Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ADVP-003 | Other Identifier | Sponsor | |
| WRAIR #2136 | Other Identifier | WRAIR |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The potential synergistic effect of administering 2 dengue vaccine candidates that were previously shown to be safe and immunogenic in humans will be evaluated in this study. A prime-boost study of tetravalent dengue virus purified inactivated vaccine (TDENV-PIV) with alum and tetravalent dengue live attenuated virus (TDENV-LAV) vaccine Formulation 17 (F17) will gather data to help better understand the human immune response to dengue vaccination and infection.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: LAV (T=0), PIV (T=28) | Experimental | Tetravalent live-attenuated dengue virus vaccine formulation 17 (TDENV-LAV) reconstituted with 0.7 mL of water-for-injection; administered subcutaneously on day 0 of the study. Tetravalent dengue purified inactivated vaccine 4 μg/serotype with alum adjuvant (TDENV-PIV 4 µg + alum adjuvant) administered intramuscularly on day 28 of the study. |
|
| Group 2: PIV (T=0), LAV (T=28) | Experimental | Tetravalent dengue purified inactivated vaccine 4 μg/serotype with alum adjuvant (TDENV-PIV 4 µg + alum adjuvant) administered intramuscularly on day 0 of the study. Tetravalent live-attenuated dengue virus vaccine formulation 17 (TDENV-LAV) reconstituted with 0.7 mL of water-for-injection; administered subcutaneously on day 28 of the study. |
|
| Group 3: LAV (T=0), PIV (T=180) | Experimental | Tetravalent live-attenuated dengue virus vaccine formulation 17 (TDENV-LAV) reconstituted with 0.7 mL of water-for-injection; administered subcutaneously on day 0 of the study. Tetravalent dengue purified inactivated vaccine 4 μg/serotype with alum adjuvant (TDENV-PIV 4 µg + alum adjuvant) administered intramuscularly on day 180 of the study. |
|
| Group 4: PIV (T=0), LAV (T=180) | Experimental | Tetravalent dengue purified inactivated vaccine 4 μg/serotype with alum adjuvant (TDENV-PIV 4 µg + alum adjuvant) administered intramuscularly on day 0 of the study. Tetravalent live-attenuated dengue virus vaccine formulation 17 (TDENV-LAV) reconstituted with 0.7 mL of water-for-injection; administered subcutaneously on day 180 of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TDENV-LAV | Biological | 0.5 mL of the post-transfection LAV F17 vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of solicited adverse events | 21 days after each vaccination | |
| Number of unsolicited adverse events | 28 days after each vaccination | |
| Number of hematological and biochemistry abnormalities | 7 and 28 days and each vaccination | |
| Number of serious adverse events | Day 208 or day 360 | |
| Number of potential immune-mediated diseases | Day 208 or day 360 | |
| Number of medically attended adverse events | Day 208 or day 360 |
| Measure | Description | Time Frame |
|---|---|---|
| Microneutralizing (MN) dengue antibody titers | Up to 1 year |
Not provided
Inclusion Criteria:
Male or female between 18 and 49 years of age (inclusive) at the time of consent
Able to provide written informed consent
Healthy as established by medical history and clinical examination before entering into the study
Able and willing to comply with the requirements of the protocol (eg, document events in memory aid, return for follow-up visits, etc.)
Female subject of non-childbearing potential (non-childbearing potential is defined as having either a current tubal ligation at least 3 months prior to enrollment or a history of a hysterectomy, ovariectomy, or is post-menopause)
Female subject is not breastfeeding and agrees not to breastfeed for 3 months after last vaccination
Female subject of childbearing potential may be enrolled in the study, if the subject has:
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the period starting 30 days preceding the first dose of study vaccine and/or planned use during the study period
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose
Planned administration or administration of a vaccine/product not foreseen by the study protocol during the period starting 14 days before or after each scheduled dose of an investigational product
Planned administration of any flavivirus vaccine for the entire study duration
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device)
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required)
Family history of congenital or hereditary immunodeficiency
History of, or current, auto-immune disease
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or related to a study procedure
Major congenital defects or serious chronic illness
History of any neurological disorders or seizures. (except for a childhood febrile seizures)
Acute disease and/or fever (oral body temperature ≥ 100.4°F/38.0°C) at the time of enrollment (a subject with a minor illness, ie, mild diarrhea, mild upper respiratory infection, etc, without fever, may be enrolled at the discretion of the investigator)
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests
Administration of immunoglobulins and/or any blood products during the period starting 90 days preceding the first dose of study vaccine or planned administration during the study period
History of chronic alcohol and/or drug abuse
Pregnant or breastfeeding female or female planning to become pregnant or planning to discontinue contraceptive precautions
A planned move to a location that will prohibit participating in the trial prior to the study end for the participant
Subject seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV)
Safety laboratory test results that are outside the acceptable values at screening:
Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MAJ Leyi Lin, MD | Walter Reed Army Institute of Research (WRAIR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Center, Walter Reed Army Institute of Research (CTC, WRAIR) | Silver Spring | Maryland | 20910 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32966573 | Derived | Lin L, Koren MA, Paolino KM, Eckels KH, De La Barrera R, Friberg H, Currier JR, Gromowski GD, Aronson NE, Keiser PB, Sklar MJ, Sondergaard EL, Jasper LE, Endy TP, Jarman RG, Thomas SJ. Immunogenicity of a Live-Attenuated Dengue Vaccine Using a Heterologous Prime-Boost Strategy in a Phase 1 Randomized Clinical Trial. J Infect Dis. 2021 May 28;223(10):1707-1716. doi: 10.1093/infdis/jiaa603. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000536 | Aluminum Hydroxide |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017607 | Aluminum Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| TDENV-PIV 4 µg + alum adjuvant | Biological | 0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant |
|
|
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| D000838 |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |