Safety and Immune Response to an Investigational Dengue Type 2 Vaccine
A Phase I Evaluation of the Safety and Immunogenicity of rDEN2/4 Δ30(ME) Dengue Serotype 2 Vaccine Given at 10^1 PFU in Healthy Flavivirus-naïve Adult Subjects
調査の概要
詳細な説明
Dengue viruses cause approximately 50 million cases of dengue fever and 1.5 million cases of the more severe diseases dengue hemorrhagic fever (DHS) and dengue shock syndrome (DSS) every year. There are four subtypes of the virus, and infection with one offers no protection from infection by the others. In fact, most cases of DHS and DSS occur in people infected by more than one subtype. In areas of the world where multiple subtypes of dengue are common, vaccines must be developed against each of the subtypes of dengue virus. This study will examine the safety and immune response of an investigational vaccine for preventing dengue virus type 2.
Participation in this study will last about 6 weeks. Participants will be randomly assigned to be injected with either the investigational study vaccine or a placebo. Participants will have a five in six chance of receiving the vaccine. The first study visit will take place on the vaccination day, on which participants will undergo a physical examination, blood draw, and pregnancy test and then receive the vaccine. Participants will be given a thermometer and temperature card and be told to record their temperatures three times per day for 16 days after vaccination. Participants will come to follow-up visits every other day for the 16 days after vaccination and then 3, 4, and 6 weeks after vaccination (Days 21, 28, and 42). Assessments completed during these visits will include a questionnaire about how the participant is feeling, pregnancy test, review of temperature cards, blood draw, and physical exam. Blood drawn will be analyzed to check participants' health, determine the amount of vaccine and antibodies in the blood, test markers in white blood cells and genes, and look for proteins that are important for fighting dengue infection.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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District of Columbia
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Washington、District of Columbia、アメリカ、20037
- Johns Hopkins Project SAVE, Center for Immunization Research
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Good general health as determined by physical examination, laboratory screening, and review of medical history
- Available for the duration of the study, approximately 6 weeks post-vaccination
- Female participants of childbearing potential must be willing to use effective contraception for the duration of the trial
Exclusion Criteria:
- Currently breastfeeding or pregnant
- Exhibits evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
- Presence of a behavioral, cognitive, or psychiatric disease that affects the ability of the participant to understand and cooperate with the requirements of the study protocol
- Has screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in protocol
- Presence of any condition that would jeopardize the safety or rights of the participant or would render the participant unable to comply with the protocol
- Significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by participant history
- History of a severe allergic reaction or anaphylaxis
- Presence of severe asthma, defined as requiring emergency room visit or hospitalization within the last 6 months
- Presence of HIV infection, determined by screening and confirmatory assays
- Presence of hepatitis C virus (HCV) infection, determined by screening and confirmatory assays
- Presence of hepatitis B virus (HBV) infection, determined by hepatitis B surface antigen (HBsAg) screening
- Presence of any known immunodeficiency syndrome
- Uses anticoagulant medications
- Has used corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 days prior to or following vaccination. An immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg prednisone or equivalent per day for greater than or equal to 14 days.
- Has received a live vaccine within 28 days or a killed vaccine within 14 days prior to vaccination or anticipates receipt of any vaccine during the 42 days following vaccination
- Has no spleen
- Has received blood products within the past 6 months, including transfusions or immunoglobulin, or anticipates receipt of any blood products or immunoglobulin during the 42 days following vaccination
- History or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus)
- Has received a flavivirus vaccine (licensed or experimental)
- Anticipates receipt of any investigational agent in the 42 days before or after vaccination
- Has definite plans to travel to a dengue endemic area during the study
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：Placebo
Participants will receive a single dose of placebo vaccine.
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プラセボの皮下注射
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実験的：Dengue Virus Subtype 2 Vaccine
Participants will receive a single dose of investigational vaccine for dengue virus subtype 2.
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Subcutaneous injection in upper arm of vaccine at dose of 10 plaque-forming units (PFU)
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Immunogenicity of vaccine, as assessed by neutralizing antibody titers
時間枠：Measured at 4 and 6 weeks after vaccination
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Measured at 4 and 6 weeks after vaccination
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Safety of vaccine, as assessed by the frequency of vaccine-related adverse events (AEs), graded by severity
時間枠：Measured throughout study
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Measured throughout study
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Number of vaccinees infected with this dengue virus subtype 2 (DEN2) candidate vaccine, as defined by either recovery of vaccine virus from the blood of vaccinated participants and/or by seroconversion to DEN2
時間枠：Measured at Days 28 and 42
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Measured at Days 28 and 42
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Frequency, quantity, and duration of viremia
時間枠：Measured after vaccination
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Measured after vaccination
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Comparison of infectivity rates, safety, and immunogenicity of a single dose of DEN2 vaccine from this trial to those variables on previous trials
時間枠：Measured at study completion
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Measured at study completion
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Blaney JE Jr, Durbin AP, Murphy BR, Whitehead SS. Development of a live attenuated dengue virus vaccine using reverse genetics. Viral Immunol. 2006 Spring;19(1):10-32. doi: 10.1089/vim.2006.19.10.
- Durbin AP, McArthur JH, Marron JA, Blaney JE, Thumar B, Wanionek K, Murphy BR, Whitehead SS. rDEN2/4Delta30(ME), a live attenuated chimeric dengue serotype 2 vaccine is safe and highly immunogenic in healthy dengue-naive adults. Hum Vaccin. 2006 Nov-Dec;2(6):255-60. doi: 10.4161/hv.2.6.3494. Epub 2006 Nov 5.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CIR 254
- #20081980 (その他の識別子：WIRB Protocol Number)
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