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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
| Naval Medical Research Center | FED |
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This is a phase I, single-blind, randomized, placebo-controlled, single-center study in healthy subjects using a staggered approach to dosing.
30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without adjuvant or placebo.
A total of 30 subjects will be randomly assigned to one of 3 different arms in order to evaluate the safety, tolerability and immunogenicity of a candidate vaccine, formulated with or without adjuvant, and the outcome compared to a placebo control group.
For each active treatment group, 12 subjects will be injected twice with 10 μg Flexyn2a candidate vaccine 4 weeks apart. A control group with 6 subjects will be injected following the same schedule with a placebo solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flexyn2a | Active Comparator | 2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart |
|
| Flexyn2a plus adjuvant | Active Comparator | 2 doses of 10 μg of Flexyn2a plus adjuvant will be injected intramuscularly 4 weeks apart |
|
| Placebo | Placebo Comparator | 2 doses of saline buffer plus adjuvant will be injected intramuscularly 4 weeks apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexyn2a | Biological | Intramuscular doses of 0.5 mL |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and severity of adverse events | Number and severity of local site injection and general adverse events will be collected and compared between the different arms of the study | until Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of antigen-specific antibodies between baseline (D0) and after injection for all groups. | Immunogenicity will be evaluated after the first and second injection and compared to pre-immune levels | until Day 56 |
| Evaluation of antigen-specific antibodies between subjects receiving the candidate vaccine with and without adjuvant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark S. Riddle, MD Dr Ph | Navy Medical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WRAIR Clinical Trial Center (CTC) | Silver Spring | Maryland | 20910 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27581434 | Derived | Riddle MS, Kaminski RW, Di Paolo C, Porter CK, Gutierrez RL, Clarkson KA, Weerts HE, Duplessis C, Castellano A, Alaimo C, Paolino K, Gormley R, Gambillara Fonck V. Safety and Immunogenicity of a Candidate Bioconjugate Vaccine against Shigella flexneri 2a Administered to Healthy Adults: a Single-Blind, Randomized Phase I Study. Clin Vaccine Immunol. 2016 Dec 5;23(12):908-917. doi: 10.1128/CVI.00224-16. Print 2016 Dec. |
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| ID | Term |
|---|---|
| D004405 | Dysentery, Bacillary |
| ID | Term |
|---|---|
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000277 | Adjuvants, Pharmaceutic |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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| Biological |
Intramuscular doses of 0.5 mL |
|
| Flexyn2a plus adjuvant | Biological | Intramuscular doses of 0.5 mL |
|
Immunogenicity will be compared between subjects receiving candidate vaccine with and without adjuvant after the first and second injection |
| until Day 56 |
| D007239 | Infections |
| D004403 | Dysentery |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |