A Trial to Evaluate the Safety and Systems Biology Response of Ebolavirus Zaire Vaccine (ChAd3-EBO-Z)

NCT03583606 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 14-0092
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This initial, proof of concept study will focus on identifying significant differences in response to the Ebolavirus Zaire vaccine (ChAd3-EBO-Z) when administered with placebo, MVA-BN(R)-Filo, or ChAd3-EBO-Z boosters after 8 days. All 60 participants will receive the ChAd3-EBO-Z vaccine and then randomized into each booster group (20 receiving each type of booster). Subjects will be followed-up for 6 months to monitor for safety outcomes and efficacy measures. There is no formal hypothesis for this study. The primary objective of this study is to assess the safety and reactogenicity of study products by study group when administered IM to healthy adults.

Conditions

Ebola Disease; Immunisation

Keywords

Adenovirus vector; Ebola Virus; Immunogenicity; Non-Human Primates Vaccination/Challenge Studies; Phase 1; Reactogenicity; Safety; Zaire ebolavirus vaccine

Outcome Measures

Primary Outcomes (26)

• Number of Participants With Clinical Safety Laboratory Adverse Events

  Laboratory parameters include white blood cells (WBC), hemoglobin, platelet count, absolute neutrophil count, alanine aminotransferase (ALT), creatinine, sodium, potassium and blood urea nitrogen (BUN). Thresholds for adverse events were considered as WBC \<= 4.4 K/mcL or \>=13.1 K/mcL (18 to \<21 years) or \<= 4.4 K/mcL or \>= 11.1 K/mcL (\>=21 years), hemoglobin \<= 11.6 g/dL (female) or \<= 13.2 g/dL (male), platelet count \<= 134 K/mcL or \>= 467 K/mcL, absolute neutrophil count \<1.8 K/mcL or \<=0.7 K/mcL (benign ethnic neutropenia), ALT \>= 50 unit/L, creatinine \>= 0.81 mg/dL (female) or \>= 1.11 mg/dL (male), sodium \<= 135 mmol/L or \>= 146 mmol/L, potassium \<= 3.4 mmol/L or \>= 5.2 mmol/L and BUN \>= 24 mg/dL. If baseline clinical labs fell within Mild range, then a laboratory AE was reported only if the value changed such that it fell into Moderate range or higher when subsequent safety laboratory testing was done.

  Day 1 to approximately 28 Days Post Second Vaccination

• Number of Participants Reporting Serious Adverse Events (SAEs)

  SAEs included any AE that resulted in death, a life-threatening event, an inpatient hospitalization or prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect.

  Day 1 to Day 182

• Number of Participants Reporting Solicited Local Reactogenicity

  Local reactogenicity solicited on a memory aid provided to participants included pain, tenderness, erythema (redness) (functional grade based on interference with daily activities), induration (hardness/swelling) (functional grade), ecchymosis (bruising) (functional grade), pruritus (itching), erythema (redness) (any measured value), induration (hardness/swelling) (any measured value), ecchymosis (bruising) (any measured value). Participants are considered reporting the local reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination.

  Day 1 to Day 8 Post First Vaccination

• Number of Participants Reporting Solicited Local Reactogenicity

  Local reactogenicity solicited on a memory aid provided to participants included pain, tenderness, erythema (redness) (functional grade based on interference with daily activities), induration (hardness/swelling) (functional grade), ecchymosis (bruising) (functional grade), pruritus (itching), erythema (redness) (any measured value), induration (hardness/swelling) (any measured value), ecchymosis (bruising) (any measured value). Participants are considered reporting the local reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination.

  Day 1 to Day 8 Post Second Vaccination

• Number of Participants Reporting Solicited Local Reactogenicity

  Local reactogenicity solicited on a memory aid provided to participants included pain, tenderness, erythema (redness) (functional grade based on interference with daily activities), induration (hardness/swelling) (functional grade), ecchymosis (bruising) (functional grade), pruritus (itching), erythema (redness) (any measured value), induration (hardness/swelling) (any measured value), ecchymosis (bruising) (any measured value). Subjects are considered reporting the local reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination.

  Day 1 to Day 15

• Number of Participants Reporting Solicited Systemic Reactogenicity

  Systemic reactogenicity solicited on a memory aid provided to participants included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Participants are considered reporting the systemic reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination.

  Day 1 to Day 8 Post First Vaccination

• Number of Participants Reporting Solicited Systemic Reactogenicity

  Systemic reactogenicity solicited on a memory aid provided to participants included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Participants are considered reporting the systemic reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination.

  Day 1 to Day 8 Post Second Vaccination

• Number of Participants Reporting Solicited Systemic Reactogenicity

  Systemic reactogenicity solicited on a memory aid provided to participants included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Participants are considered reporting the systemic reactogenicity if they reported mild or greater severity at any time during the 7 days post-vaccination.

  Day 1 to Day 15

• Number of Participants Reporting Vaccine-related Medically Attended Adverse Events (MAAEs)

  Vaccine-related MAAEs include any AEs for which the participant received medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason for which there is evidence to suggest a causal relationship between the study product and the adverse event.

  Day 1 to Day 182

• Number of Participants Reporting Vaccine-related Unsolicited Adverse Events (AEs)

  Vaccine-related unsolicited AEs include any untoward medical occurrence in a participant for which there is evidence to suggest a causal relationship between the study product and the adverse event.

  Day 1 to approximately 28 Days Post Second Vaccination

• Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - White Blood Cells

  Thresholds for adverse events were considered as WBC 2.5 - 4.4 K/mcL or 13.1 - 15.0 K/mcL (18 to \<21 years) or 2.5 - 4.4 K/mcL or 11.1 - 15.0 (\>=21 years) (mild), 1.5 - 2.4 K/mcL or 15.1 - 20.0 K/mcL (moderate), \<1.5 K/mcL or \>20.0 K/mcL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.

  Day 1 to approximately 28 Days Post Second Vaccination

• Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Hemoglobin

  Thresholds for adverse events were considered as hemoglobin 10.1 - 11.6 g/dL (female) or 11.0 - 13.2 (male) (mild), 8.5 - 10 g/dL (female) or 9.5 - 10.9 g/dL (male) (moderate), \<8.5 g/dL (female) or \<9.5 g/dL (male) (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.

  Day 1 to approximately 28 Days Post Second Vaccination

• Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Platelet Count

  Thresholds for adverse events were considered as platelet count 125 - 134 K/mcL or 467 - 517 K/mcL (mild), 100 - 124 K/mcL or 518 - 750 K/mcL (moderate), \<100 K/mcL or \>750 K/mcL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.

  Day 1 to approximately 28 Days Post Second Vaccination

• Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Absolute Neutrophil Count

  Thresholds for adverse events were considered as absolute neutrophil count 1.5 - \<1.8 K/mcL or 0.6 - 0.7 K/mcL (benign ethnic neutropenia) (mild), 1.0 - \<1.5 K/mcL or 0.4 - 0.5 K/mcL (benign ethnic neutropenia) (moderate), \<1.0 K/mcL or \<0.4 K/mcL (benign ethnic neutropenia) (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.

  Day 1 to approximately 28 Days Post Second Vaccination

• Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - ALT

  Thresholds for adverse events were considered as 50 - 123 unit/L (mild), 124 - 245 unit/L (moderate), \>245 unit/L (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.

  Day 1 to approximately 28 Days Post Second Vaccination

• Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Creatinine (Increase)

  Thresholds for adverse events were considered as creatinine 0.81 - 1.70 mg/dL (female) or 1.11 - 1.70 mg/dL (male) (mild), 1.71 - 2.00 mg/dL (moderate), \>2.00 mg/dL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.

  Day 1 to approximately 28 Days Post Second Vaccination

• Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Sodium

  Thresholds for adverse events were considered as sodium 130 - 135 mmol/L or 146 - 150 mmol/L (mild), 123 - 129 mmol/L or 151 - 157 mmol/L (moderate), \<123 mmol/L or \>157 mmol/L (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.

