T cell immune response was assessed via Intracellular Cytokine Staining (ICS) and included: breadth which was by looking at response to at least 1, 2, 3 antigens and to all 4 antigens [p17, p24, Necrosis Factor (Nef) and Reverse Transcriptase (RT)], intensity which was defined as frequency of the 4 antigent-specific CD40L+CD4+ T cells expressing at least Interleukin 2 (IL-2) or Tumor Necrosis Factor alpha (TNFa) and/or Interferon gamma (INFg) and cytokine co-expression profile defined as the frequency of the 4 antigen-specific CD40L+CD4+ Tcells expressing IL-2 and/or TNFa and/or IFNg.
Measured: Months 0, 4, 12 and at Day 44

Timeline

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

3 Feb 200918 Aug 2010

First posted25 Dec 2008 (estimated)
Study start3 Feb 2009
Primary completion18 Aug 2010
Study completion18 Aug 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00814762
Sponsor's protocol ID: 112353
Status last verified: Jun 2018
First submitted: 23 Dec 2008
Last updated: 18 Jun 2018
Results posted: No

Publications

Harrer T, Plettenberg A, Arasteh K, Van Lunzen J, Fatkenheuer G, Jaeger H, Janssens M, Burny W, Collard A, Roman F, Loeliger A, Koutsoukos M, Bourguignon P, Lavreys L, Voss G. Safety and immunogenicity of an adjuvanted protein therapeutic HIV-1 vaccine in subjects with HIV-1 infection: a randomised placebo-controlled study. Vaccine. 2014 May 7;32(22):2657-65. doi: 10.1016/j.vaccine.2013.10.030. Epub 2013 Oct 19.
PubMed 24144472

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 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Evaluate the Safety and Reactogenicity of the HIV Vaccine SB732462 in HIV Infected Subjects Aged 18 to 55 Years Old
ClinicalTrials.gov ID: NCT00814762
Acronym / sponsor ID: 112353
Conditions: AIDS
Keywords: immunogenicity, HIV, reactogenicity, safety, vaccine, HIV Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 3 Feb 2009 (actual)
Primary completion: 18 Aug 2010 (actual)
Study completion: 18 Aug 2010 (actual)
First posted: 25 Dec 2008 (estimated)
Results: Not posted in the source record

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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
HIV 732462 Group	Experimental	Biological: HIV Vaccine 732462Subjects received 2 doses of the HIV Vaccine 732462 into the deltoid muscle of the dominant arm, on a 0, 1 Month schedule.
Placebo Group	Placebo comparator	Biological: Placebo vaccineSubjects received 2 doses of the placebo vaccine into the deltoid muscle of the dominant arm, on a 0, 1 Month schedule.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (14 listed)

A male or female, aged between and including 18-55 years at the time of first vaccination.
Known to be HIV-1 infected and under care of an HIV physician for a minimum of 6 months. However, subjects who initially presented with primary HIV infection need to have been diagnosed and under care for 12 months.
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.
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 throughout the duration of the study.

Key exclusion criteria (26 listed)

The following criteria should be checked at the time of screening and before vaccination. If any apply, the subject must not be included in the study:
Infection with HIV-2
Had an AIDS defining illness (CDC Classification).
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine/placebo, or planned use of any investigational or non-registered product other than the study vaccine during the study period.
Drug therapy with immunomodulators or steroids within the three months preceding the first dose of study vaccine/placebo or planned administration during the study period

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 732462Two doses reconstituted adjuvanted vaccine, injected intramuscularly, at an interval of approximately one month.	Biological	HIV 732462 Group
Placebo vaccineTwo doses of placebo, injected intramuscularly, at an interval of approximately one month	Biological	Placebo Group

