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Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults

2021년 10월 13일 업데이트: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of High-Dose Live Recombinant Canarypox ALVAC-HIV Vaccine (vCP1452) in Healthy, HIV-1 Uninfected Adult Participants

The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe and to study how the immune system responds to the vaccine. This trial is designed to determine whether a higher vaccine dose (6 times the usual dose) will elicit a higher immune response.

As of May 2001, over 200 people received the ALVAC-HIV (vCP1452) vaccine at the lower dose. The higher dose of the vaccine to be used in this study has not been given to humans previously. High doses of a similar vaccine have been given to a few people without serious side effects. In a recent study done in mice, higher doses of ALVAC-HIV produced stronger immune responses. It is possible that the doses of ALVAC-HIV given to humans are below the amount needed for the maximum immune response. Because the exact relationship between an increased immune response and its effectiveness in preventing HIV infection is uncertain, the HVTN will use the highest dose that can be manufactured.

연구 개요

상태

완전한

정황

개입 / 치료

생물학적: ALVAC(2)120(B,MN)GNP(vCP1452)

상세 설명

To date, adverse reactions to immunization with the various ALVAC-HIV candidate vaccines, including ALVAC-HIV (vCP1452), have been similar to those observed in healthy adults who have received other licensed vaccines of similar types. In a previous trial, even high doses of recombinant ALVAC vaccine were well tolerated in a group of participants that were significantly immunocompromised. In a recent study done in mice concerning dose escalation using the ALVAC-HIV vectors, the data demonstrated more robust immune responses with higher doses of ALVAC-HIV (vCP1452) in mice. It is certainly possible that the doses of ALVAC-HIV given to humans are well below the amount needed for a maximal cytotoxic T lymphocyte (CTL) response. As the predictive value of a CTL response is at present unknown with respect to its efficacy in preventing or ameliorating HIV acquisition or infection, the HVTN will utilize the highest dose that can be currently manufactured.

All study products are to be administered intramuscularly. Participants will receive 1 of 3 injections. Group A will receive a high dose of vaccine, group B will receive a low dose of vaccine, and group C will receive a placebo. Participants are inoculated at 4 time points. Assessment of product safety includes clinical observation, monitoring of hematological, chemical, and immunologic parameters, and a social harms questionnaire. Safety will be evaluated by monitoring of participants for local and systemic adverse reactions during the course of the trial. Participants will be monitored longitudinally for HIV-specific serologic and cellular immune responses.

연구 유형

중재적

등록 (실제)

110

단계

1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

미국
- Alabama
  - Birmingham, Alabama, 미국, 35294
    - Alabama Vaccine CRS
- California
  - San Francisco, California, 미국, 94102
    - San Francisco Vaccine and Prevention CRS
  - San Francisco, California, 미국
    - UCSF, Gen. Clinical Research Ctr., Mt. Zion Hosp.
- Maryland
  - Baltimore, Maryland, 미국
    - Project Brave HIV Vaccine CRS
- Massachusetts
  - Boston, Massachusetts, 미국, 02115
    - Brigham and Women's Hosp. CRS
  - Boston, Massachusetts, 미국, 02115
    - Fenway Community Health Clinical Research Site (FCHCRS)
- Missouri
  - Saint Louis, Missouri, 미국, 63110
    - Saint Louis Univ Health Sciences Ctr
- New York
  - New York, New York, 미국, 10021
    - NY Blood Ctr./Union Square CRS
  - Rochester, New York, 미국, 14642
    - Univ. of Rochester HVTN CRS
- Rhode Island
  - Providence, Rhode Island, 미국, 02906
    - Miriam Hospital's HVTU
- Tennessee
  - Nashville, Tennessee, 미국, 37232
    - Vanderbilt Vaccine CRS
- Virginia
  - Annandale, Virginia, 미국
    - Infectious Diseases Physicians, Inc.
- Washington
  - Seattle, Washington, 미국, 98109
    - FHCRC/UW Vaccine CRS

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria

Participants may be eligible for this study if they:

Are between the ages of 18 and 60.
Are in good general health.
Have a CD4 count of 400 or more cells/mm3.
Do not have hepatitis C or active hepatitis B.
Have had a negative HIV blood test within 8 weeks prior to enrollment.
Use approved methods of contraception.
Have access to a participating site and are available for follow-up for 18 months.
Complete a questionnaire evaluating the participant's understanding of the study prior to enrollment.
Give written informed consent.

Exclusion Criteria

Participants may not be eligible for this study if they:

Are pregnant or breast-feeding.
Have received a live vaccine within 30 days prior to enrollment.
Have received a killed vaccine or allergy treatment with injections within 14 days prior to study vaccine.
Have used experimental research agents within 30 days prior to enrollment.
Have received HIV-1 vaccines or placebo in a previous HIV vaccine trial.
Have received blood products 120 days before HIV screening.
Have received immunoglobulin 60 days before HIV screening.
Have a history of serious harmful reactions to vaccines.
Have a history of disease of the immune system.
Have a history of cancer, unless it has been surgically removed and in the estimate of the investigator is not likely to happen again during the study period.
Are using or have used (within past 6 months) drugs that interfere with the immune system.
Have a history of type I or type II diabetes.
Have thyroid disease.
Have unstable asthma.
Are currently taking preventive anti-TB therapy.
Have a seizure disorder.
Have a bleeding disorder that was diagnosed by a physician.
Have had their spleen removed.
Have angioedema with serious episodes.
Have active syphilis.
Have hypertension.
Have mental problems that would interfere with the protocol.
Have any other problems that, in the judgment of the investigator, would interfere with the study.
Have a body mass index less than 20.
Are allergic or sensitive to egg products.
Have active tuberculosis.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 방지
마스킹: 더블

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Institute of Allergy and Infectious Diseases (NIAID)

수사관

연구 의자: Paul Goepfert

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

Goepfert PA, Horton H, McElrath MJ, Gurunathan S, Ferrari G, Tomaras GD, Montefiori DC, Allen M, Chiu YL, Spearman P, Fuchs JD, Koblin BA, Blattner WA, Frey S, Keefer MC, Baden LR, Corey L; NIAID HIV Vaccine Trials Network. High-dose recombinant Canarypox vaccine expressing HIV-1 protein, in seronegative human subjects. J Infect Dis. 2005 Oct 1;192(7):1249-59. doi: 10.1086/432915. Epub 2005 Aug 31.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 완료 (실제)

2005년 12월 1일

연구 등록 날짜

최초 제출

2001년 11월 29일

QC 기준을 충족하는 최초 제출

2001년 11월 29일

처음 게시됨 (추정)

2001년 11월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 10월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 10월 13일

마지막으로 확인됨

2021년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

HVTN 039
10200 (기타 식별자: CTEP)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .