A Phase 1 interventional study of HIV Vaccine 732462 and Placebo vaccine in AIDS, sponsored by GlaxoSmithKline. Completed at 6 sites in Germany. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-06-18.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Other
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.
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.
GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
All subjects must satisfy the following criteria at screening and before vaccination:
Additional inclusion criteria for subjects enrolled in the first cohort (HIV-infected subjects receiving HAART):
Additional inclusion criteria for subjects enrolled in second cohort (treatment-naïve HIV-infected subjects):
Exclusion Criteria:
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:
Unstable asthma defined as:
Subjects received 2 doses of the HIV Vaccine 732462 into the deltoid muscle of the dominant arm, on a 0, 1 Month schedule.
Biological: HIV Vaccine 732462
Subjects received 2 doses of the placebo vaccine into the deltoid muscle of the dominant arm, on a 0, 1 Month schedule.
Biological: Placebo vaccine
Two doses reconstituted adjuvanted vaccine, injected intramuscularly, at an interval of approximately one month.
Two doses of placebo, injected intramuscularly, at an interval of approximately one month
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: From Day 0 to Month 12
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.
Time frame: 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.
Time frame: 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.
Time frame: Months 0, 4, 12 and at Day 44
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline