PXVX0200 (CVD103-HgR) vs Shanchol in Mali
A Phase 2 Randomized, Double-Blinded Study to Compare in Malian Adults the Immunogenicity, Clinical Acceptability and Excretion Pattern Following the Ingestion of a Single Dose of PXVX0200 (CVD 103-HgR) Live Oral Cholera Vaccine Containing Either 108 Colony Forming Units [Cfu] or 109 Cfu Using Shanchol™ Killed Whole Cell Oral Cholera Vaccine as an Immunological Comparator
To compare the ability of a single dose of PXVX0200 at two different dose levels, to placebo to elicit a significant antibody response 14 days after vaccination, compared to baseline.
To compare the ability of a single dose of PXVX0200 to a comparator vaccine Shanchol, a two dose administration, to elicit antibody response by 14 days after vaccination.
調査の概要
詳細な説明
Currently there are two licensed inactivated vibrio oral vaccines (Dukoral® [Crucell; Leiden, The Netherlands] and Shanchol™ [Shantha Biotechnics; Hyderabad, India]) that are pre-qualified by the World Health Organization (WHO) for procurement by United Nations (UN) agencies. Each of these vaccines requires a two-dose regimen which is difficult to implement in the face of explosive outbreaks of cholera in unsettled situations in developing countries. For this reason there is great interest in identifying a cholera vaccine that can provide rapid onset of protection following the ingestion of just a single oral dose.
This Phase 2 randomized, observer-blinded and subject-blinded clinical trial to be conducted in Bamako, Mali will assess the immunogenicity of the 10^8 cfu versus the 10^9 cfu formulation of PaxVax-manufactured CVD 103-HgR.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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-
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Bamako、マリ
- Centre pour le Développement des Vaccins, Mali (CVD-Mali)
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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:
- Able to understand the study and give consent (either written or through a process that involves audio tapes explaining all aspects of the study and the consent form in local languages [Bambara and French] followed by making a mark and signature by a literate witness)
- Healthy men or women, age 18 to 45 years (inclusive) without significant medical history
- Women of child-bearing potential must have negative urine pregnancy test at baseline, prior to vaccination. They must also be willing to use adequate birth control for the duration of the 28-day study and have additional pregnancy tests if indicated. Effective methods of birth control for this study include abstinence, intrauterine device (IUD), oral or depot contraceptive, or barrier plus spermicide
- Willingness to remain in the study area until at least 42 days after receipt of the first vaccine dose
Exclusion Criteria:
- Health care workers who have direct contact with patients who are immune deficient, HIV-positive, or have an unstable medical condition
- Clinically significant history of immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurologic illness, psychiatric disorder requiring hospitalization, current drug or alcohol abuse
- History of an abnormal stool pattern or regular use of laxatives
- Previously received a licensed or investigational cholera vaccine
- History of cholera illness
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:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:PXVX0200 10E8 then placebo
PXVX0200 10E8 on day 0; Placebo on day 14
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Oral dose of PXVX0200 10E8
Oral dose of sodium bicarbonate buffer
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実験的:Placebo, then PXVX0200 10E8
Placebo on day 0; PXVX0200 10E8 on day 14
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Oral dose of PXVX0200 10E8
Oral dose of sodium bicarbonate buffer
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実験的:PXVX0200 10E9 then Placebo
PXVX0200 10E9 on day 0; Placebo on day 14
|
Oral dose of sodium bicarbonate buffer
Oral dose of PXVX0200 10E9
|
実験的:Placebo then PXVX0200 10E9
Placebo on day 0; PXVX0200 10E9 on day 14
|
Oral dose of sodium bicarbonate buffer
Oral dose of PXVX0200 10E9
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アクティブコンパレータ:Shanchol
Two doses of Shanchol, on day 0 and day 14
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Licensed comparator
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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 |
メジャーの説明 |
時間枠 |
---|---|---|
To elicit a significant rise in serum Inaba vibriocidal antibody after a single vaccination
時間枠:14 days
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A comparison of the ability of a single ≥2 x10E9 cfu oral dose versus a single ≥2 x10E8 cfu oral dose of PXVX0200 (CVD 103-HgR) versus placebo to elicit a significant (> 4-fold) rise in serum Inaba vibriocidal antibody 14 days after vaccination, compared to baseline
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14 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
To measure antibody response for a 10E8 dose and 10E9 dose of PXVX0200 oral vaccine
時間枠:14 days
|
To compare the ability of a single ≥2 x108 cfu dose of PXVX0200 (CVD 103-HgR) or ≥2 x109 oral dose of PXVX0200 (CVD 103-HgR) versus Shanchol™ to elicit serum Inaba vibriocidal antibody mean fold rise (compared to baseline titer) and GMT
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14 days
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To plot the kinetics of the serum Inaba Vibriocidal antibody response
時間枠:Baseline and post-vaccination time point.
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To plot the kinetics of the serum Inaba vibriocidal antibody response after ingestion of a single oral dose of PXVX0200 (CVD 103-HgR) containing ≥2 x10E8 cfu or ≥2 x10E9 cfu versus Shanchol™.
(With GMT on the Y axis and time points on the X axis, the GMTs at baseline and at each post-vaccination time point will be connected as a line graph).
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Baseline and post-vaccination time point.
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Assess fecal shedding of PXVX0200
時間枠:Day 1-3, day 7 and day 14
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Shedding of CVD 103-HgR in stool as determined by stool culture (whole specimen or rectal swab)
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Day 1-3, day 7 and day 14
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Compare rate of diarrhea
時間枠:7 days
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To compare the rate of diarrhea (≥ 4 loose stools within 24 hours) following administration of each vaccine regimen versus placebo over 7 days of follow-up
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7 days
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Plot seroconversion
時間枠:Day 7, 14, 21, 28, 35 and 42
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To plot the seroconversion (≥ 4-fold increase over baseline), mean fold rise (comparing baseline titer with post-vaccination titer), and kinetics of serum IgG cholera antitoxin antibody following the ingestion of a single oral dose of PXVX0200 (CVD 103-HgR) containing ≥2 x10E8 cfu or ≥2 x10E9 cfu versus Shanchol™.
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Day 7, 14, 21, 28, 35 and 42
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Assess reactogenicity
時間枠:For seven days after each dose of PXVX0200
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Assess tiredness, vomiting, loss of appetite, abdominal pain and headache
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For seven days after each dose of PXVX0200
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協力者と研究者
捜査官
- 主任研究者:Samba O Sow, MD, MS、Centre pour le Developpement des Vaccins - Mali
出版物と役立つリンク
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 (実際)
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
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