A-043 Phase II study to Evaluate Safety, Immunogencity and Prevention of Infection with Mtb of H56:IC31 in Healthy Adolescents

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201704002006214
• Date of registration: 30/01/2017
• Prospective Registration: Yes
• Primary sponsor: Aeras
• Public title: A-043 Phase II study to Evaluate Safety, Immunogencity and Prevention of Infection with Mtb of H56:IC31 in Healthy Adolescents
• Scientific title: A Randomized, Placebo Controlled, Double-Blind Phase II Study to Evaluate Safety, Immunogencitiy and Prevention of Infection with Mycobacterium tuberculosis (Mtb) of H56:IC31 in Healthy Adolescents
• Date of first enrolment: 30/06/2017
• Target sample size: 1400
• Recruitment status: Pending
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2006
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,random numbers generated by IWRS; stratified by site,Central randomization by phone/internet
• Phase: Not Applicable

Countries of recruitment

South Africa, Tanzania

Contacts

• Name: Dereck Tait
• Affiliation: Sr. Director Clinical Development/Aeras

• Name: Dereck Tait
• Affiliation: Sr. Director Clinical Development/Aeras

Key inclusion & exclusion criteria

Inclusion criteria: 1. Has completed the written informed consent and assent process
2. Is age ¿ 12 years and ¿ 17 years on Study Day 0
3. Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study
4. For female participants: agrees to avoid pregnancy from 21 days prior to Study Day 0 through 6 months after the last study vaccination. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, or intrauterine device (IUD)
5. Has general good health, confirmed by medical history and physical examination
6. Had BCG vaccination at least 5 years ago documented by confirmation of parent/guardian that the participant received all childhood vaccines or by presence of healed BCG scar
7. Tests ESAT-6 free IGRA and QFT-Plus negative at screening, using a pre-determined threshold for ESAT-6 free IGRA and the manufacturer¿s recommended threshold for QFT-Plus of 0.35 IU/mL in either of the TB antigen tubes after nil-subtraction


Exclusion criteria: 1.Acute illness on Study Day 0
2.Axillary temperature <37.5 C on Study Day 0
3.Abnormal laboratory values from the most recent blood collected prior to randomization as follows (abnormal results may be repeated once and if found to be resolved the participant will not be excluded):
4.Urinalysis abnormality greater than Grade 1 on the Toxicity Scale (with the exception of hematuria in a menstruating female), or urinalysis abnormality judged clinically significant by the investigator
5.History or evidence of any clinically significant systemic disease, or any acute or chronic illness that might affect the safety, immunogenicity, or efficacy of investigational product in the opinion of the investigator
6.History of treatment for active TB disease or latent Mtb infection
7.History or evidence, including chest X-ray, of active TB disease
8.Shared household with an individual receiving anti-TB treatment, or known to have incompletely treated culture or smear positive TB, at screening
9.History of autoimmune disease or immunosuppression
10.Used immunosuppressive medication within 42 days before Study Day 0 (inhaled and topical corticosteroids are permitted)
11.Received immunoglobulin or blood products within 42 days before Study Day 0
12.Received any investigational drug or investigational vaccine within 180 days before Study Day 0, or planned participation in any other clinical trial during the study period
13.Received investigational TB vaccine at any time prior to Study Day 0
14.Administration of a licensed vaccine in the period starting 28 days before and ending 28 days after each dose of investigational product
15.History or laboratory evidence of any past or present possible immunodeficiency state.
16.History of allergic disease or reactions.
17.History of alcohol or drug abuse
18.Any female currently pregnant or lactating/nursing, or positive urine pregnancy test
19.Received a tuberculin skin test (TST) within 3 months (90 days) prior to Study day 0


Age minimum: 12 Year(s)
Age maximum: 17 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis

Tuberculosis

Intervention(s)

Placebo

H56:IC31

Primary Outcome(s)

Frequency and severity of Adverse Events

ESAT-6 free IGRA conversion from a negative to a positive test after day 84

Secondary Outcome(s)

¿ Primary ESAT-6 free IGRA conversion from a negative to a positive test at any time point after Day 84 and through end of follow up for the primary endpoint, AND persisting without ESAT-6 free IGRA reversion from a positive to a negative test through 6 months after ESAT-6 free IGRA conversion.

Initial ESAT-6 free IGRA reversion from a positive to a negative test at any time point after primary ESAT-6 free IGRA conversion through the end of follow up.

Primary ESAT-6 free IGRA conversion from a negative to a positive test at any time point after Day 84 and through end of follow up for the primary endpoint, AND persisting without ESAT-6 free IGRA reversion from a positive to a negative test through 6 months after ESAT-6 free IGRA conversion.

Primary ESAT-6 free IGRA conversion from a negative to a positive test at any time point after randomization and through end of follow up for the primary endpoint, AND persisting without ESAT-6 free IGRA reversion from a positive to a negative test through 6 months after ESAT-6 free IGRA conversion.

Source(s) of Monetary Support

GLOBVAC

Wellcome Trust

Ethics review

Status: Not approved
Approval date:
Contact:

University of Witwatersrand Ethics Committee