- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01017536
Safety and Immunogenicity of AERAS-402 in HIV-infected, Bacillus Calmette-Guerin (BCG)-Vaccinated Adults
25 juli 2016 uppdaterad av: Aeras
Phase II Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of AERAS-402 in HIV-infected, BCG-vaccinated Adults With CD4+ Lymphocyte Counts Greater Than 350 Cells/mm3
This was a Phase II, randomized, double-blind, placebo-controlled trial conducted at 1 site in South Africa.
A total of 26 subjects were randomized 1:1 to receive 2 doses of either AERAS-402 at 3 x 10^10 vp (N=13) or placebo (N=13) on Study Days 0 and 28.
Dose-escalation to a second group of 40 subjects was planned, but although no safety concerns were identified, the sponsor decided not to continue the study.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Further study details as provided by Aeras.
Studietyp
Interventionell
Inskrivning (Faktisk)
26
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
North-West
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Klerksdorp, North-West, Sydafrika, 2570
- Aurum Institute
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år till 45 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Age 21 years through 45 years (i.e., subject had not yet reached his/her 46th birthday at day of randomization).
- Had completed the written informed consent process prior to undergoing any screening evaluations.
- Had BCG vaccination at least 5 years previously, documented by medical history or presence of scar.
- Females: Ability to avoid pregnancy for at least 6 months after receiving the last study vaccination: Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) must have avoided pregnancy from 28 days prior to administration of the study vaccine and must have agreed to avoid pregnancy through at least 6 months after receiving the last study vaccination. Acceptable methods of avoiding pregnancy included a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), or use of a combination of at least two forms of acceptable contraception: hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), and the use of a condom or a diaphragm; or the use of a condom or a diaphragm combined with spermicide.
- Was able to carry out activities of daily living independently.
- Had Body Mass Index (BMI) of at least 19 (wt./ht.2) by nomogram.
- Had ability to complete follow-up period as required by the protocol.
- Was able and willing to commit to avoiding elective surgery for at least 6 months after receiving the last study vaccination.
- Was able and willing to stay in contact with the study site for the duration of the study.
- Had committed to simultaneous enrollment in Aeras Vaccine Development Registry Protocol.
- Had laboratory evidence of human immunodeficiency virus (HIV) infection, defined as a positive HIV-1 ELISA test plus a positive confirmatory test (e.g., a second HIV-1 ELISA, PCR, or rapid ELISA).
- Had four (4) (for Group 1) or three (3) (for Group 2)* CD4+ lymphocyte count tests, each performed at least four days apart within the 42-day screening period, with at least three (for Group 1) or two (for Group 2) CD4+ lymphocyte count results greater than 350 cells / mm3.
- Not currently receiving antiretroviral drugs.
- Committed to not participate in any other clinical trials during the first 12 months of participation in this study.
Exclusion Criteria:
- Acute illness.
- Fever ≥37.5°C.
- Significant symptomatic infection.
- Used immunosuppressive medication within 42 days prior to randomization (inhaled and topical corticosteroids were permitted).
- Received immunoglobulin or blood products within 42 days prior to randomization.
- Received any investigational drug therapy or vaccine within 182 days prior to randomization.
- History of having received any adenovirus-vector-based vaccine.
- Medical history that may have compromised the evaluation of safety of the subject in the study (e.g., diabetes, seizure disorder, sickle cell disease).
- Pregnant or breastfeeding female, or intention to become pregnant during the study within 6 months after receiving the last study vaccination.
- Liver function tests >Grade 2 per the toxicity table.
- Currently receiving treatment for TB, or evidence of active TB disease based on history, physical examination, chest X-ray, or laboratory evaluation (INH prophylaxis was permitted).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: Placebo
Thirteen subjects received placebo vaccine that did not contain any AERAS-402.
|
Placebo was the identical buffer solution in which AERAS-402 is formulated.
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Experimentell: Investigational Vaccine
Thirteen subjects received active vaccine 3 x 10^10 vp AERAS-402.
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AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
CD4+ Lymphocyte Count
Tidsram: CD4+ counts from samples collected on Study days 0 and 182.
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Assess the effect of AERAS-402 on the CD4+ lymphocyte count after 6 months in HIV-infected, BCG-vaccinated adult subjects with no evidence of active tuberculosis (TB disease) Change in cells/mm^3 pre-vaccination to Study Day 182
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CD4+ counts from samples collected on Study days 0 and 182.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in HIV Viral Load in HIV-infected, BCG-vaccinated Adult Subjects Before and After Administration of AERAS-402 (From Day 1 to Day 182)
Tidsram: 6 months (day 182) post Study Day 0 vaccination.
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6 months (day 182) post Study Day 0 vaccination.
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Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease
Tidsram: Study days 28 and 56
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Intracellular cytokine staining (ICS) assay immune response was expressed as the percentage of CD4+ and CD8+ T cells producing any one of three cytokines (IFN-γ, TNF-α, or IL-2) or any combination of the three cytokines simultaneously after stimulation with Ag85A, Ag85B, and TB10.4 peptide pools.
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Study days 28 and 56
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Bernard Landry, MPH, Aeras
- Huvudutredare: Gavin Churchyard, MD, PhD, Aurum Institute
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2009
Primärt slutförande (Faktisk)
1 mars 2012
Avslutad studie (Faktisk)
1 maj 2012
Studieregistreringsdatum
Först inskickad
18 november 2009
Först inskickad som uppfyllde QC-kriterierna
18 november 2009
Första postat (Uppskatta)
20 november 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
9 september 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 juli 2016
Senast verifierad
1 juli 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- C-017-402
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
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