Safety, Virological and Immunological Assessment of Live Attenuated Dengue Serotype 2 rDEN2delta30-7169 in Thai Healthy Volunteers

Phase 1

• Conditions: Dengue infection; Dengue

• Registration Number: TCTR20220706004
• Lead Sponsor: Division of Dengue Hemorrhagic Fever Research, Faculty of Medicine Siriraj Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-06
• Study Completion: 2023-01-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. Thai healthy volunteers, aged between 18 to 30 years old and weight is greater than or equal to 45 kg and have Thai language literacy.
2. Don't have any history of previous dengue, zika or Japanese encephalitis virus infection
3. Have not given blood donation in the past 3 months
4. Education: higher than high school
5. Display flavivirus immunity profile defined by the standard PRNT 50% (PRNT50) as follows: flavivirus naive is defined as the PRNT50 titer against
DENV1 < 1:5
DENV2 < 1:5
DENV3 < 1:5
DENV4 < 1:5
ZIKV < 1:5
JEV < 1:5
6. Willingness to participate in the study as evidenced by signing the informed consent document.
7. Female participants of childbearing potential should be agreed to either abstinence or use at least one primary form of contraception from the time of screening for rDEN2delta30-7169 administration until 1 month after complete course of Dengvaxia vaccination (Study Day 568).

Exclusion Criteria

1. For female participants: Currently pregnant, as determined by positive beta-human choriogonadotropin (HCG) test or breast-feeding, and given birth or abortion within 6 months.
2. History of previous acute undifferentiated febrile illness leading to hospitalization in the past 3 months
3. Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the subject's ability to understand and cooperate with the requirements of the study protocol.
4. Any significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by subject history.
5. History of a severe allergic reaction or anaphylaxis
6. Severe asthma (emergency room visit or hospitalization within the last 6 months).
7. Any known immunodeficiency syndrome.
8. Having any pre-existing medical conditions consist of thrombocytopenia, autoimmune disease and cancer based on history, physical examination, and/or laboratory studies.
9. Current use of anticoagulant medications (this includes anti-platelet medication such as aspirin or non-steroidal anti-inflammatory medications).
10. Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following vaccination. An immunosuppressive dose of corticosteroids is defined as equal or greater than 10 mg of a prednisone equivalent per day for equal or greater than 14 days.
11. Asplenia
12. Receipt of any vaccine within 28 days or a killed vaccine within 14 days prior to receive virus administration, or anticipated receipt of any vaccine during the 28 days following rDEN2delta30-7169 administration.
13. Receipt of blood products within the past 6 months, including transfusions or immunoglobulin, or anticipated receipt of any blood products or immunoglobulin during the 28 days following rDEN2delta30-7169 administration.
14. Previous receipt of a flavivirus vaccine (licensed or experimental).
15. Screening laboratory values of Grade 1 or above (as defined in this protocol) for ANC (<750 /mm3), Platelet (<100,000 /mm3), PT (> 1.25 x ULN), APTT (> 1.66 x ULN), ALT (>2.5 x ULN) and serum creatinine (> 1.3 x ULN OR Increase to >1.3 x participant's baseline)
16. Body temperature higher than 37.5 degree Celsius
17. HIV infection, as indicated by anti-HIV screening assays.
18. Hepatitis C virus (HCV) infection, as indicated by anti-HCV screening assays.
19. Hepatitis B virus (HBV) infection, as indicated by hepatitis B surface antigen (HBsAg) and/or anti-HBc screening.
20. Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial, or would render the subject unable to comply with the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The safety of rDEN2delta30-7169 in flavivirus naive participants Study Day 0-21 Occurrence of solicited local and general adverse events (AEs) and serious adverse events (SAEs)