Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for AIDS, a condition caused by HIV infection. It is currently in Phase 2 clinical development and is not yet approved for use. The vaccine is designed to elicit an immune response against HIV, though it is still under investigation.
GSK Biologicals' HIV vaccine is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is in Phase 2 clinical development for AIDS and is being studied as a preventive or therapeutic intervention, though it remains investigational.
GSK Biologicals' HIV vaccine is in Phase 2 clinical development. It is an investigational vaccine for AIDS and has completed one Phase 2 trial. It is not FDA approved and remains in clinical testing to evaluate its safety and immune response.
GSK Biologicals' HIV vaccine has one 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 participants in Belgium and was active-controlled, though it did not use a double-blind design.
GSK Biologicals' HIV vaccine is classified as a monoclonal antibody modality, though it is referred to as a vaccine. It is being studied for AIDS in a Phase 2 trial. The trial NCT00972725 evaluated the immune response after administration of one chloroquine dose.