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Safety and Effectiveness of PENNVAX-B Vaccine Alone, With Il-12, or IL-15 in Healthy Adults

13. oktober 2021 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of PENNVAX-B (Gag, Pol, Env) Given Alone, With IL-12 DNA, or With a Dose Escalation of IL-15 DNA, in Healthy, HIV-1-uninfected Adults Participants

The purpose of this study is to determine the safety, tolerability, and immune response to the DNA HIV vaccine, PENNVAX-B alone, in combination with IL-12, or with 2 different doses of IL-15.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A vaccine that is effective against multiple strains of HIV remains the best option for preventing the spread of HIV. Plasmid DNA vaccines are inexpensive and easy to construct. When DNA vaccines are administered in combination with cytokines, such as IL-12 or IL-15, the immune response to the vaccine is increased. The purpose of this study is to determine the safety and tolerability of the DNA plasmid vaccine, PENNVAX-B when administered alone, or with IL-12 or IL-15 DNA adjuvants. The most effective and safe dose of IL-15 will also be determined during this study.

This study will last approximately 12 months. Participants will be randomly assigned to one of four groups. Group 1 will receive an injection of PENNVAX-B combined with 0.8 mg IL-15 in each deltoid or placebo. Group 2 will receive an injection of PENNVAX-B alone or placebo. Group 3 will receive an injection of PENNVAX-B combined with IL-12 in each deltoid or placebo. Group 4 will receive PENNVAX-B combined with 2 mg IL-15 or placebo. Injections will occur at study entry, Months 1, 3, and 6. Additional study visits will occur on Days 14, 42, 98, 182, 273, and 364. At these visits a brief physical, blood collection, interview, and risk reduction counseling will occur. At some visits HIV testing, urine collection, and pregnancy tests will also occur.

As of 05/30/08, participants will be enrolled into Groups 3 and 4 at a limited pace to allow for additional safety reviews for the first few participants in these groups. Additionally, safety data will be reviewed for Groups 1 and 2 to determine whether the remainder of participants in Groups 2, 3, and 4 will be enrolled.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • Alabama Vaccine CRS
    • California
      • San Francisco, California, Forenede Stater
        • San Francisco Vaccine and Prevention CRS
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater
        • Brigham and Women's Hosp. CRS
    • New York
      • Bronx, New York, Forenede Stater, 10456
        • NY Blood Ctr./Bronx CRS
      • New York, New York, Forenede Stater, 10003
        • NY Blood Ctr./Union Square CRS
      • New York, New York, Forenede Stater, 10032
        • HIV Prevention & Treatment CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater
        • 3535 Market Street CRS
    • Tennessee
      • Nashville, Tennessee, Forenede Stater
        • Vanderbilt Vaccine CRS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • HIV-1 and -2 uninfected
  • Willing to receive HIV test results
  • Good general health
  • Certain laboratory values within normal range or with site physician approval
  • Negative for Hepatitis B surface antigen
  • Negative Hepatitis C test
  • Willing to use acceptable methods of contraception

Exclusion Criteria:

  • HIV vaccines or placebos in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
  • Immunosuppressive medications within 168 days prior to first study vaccination. Participants using corticosteroid nasal spray for allergies or topical corticosteroids for mild, uncomplicated dermatitis are not excluded.
  • Blood products within 120 days prior to first study vaccination
  • Receipt of immunoglobulin within 60 days prior to first vaccination
  • Live attenuated vaccines within 30 days prior to first study vaccination
  • Any vaccine that is not a live attenuated vaccine within 14 days prior to first study vaccination
  • Investigational research agents within 60 days prior to first study vaccination
  • Current anti-tuberculosis (TB) preventive therapy or treatment clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health. More information about this criterion can be found in the protocol.
  • Any medical, psychiatric, social, occupational, or other condition or responsibility that in the opinion of the investigator would interfere with the study. More information about this criterion can be found in the protocol.
  • Allergy to amide-type local anesthetics
  • Serious adverse reactions to vaccines
  • Autoimmune disease or immunodeficiency
  • Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded.
  • Asthma other than mild, well-controlled asthma. More information on this criterion can be found in the protocol.
  • Type 1 or type 2 diabetes mellitus. Participants with histories of isolated gestational diabetes are not excluded.
  • Thyroidectomy or thyroid disease requiring medication during the 12 months prior to study entry
  • Accumulation of fluid in the blood vessels (angioedema) within 3 years prior to study entry if episodes are considered serious or have required medication in the 2 years prior to study entry
  • Uncontrolled hypertension
  • Body Mass Index of 40 or greater OR of 35 or greater if certain other criteria apply. More information about these criteria can be found in the protocol
  • Bleeding disorder
  • Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded.
  • Seizure disorder
  • Absence of the spleen
  • Pregnancy or breastfeeding

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
PENNVAX-B with 0.8 mg IL-15 administered in both deltoids at Months 0, 1, 3, and 6
Biologisk: PennVax B
DNA vaccine containing the HIV genes Gag, Pol, and Env
Biologisk: IL-15
Cytokine injection
Eksperimentel: 2
PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6
Biologisk: PennVax B
DNA vaccine containing the HIV genes Gag, Pol, and Env
Eksperimentel: 3
PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6
Biologisk: PennVax B
DNA vaccine containing the HIV genes Gag, Pol, and Env
Biologisk: IL-12
Cytokine injection
Eksperimentel: 4
PENNVAX-B with 2 mg IL-15 injected into both deltoids at Months 0, 1, 3, and 6
Biologisk: PennVax B
DNA vaccine containing the HIV genes Gag, Pol, and Env
Biologisk: IL-15
Cytokine injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Safety data including local and systemic reactogenicity sign and symptoms, laboratory measures of safety, and adverse and serious adverse events
Tidsramme: Throughout study
Throughout study
Safety data from Groups 1 and 4
Tidsramme: Throughout study
Throughout study

Sekundære resultatmål

Resultatmål
Tidsramme
HIV-1 specific interferon gamma ELISpot and/or intracellular cytokine staining T cell response
Tidsramme: 2 weeks after 3rd and 4th vaccinations
2 weeks after 3rd and 4th vaccinations
HIV-1 specific neutralizing and binding antibody assays
Tidsramme: 2 weeks after 3rd and 4th vaccinations
2 weeks after 3rd and 4th vaccinations

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbejdspartnere

HIV Vaccine Trials Network

Efterforskere

  • Studiestol: Scott Parker, MD, HVTN, FHCRC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2007

Primær færdiggørelse (Faktiske)

1. januar 2010

Studieafslutning (Faktiske)

1. januar 2010

Datoer for studieregistrering

Først indsendt

10. september 2007

Først indsendt, der opfyldte QC-kriterier

10. september 2007

Først opslået (Skøn)

12. september 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HVTN 070
  • 10490 (Anden identifikator: CTEP)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-infektioner

Kliniske forsøg med PennVax B

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in South Korea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner