Efficacy of Influenza Vaccine in HIV Infected Adults
Vaccination of HIV infected individuals with the sub-unit influenza vaccine is safe; however it induces only moderate immune responses and likewise is modest in its protection compared to HIV uninfected individuals. Based upon the available data, the South African Thoracic Society has provisionally recommended the use of influenza vaccine in HIV infected individuals with CD4+ counts of > 200/ml and viral loads of < 100 000 copies/ml.(Green R et al. In press, SAMJ). This proposal is however based upon recommendations made elsewhere with minimal level of evidence regarding its benefit, and no evidence from countries with a high prevalence of HIV. Very few HIV infected adults, however, actually do receive influenza vaccine in South Africa, partly because of the absence of compelling data regarding the burden of disease in Africa as well as lack of vaccine effectiveness and issues related to physician awareness and access to influenza vaccine in the public immunization program.
The conflicting evidence, between developed countries and Africa, regarding the effectiveness of PPV highlight the drawbacks of extrapolating vaccine effectiveness data from developed countries to developing countries. Differences in the epidemiology of HIV between developed countries in which the prevalence of HIV is low to that of high-burden sub-Saharan African countries include:
- differences in the mode of transmission of HIV and demographics of the infected population.
- differences in standard of care, including access to prophylaxis against opportunistic infections and use of highly active anti-retroviral therapy (HAART)
- differences in risk for disease from opportunistic pathogens, e.g. Mycobacterium tuberculosis, etc.
These differences may all contribute to differences in the risk and severity of influenza illness among HIV infected adults from these communities as well as possibly responsiveness and effectiveness of vaccination.
The investigators are conducting a double-blinded, placebo controlled randomized trial at the HIV treatment clinic at Helen Joseph Hospital to determine the effectiveness of influenza vaccination in HIV infected adults in South Africa. The significance of the findings from this study will help quantify the burden of influenza illness in African HIV infected adults, as well as assist in making more informed recommendations for the use of influenza vaccine in HIV infected adults and in guiding national policy for preparing for a future influenza virus-pandemic.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Gauteng
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Johannesburg、Gauteng、南アフリカ
- Helen Joseph Hospital
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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:
- HIV infected adult on stable first line HAART for more than 3 months or anti-retroviral naïve HIV infected adult with a CD4+ cell count >100 cells/ml performed within the previous 3 months in relation to the date of randomization.
- Age 18-55 years.
- Willing and able to maintain weekly contact at least during period of April - August (i.e. presupposed influenza period) either through SMS or telephonic contact.
- Willing and able to adhere to study protocol re: attendance to clinic for scheduled and illness visits.
Exclusion Criteria:
- Any contraindication to influenza vaccination, including known allergy to egg.
- Currently on treatment for tuberculosis or received treatment for tuberculosis in the past 6 months.
- History of chronic lung disease which required maintenance therapy either currently or in the past 6 months.
- Any contraindication to intramuscular injections.
- Current known grade 3 or grade 4 laboratory or clinical toxicity as per DAIDS toxicity tables.
- Any previous history of influenza or pneumococcal vaccination.
- Any plan to vaccinate against influenza or pneumococcal disease during the course of the study.
- Plan to emigrate from the study area within the next year.
- On steroid therapy for >21 days (current or within the past 30 days).
- In the investigators opinion unable to maintain study procedures.
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 |
|---|---|
|
介入なし：2
|
|
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アクティブコンパレータ：1
To receive a sub-unit influenza vaccine
|
Purified polyvalent vaccine for active immunisation against influenza.The vaccine is an inactivated split virus mixture of different group A and B viral strains.
One 0.5 ml dose, intramuscular route.
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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 |
|---|---|
|
First episode of culture-confirmed influenza illness caused by community-acquired subtypes antigenically similar to the strains included in the influenza vaccine which occurred at least 14 days following study-vaccine administration.
時間枠：1st May 2008 and ending 30th September 2008.
|
1st May 2008 and ending 30th September 2008.
|
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The antibody response for each virus strain. Seroconversion will be defined as a ≥4-fold increase in antibody titer relative to that season's baseline titer for each strain.
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二次結果の測定
結果測定 |
|---|
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Incidence of solicited reactogenic events occurring within 72 hours of vaccination.
|
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Changes in CD4+ cell count and HIV viral load.
|
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Hospitalization or death for any physician-diagnosed respiratory illness in which influenza virus antigenically similar to vaccine strain is identified.
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協力者と研究者
捜査官
- 主任研究者：Shabir A Madhi, MBBCH PhD、University of Witwatersrand, South Africa
- 主任研究者：Ian Sanne, MBBCh、Clinical HIV Research Unit
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 (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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CHRU02 (Ethics ref no 080212)
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