Trial Outcomes & Findings for ADVP005; Dengue CVD 12000 - Dengue-1-Virus Live Virus Human Challenge (DENV-1-LVHC) (NCT NCT04786457)
NCT ID: NCT04786457
Last Updated: 2025-02-27
Results Overview
Number of Participants with Solicited Injection Site Erythema - solicited injection site adverse event until 7 days post virus inoculation
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
Days 2, 4, 5, 6, and 7
Results posted on
2025-02-27
Participant Flow
18 volunteers assessed - 6 ineligible (lab results n = 4, abnormal physical findings n = 1, Other n = 1), Decline participation n = 2
Participant milestones
| Measure |
Vaccinees
Previously vaccinated with: Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with Alum adjuvant prime and boosted with tetravalent live attenuated Dengue virus vaccine
|
Controls
Not previously vaccinated with tetravalent dengue vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ADVP005; Dengue CVD 12000 - Dengue-1-Virus Live Virus Human Challenge (DENV-1-LVHC)
Baseline characteristics by cohort
| Measure |
Vaccinee
n=6 Participants
Recipient of tetravalent dengue prime boost vaccine
|
Control
n=4 Participants
Dengue and flavivirus naive
|
Total
n=10 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
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 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
|
32.5 Years
n=5 Participants
|
40.7 Years
n=7 Participants
|
36.6 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
PRIMARY outcome
Timeframe: Days 2, 4, 5, 6, and 7Number of Participants with Solicited Injection Site Erythema - solicited injection site adverse event until 7 days post virus inoculation
Outcome measures
| Measure |
Vaccinees
n=6 Participants
Previously vaccinated with: Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with Alum adjuvant prime and boosted with tetravalent live attenuated Dengue virus vaccine
|
Controls
n=4 Participants
Not previously vaccinated with tetravalent dengue vaccine
|
|---|---|---|
|
Number of Participants With Solicited Injection Site Adverse Events
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Days 2, 4, 5-16, 28 (until 28 days post virus inoculation or 7 days post hospitalization, whichever is later, up to a maximum of 28 days)Number of Participants with Injection site pain - unsolicited injection site adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Outcome measures
| Measure |
Vaccinees
n=6 Participants
Previously vaccinated with: Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with Alum adjuvant prime and boosted with tetravalent live attenuated Dengue virus vaccine
|
Controls
n=4 Participants
Not previously vaccinated with tetravalent dengue vaccine
|
|---|---|---|
|
Number of Participants With Unsolicited Injection Site Adverse Events
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Days 2, 4-16, 19, 22, 25, and 28 (until 28 days post virus inoculation or 7 days post hospitalization, whichever is later, up to a maximum of 28 days)Number of participants with solicited systemic adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Outcome measures
| Measure |
Vaccinees
n=5 Participants
Previously vaccinated with: Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with Alum adjuvant prime and boosted with tetravalent live attenuated Dengue virus vaccine
|
Controls
n=4 Participants
Not previously vaccinated with tetravalent dengue vaccine
|
|---|---|---|
|
Number of Participants With Solicited Systemic Adverse Events
Fever
|
4 participants
|
2 participants
|
|
Number of Participants With Solicited Systemic Adverse Events
Abdominal Pain
|
2 participants
|
2 participants
|
|
Number of Participants With Solicited Systemic Adverse Events
Eye pain / Headache
|
5 participants
|
4 participants
|
|
Number of Participants With Solicited Systemic Adverse Events
Muscle Pain
|
4 participants
|
4 participants
|
|
Number of Participants With Solicited Systemic Adverse Events
Joint or Bone Pain
|
3 participants
|
2 participants
|
|
Number of Participants With Solicited Systemic Adverse Events
Fatigue
|
4 participants
|
4 participants
|
|
Number of Participants With Solicited Systemic Adverse Events
Nausea or Vomiting
|
3 participants
|
1 participants
|
|
Number of Participants With Solicited Systemic Adverse Events
Rash
|
3 participants
|
4 participants
|
PRIMARY outcome
Timeframe: Days 2, 4-16, 19, 22, 25, and 28 (until 28 days post virus inoculation or 7 days post hospitalization, whichever is later, up to a maximum of 28 days)Number of participants with incidence of abnormal laboratory measurements until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Outcome measures
| Measure |
Vaccinees
n=5 Participants
Previously vaccinated with: Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with Alum adjuvant prime and boosted with tetravalent live attenuated Dengue virus vaccine
|
Controls
n=4 Participants
Not previously vaccinated with tetravalent dengue vaccine
|
|---|---|---|
|
Number of Participants With Incidence of Abnormal Laboratory Measurements
Leukopenia
|
4 participants
|
4 participants
|
|
Number of Participants With Incidence of Abnormal Laboratory Measurements
Thrombocytopenia
|
0 participants
|
1 participants
|
|
Number of Participants With Incidence of Abnormal Laboratory Measurements
AST
|
4 participants
|
3 participants
|
|
Number of Participants With Incidence of Abnormal Laboratory Measurements
ALT
|
4 participants
|
3 participants
|
|
Number of Participants With Incidence of Abnormal Laboratory Measurements
Fibrinogen
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Days 1-16Population: only people with dengue were assessed (n=9).
Scales: Clinical Symptoms: None=0, Mild=1, Moderate=2, Severe=3 (Min Score=0, Max=3) Laboratory Abnormalities: None=0, Mild=1, Moderate=2, Severe=3 based on modified FDA CBER laboratory scale (per protocol) (Min=0, Max=3) Symptoms (Clinical symptoms or Laboratory Abnormalities) duration: 1 point/day (Day 1-16) (Min=0, Max=16) Subscale A (Symptom Duration): 1 point/day (Day 1-16) across 10 Clinical/Laboratory findings (Min = 0, Max = 160) Subscale B (Symptom # per day): 1 point/ Clinical/Laboratory finding (n=10) per day across 16 days Min=0, Max=160 Subscale C (Max Severity Score/day): None=0, Mild=1, Moderate=2, Severe=3 across 16 days: Min=0, Max=48 Total Range in DII score (total scale) which equates to subscale (A + B + C)/3: Min=0, Max=122.7 https://doi.org/10.1016/s1473-3099(24)00100-2.
Outcome measures
| Measure |
Vaccinees
n=5 Participants
Previously vaccinated with: Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with Alum adjuvant prime and boosted with tetravalent live attenuated Dengue virus vaccine
|
Controls
n=4 Participants
Not previously vaccinated with tetravalent dengue vaccine
|
|---|---|---|
|
Dengue-Related Illness Index
|
19.4 Dengue-Related Illness Index Score
Interval 15.7 to 22.0
|
23.1 Dengue-Related Illness Index Score
Interval 21.0 to 26.7
|
PRIMARY outcome
Timeframe: Days 2, 4-16, 19, 22, 25, and 28 (until 28 days post virus inoculation or 7 days post hospitalization, whichever is later, up to a maximum of 28 days)Number of participants with unsolicited systemic adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Outcome measures
| Measure |
Vaccinees
n=6 Participants
Previously vaccinated with: Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with Alum adjuvant prime and boosted with tetravalent live attenuated Dengue virus vaccine
|
Controls
n=4 Participants
Not previously vaccinated with tetravalent dengue vaccine
|
|---|---|---|
|
Number of Participants With Unsolicited Systemic Adverse Events
Gastrointestinal Upset
|
0 participants
|
1 participants
|
|
Number of Participants With Unsolicited Systemic Adverse Events
Generalized Muscle Pain
|
0 participants
|
1 participants
|
|
Number of Participants With Unsolicited Systemic Adverse Events
Headache
|
0 participants
|
1 participants
|
|
Number of Participants With Unsolicited Systemic Adverse Events
Shoulder Pain - Left
|
1 participants
|
0 participants
|
|
Number of Participants With Unsolicited Systemic Adverse Events
Lower Back Pain
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Days 2, 4-16, 19, 22, 25, and 28 (until 28 days post virus inoculation or 7 days post hospitalization, whichever is later, up to a maximum of 28 days)Number of participants with SAEs until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Outcome measures
| Measure |
Vaccinees
n=6 Participants
Previously vaccinated with: Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with Alum adjuvant prime and boosted with tetravalent live attenuated Dengue virus vaccine
|
Controls
n=4 Participants
Not previously vaccinated with tetravalent dengue vaccine
|
|---|---|---|
|
Number of Participants With Short-Term SAEs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 2-180Number of participants with SAEs until 6 months post virus inoculation
Outcome measures
| Measure |
Vaccinees
n=6 Participants
Previously vaccinated with: Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with Alum adjuvant prime and boosted with tetravalent live attenuated Dengue virus vaccine
|
Controls
n=4 Participants
Not previously vaccinated with tetravalent dengue vaccine
|
|---|---|---|
|
Number of Participants With Long-Term SAEs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 2-28Population: Per protocol analysis
Number of participants with persistent 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 |
Vaccinees
n=6 Participants
Previously vaccinated with: Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with Alum adjuvant prime and boosted with tetravalent live attenuated Dengue virus vaccine
|
Controls
n=4 Participants
Not previously vaccinated with tetravalent dengue vaccine
|
|---|---|---|
|
Number of Participants With Persistent Fever
|
4 Participants
|
1 Participants
|
Adverse Events
Vaccinees
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Controls
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vaccinees
n=6 participants at risk
Previously vaccinated with: Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with Alum adjuvant prime and boosted with tetravalent live attenuated Dengue virus vaccine
|
Controls
n=4 participants at risk
Not previously vaccinated with tetravalent dengue vaccine
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection Site Erythema
|
0.00%
0/6 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
25.0%
1/4 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
|
General disorders
Injection Site Pain
|
0.00%
0/6 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
25.0%
1/4 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
|
Immune system disorders
Fever
|
66.7%
4/6 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
50.0%
2/4 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
2/6 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
50.0%
2/4 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
|
General disorders
Eye Pain / Headache
|
83.3%
5/6 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
100.0%
4/4 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
66.7%
4/6 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
100.0%
4/4 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
|
Musculoskeletal and connective tissue disorders
Joint or Bone Pain
|
50.0%
3/6 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
50.0%
2/4 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
|
Immune system disorders
Fatigue
|
66.7%
4/6 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
100.0%
4/4 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
|
Gastrointestinal disorders
Nausea or Vomiting
|
50.0%
3/6 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
25.0%
1/4 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
3/6 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
100.0%
4/4 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
16.7%
1/6 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
0.00%
0/4 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
|
Musculoskeletal and connective tissue disorders
Lower Back Pain
|
0.00%
0/6 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
25.0%
1/4 • Local injection site adverse events were collected through day 7 post challenge. Solicited, unsolicited, and solicited lab adverse events were collected through Day 28. SAEs were also collected through 6-months post inoculation.
Daily AEs were assessed.
|
Additional Information
Kirsten E. Lyke, MD
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Phone: 410-706-5328
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place