Trial Outcomes & Findings for Dengue 4 Human Infection Model (Dengue CVD 11000; DHIM-4) (NCT NCT05268302)

NCT ID: NCT05268302

Last Updated: 2025-04-17

Results Overview

solicited injection site adverse events until 7 days post virus inoculation

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 20 participants
• Primary outcome timeframe: Days 1-7 post-challenge
• Results posted on: 2025-04-17

Participant Flow

Participant milestones

Measure	Main/Low Dose DHIM-4 Received 95 pfu DENV-4, primary	Homologous Rechallenge Received 95 pfu DENV-4, secondary
Overall Study STARTED	14	6
Overall Study Detectable DENV Viremia	14	0
Overall Study COMPLETED	14	5
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Main/Low Dose DHIM-4 Received 95 pfu DENV-4, primary	Homologous Rechallenge Received 95 pfu DENV-4, secondary
Overall Study Death	0	1

Baseline Characteristics

Dengue 4 Human Infection Model (Dengue CVD 11000; DHIM-4)

Baseline characteristics by cohort

Measure	Main/Low Dose DHIM-4 n=14 Participants Received 95 pfu DENV-4, primary	Homologous Rechallenge n=6 Participants Received 95 pfu DENV-4, secondary	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	33.6 years n=5 Participants	32.5 years n=7 Participants	33 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	6 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Days 1-7 post-challenge

solicited injection site adverse events until 7 days post virus inoculation

Outcome measures

Measure	Main/Low Dose DHIM-4 n=14 Participants Received 95 pfu DENV-4, primary	Homologous Rechallenge n=6 Participants Received 95 pfu DENV-4, secondary
Number of Participants With Solicited Injection Site Adverse Events	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Days 2, 4-16, 28

unsolicited injection site adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later

Outcome measures

Measure	Main/Low Dose DHIM-4 n=14 Participants Received 95 pfu DENV-4, primary	Homologous Rechallenge n=6 Participants Received 95 pfu DENV-4, secondary
Number of Participants With Unsolicited Injection Site Adverse Events	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Days 2, 4-16, 28

solicited systemic adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later

Outcome measures

Measure	Main/Low Dose DHIM-4 n=14 Participants Received 95 pfu DENV-4, primary	Homologous Rechallenge n=6 Participants Received 95 pfu DENV-4, secondary
Number of Participants With Solicited Systemic Adverse Events Fever	3 Participants	0 Participants
Number of Participants With Solicited Systemic Adverse Events Headache/Eye Pain	10 Participants	2 Participants
Number of Participants With Solicited Systemic Adverse Events Abdominal Pain	3 Participants	0 Participants
Number of Participants With Solicited Systemic Adverse Events Muscle Pain	9 Participants	1 Participants
Number of Participants With Solicited Systemic Adverse Events Joint or Bone Pain	9 Participants	0 Participants
Number of Participants With Solicited Systemic Adverse Events Fatigue	14 Participants	2 Participants
Number of Participants With Solicited Systemic Adverse Events Nausea/Vomiting	6 Participants	0 Participants
Number of Participants With Solicited Systemic Adverse Events Rash	14 Participants	0 Participants

PRIMARY outcome

Timeframe: Days 2, 4-16, 28

Incidence of abnormal laboratory measurements until 28 days post virus inoculation or 7 days post hospitalization, whichever is later

Outcome measures

Measure	Main/Low Dose DHIM-4 n=14 Participants Received 95 pfu DENV-4, primary	Homologous Rechallenge n=6 Participants Received 95 pfu DENV-4, secondary
Incidence of Abnormal Laboratory Measurements Increased AST (Aspartate Aminotransferase)	9 Participants	2 Participants
Incidence of Abnormal Laboratory Measurements Increased ALT (Alanine Aminotransferase)	3 Participants	2 Participants
Incidence of Abnormal Laboratory Measurements Low fibrinogen	2 Participants	1 Participants
Incidence of Abnormal Laboratory Measurements Leukopenia	4 Participants	0 Participants
Incidence of Abnormal Laboratory Measurements Neutropenia	5 Participants	3 Participants
Incidence of Abnormal Laboratory Measurements Low hemoglobin	4 Participants	4 Participants
Incidence of Abnormal Laboratory Measurements Low glucose	1 Participants	0 Participants
Incidence of Abnormal Laboratory Measurements High glucose	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Days 2, 4-16, 28

dengue-related like adverse events until 28 days post virus inoculation or 7 days post inpatient whichever is later

Outcome measures

Measure	Main/Low Dose DHIM-4 n=14 Participants Received 95 pfu DENV-4, primary	Homologous Rechallenge n=6 Participants Received 95 pfu DENV-4, secondary
Number of Participants With Dengue-Related Adverse Events Fever	3 Participants	0 Participants
Number of Participants With Dengue-Related Adverse Events Headache/Eye Pain	10 Participants	2 Participants
Number of Participants With Dengue-Related Adverse Events Abdominal Pain	3 Participants	0 Participants
Number of Participants With Dengue-Related Adverse Events Muscle Pain	9 Participants	1 Participants
Number of Participants With Dengue-Related Adverse Events Joint/Bone Pain	9 Participants	0 Participants
Number of Participants With Dengue-Related Adverse Events Fatigue	14 Participants	2 Participants
Number of Participants With Dengue-Related Adverse Events Nausea/Vomiting	6 Participants	0 Participants
Number of Participants With Dengue-Related Adverse Events Rash	14 Participants	0 Participants
Number of Participants With Dengue-Related Adverse Events Leukopenia	4 Participants	0 Participants
Number of Participants With Dengue-Related Adverse Events Liver Function Abnormality	9 Participants	2 Participants
Number of Participants With Dengue-Related Adverse Events Thrombocytopenia	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Days 2, 4-16, 28

unsolicited systemic adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later

Outcome measures

Measure	Main/Low Dose DHIM-4 n=14 Participants Received 95 pfu DENV-4, primary	Homologous Rechallenge n=6 Participants Received 95 pfu DENV-4, secondary
Number of Participants With Unsolicited Systemic Adverse Events Bradycardia	1 Participants	0 Participants
Number of Participants With Unsolicited Systemic Adverse Events Tachycardia	4 Participants	2 Participants
Number of Participants With Unsolicited Systemic Adverse Events Hypertension	2 Participants	2 Participants
Number of Participants With Unsolicited Systemic Adverse Events COVID-19 Infection	3 Participants	0 Participants
Number of Participants With Unsolicited Systemic Adverse Events Nasopharyngitis	1 Participants	0 Participants
Number of Participants With Unsolicited Systemic Adverse Events Pruritis	2 Participants	0 Participants
Number of Participants With Unsolicited Systemic Adverse Events Sensitive Skin	2 Participants	0 Participants
Number of Participants With Unsolicited Systemic Adverse Events Chills	1 Participants	0 Participants
Number of Participants With Unsolicited Systemic Adverse Events Feeling Abnormal	1 Participants	0 Participants
Number of Participants With Unsolicited Systemic Adverse Events Pain	1 Participants	0 Participants
Number of Participants With Unsolicited Systemic Adverse Events Dyspnea	1 Participants	0 Participants
Number of Participants With Unsolicited Systemic Adverse Events Nasal Congestion	1 Participants	0 Participants
Number of Participants With Unsolicited Systemic Adverse Events Oropharyngeal Pain	1 Participants	0 Participants
Number of Participants With Unsolicited Systemic Adverse Events Decreased Appetite	2 Participants	0 Participants
Number of Participants With Unsolicited Systemic Adverse Events Food Poisoning	0 Participants	1 Participants
Number of Participants With Unsolicited Systemic Adverse Events Craniocerebral Injury	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Days 2, 4-16, 28

Number of SAEs until 28 days post virus inoculation or 7 days post hospitalization, whichever is later

Outcome measures

Measure	Main/Low Dose DHIM-4 n=14 Participants Received 95 pfu DENV-4, primary	Homologous Rechallenge n=6 Participants Received 95 pfu DENV-4, secondary
Number of Participants With Short-Term SAEs	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Days 2, 4-16, 28, 180

Number of SAEs until 6 months post virus inoculation

Outcome measures

Measure	Main/Low Dose DHIM-4 n=14 Participants Received 95 pfu DENV-4, primary	Homologous Rechallenge n=6 Participants Received 95 pfu DENV-4, secondary
Number of Participants With Long-Term SAEs	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Days 2, 4-16, 28, 180

The occurrence of fever defined as greater than or equal to 38°C (100.4° F) measured at least 2 times at least 4 hours apart

Outcome measures

Measure	Main/Low Dose DHIM-4 n=14 Participants Received 95 pfu DENV-4, primary	Homologous Rechallenge n=6 Participants Received 95 pfu DENV-4, secondary
Number of Participants With Fever	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Days 2, 4-16, 28

RNAemia measurement by PCR through Day 28 post-challenge. RNA detection is in Cycle threshold (Ct). Viremia is determined by the presence of dengue virus RNA through Day 28 post-challenge. (Was viremia detected?)

Outcome measures

Measure	Main/Low Dose DHIM-4 n=14 Participants Received 95 pfu DENV-4, primary	Homologous Rechallenge n=6 Participants Received 95 pfu DENV-4, secondary
Number of Participants With Detected Viremia	14 participants with detected viremia	0 participants with detected viremia

SECONDARY outcome

Timeframe: Day 28

Microneutrilization (50%) Geometric Mean Titer Dengue antibodies

Outcome measures

Measure	Main/Low Dose DHIM-4 n=14 Participants Received 95 pfu DENV-4, primary	Homologous Rechallenge n=6 Participants Received 95 pfu DENV-4, secondary
Microneutrilization (50%) Geometric Mean Titer	539.52 titer Interval 318.64 to 913.49	903.69 titer Interval 284.5 to 2870.54

Adverse Events

Main/Low Dose DHIM-4

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Homologous Rechallenge

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Measure	Main/Low Dose DHIM-4 n=14 participants at risk Received 95 pfu DENV-4, primary	Homologous Rechallenge n=6 participants at risk Received 95 pfu DENV-4, secondary
Injury, poisoning and procedural complications Injury/Craniocerebral Injury/Traumatic Brain Injury	0.00% 0/14 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	16.7% 1/6 • Number of events 1 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.

Other adverse events

Measure	Main/Low Dose DHIM-4 n=14 participants at risk Received 95 pfu DENV-4, primary	Homologous Rechallenge n=6 participants at risk Received 95 pfu DENV-4, secondary
Cardiac disorders Bradycardia	7.1% 1/14 • Number of events 1 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Cardiac disorders Tachycardia	28.6% 4/14 • Number of events 5 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	33.3% 2/6 • Number of events 3 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Vascular disorders Hypertension	14.3% 2/14 • Number of events 2 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	33.3% 2/6 • Number of events 2 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Infections and infestations COVID-19	21.4% 3/14 • Number of events 3 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Infections and infestations Nasopharyngitis	7.1% 1/14 • Number of events 1 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Skin and subcutaneous tissue disorders Pruritis	14.3% 2/14 • Number of events 2 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Skin and subcutaneous tissue disorders Sensitive Skin	14.3% 2/14 • Number of events 2 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
General disorders Chills	7.1% 1/14 • Number of events 1 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
General disorders Feeling Abnormal	7.1% 1/14 • Number of events 1 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
General disorders Pain	7.1% 1/14 • Number of events 1 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.1% 1/14 • Number of events 1 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	7.1% 1/14 • Number of events 1 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	7.1% 1/14 • Number of events 1 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Metabolism and nutrition disorders Decreased Appetite	14.3% 2/14 • Number of events 2 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Gastrointestinal disorders Food Poisoning	0.00% 0/14 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	16.7% 1/6 • Number of events 1 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Injury, poisoning and procedural complications Craniocerebral Injury	0.00% 0/14 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	16.7% 1/6 • Number of events 1 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Immune system disorders Fever	21.4% 3/14 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
General disorders Headache/Eye Pain	71.4% 10/14 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	33.3% 2/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Gastrointestinal disorders Abdominal Pain	21.4% 3/14 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Musculoskeletal and connective tissue disorders Muscle Pain	64.3% 9/14 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	16.7% 1/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Musculoskeletal and connective tissue disorders Joint or Bone Pain	64.3% 9/14 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Nervous system disorders Fatigue	100.0% 14/14 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	33.3% 2/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Gastrointestinal disorders Nausea/Vomiting	42.9% 6/14 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Skin and subcutaneous tissue disorders Rash	100.0% 14/14 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Hepatobiliary disorders Liver Function Abnormality	64.3% 9/14 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	33.3% 2/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.
Blood and lymphatic system disorders Leukopenia	28.6% 4/14 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.	0.00% 0/6 • Local Solicited and Unsolicited AEs were quantified through Day 7 post-challenge. Systemic Solicited and Unsolicited AEs were quantified through Day 28 post-challenge. Severe Adverse Events were quantified through 6 months post-challenge.

Additional Information

Kirsten E. Lyke, MD

University of Maryland, Baltimore Center for Vaccine Development and Global Health (CVD)

Phone: 410-706-5328

Email: klyke@som.umaryland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place