  Day 1 to approximately 28 Days Post Second Vaccination

• Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - Potassium

  Thresholds for adverse events were considered as potassium 3.0 - 3.4 mmol/L or 5.2 - 6.0 mmol/L (mild), 2.5 - 2.9 mmol/L or 6.1 - 6.5 mmol/L (moderate), \<2.5 mmol/L or \>6.5 mmol/L (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.

  Day 1 to approximately 28 Days Post Second Vaccination

• Number of Participants by Severity of Clinical Safety Laboratory Adverse Events - BUN

  Thresholds for adverse events were considered as BUN 24 - 26 mg/dL (mild), 27 - 31 mg/dL (moderate), \>31 mg/dL (severe). If baseline clinical labs fell within mild range, then a laboratory AE was reported only if the value changed such that it fell into moderate range or higher when subsequent safety laboratory testing was done.

  Day 1 to approximately 28 Days Post Second Vaccination

• Number of Participants by Severity of Solicited Local Reactogenicity

  Local reactogenicity solicited on memory aid include pain; tenderness; pruritus (itch); erythema (redness), induration (hardness/swelling), and ecchymosis (bruising) (functional and measurement). Thresholds for severity were pain: aware, no interference with activity, no pain med (mild), aware, interferes with activity or requires repeated use of a non-narcotic pain reliever for \>24 hr (moderate), aware, prevents activity or requires prescription med use (severe); tenderness: area surrounding injection hurts when touched or with arm motion, no interference with daily activity (mild), hurts when touched or with arm motion, interferes with activity (moderate), hurts when touched or with arm motion and prevents activity (severe); functional erythema, induration, ecchymosis, and pruritus: no activity interference (mild), interferes with activity (moderate), prevents activity (severe); erythema, induration, and ecchymosis (measurement): \<20mm (mild), 20 - 50mm (moderate), \>50mm (severe).

  Day 1 to Day 8 Post First Vaccination

• Number of Participants by Severity of Solicited Local Reactogenicity

  Local reactogenicity solicited on memory aid include pain; tenderness; pruritus (itch); erythema (redness), induration (hardness/swelling), and ecchymosis (bruising) (functional and measurement). Thresholds for severity grading were pain: aware, no interference with activity, no pain med (mild), aware, interferes with activity or requires repeated use of a non-narcotic pain reliever for \>24hr (moderate), aware, prevents activity or requires prescription med use (severe); tenderness: area surrounding injection hurts when touched or with arm motion, no interference with daily activity (mild), hurts when touched or with arm motion, interferes with activity (moderate), hurts when touched or with arm motion, prevents activity (severe); functional erythema, induration, ecchymosis, and pruritus: no activity interference (mild), interferes with activity (moderate), prevents activity (severe); erythema, induration, and ecchymosis (measurement): \<20mm (mild), 20-50mm (moderate), \>50mm (severe).

  Day 1 to Day 8 Post Second Vaccination

• Number of Participants by Severity of Solicited Local Reactogenicity

  Local reactogenicity solicited on memory aid include pain; tenderness; pruritus (itch); erythema (redness), induration (hardness/swelling), and ecchymosis (bruising) (functional and measurement). Thresholds for severity grading were pain: aware, no interference with activity, no pain med (mild), aware, interferes with activity or requires repeated use of a non-narcotic pain reliever for \>24hr (moderate), aware, prevents activity or requires prescription med use (severe); tenderness: area surrounding injection hurts when touched or with arm motion, no interference with daily activity (mild), hurts when touched or with arm motion, interferes with activity (moderate), hurts when touched or with arm motion, prevents activity (severe); functional erythema, induration, ecchymosis, and pruritus: no activity interference (mild), interferes with activity (moderate), prevents activity (severe); erythema, induration, and ecchymosis (measurement): \<20mm (mild), 20-50mm (moderate), \>50mm (severe).

  Day 1 to Day 15

• Number of Participants by Severity of Solicited Systemic Reactogenicity

  Systemic reactogenicity solicited on memory aid included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Thresholds for severity include feverishness, malaise, fatigue, myalgia, nausea, and loss of appetite: Noticeable but does not interfere with daily activity (Mild), Interferes with daily activity (Moderate), Significant interference, prevents daily activity (Severe); headache: Noticeable but does not interfere with daily activity (Mild), Any use of pain reliever or interferes with daily activity (Moderate), Significant interference, prevents daily activity, or requires any use of a prescription medication (Severe); elevated oral temperature: 37.8°C - 38.4°C or 100.00°F - 101.1°F (Mild), 38.5°C - 38.9°C or 101.2°F - 102.0°F (Moderate), \>38.9°C or \>102.0°F (Severe).

  Day 1 to Day 8 Post First Vaccination

• Number of Participants by Severity of Solicited Systemic Reactogenicity

  Systemic reactogenicity solicited on memory aid included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Thresholds for severity include feverishness, malaise, fatigue, myalgia, nausea, and loss of appetite: Noticeable but does not interfere with daily activity (Mild), Interferes with daily activity (Moderate), Significant interference, prevents daily activity (Severe); headache: Noticeable but does not interfere with daily activity (Mild), Any use of pain reliever or interferes with daily activity (Moderate), Significant interference, prevents daily activity, or requires any use of a prescription medication (Severe); elevated oral temperature: 37.8°C - 38.4°C or 100.00°F - 101.1°F (Mild), 38.5°C - 38.9°C or 101.2°F - 102.0°F (Moderate), \>38.9°C or \>102.0°F (Severe).

  Day 1 to Day 8 Post Second Vaccination

• Number of Participants by Severity of Solicited Systemic Reactogenicity

  Systemic reactogenicity solicited on memory aid included feverishness (chills/shivering/sweating), malaise (general unwell feeling), fatigue (tiredness), myalgia (body aches/muscular pain not at injection site), headache, nausea, loss of appetite, and elevated oral temperature. Thresholds for severity include feverishness, malaise, fatigue, myalgia, nausea, and loss of appetite: Noticeable but does not interfere with daily activity (Mild), Interferes with daily activity (Moderate), Significant interference, prevents daily activity (Severe); headache: Noticeable but does not interfere with daily activity (Mild), Any use of pain reliever or interferes with daily activity (Moderate), Significant interference, prevents daily activity, or requires any use of a prescription medication (Severe); elevated oral temperature: 37.8°C - 38.4°C or 100.00°F - 101.1°F (Mild), 38.5°C - 38.9°C or 101.2°F - 102.0°F (Moderate), \>38.9°C or \>102.0°F (Severe).

  Day 1 to Day 15

• Number of Participants by Severity of Vaccine-related Unsolicited Adverse Events (AEs)

  Vaccine-related unsolicited AEs include any untoward medical occurrence in a participant for which there is evidence to suggest a causal relationship between the study product and the adverse event. Thresholds for severity include events require minimal or no treatment and do not interfere with the subject's daily activities (mild), events result in a low level of inconvenience or concern with therapeutic measures and may cause some interference with functioning and daily activities (moderate), and events interrupt the subject's daily activities and may require systemic drug therapy or other treatment and are usually incapacitating (severe). Participants are counted once per preferred term and are summarized according to their highest severity. No severe events were reported.

  Day 1 to approximately 28 Days Post Second Vaccination

Secondary Outcomes (6)

• Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - ITT Population

  Day 8, 15, 22, 29 and 36 compared to baseline (Day 1) reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively.

• Geometric Mean Fold Rise (GMFR) as Measured by Anti-EBOV GP ELISA - Per Prototocol Population

  Day 8, 15, 22, 29 and 36 compared to baseline (Day 1) reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively.

• Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - ITT Population

  Day 1, 8, 15, 22, 29 and 36 reported as Day 1 first vaccination, Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively.

• Geometric Mean Titer (GMT) as Measured by Anti-EBOV GP ELISA - Per Protocol Population

  Day 1, 8, 15, 22, 29 and 36 reported as Day 1 first vaccination, Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively.

• Seroconversion as Measured by Anti-EBOV GP ELISA - ITT Population

  Day 8, 15, 22, 29 and 36 reported as Day 8 post-first vaccination, Day 8 post-second vaccination, Day 15 post-second vaccination, Day 22 post-second vaccination, and Day 29 post-second vaccination, respectively.

Study Arms (3)

ChAd3-EBO-Z + ChAd3-EBO-Z

EXPERIMENTAL

ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and ChAd3-EBO-Z (2 x 10\^11 vp) intramuscularly into the opposite arm on Day 8, n = 20

Biological: ChAd3-EBO-Z

ChAd3-EBO-Z + Placebo

EXPERIMENTAL

ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and placebo intramuscularly into the opposite arm on Day 8, n = 20

Biological: ChAd3-EBO-Z; Other: Placebo

ChAd3-EBO-Z + MVA- BN-Filo

EXPERIMENTAL

ChAd3-EBO-Z (2 x 10\^11 virus particles (vp)) intramuscularly into the deltoid on Day 1 and MVA-BN-Filo (1 x 10\^8 Infectious Units (IU)) intramuscularly into the opposite arm on Day 8, n = 20

Biological: ChAd3-EBO-Z; Biological: MVA Multi-Filo Ebola Vaccine

Interventions

ChAd3-EBO-Z BIOLOGICAL

Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10\^11 virus particles (vp)).

ChAd3-EBO-Z + ChAd3-EBO-Z; ChAd3-EBO-Z + MVA- BN-Filo; ChAd3-EBO-Z + Placebo

MVA Multi-Filo Ebola Vaccine BIOLOGICAL

A booster vaccination of replication defective MVA-BN-Filo administered by an IM injection into the deltoid as a single dose of 1 x 10\^8 Infectious Units (IU).

ChAd3-EBO-Z + MVA- BN-Filo

Placebo OTHER

0.5 mL normal saline administered via IM injection into the deltoid.

ChAd3-EBO-Z + Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provide written informed consent before initiation of any study procedures.
• Are able to understand and comply with planned study procedures and be available for all study visits/phone calls.
• Males or non-pregnant females ages 18-45, inclusive.
• Subject must have a body mass index (BMI) \> / = 18.5 and \< 35 kg/m\^2.
• Are in good health.

You may not qualify if:

• Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius).
• Pulse is 47 to 105 beats per minute (bpm), inclusive.
• Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive.
• Diastolic blood pressure (BP) is 55 to 95 mm Hg, inclusive.
• Have acceptable screening laboratories within 28 days prior to enrollment
• Screening labs include white blood cell (WBC), Hgb, platelet count, ANC, sodium, potassium, creatinine, albumin, total protein, PT, PTT, alanine aminotransferase (ALT). Blood Urea Nitrogen (BUN) will be obtained only if creatinine is above normal range.
• Screening laboratory values that are outside the range of eligibility but are thought to be due to an acute condition or due to laboratory error may be repeated once.
• Have normal screening laboratories for urine protein. Trace protein is acceptable.
• Drug screen for opiates is negative.
• Hemoglobin A1C (HgbA1C) \< 6.3% at screening.
• HIV 1/2 antibody negative.
• HCV antibody negative.
• HBsAg negative.
• Women of childbearing potential, must be using an effective method of contraception from 30 days prior to the first study vaccination until 90 days after the second study vaccination.
• \- Women of childbearing potential are not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with history of documented radiological confirmation test at least 90 days after the procedure (or with use of another birth control method if history of confirmation test not confirmed), still menstruating, or \< 1 year of the last menses if menopausal.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center Vaccine Research Center

Cincinnati, Ohio, 45229-3039, United States

Location

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Results Point of Contact

• Title: Paul Spearman, MD
• Organization: Cincinnati Children's Hospital

paul.spearman@cchmc.org

513-636-4509

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 11, 2018
• Study Start: November 12, 2018
• Primary Completion: January 14, 2020
• Study Completion: January 14, 2020
• Last Updated: July 29, 2025
• Results First Posted: June 2, 2021

Record last verified: 2020-07-15

Locations

US (1)