NCT00322946 is a Phase 1 clinical trial of rDEN4delta30-4995 in Dengue, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT00322946?

NCT00322946 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT00322946?

Interventions in NCT00322946: rDEN4delta30-4995, Placebo.

Is NCT00322946 still recruiting?

NCT00322946 is currently completed. Last updated 5 August 2009.

Last reviewed 2009-08-05 · How we verify

NCT00322946

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 1 Study of the Safety and Immunogenicity of rDEN4delta30-4995, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 4

Completed Phase 1 Last updated 5 August 2009

What this trial tests

Phase 1 trial testing rDEN4delta30-4995 in Dengue in 84 participants. Completed.

Timeline

1 January 2007

Primary endpoint
1 August 2009

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	84
Start date	1 January 2007
Primary completion	1 August 2009
Sites	1 location across United States

Drugs / interventions tested

rDEN4delta30-4995 — full drug profile →
Placebo

Conditions studied

Dengue — all drugs for Dengue →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 50, any sex, with Dengue. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Frequency of vaccine-related adverse events, graded by severity for each dose
Time frame: Throughout study
Immunogenicity of the rDEN4delta30-4995 vaccine against DEN4 virus by measurement of plaque reduction neutralization titers (PRNT)
Time frame: At Days 28 and 42

Sponsor's own description

Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to evaluate the safety and immune response to the dengue vaccine DEN4delta30-4995 in healthy adults.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Dengue vaccines: recent developments, ongoing challenges and current candidates.
McArthur MA, Sztein MB, Edelman R. · · 2013 · cited 66× · PMID 23984962 · DOI 10.1586/14760584.2013.815412
Phase 1 trial of the dengue virus type 4 vaccine candidate rDEN4{Delta}30-4995 in healthy adult volunteers.
Wright PF, Durbin AP, Whitehead SS, Ikizler MR, et al · · 2009 · cited 29× · PMID 19861619 · DOI 10.4269/ajtmh.2009.09-0131

Verify or expand the search:

Other recruiting trials for Dengue

Currently open trials in the same condition.

NCT07501793 — Demographic Characteristics of TAK-003 Dengue Vaccine Recipients in Vietnam · active not recruiting
NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
NCT07007585 — Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection · recruiting
NCT06894901 — Impact of IIT-SIT on Dengue Clusters · NA · recruiting
NCT07158190 — Evaluation of T-cell Responses After Vaccination With the Attenuated Tetravalent Dengue Vaccine (Takeda). · active not recruiting

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

NCT07216794 — Small Trial of Alendronate Impact on the Reservoir of HIV · Phase 2 · not yet recruiting
NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) · Phase 1 · not yet recruiting
NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00322946 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 5 August 2009

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00322946.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing