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Clinical Trials/NCT00972725
NCT00972725
Completed
Phase 2

A Study to Evaluate the Safety and Immunogenicity of a Booster Dose of GSK Biologicals' HIV Candidate Vaccine (732461) After Administration of Chloroquine in Healthy Adults.

GlaxoSmithKline1 site in 1 country28 target enrollmentDecember 1, 2009

Overview

Phase
Phase 2
Intervention
GSK Biologicals' HIV vaccine (732461)
Conditions
AIDS
Sponsor
GlaxoSmithKline
Enrollment
28
Locations
1
Primary Endpoint
Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the safety and reactogenicity of one booster dose of a HIV candidate vaccine after administration of one oral dose of chloroquine.

Detailed Description

The Protocol Posting has been updated following Protocol amendment 1, October 2009.

Registry
clinicaltrials.gov
Start Date
December 1, 2009
End Date
October 4, 2010
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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 protocol.
  • Good general health without significant medical history or physical examination findings.
  • Negative for anti-HBc and anti-Hepatitis C Virus antibodies.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception until study completion.

Exclusion Criteria

  • Clinically significant laboratory value above normal range for blood urea nitrogen, creatinine, alanine aminotransferase and aspartate aminotransferase, or clinically significant laboratory value above or below normal range for Hemoglobin, as per investigator judgment.
  • Women who are pregnant or breast-feeding.
  • Receipt of live attenuated vaccines within 30 days of vaccination.
  • Receipt of medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) or allergy treatment with antigen injections (including a tuberculin skin test) within \<= 21days preceding and planned \<= 21 days following the study vaccine administration.
  • Receipt of blood products 120 days prior to vaccination.
  • Receipt of immunoglobulin 120 days prior to vaccination.
  • Subject has donated blood in the last 3 months.
  • Bleeding disorder that was diagnosed by a physician; e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first.
  • History of serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema and abdominal pain.

Arms & Interventions

GSK732461+Nivaquine Group

Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.

Intervention: GSK Biologicals' HIV vaccine (732461)

GSK732461+Nivaquine Group

Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.

Intervention: Chloroquine

GSK732461 Group

Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.

Intervention: GSK Biologicals' HIV vaccine (732461)

Outcomes

Primary Outcomes

Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens

Time Frame: At Day 14

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).

Number of Subjects With Solicited Local Symptoms

Time Frame: During the 7 Day (Days 0-6) post-vaccination period

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 Solicited General Symptoms

Time Frame: During the 7 Day (Days 0-6) post-vaccination period

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.

Number of Subjects With Unsolicited Adverse Events (AEs)

Time Frame: During the 32 Day (Days 2-29) post-chloroquine administration and during the 30 Day (Days 0-29) post-vaccine administration period

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.

Number of Subjects With Serious Adverse Events (SAEs)

Time Frame: During the entire study period (from Day 0 up to Day 360)

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 AEs of Specific Interest and Immune-Mediated Disorders (IMDs)

Time Frame: During the entire study period (from Day 0 up to Day 360)

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.

Levels of Haematological and Biochemical Parameters

Time Frame: At Day 180

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.

Secondary Outcomes

  • Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine(At Day 0, 7, 14, 30 and 180)
  • Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine(At Day 0, 7, 14, 30 and 180)
  • Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine(At Day 0, 7, 14, 30 and 180)
  • Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine(At Day 0, 7, 14, 30 and 180)
  • Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine(At Day 0, 7, 14, 30 and 180)
  • Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine(At Day 0, 7, 14, 30 and 180)
  • Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine(At Day 0, 7, 14, 30 and 180)
  • Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens(At Day 0, 7, 14, 30 and 180)
  • Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines(At Day 0, 7, 14, 30 and 180)
  • Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines(At Day 0, 7, 14, 30 and 180)
  • Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines(At Day 0, 7, 14, 30 and 180)
  • Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines(At Day 0, 7, 14, 30 and 180)
  • Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines(At Day 0, 7, 14, 30 and 180)
  • Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines(At Day 0, 7, 14, 30 and 180)
  • Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines(At Day 0, 7, 14, 30 and 180)
  • Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines(At Day 0, 7, 14, 30 and 180)
  • Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations(At Day 0, 7, 14, 30 and 180)

Study Sites (1)

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