ALVAC-HIV MN120TMG (vCP205) och rgp120/HIV-1 SF-2 och ALVAC-RG Rabies glykoprotein (vCP65) i HIV-infektioner - Kliniska prövningsregister

Studieöversikt

Status

Avslutad

Betingelser

HIV-infektioner

Intervention / Behandling

Detaljerad beskrivning

ALVAC-HIV vCP205 is a second-generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens. vCP205 expresses proteins from two strains of HIV (MN and LAI). rgp120/HIV-1SF2 expresses proteins from a different strain of HIV. This study will help to show how the immune system responds to proteins from more than one strain of virus.

Six groups of 25 volunteers each are randomized to receive simultaneous or sequential doses of ALVAC-HIV vCP205 and SF2 rgp120 or control vaccines (ALVAC-RG rabies glycoprotein vCP65 or BIOCINE Placebo Vaccine 2). In each group, 21 volunteers receive vaccine and 4 receive control vaccines. Volunteers are stratified by lower or higher risk sexual behavior. Immunizations are given to three groups at months 0, 1, 3, 6, 9, and 12, and to the other three groups at months 0, 1, 6, 9, and 12. Volunteers are followed for 24 months.

Studietyp

Interventionell

Inskrivning

150

Fas

Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Förenta staterna
- Alabama
  - Birmingham, Alabama, Förenta staterna, 35294
    - UAB AVEG
- Maryland
  - Baltimore, Maryland, Förenta staterna
    - JHU AVEG
- Missouri
  - Saint Louis, Missouri, Förenta staterna, 63104
    - St. Louis Univ. School of Medicine AVEG
- New York
  - Rochester, New York, Förenta staterna, 14642
    - Univ. of Rochester AVEG
- Tennessee
  - Nashville, Tennessee, Förenta staterna, 37232
    - Vanderbilt Univ. Hosp. AVEG
- Washington
  - Seattle, Washington, Förenta staterna, 98144
    - UW - Seattle AVEG

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 60 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria

Volunteers must have:

Normal history and physical exam.
Negative ELISA and Western blot for HIV.
CD4 count >= 400 cells/mm3.
Normal urine dipstick with esterase and nitrite.

NOTE:

No more than 10 percent of volunteers in each stratum may be over age 50.

Risk Behavior:

Allowed for volunteers stratified to the higher risk stratum:

High risk behavior for HIV infection, such as

injection drug use within the past 12 months.
higher or intermediate risk sexual behavior.

Exclusion Criteria

Co-existing Condition:

Subjects with the following symptoms or conditions are excluded:

Positive hepatitis B surface antigen.
Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
Occupational responsibilities that preclude compliance.
Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (> 6 months) treated infection are eligible.
Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
Allergy to egg products or neomycin.
Occupational exposure to birds.

Subjects with the following prior conditions are excluded:

History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
History of anaphylaxis or other serious adverse reactions to vaccines.
Prior immunization against rabies.
History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
History of cancer unless there has been surgical excision that is considered to have achieved cure.

Prior Medication:

Excluded:

Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.
Experimental agents within 30 days prior to study entry.
Prior HIV vaccines.
Prior rabies immunization.

Prior Treatment:

Excluded:

Blood products or immunoglobulin within the past 6 months.

For volunteers stratified to the lower risk stratum:

High risk behavior for HIV infection, such as

injection drug use within the past 12 months.
higher or intermediate risk sexual behavior.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Primärt syfte: Förebyggande
Maskning: Dubbel

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Evans T, Corey L, Clements-Mann ML, Weinhold K, Belshe RB, Excler JL, Duliege AM. CD8+ CTL induced in AIDS vaccine evaluation group phase I trials using canarypox vectors (ALVAC) encoding multiple HIV gene products (vCP125, vCP205, vCP300) given with or without subunit boost. Int Conf AIDS. 1998;12:277 (abstract no 495/21192)
Kaslow RA, Rivers C, Goepfert P, Tang J, El Habib R, Weinhold K, Mulligan MJ. Association of HLA class I alleles with cytotoxic T-lymphocyte (CTL) responses to gag and env in recipients of ALVAC-HIV canarypox vaccines. 7th Conference on Retroviruses and Opportunistic Infections. 2000 Jan 30-Feb 2 [Poster 818]
Bender TJ, Tang J, Rivers C, Mulligan MJ, Kaslow RA. Grouping by HLA class I supertype does not enhance HLA associations with CTL responses to ALVAC-HIV canarypox vaccine components. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 193)
Corey L, Weinhold K, Montefiori D, McElrath J, Excler JL, Duliege AM, Stablein D. Combination candidate HIV vaccines using a canarypox vector (vCP205) followed by boosting with gp120(SF-2). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:209 (abstract no LB18)
Corey L, Weinhold K, Montefiori D, Stablein D. CTL and neutralizing antibody responses with a combination HIV-1 vaccine regimen. Int Conf AIDS. 1998;12:636 (abstract no 33221)
AIDS Vaccine Evaluation Group 022 Protocol Team. Cellular and humoral immune responses to a canarypox vaccine containing human immunodeficiency virus type 1 Env, Gag, and Pro in combination with rgp120. J Infect Dis. 2001 Feb 15;183(4):563-70. doi: 10.1086/318523. Epub 2001 Jan 18.
Gupta K, Hudgens M, Corey L, McElrath MJ, Weinhold K, Montefiori DC, Gorse GJ, Frey SE, Keefer MC, Evans TG, Dolin R, Schwartz DH, Harro C, Graham B, Spearman PW, Mulligan M, Goepfert P; AIDS Vaccine Evaluation Group. Safety and immunogenicity of a high-titered canarypox vaccine in combination with rgp120 in a diverse population of HIV-1-uninfected adults: AIDS Vaccine Evaluation Group Protocol 022A. J Acquir Immune Defic Syndr. 2002 Mar 1;29(3):254-61. doi: 10.1097/00126334-200203010-00005.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Avslutad studie (Faktisk)

1 maj 1999

Studieregistreringsdatum

Först inskickad

2 november 1999

Först inskickad som uppfyllde QC-kriterierna

30 augusti 2001

Första postat (Uppskatta)

31 augusti 2001

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 november 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 oktober 2021

Senast verifierad

1 oktober 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

AVEG 022A
10573 (Registeridentifierare: DAIDS ES Registry Number)

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A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers