CVT 試験、ESCUDDO-CVT 試験で HPV ワクチンを 1 回、2 回、および 3 回接種した女性の長期追跡調査
コスタリカ HPV-16/18 ワクチン試験 (CVT) で 2 価 HPV ワクチンを 1 回、2 回、および 3 回接種した女性の 15 年間の免疫学的追跡調査: 耐久性データの生成: ESCUDDO-CVT 研究
This study is extending follow up of women who participated in the Costa Rica Vaccine Trial (CVT) and received one dose or two doses of the human papillomavirus (HPV) vaccine, along with a group of women who received three doses. It also studies the stability of HPV defenses in these groups of women for up to 20 years after initial vaccination. Studying samples of blood in the laboratory may provide information on how long one, two, and three doses of the vaccine provide protection against HPV. The results of this study may also help researchers learn whether one dose of HPV vaccine is enough to protect against HPV.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
PRIMARY OBJECTIVES:
I. Estimate the change in antibody levels between years 11 and 20. II. Estimate the proportion of individuals who become seronegative (i.e.: serorevert) between years 11 and 20.
SECONDARY OBJECTIVES:
I. Assess the prevalence and distribution of type-specific HPV infections at least 18 years after HPV vaccination.
II. Assess the number and type of premalignant lesions present at least 18 years after vaccination.
III. For each dose regimen, characterize HPV-specific memory B cells and long-lived plasma cells present at least 18 years after HPV vaccination, and compare these characteristics with results from earlier time points.
OUTLINE: This is an observational study.
Patients complete a short questionnaire regarding risk factors for HPV infection and undergo collection of blood samples for testing HPV16 and HPV18 levels on study.
研究の種類
研究の種類
入学 (実際)
入学
連絡先と場所
研究場所
-
-
Guanacaste Province
-
Liberia、Guanacaste Province、コスタリカ、50101
- Agencia Costarricense de Investigaciones Biomédicas (ACIB)
-
-
参加基準
適格基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Women who participated in the Costa Rica Vaccine Trial and received the HPV vaccine
説明
Inclusion Criteria:
- Participation in the CVT Long Term Follow-Up (LTFU) study
Exclusion Criteria:
- A random subset of the three-dose women
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
|
Observational (questionnaire, biospecimen collection)
Patients complete a short questionnaire regarding risk factors for HPV infection and undergo collection of blood samples for testing HPV16 and HPV18 levels on study. |
Undergo collection of blood samples
他の名前：
Complete questionnaire |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Seropositivity
時間枠：Up to 20 years after initial vaccination
|
Negative/positive status will be assessed using the standard predefined cutoffs established at the testing laboratory. |
Up to 20 years after initial vaccination
|
|
Change in antibody levels
時間枠：Between years 11 and 20 after initial vaccination
|
Will report the geometric mean titer levels and their 95% confidence intervals at years 1, 2, 3, 4, 7, 9, 11, 14, 16, 18, and 20 for the 1-dose, 2-dose and 3-dose groups and for both human papillomavirus (HPV)-16 and HPV-18 antibodies. Will estimate these quantities using a weighted linear mixed models with log-titer level as the dependent variable and year as the independent variable, adjusting for laboratory batch and including a random-effects for participant and, when needed, participant: study year. For the three-dose analysis, will also include a covariate for study group. Moreover, will model the 19-year trend (e.g. excluding peak titers at year 1) by including time as a single continuous variable (i.e. linear effect) and then model time flexibly using a natural spline to assess a potentially non-linear relationship. |
Between years 11 and 20 after initial vaccination
|
|
Proportion of individuals who serorevert
時間枠：Between years 11 and 20 after initial vaccination
|
For each dose regimen and for HPV 16, HPV 18, and a composite endpoint of either HPV type, will estimate the proportion of individuals who serorevert (i.e., become antibody negative by the assay cutoff) in years 1, 2, 3, 4, 7, 9, 11, 14, 16, 18, and 20. Will also report 95% confidence intervals for these estimates. Again, will follow the approach described in our previous work. Note, will consider both standard and updated cutoffs and will use batch-adjusted levels. Can obtain the relative risk for seroreversion and its 95% confidence interval using score tests. Will then use generalized linear mixed models with seroreversion as the outcome and all other parameters similar to above to assess trends over time. |
Between years 11 and 20 after initial vaccination
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Aimee R Kreimer、National Cancer Institute (NCI)
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- NCI-2020-07430
- NCI-2020-07430 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- 999917173
- 20G012-07
- CEC-ICIC-E095-2017 (その他の識別子：National Cancer Institute)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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