Phase 1
Completed N=84
Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents
Source: ClinicalTrials.gov NCT02378207 ↗Enrolled (actual)
84
Serious AEs
2.4%
Results posted
Nov 2019
Primary outcomePrimary: Number of Participants With Adverse Events — 22; 20; 24; 10 participants
Summary
The aims of the phase 1b trial described here are to facilitate identification of assays and immune responses that could then be evaluated as correlates of risk and correlates of protection in efficacy studies and ultimately to provide leads for biomarkers of protection against tuberculosis. This study will complement one ongoing study (NCT02075203) evaluating the prevention of M. Tuberculosis infection using H4:IC31 (also known as AERAS-404).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
22; 20; 24; 10 | — |
| PRIMARY Percentage of Participants With Response Rates to TB Antigens as Compared to Baseline |
40.0; 45.0; 0.0; 0.0; 21.1; 5.6 | — |
| SECONDARY Evaluate Humoral Responses Elicited by the Different Vaccine Regimens. |
— | — |
| SECONDARY * Evaluate Immune Response From Vaccine Regimens by Measuring Early (Innate) Vaccine-induced Peripheral Blood Transcription Profiles; Determine Which Responses Are Associated With Antigen-specific Adaptive Responses * Evaluate Adaptive Immune Response. |
— | — |
| SECONDARY Evaluate Changes in Innate Cells in Response to the Vaccine Regimens |
— | — |
| SECONDARY Measure Non-classical Major Histocompatibility Complex (MHC)-Restricted T-cell Vaccine-induced Responses, Such as to Mycobacterial Lipids (CD1-restricted) and Metabolites (MR1-restricted). |
— | — |
| SECONDARY Evaluate QFT-GIT and ESAT-6 Free IGRA Discordance and Conversion/Reversion Rate During the Course of the Trial. |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age of 12 to ≤ 17 years at enrollment
- Minimum weight ≥ 40 kg
- Previous BCG vaccination at least 5 years ago documented by scarification or medical card
- No evidence of active TB disease, as determined by history, physical examination and, if deemed appropriate, sputum investigation and / or chest x-ray.
- Negative QFT-GIT test at screening, using the manufacturer's recommended threshold of 0.35 IU/mL
- Assessed by the clinic staff as being at low risk for HIV infection
- Hemoglobin ≥ 11.7 g/dL for females, ≥ 12.5 g/dL for males
- Negative HIV-1 and -2 blood test
- Agree to consistently use effective contraception for sexual activity that could lead to pregnancy from at least 20 days prior to enrollment through the last required protocol clinic visit.
(additional minor criteria not added due to space constraints)
Exclusion Criteria
- Blood products received within 120 days before first vaccination
- Investigational research agents received within 182 days before first vaccination
- Intent to participate in another study of an investigational research agent during the planned duration of the HVTN 602 / AERAS A-042 study
- Pregnant or breastfeeding
- History of alcohol or drug abuse
- A significant contact with active TB disease: for example, shared residency with an individual receiving anti-TB treatment, or with an individual known to have incompletely treated culture or smear positive TB
- TB prophylaxis within 90 days prior to enrollment
- History of treatment for active TB disease or latent Mtb infection
- Positive and indeterminate QFT-GIT result
- Received a tuberculin skin test (TST) within 90 days prior to enrollment
- Vaccines and other Injections
- Immunosuppressive medications received within 168 days before first vaccination.
- Serious adverse reactions to vaccines including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain.
- Immunoglobulin received within 60 days before first vaccination
- Autoimmune disease Not excluded: mild, well-controlled psoriasis
- Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. Including but not limited to: Diabetes mellitus type 1 or type 2, Thyroidectomy, or Thyroid disease, Asthma, Asplenia, Bleeding disorders, malignancy, Seizure disorder, and Angioedema
(additional minor criteria not added due to space constraints)
Data sourced from ClinicalTrials.gov (NCT02378207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.