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Also known as GSK Biologicals' HIV vaccine (732461)
GSK Biologicals' HIV vaccine · 1 trial · 1 indication
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).
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| GSK732461 Group | ACTIVE_COMPARATOR | Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' HIV vaccine (732461) | BIOLOGICAL | 1 dose intramuscular injection |
| Chloroquine | DRUG | One dose of 300 mg |
Inclusion Criteria: * A male or female between, and including, 18 to 52 years of age at the time of vaccination. * Written informed consent prior to any study related procedure on the subject. * Subjects who the investigator believes that they can and will comply with the requirements of the protoc...
GSK Biologicals' HIV vaccine is an investigational vaccine candidate developed by GSK plc for AIDS. It is a Phase 2 preventive vaccine studied in healthy adult volunteers. It is not an approved product and remains in clinical development.
GSK Biologicals' HIV vaccine is being studied for AIDS, specifically to evaluate the immune response it generates in healthy volunteers. The completed Phase 2 trial administered one chloroquine dose alongside the candidate vaccine to assess immune response in adults aged 18 years and older.
GSK Biologicals' HIV vaccine is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the vaccine unit associated with the candidate. The company sponsored the Phase 2 study of the vaccine in Belgium.
GSK Biologicals' HIV vaccine is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The vaccine is investigational and has not been approved for use.
GSK Biologicals' HIV vaccine was studied in the completed Phase 2 trial NCT00972725, titled Evaluation of the Immune Response of a HIV Candidate Vaccine After Administration of One Chloroquine Dose. The trial enrolled 28 healthy volunteers in Belgium, was randomized, and used an active control.
Yes, GSK Biologicals' HIV vaccine is also known as GSK Biologicals' HIV vaccine (732461). The number 732461 is an alternate identifier used for the same GSK plc vaccine candidate studied in the Phase 2 AIDS trial.