Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Efficacy of Influenza Vaccine in HIV Infected Adults

8. oktober 2008 oppdatert av: University of Witwatersrand, South Africa

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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

507

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Gauteng
      • Johannesburg, Gauteng, Sør-Afrika
        • Helen Joseph Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 55 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: 2
Aktiv komparator: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
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.
Tidsramme: 1st May 2008 and ending 30th September 2008.
1st May 2008 and ending 30th September 2008.
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.

Sekundære resultatmål

Resultatmål
Incidence of solicited reactogenic events occurring within 72 hours of vaccination.
Changes in CD4+ cell count and HIV viral load.
Hospitalization or death for any physician-diagnosed respiratory illness in which influenza virus antigenically similar to vaccine strain is identified.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Shabir A Madhi, MBBCH PhD, University of Witwatersrand, South Africa
  • Hovedetterforsker: Ian Sanne, MBBCh, Clinical HIV Research Unit

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2008

Primær fullføring (Faktiske)

1. september 2008

Studiet fullført (Faktiske)

1. september 2008

Datoer for studieregistrering

Først innsendt

19. september 2008

Først innsendt som oppfylte QC-kriteriene

19. september 2008

Først lagt ut (Anslag)

23. september 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. oktober 2008

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. oktober 2008

Sist bekreftet

1. september 2008

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • CHRU02 (Ethics ref no 080212)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på HIV-infeksjoner

Kliniske studier på MUTAGRIP

3
Abonnere