Phase 2 N=30 Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
Cystic Fibrosis · Bronchiectasis Adult · Non-Tuberculous Mycobacteria
Primary: BCG Uptake — 48.06; 0.84; 35.97 spot forming units
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=15 γ-irradiated BCG to Train Innate Immunity
Innate Immune Response
Primary: Cytokine Production Measured by ELISA Compared to Baseline — 1.2 ratio
Phase 1 N=12 Aerosol BCG Challenge Study in Historically BCG-vaccinated Volunteers
Tuberculosis
Primary: To Quantify BCG Recoverable From Bronchial Sample — 0; 0; 0; 0 Volunteers with detectable BCG
N/A N=96 Comparative Study of Bacille Calmette Guerin (BCG) Delivery Via Disposable Syringe Jet Injector and Needle & Syringe
Tuberculosis
Primary: Injection Site Adverse Events (Following Injection) — 138; 141; 126; 146 Adverse events — p=0.475
Phase 2 N=149 Early Versus Delayed BCG Vaccination of HIV-exposed Infants
HIV Exposure · HIV Infection
Primary: T Cell Activation — 1.8; 1.3 percentage of CD4+ T cells
Phase 3 N=1,676 Using BCG to Protect Senior Citizens During the COVID-19 Pandemic
Covid19 · Non-specific Effects of Vaccines · Heterologous Immunity
Primary: Acute Infection — 424; 469; 212; 236 Events — p=< 0.05
Phase 1 N=36 Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.
Tuberculosis · Healthy
Primary: Number of Participants With Adverse Events up to 210 Days After Vaccination — 9; 9; 9; 9 participants
Phase 4 N=659 BCG Vaccine for Health Care Workers as Defense Against COVID 19
Coronavirus · Coronavirus Infection · Coronavirus as the Cause of Diseases Classified Elsewhere
Primary: Number of New COVID 19 Infections — 25; 21 Participants
Phase 4 N=4,262 Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children.
Prospective · Single-blind · Clinical
Primary: All-cause Hospitalisations — 637; 633 Events
Phase 1 N=20 Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines
Tuberculosis
Primary: Assess Viable BCG Bacteria From Intradermal Challenge Site From Culture. — 20,440; 80; 5; 10,673 CFU
Phase 2 N=20 A Pilot Study of the Effects of BCG Immunization on CSF and Blood-based Biomarkers in Older Adults.
Healthy
Primary: Median Fold Change of Cytokine Levels From Day 0 to Day 90 — 3254; 1.997; 16.83; -33.89 pg/mL
Phase 1 N=84 Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents
Tuberculosis
Primary: Number of Participants With Adverse Events — 22; 20; 24; 10 participants
Phase 2 N=98 A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456)
Latent Tuberculosis Bacteriology and Histology Unknown · Latent Tuberculosis
Primary: Number and Percentage of Unsolicited and Solicited Adverse Events Recorded Post Day 0 Vaccination. — 7; 8; 15; 15 Participants
Phase 1 N=6 Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas
Transitional Cell Carcinoma
Primary: Number of Participants With Dose Limiting Toxicities — 0; 0; 0; 0 Participants
Phase 2 N=989 Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents
Tuberculosis
Primary: Safety Profile of H4:IC31 and BCG Revaccination in HIV-uninfected, Remotely BCG Vaccinated Adolescents. — 286; 1257; 272 number of AEs
Phase 2 N=625 DAR-901 TB Booster Vaccine to Prevent TB in Adolescents
Tuberculosis
Primary: New Infection With Mycobacterium Tuberculosis — 19; 18 Participants
N/A N=150 Specificity Trial of the Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers
Tuberculosis
Primary: Number of the Volunteers With the True Negative RTA Result — 145; 5 Participants
Phase 2 N=487 Study of AERAS-402 in Healthy Infants
Tuberculosis
Primary: Adverse Events Collected Per Subject — 94.2; 96.1; 100.0; 100.0 percentage of subjects with an AE
Phase 2 N=26 Safety and Immunogenicity of AERAS-402 in HIV-infected, Bacillus Calmette-Guerin (BCG)-Vaccinated Adults
Tuberculosis · HIV Infections
Primary: CD4+ Lymphocyte Count — -136.0; -107.0 cells/mm^3
Phase 2 N=180 Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults
Tuberculosis
Primary: Number of Subjects With Solicited Local Symptoms — 8; 3; 35; 33 Subjects
Phase 2 N=37 Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.
Tuberculosis
Primary: Number of Subjects With Solicited Local Symptoms — 20; 6; 1; 1 Subjects
Phase 2 N=300 Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Healthy Infants
Tuberculosis
Primary: Number of Subjects With Grade 3 Solicited Local Symptoms After Dose 1, Dose 2 and Across Doses — 0; 0; 0; 0 Participants
Phase 3 N=750 Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine
Poliomyelitis
Primary: Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity — 187; 179; 175; 149 Participants
Phase 2 N=15 A Trial to Evaluate the Effects of BCG in Adults With MCI and Mild-to-Moderate AD
Mild Cognitive Impairment · Mild Dementia · Moderate Dementia
Primary: Blood Biomarkers of Pharmacodynamic Response- Cytokines — 26.672; 190.829; 20.309; 2293.879 picogram/milliliter (pg/ml)
Phase 2 N=45 Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid
Botulism
Primary: Four-Fold Increase in Neutralizing Antibody Concentration (NAC) — 0.75; 0.84; 0.75; 0.89 proportion of participants
Phase 2 N=32 Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG®
Botulism
Primary: Proportion of Subjects Achieving Greater Than 3- or 4-Fold Increases in Neutralizing Antibody Concentration (NAC) — .844; .938; .875; .906 proportion of participants
N/A N=305 Boostrix® Pregnancy Registry
Pertussis
Primary: Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy…
Phase 2 N=523 Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally
Smallpox
Primary: Geometric Mean Titer (GMT) Based on Vaccinia-specific Individual Peak Plaque Reduction Neutralization Titers (PRNT) Following 2 Doses of IMVAMUNE® Lyophilized Versus…
Phase 2 N=32 Study of Bacillus Calmette-Guerin (BCG) Combined With PANVAC Versus BCG Alone in Adults With High Grade Non-Muscle Invasive Bladder Cancer Who Failed At Least 1 Course of BCG
Bladder Cancer
Primary: Percentage of Participants Without Recurrence (Recurrence-free Survival (RFS)) With Bacillus Calmette-Guerin (BCG) + PANVAC Compared With BCG Alone at 6 and 12 Months…
Phase 1 N=24 A Study to Assess Safety, Tolerability and Immunogenicity of the Live Attenuated hRSV Vaccine rBCG-N-hRSV
Respiratory Syncytial Virus Infections
Primary: Number of Subjects With Required Adverse Events Grade II, III, and IV, Laboratory Adverse Events Grade II, III, and IV, and Severe Considered Adverse Events Related to…