22 completed, 1 active not recruiting, 1 terminated. 24 Phase 1, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 24 | Completed 22, Active not recruiting 1, Terminated 1 |
| Phase 2 | 3 | Completed 3 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| First-in-Human Trial of the Novel Tuberculosis Vaccine Candidate, H107e/CAF®10b H107e, CAF®10b, H107e/CAF®10b - low adjuvant dose - Healthy | Phase 1 | Active not recruiting | Statens Serum Institut | 140 | 2024-03-14 | 2026-03-10 |
| Safety and Efficacy of R0.6C Vaccine R0.6C transmission blocking vaccine - Malaria, Malaria,Falciparum | Phase 1 | Completed | Radboud University Medical Center | 32 | 2021-05-17 | 2025-03-05 |
| Safety and Immunogenicity of a Chlamydia Vaccine CTH522 CTH522-CAF01 IM, CTH522-CAF09b IM, CTH522 ID - Trachoma | Phase 1 | Completed | Statens Serum Institut | 65 | 2020-02-17 | 2024-08-22 |
| Safety of Chlamydia Vaccine CTH522 in Healthy Women Aged 18 to 45 Years CTH522-CAF01, CTH522-Al(OH)3, Placebo - Chlamydia Trachomatis | Phase 1 | Completed | Statens Serum Institut | 35 | 2016-07-01 | 2017-08-10 |
| Therapeutic Vaccination and Immune Modulation - New Treatment Strategies for the MDR Tuberculosis Pandemic etoricoxib, H56:IC31 - Tuberculosis | Phase 1 | Completed | Anne Margarita Dyrhol Riise | 39 | 2015-11-01 | 2022-04-08 |
| Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents H4:IC31, H56:IC31, BCG - Tuberculosis | Phase 1 | Completed | Aeras | 84 | 2015-05-01 | 2019-11-18 |
| A Phase I Study of Safety & Immunogenicity of AERAS-456 in HIV-Neg. Adults Treated for Drug-susceptible Pulmonary TB H56:IC31, Placebo - Tuberculosis | Phase 1 | Completed | Aeras | 22 | 2014-11-21 | 2024-07-30 |
| 3 Adjuvated Reduced Dose IPV-Al SSI Vaccines and Non-adjuvated Full Dose IPV SSI, as Booster Vaccination to Adolescents 1/3 IPV-Al SSI, manufactured by SSI, Denmark, 1/5 IPV-Al SSI, manufactured by SSI, Denmark, 1/10 IPV-Al SSI, manufactured by SSI, Denmark - Immunization, Booster | Phase 1 / Phase 2 | Completed | Statens Serum Institut | 240 | 2014-11-13 | 2018-11-14 |
| A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456) H56ug/IC31nmol, Placebo - Latent Tuberculosis Bacteriology and Histology Unknown, Latent Tuberculosis | Phase 1 / Phase 2 | Completed | Aeras | 98 | 2013-08-01 | 2019-12-19 |
| Phase 1/II, Safety and Immunogenicity Study of AERAS-404 in BCG-Primed Infants AERAS-404, Placebo - Tuberculosis | Phase 1 / Phase 2 | Completed | Aeras | 243 | 2013-07-01 | 2018-04-09 |
| Safety and Immunogenicity Study of AERAS-456 Vaccine for Tuberculosis H56:IC31 - Latent Tuberculosis, Latent Tuberculosis Bacteriology and Histology Unknown | Phase 1 | Completed | Aeras | 25 | 2011-11-01 | 2019-08-21 |
| A Safety and Dose Finding Trial of C-Tb, When Given to Adult Patients Recently Diagnosed With Active Tuberculosis rdESAT-6 + rCFP-10 (C-Tb) - Tuberculosis | Phase 1 | Completed | Statens Serum Institut | 38 | 2010-01-01 | 2013-01-21 |