Primary outcome

Number of subjects with solicited local symptoms
Time frame: During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)
Assessed solicited local symptoms were: pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain causing inability to perform usual social and functional activities. Grade 1 redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) of injection site.
Number of subjects with solicited general symptoms
Time frame: During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)
Assessed solicited general symptoms were abdominal pain, anorexia, diarrhoea, fatigue, headache, myalgia, nausea, sweating, vomiting and temperature [oral temperature equal to or above (≥) 37.7 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms causing inability to perform usual social and functional activities. Grade 3 anorexia = loss of appetite associated with significant weight loss. Grade 3 diarrhoea = bloody diarrhoea or increase of ≥7 stools per 24 hour period, or IV fluid replacement. Grade 3 nausea/vomiting = persistent nausea/vomiting resulting in minimal oral intake for more (>) than 48 hours/in orthostatic hypotension or aggressive rehydration indicated. Grade 3 temperature = temperature between 39.4- 40.5 °C
Number of subjects with unsolicited Adverse Events (AEs)
Time frame: Day 0-Day 29 after each vaccination
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 medically attended visits
Time frame: From Screening at Day -42 and up to the additional visit post study end, 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. Medically attended visits include any kind of medical attention such as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
Number of subjects with study pre-defined Human Immunodeficiency Virus (HIV)-related adverse events
Time frame: From Day 0 to study end at Month 12
Study pre-defined HIV-related AEs included: cluster of differentiation-4 (CD4) count decrease [(≥)25% post vaccination], viral load increase [(≥)50 copies per (/) milliliter (mL) of HIV ribonucleic acid (RNA) post-vaccination, for cohort A and at least 0.5 log post-vaccination for cohort B], initiation of Highly Active Anti-Retroviral Therapy (HAART) for cohort B, or changes in HAART for cohort A, abnormal biochemistry and haematology parameters.
Number of subjects presenting abnormal biochemical and haematological values (any and grade ≥ 3)
Time frame: From Day 0 to study end at Month 12
Assessed biochemical and haematological parameters included: Absolute neutrophil count (ANC), Haemoglobin (Hgb), Partial Thromboplastin Time (PTT), Platelets decreased (PLT/D), WBC decreased (WBC/D), Albumin serum low (ALB/SL), Alkaline Phosphatase (ALP), Alanine aminotransferase (SGPT), Aspartate aminotransferase (SGOT), Bilirubin Total (BL/T), Creatinine (CRT), Potassium serum high (K/SH), Potassium serum low (K/SL), Sodium serum high (Na/SH), Sodium serum low (NA/SL), Uric acid (UA).
Time to initiation of HAART therapy (for treatment-naïve HIV-infected subjects) or change in HAART therapy (for HIV-infected subjects receiving HAART)
Time frame: From Day 0 to Month 12
Time to HAART initiation and/or HAART changes was expressed in days from administration of first dose.

3 secondary outcomes

CD4 count and change of CD4 count from baseline
Time frame: From Day 0 to Month 12
Viral load and change in viral load from baseline
Time frame: From Day 0 to Month 12
Cluster of differentiation 40 ligand (CD40L+) CD4+ T-cell-mediated immune response (as measured by ICS)
Time frame: Months 0, 4, 12 and at Day 44

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
Derived from this study: PubMed 24144472Harrer T, Plettenberg A, Arasteh K, Van Lunzen J, Fatkenheuer G, Jaeger H, Janssens M, Burny W, Collard A, Roman F, Loeliger A, Koutsoukos M, Bourguignon P, Lavreys L, Voss G. Safety and immunogenicity of an adjuvanted protein therapeutic HIV-1 vaccine in subjects with HIV-1 infection: a randomised placebo-controlled study. Vaccine. 2014 May 7;32(22):2657-65. doi: 10.1016/j.vaccine.2013.10.030. Epub 2013 Oct 19.
Results for study 112353 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HIV Vaccine 732462 in people with AIDS, run by GlaxoSmithKline at 6 sites in Germany.

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 14 inclusion and 26 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 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 solicited local symptoms (time frame: During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)). The study lists 7 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 NCT00814762, 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 18 Jun 2018.