A Phase 1/2 interventional study of Placebo and WRAIR-PAM-CF1 in Bacterial Disease Carrier and Cystic Fibrosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1/2, Interventional, and Treatment
This is a phase 1b/2 study of a single dose of intravenous (IV) bacteriophage in males and non-pregnant females, at least 18 years old, diagnosed with Cystic Fibrosis (CF). This clinical trial is designed to assess the safety and microbiological activity of bacteriophage product Walter Reed Army Institute of Research- PAM-Cystic Fibrosis1 (WRAIR-PAM-CF1), directed at Pseudomonas aeruginosa in clinically stable CF individuals chronically colonized with P. aeruginosa. WRAIR-PAM-CF1 is a 4 component anti-pseudomonal bacteriophage mixture containing between 4 x 10\^7 and 4 x 10\^9 Plaque Forming Units (PFU) of bacteriophage. Enrollment will occur at up to 20 clinical sites in the United States. In stage 1, two eligible subjects will be assigned to each of the three dosing arms receiving a single dosage of the IV bacteriophage therapy (4 x 10\^7 PFU, 4 x 10\^8 PFU, and 4 x 10\^9 PFU; total of 6 sentinel subjects), followed by 30 plus or minus 7 days observation period. If no Serious Adverse Events (SAEs)(related to the study product) are identified during the 96 hours after bacteriophage administration for all Sentinel Subjects in Stage 1, the study will proceed to Stage 2. In Stage 2a, 32 subjects will be enrolled into one of 4 arms (placebo IV, 4 x 10\^7 PFU, 4 x 10\^8 PFU, and 4 x 10\^9 PFU) in a 1:1:1:1 allocation. An interim analysis will be performed after all subjects have completed follow up visit 5 on Day 8+3 to select the IV bacteriophage dose with the most favorable safety and microbiological activity profile. During Stage 2b, subjects will be randomized into the bacteriophage (dose selected based on Interim Analysis following Stage 2a) or placebo arm. The final sample size is expected to be up to 72 subjects total with up to 25 subjects in the placebo arm and up to 25 subjects in the Stage 2b bacteriophage dose.
This is a phase 1b/2, multicenter, randomized placebo-controlled double-blind study of a single dose of intravenous (IV) bacteriophage in males and non-pregnant females, at least 18 years old, diagnosed with Cystic Fibrosis (CF). This clinical trial is designed to assess the safety and microbiological activity of bacteriophage product Walter Reed Army Institute of Research- PAM-Cystic Fibrosis1 (WRAIR-PAM-CF1), directed at Pseudomonas aeruginosa (P. aeruginosa) in clinically stable CF individuals chronically colonized with P. aeruginosa. WRAIR-PAM-CF1 is a 4 component anti-pseudomonal bacteriophage mixture containing between 4 x 10\^7 and 4 x 10\^9 Plaque Forming Units (PFU) of bacteriophage. Enrollment will occur at up to 20 clinical sites in the United States. In stage 1, two sentinel subjects will be assigned to each of the three dosing arms receiving a single dosage of the IV bacteriophage therapy (4 x 10\^7 PFU, 4 x 10\^8 PFU, and 4 x 10\^9 PFU; total of 6 sentinel subjects), followed by 30 plus or minus 7 days observation period. If no Serious Adverse Events (SAEs) (related to the study product) are identified during the 96 hours after bacteriophage administration for all Sentinel Subjects in Stage 1, the study will proceed to Stage 2. In Stage 2a, 32 subjects will be enrolled into one of 4 arms (placebo IV, 4 x 10\^7 PFU, 4 x 10\^8 PFU, and 4 x 10\^9 PFU) in a 1:1:1:1 allocation. An interim analysis will be performed after all subjects have completed follow up visit 5 on Day 8+3 to select the IV bacteriophage dose with the most favorable safety and microbiological activity profile. During Stage 2b, subjects will be randomized into the bacteriophage (dose selected based on Interim Analysis following Stage 2a) or placebo arm. The final sample size is expected to be up to 72 subjects total with up to 25 subjects in the placebo arm and up to 25 subjects in the Stage 2b bacteriophage dose. The primary objectives of this study are to 1) describe the safety of a single dose of IV bacteriophage therapy in clinically stable CF subjects with P. aeruginosa in expectorated sputum; 2) describe the microbiological activity of a single dose of IV bacteriophage therapy in clinically stable CF subjects with P. aeruginosa in expectorated sputum; 3) describe the benefit to risk profile of a single dose of IV bacteriophage therapy in clinically stable CF subjects with P. aeruginosa in expectorated sputum.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 73 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects must meet all the inclusion criteria to be eligible to participate in the study:
Confirmed Cystic Fibrosis (CF) diagnosis based on a compatible clinical syndrome confirmed by either an abnormal sweat chloride testing or CFTR gene variations.*
*Can be obtained from documentation in medical records; actual test results not necessary.
Likely able to produce at least 2 mL of sputum during a 30-minute sputum collection following a hypertonic saline treatment or other approach to increase sputum production.**
**Determined by investigator or their designee judgement. Approaches for obtaining sputum may include, but are not limited to, inhaled hypertonic saline (e.g., 3%, 7%, or 10%), inhaled hypertonic bicarbonate, inhaled mannitol, or spontaneously expectorated sputum. The same approach is recommended, whenever possible, for all sputum collections for a given subject.
Exclusion Criteria:
Subjects who meet any of the exclusion criteria will not be enrolled in the study:
Elevated Elevated liver function tests (LFTs) obtained at screening.*
*a. Alanine aminotransferase (ALT) > 5 x the upper limit of normal (ULN) or aspartate transaminase (AST) > 5 x ULN or total bilirubin > 3 x ULN, OR b. Total bilirubin > 1.5 x ULN combined with either ALT > 3 x ULN or AST > 3 x ULN. ULN reflects local laboratory ranges.
Acute clinical illness requiring a new (oral, parenteral), or inhaled antibiotic(s) \</= 30 days prior to the baseline visit.*
*Does not include chronic suppressive medications or cyclic dosing medications such as inhaled antibiotics.
Women who are pregnant, planning to become pregnant during the study period, or breastfeeding.* *Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin test during screening and agree to use an effective method of contraception for the duration of the trial.*
*A female is considered of childbearing potential unless postmenopausal, or surgically sterilized and at least 3 months has passed since sterilization procedure.
Anticipated need to change chronic antibiotic regimens during the study period.*
*Subjects on cyclic dosing medications such as inhaled antibiotics, must be able and express willingness to keep the therapies at the time of screening constant (either remain on the therapy or not remain on the therapy) for the duration of the follow-up period (approximately 30 days). Subjects on chronic suppressive antimicrobial therapy must be able and express willingness to stay on the therapies for the duration of their follow-up period. This includes chronic azithromycin therapy.
4x10\^7 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage. Stage 1: N=2 (sentinel subjects); Stage 2a: N=8
Biological: WRAIR-PAM-CF1
4x10\^8 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage. Stage 1: N=2 (sentinel subjects); Stage 2a: N=8
Biological: WRAIR-PAM-CF1
4x10\^9 plaque forming units (PFU) of WRAIR-PAM-CF1 administered intravenously with approximately 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage. Stage 1: N=2 (sentinel subjects); Stage 2a: N=8
Biological: WRAIR-PAM-CF1
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage. N=8
Other: Placebo
25 mL of 0.9 percent Sodium Chloride saline solution administered intravenously for 30 mins as a single dosage. N=17
Other: Placebo
WRAIR-PAM-CF1 concentration determined after post stage 2a analysis, administered intravenously with 25 mL of 0.9 percent Sodium Chloride saline solution for 30 mins as a single dosage. N=17
Biological: WRAIR-PAM-CF1
0.9 percent sodium chloride
Bacteriophage combination composed of the following phages: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83, and PaWRA02Phi87.
Number of Participants That Experienced Grade 2 or Higher Treatment-emergent Adverse Events in the ITT Population
An event that occurred during the treatment period was considered a treatment-emergent AE if it was not present before the first dose of investigational product or was present before the first dose of investigational product and increased in severity during the treatment period.
Time frame: Day 1 through Day 30
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo in Stage 2a and 2b
Mean change from baseline in log10-transformed counts of P. aeruginosa colony forming units per milliliter (CFU/mL) is presented for each time point through Day 30 as well as for each participant's minimum and maximum change from baseline. Undetectable colony counts are substituted with the limit of detection (LOD) of the assay (1 x 10\^4 CFU/mL).
Time frame: Day 1 Post-infusion, Day 2, Day 5, Day 8, and Day 30
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated by: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1 x 10\^4 CFU/mL)
Time frame: Day 1 Post-infusion, Day 2, Day 5, and Day 8
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo, Sensitivity Analysis for Stage 2a and 2b
Mean change from baseline in log10-transformed counts of P. aeruginosa colony forming units per milliliter (CFU/mL) is presented for each time point through Day 30 as well as for each participant's minimum and maximum change from baseline. Undetectable colony counts are treated as missing.
Time frame: Day 1 Post-infusion, Day 2, Day 5, Day 8, and Day 30
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1 = No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3 = No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4 = SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Time frame: Day 1 Post-infusion, Day 2, Day 5, and Day 8
Number of Susceptible to 4-bacteriophage Cocktail Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated by: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1 x 10\^4 CFU/mL)
Time frame: Baseline through Day 8
Number of Non-susceptible to 4-bacteriophage Cocktail Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and \>2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and \<1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10\^4 CFU/mL).
Time frame: Baseline through Day 8
Number of Co-colonized With Clinically Meaningful Organism Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and \>2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and \<1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10\^4 CFU/mL).
Time frame: Baseline through Day 8
Number of Not Co-colonized With Clinically Meaningful Organism Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and \>2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and \<1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10\^4 CFU/mL).
Time frame: Baseline through Day 8
Number of Susceptible to 4-bacteriophage Cocktail Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1 = No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3 = No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4 = SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Time frame: Baseline through Day 8
Number of Non-susceptible to 4-bacteriophage Cocktail Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1 = No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3 = No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4 = SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Time frame: Baseline through Day 8
Number of Co-colonized With Clinically Meaningful Organism Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1 = No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3 = No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4 = SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Time frame: Baseline through Day 8
Number of Not Co-colonized With Clinically Meaningful Organism Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1 = No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3 = No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4 = SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Time frame: Baseline through Day 8
The study population included male and female adults, aged 18 or higher, with a confirmed cystic fibrosis diagnosis. Participants were enrolled from 03OCT2022 to 12MAR2025.
| Milestone | 4x10^7 PFU - Stage 1 | 4x10^8 PFU - Stage 1 | 4x10^9 PFU - Stage 1 | 4x10^7 PFU - Stage 2a | 4x10^8 PFU - Stage 2a and 2b | 4x10^9 PFU - Stage 2a | Placebo - Stage 2a and 2b |
|---|---|---|---|---|---|---|---|
| Started | 2 | 2 | 2 | 8 | 26 | 9 | 24 |
| Completed | 2 | 2 | 2 | 8 | 26 | 8 | 23 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Treatment not administered | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
An event that occurred during the treatment period was considered a treatment-emergent AE if it was not present before the first dose of investigational product or was present before the first dose of investigational product and increased in severity during the treatment period.
| Participants | 4x10^7 PFU - Stage 2a | 4x10^8 PFU - Stage 2a and 2b | 4x10^9 PFU - Stage 2a | Placebo - Stage 2a and 2b |
|---|---|---|---|---|
| Number of Participants That Experienced Grade 2 or Higher Treatment-emergent Adverse Events in the ITT Population | 2 | 7 | 4 | 8 |
Mean change from baseline in log10-transformed counts of P. aeruginosa colony forming units per milliliter (CFU/mL) is presented for each time point through Day 30 as well as for each participant's minimum and maximum change from baseline. Undetectable colony counts are substituted with the limit of detection (LOD) of the assay (1 x 10\^4 CFU/mL).
| log10 (CFU/mL) | 4x10^8 PFU - Stage 2a and 2b | Placebo - Stage 2a and 2b |
|---|---|---|
| Day 1 Post-infusion | 0.0 ± 1.2 | 0.1 ± 1.4 |
| Day 2 | -0.3 ± 1.5 | 0.3 ± 1.4 |
| Day 5 | -0.1 ± 1.3 | 0.3 ± 1.4 |
| Day 8 | -0.4 ± 1.5 | 0.2 ± 1.7 |
| Day 30 | 0.0 ± 1.7 | 0.5 ± 1.7 |
| Maximum change | 1.0 ± 1.3 | 1.3 ± 1.3 |
| Minimum change | -1.4 ± 1.3 | -0.7 ± 1.3 |
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated by: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1 x 10\^4 CFU/mL)
| Participants | 4x10^8 PFU - Stage 2a and 2b | Placebo - Stage 2a and 2b |
|---|---|---|
| Day 1 Post-infusion — Rank 1 | 0 | 1 |
| Day 1 Post-infusion — Rank 2 | 5 | 5 |
| Day 1 Post-infusion — Rank 3 | 21 | 18 |
| Day 1 Post-infusion — Rank 4 | 0 | 0 |
| Day 1 Post-infusion — Missing | 0 | 0 |
| Day 2 — Rank 1 | 3 | 1 |
| Day 2 — Rank 2 | 2 | 1 |
| Day 2 — Rank 3 | 20 | 21 |
| Day 2 — Rank 4 | 0 | 0 |
| Day 2 — Missing | 1 | 1 |
| Day 5 — Rank 1 | 1 | 1 |
| Day 5 — Rank 2 | 7 | 1 |
| Day 5 — Rank 3 | 18 | 21 |
| Day 5 — Rank 4 | 0 | 0 |
| Day 5 — Missing | 0 | 1 |
| Day 8 — Rank 1 | 4 | 2 |
| Day 8 — Rank 2 | 6 | 3 |
| Day 8 — Rank 3 | 15 | 17 |
| Day 8 — Rank 4 | 0 | 0 |
| Day 8 — Missing | 1 | 2 |
| Maximum — Rank 1 | 6 | 2 |
| Maximum — Rank 2 | 10 | 7 |
| Maximum — Rank 3 | 10 | 15 |
| Maximum — Rank 4 | 0 | 0 |
| Maximum — Missing | 0 | 0 |
Mean change from baseline in log10-transformed counts of P. aeruginosa colony forming units per milliliter (CFU/mL) is presented for each time point through Day 30 as well as for each participant's minimum and maximum change from baseline. Undetectable colony counts are treated as missing.
| log10 (CFU/mL) | 4x10^8 PFU - Stage 2a and 2b | Placebo - Stage 2a and 2b |
|---|---|---|
| Day 1 Post-infusion | -0.1 ± 0.9 | 0.1 ± 1.1 |
| Day 2 | -0.5 ± 1.1 | 0.1 ± 1.2 |
| Day 5 | -0.3 ± 1.0 | 0.3 ± 1.3 |
| Day 8 | -0.6 ± 1.3 | 0.7 ± 1.3 |
| Day 30 | -0.3 ± 1.4 | 0.1 ± 1.6 |
| Maximum change | 0.7 ± 1.0 | 1.0 ± 1.2 |
| Minimum change | -1.3 ± 1.2 | -0.7 ± 1.2 |
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1 = No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3 = No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4 = SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
| Participants | 4x10^8 PFU - Stage 2a and 2b | Placebo - Stage 2a and 2b |
|---|---|---|
| Day 1 Post-infusion — Rank 1 | 0 | 0 |
| Day 1 Post-infusion — Rank 2 | 4 | 4 |
| Day 1 Post-infusion — Rank 3 | 14 | 12 |
| Day 1 Post-infusion — Rank 4 | 0 | 0 |
| Day 1 Post-infusion — Missing | 8 | 8 |
| Day 2 — Rank 1 | 2 | 0 |
| Day 2 — Rank 2 | 1 | 1 |
| Day 2 — Rank 3 | 14 | 13 |
| Day 2 — Rank 4 | 0 | 0 |
| Day 2 — Missing | 9 | 10 |
| Day 5 — Rank 1 | 1 | 0 |
| Day 5 — Rank 2 | 6 | 1 |
| Day 5 — Rank 3 | 12 | 14 |
| Day 5 — Rank 4 | 0 | 0 |
| Day 5 — Missing | 7 | 9 |
| Day 8 — Rank 1 | 2 | 0 |
| Day 8 — Rank 2 | 5 | 0 |
| Day 8 — Rank 3 | 9 | 12 |
| Day 8 — Rank 4 | 0 | 0 |
| Day 8 — Missing | 10 | 12 |
| Maximum — Rank 1 | 3 | 0 |
| Maximum — Rank 2 | 10 | 5 |
| Maximum — Rank 3 | 6 | 11 |
| Maximum — Rank 4 | 0 | 0 |
| Maximum — Missing | 7 | 8 |
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated by: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1 x 10\^4 CFU/mL)
| Participants | 4x10^8 PFU - Stage 2a and 2b | Placebo - Stage 2a and 2b |
|---|---|---|
| Number of Susceptible to 4-bacteriophage Cocktail Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit | 12 | 13 |
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and \>2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and \<1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10\^4 CFU/mL).
| Participants | 4x10^8 PFU - Stage 2a and 2b | Placebo - Stage 2a and 2b |
|---|---|---|
| Number of Non-susceptible to 4-bacteriophage Cocktail Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit | 14 | 11 |
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and \>2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and \<1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10\^4 CFU/mL).
| Participants | 4x10^8 PFU - Stage 2a and 2b | Placebo - Stage 2a and 2b |
|---|---|---|
| Number of Co-colonized With Clinically Meaningful Organism Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit | 7 | 2 |
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and \>2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and \<1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10\^4 CFU/mL).
| Participants | 4x10^8 PFU - Stage 2a and 2b | Placebo - Stage 2a and 2b |
|---|---|---|
| Number of Not Co-colonized With Clinically Meaningful Organism Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit | 19 | 22 |
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1 = No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3 = No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4 = SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
| Participants | 4x10^8 PFU - Stage 2a and 2b | Placebo - Stage 2a and 2b |
|---|---|---|
| Participants with Non-missing DOOR | 8 | 9 |
| Participants with Missing DOOR | 4 | 4 |
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1 = No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3 = No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4 = SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
| Participants | 4x10^8 PFU - Stage 2a and 2b | Placebo - Stage 2a and 2b |
|---|---|---|
| Participants with Non-missing DOOR | 11 | 7 |
| Participants with Missing DOOR | 3 | 4 |
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1 = No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3 = No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4 = SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
| Participants | 4x10^8 PFU - Stage 2a and 2b | Placebo - Stage 2a and 2b |
|---|---|---|
| Participants With Non-missing DOOR | 4 | 1 |
| Participants With Missing DOOR | 3 | 1 |
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1 = No SAE (related to study product) and \> 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3 = No SAE (related to study product) and \< 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4 = SAE (related to study product). The DOOR probability is estimated using: Pr\[DOOR\]= Pr\[DOORIV \> DOORP\] + 1/2Pr\[DOORIV = DOORP\] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr\[DOORIV \> DOORP\] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr\[DOORIV = DOORP\] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
| Participants | 4x10^8 PFU - Stage 2a and 2b | Placebo - Stage 2a and 2b |
|---|---|---|
| Participants With Non-missing DOOR | 15 | 15 |
| Participants with Missing DOOR | 4 | 7 |
Collected over Safety was evaluated from Day 1 (post-study product administration) through Day 30. Events of special interest (ESIs) were collected from Day 1 through Day 8.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 4x10^7 PFU - Stage 1 | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| 4x10^8 PFU - Stage 1 | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| 4x10^9 PFU - Stage 1 | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| 4x10^7 PFU - Stage 2a | 0/8 (0%) | 0/8 (0%) | 3/8 (37.5%) |