| Trial on the Safety of a New Liposomal Adjuvant System, CAF01, When Given With the Tuberculosis Subunit Vaccine Ag85B-ESAT-6 as Two Injections With Two Months Interval to Healthy Adult Volunteers 50 µg Ag85B-ESAT-6 alone, 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01, 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01 - Tuberculosis | Phase 1 | Completed | Statens Serum Institut | 38 | 2009-10-01 | 2013-01-21 |
| Immunization With HIV-1 Peptides in Adjuvant for Treatment of Patients With Chronic HIV-infection peptide vaccine (AFO-18) - HIV INFECTIONS | Phase 1 | Completed | Gitte Kronborg | 11 | 2009-09-01 | 2014-03-27 |
| HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease AFO-18, Saline - Aids, Cdc Group I | Phase 1 | Completed | Statens Serum Institut | 18 | 2009-08-01 | 2013-08-08 |
| A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Antigen (Ag85B-ESAT-6), Antigen (Ag85B-ESAT-6) with adjuvant (IC31) - Tuberculosis | Phase 1 | Completed | Statens Serum Institut | 39 | 2008-12-01 | 2015-04-17 |
| A Phase I Study to Evaluate Safety and Immunogenicity of AERAS 404 (C-011-404) AERAS-404 (mcg H4/nmol IC31), Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaCl - Tuberculosis | Phase 1 | Completed | Aeras | 40 | 2008-12-01 | 2016-04-27 |
| Safety and Risk of Sensitisation of the rdESAT-6 + rCFP-10 Skin Test Following Repeated Intradermal Administration rdESAT-6 + rCFP-10 - Tuberculosis | Phase 1 | Completed | Statens Serum Institut | 42 | 2008-11-01 | 2013-01-21 |
| A Phase I Study to Evaluate Safety and Immunogenicity of AERAS 404 Administered in Adults AERAS-404, Placebo - Tuberculosis | Phase 1 | Completed | Aeras | 60 | 2008-05-01 | 2014-03-17 |
| A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-404 Administered as Different Amounts of Antigen and Adjuvant Combinations in HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection AERAS-404, Placebo - Tuberculosis | Phase 1 | Completed | Aeras | 64 | 2007-11-01 | 2014-02-19 |
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Tuberculosis (15) · HIV Infections (2) · Latent Tuberculosis (2) · Acquired Immunodeficiency Syndrome (1) · Chlamydia Infections (1) · Disease (1) · Malaria (1) · Malaria, Falciparum (1) · Trachoma (1)
Sodium Chloride (2) · Adjuvants, Pharmaceutic (1) · Antigens (1) · Etoricoxib (1) · IC31 adjuvant (1) · Peptides (1) · Protein Subunit Vaccines (1) · Tromethamine (1)
South Africa (7) · Denmark (4) · Netherlands (4) · United Kingdom (4) · Finland (1) · Guinea-Bissau (1) · Norway (1) · Sweden (1)
Angelique Luabeya, MD (2) · Jaap van Dissel, MD, Prof. (2) · Zhongkai Shi, MD (2) · Alvaro Borges, MD (1) · Anders Fomsgaard, DMSc (1) · Anders Fomsgaard, MD (1) · Anders Fomsgaard, MD DMSc (1) · Ann Ginsberg, MD, PhD (1) · Anne Margarita Dyrhol-Riise, PhD (1) · Avy Violari, MD (1) · David JM Lewis, MD (1) · David JM Lewis, Professor (1) · Dereck Tait, MBChB (1) · Dereck Tait, MD (1) · Gavin Churchyard, PhD (1)
PMID 28216183, PMID 20226890, PMID 20593018, PMID 21178394, PMID 21256189, PMID 23314272, PMID 23634822, PMID 23691171, PMID 28027810, PMID 29321075, PMID 30092143, PMID 30888024, PMID 31416692, PMID 32382714, PMID 34811370, PMID 37721470, PMID 38396019, PMID 38615673, PMID 38649867
2014 (2), 2008 (1), 2009 (1), U01AI068632 (1)