Phase 1 ID93 + GLA-SE Vaccine Trial in BCG-Vaccinated Healthy Adult Volunteers

NCT01927159 | Completed Phase 1 DMC

• 1 other identifier: IDRI-TBVPX-114
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety, tolerability, and immunogenicity in BCG-vaccinated healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis.

Conditions

Pulmonary Tuberculosis

Keywords

Tuberculosis; TB; Pulmonary; Vaccine; Adjuvant

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  Solicited and unsolicited adverse events will be recorded for 28 days following each study injection; serious adverse events and adverse events of special interest will be recorded for the duration of the study.

  294 days

Secondary Outcomes (1)

• Immunogenicity

  Days 0, 14, 42, 112, 126, 196, 294

Study Arms (5)

10 mcg ID93 + 2 mcg GLA-SE Vaccine (QFT-)

EXPERIMENTAL

Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 112. High dose of antigen and low dose of adjuvant. This group limited to adults with negative Quantiferon Gold TB (QFT) test.

Biological: ID93 + GLA-SE

2 mcg ID93 + 2 mcg GLA-SE Vaccine

EXPERIMENTAL

Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 112. Low dose of antigen and low dose of adjuvant.

Biological: ID93 + GLA-SE

10 mcg ID93 + 2 mcg GLA-SE Vaccine

EXPERIMENTAL

Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 112. High dose of antigen and low dose of adjuvant.

Biological: ID93 + GLA-SE

10 mcg ID93 + 5 mcg GLA-SE Vaccine

EXPERIMENTAL

Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 112. High dose of antigen and high dose of adjuvant.

Biological: ID93 + GLA-SE

Saline

PLACEBO COMPARATOR

Three intramuscular injections of saline at Days 0, 28, and 112.

Other: Placebo

Interventions

ID93 + GLA-SE BIOLOGICAL

10 mcg ID93 + 2 mcg GLA-SE Vaccine; 10 mcg ID93 + 2 mcg GLA-SE Vaccine (QFT-); 10 mcg ID93 + 5 mcg GLA-SE Vaccine; 2 mcg ID93 + 2 mcg GLA-SE Vaccine

Placebo OTHER

Saline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Has completed the written informed consent process prior to start of screening evaluations
• Male or female who is ≥18 years and ≤50 years of age at the time of randomization
• 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
• Agrees to avoid elective surgery for the full duration of the study
• For female participants: agrees to avoid pregnancy from 21 days prior to Study Day 0 and for the full duration of the study. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) 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, intrauterine device (IUD), or the combination of a condom or diaphragm with spermicide gel
• Has general good health, confirmed by medical history and physical examination
• Has body mass index (BMI) between 19 and 33 (weight/height2) by nomogram
• Had BCG vaccination at least 5 years ago, documented through medical history or presence of scar

You may not qualify if:

• Acute illness at the time of randomization
• Oral temperature ≥37.5°C at the time of randomization
• Clinically significant abnormal laboratory values for any of the following screening laboratory parameters, per local laboratory normal ranges from blood collected within 30 days prior to Study Day 0 randomization as follows:
• hemoglobin, hematocrit, absolute neutrophil count, absolute lymphocyte count, or platelet count below lower limit of normal (LLN)
• white blood cell count above upper limit of normal (ULN) or below LLN (i.e., must be within normal limits)
• ALT, AST, total bilirubin, alkaline phosphatase, creatinine, or blood urea nitrogen (BUN) above ULN
• Evidence of systemic or local disease process on screening urinalysis
• Evidence of significant active infection
• History of treatment for active or latent tuberculosis or evidence of active tuberculosis
• Shared a residence within the last year prior to randomization with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis
• History of autoimmune disease or immunosuppression
• Used immunosuppressive medication within 42 days before randomization (inhaled and topical corticosteroids are permitted)
• Received immunoglobulin or blood products within 42 days before randomization
• Received any investigational drug therapy or investigational vaccine within 182 days before randomization, or planned participation in any other investigational study during the study period
• Received investigational Mtb vaccine at any time prior to randomization

Sponsors & Collaborators

• Access to Advanced Health Institute (AAHI): lead
• Aeras: collaborator
• South African Tuberculosis Vaccine Initiative: collaborator

Study Sites (1)

SATVI

Worcester, Western Cape, 6850, South Africa

Location

Related Publications (1)

• Penn-Nicholson A, Tameris M, Smit E, Day TA, Musvosvi M, Jayashankar L, Vergara J, Mabwe S, Bilek N, Geldenhuys H, Luabeya AK, Ellis R, Ginsberg AM, Hanekom WA, Reed SG, Coler RN, Scriba TJ, Hatherill M; TBVPX-114 study team. Safety and immunogenicity of the novel tuberculosis vaccine ID93 + GLA-SE in BCG-vaccinated healthy adults in South Africa: a randomised, double-blind, placebo-controlled phase 1 trial. Lancet Respir Med. 2018 Apr;6(4):287-298. doi: 10.1016/S2213-2600(18)30077-8.

  PMID: 29595510 DERIVED

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michele Tameris, M.B.Ch.B.

  SATVI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 22, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

ZA (1)