| 4x10^8 PFU - Stage 2a and 2b | 0/26 (0%) | 0/26 (0%) | 4/26 (15.4%) |
| 4x10^9 PFU - Stage 2a | 0/8 (0%) | 1/8 (12.5%) | 3/8 (37.5%) |
| Placebo - Stage 2a and 2b | 0/24 (0%) | 0/24 (0%) | 9/24 (37.5%) |
| Event | 4x10^7 PFU - Stage 1 | 4x10^8 PFU - Stage 1 | 4x10^9 PFU - Stage 1 | 4x10^7 PFU - Stage 2a | 4x10^8 PFU - Stage 2a and 2b | 4x10^9 PFU - Stage 2a | Placebo - Stage 2a and 2b |
|---|---|---|---|---|---|---|---|
| Cystic Fibrosis Pulmonary ExacerbationInfections and infestations | 0/2 | 0/2 | 0/2 | 0/8 | 0/26 | 1/8 | 0/24 |
| Event | 4x10^7 PFU - Stage 1 | 4x10^8 PFU - Stage 1 | 4x10^9 PFU - Stage 1 | 4x10^7 PFU - Stage 2a | 4x10^8 PFU - Stage 2a and 2b | 4x10^9 PFU - Stage 2a | Placebo - Stage 2a and 2b |
|---|---|---|---|---|---|---|---|
| PalpitationsCardiac disorders | 1/2 | 0/2 | 0/2 | 0/8 | 0/26 | 0/8 | 0/24 |
| Abdominal PainGastrointestinal disorders | 1/2 | 0/2 | 0/2 | 0/8 | 0/26 | 0/8 | 0/24 |
| NauseaGastrointestinal disorders | 1/2 | 0/2 | 0/2 | 0/8 | 0/26 | 0/8 | 0/24 |
| Infective Pulmonary Exacerbation Of Cystic FibrosisInfections and infestations | 0/2 | 1/2 | 0/2 | 1/8 | 0/26 | 1/8 | 3/24 |
| Decreased AppetiteMetabolism and nutrition disorders | 0/2 | 0/2 | 1/2 | 0/8 | 0/26 | 0/8 | 0/24 |
| HeadacheNervous system disorders | 0/2 | 1/2 | 0/2 | 0/8 | 0/26 | 0/8 | 3/24 |
| NocturiaRenal and urinary disorders | 0/2 | 0/2 | 1/2 | 0/8 | 0/26 | 0/8 | 0/24 |
| Blood Pressure Systolic IncreasedInvestigations | 0/2 | 0/2 | 0/2 | 0/8 | 4/26 | 0/8 | 3/24 |
| FatigueGeneral disorders | 0/2 | 0/2 | 0/2 | 1/8 | 0/26 | 0/8 | 0/24 |
| Infusion Site BruisingGeneral disorders | 0/2 | 0/2 | 0/2 | 1/8 | 0/26 | 0/8 | 0/24 |
| Age, Continuous(years) | 4x10^7 PFU - Stage 1 | 4x10^8 PFU - Stage 1 | 4x10^9 PFU - Stage 1 | 4x10^7 PFU - Stage 2a | 4x10^8 PFU - Stage 2a and 2b | 4x10^9 PFU - Stage 2a | Placebo - Stage 2a and 2b | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 60.5 ± 10.6 | 49.0 ± 5.7 | 32.0 ± 4.2 | 36.3 ± 12.9 | 45.3 ± 14.8 | 38.7 ± 15.5 | 40.8 ± 13.5 | 42.2 ± 14.2 |
| Sex: Female, Male(Participants) | 4x10^7 PFU - Stage 1 | 4x10^8 PFU - Stage 1 | 4x10^9 PFU - Stage 1 | 4x10^7 PFU - Stage 2a | 4x10^8 PFU - Stage 2a and 2b | 4x10^9 PFU - Stage 2a | Placebo - Stage 2a and 2b | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 2 | 0 | 1 | 4 | 12 | 2 | 15 | 36 |
| Male | 0 | 2 | 1 | 4 | 14 | 7 | 9 | 37 |
| Ethnicity (NIH/OMB)(Participants) | 4x10^7 PFU - Stage 1 | 4x10^8 PFU - Stage 1 | 4x10^9 PFU - Stage 1 | 4x10^7 PFU - Stage 2a | 4x10^8 PFU - Stage 2a and 2b | 4x10^9 PFU - Stage 2a | Placebo - Stage 2a and 2b | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 3 | 2 | 2 | 7 |
| Not Hispanic or Latino | 2 | 2 | 2 | 8 | 23 | 7 | 22 | 66 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 4x10^7 PFU - Stage 1 | 4x10^8 PFU - Stage 1 | 4x10^9 PFU - Stage 1 | 4x10^7 PFU - Stage 2a | 4x10^8 PFU - Stage 2a and 2b | 4x10^9 PFU - Stage 2a | Placebo - Stage 2a and 2b | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 5 |
| White | 1 | 2 | 1 | 7 | 24 | 8 | 21 | 64 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 3 |
| Region of Enrollment(participants) | 4x10^7 PFU - Stage 1 | 4x10^8 PFU - Stage 1 | 4x10^9 PFU - Stage 1 | 4x10^7 PFU - Stage 2a | 4x10^8 PFU - Stage 2a and 2b | 4x10^9 PFU - Stage 2a | Placebo - Stage 2a and 2b | Total |
|---|---|---|---|---|---|---|---|---|
| United States | 2 | 2 | 2 | 8 | 26 | 9 | 24 | 73 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institute of Allergy and Infectious Diseases (NIAID)