NCT00230061

Brief Summary

In this study we compare the efficacy of two different HBV-vaccination schedules in HIV-infected persons concerning immune response and compliance. Short schedule: t=0,1,3 weeks and standard schedule: t=0,1,6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_4 hiv-infections

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

June 2, 2010

Status Verified

June 1, 2010

Enrollment Period

4.1 years

First QC Date

September 28, 2005

Last Update Submit

June 1, 2010

Conditions

HIV InfectionsHepatitis B

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

  • Measurement of anti-Hbs titer after completing hepatitis B vaccination.

Secondary Outcomes (1)

  • To compare response and compliance between two vaccination schedules: short and standard

Interventions

HBVAXPRO, Hepatitis B (Recombinant) vaccine, 10 mcg/mlBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV positive
  • Negative for HBsAg and anti-HBc
  • years or older

You may not qualify if:

  • previous Hepatitis B vaccination
  • current opportunistic infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

Related Publications (17)

  • Bodsworth NJ, Cooper DA, Donovan B. The influence of human immunodeficiency virus type 1 infection on the development of the hepatitis B virus carrier state. J Infect Dis. 1991 May;163(5):1138-40. doi: 10.1093/infdis/163.5.1138.

    PMID: 2019762BACKGROUND

  • Sinicco A, Raiteri R, Sciandra M, Bertone C, Lingua A, Salassa B, Gioannini P. Coinfection and superinfection of hepatitis B virus in patients infected with human immunodeficiency virus: no evidence of faster progression to AIDS. Scand J Infect Dis. 1997;29(2):111-5. doi: 10.3109/00365549709035869.

    PMID: 9181644BACKGROUND

  • Ockenga J, Tillmann HL, Trautwein C, Stoll M, Manns MP, Schmidt RE. Hepatitis B and C in HIV-infected patients. Prevalence and prognostic value. J Hepatol. 1997 Jul;27(1):18-24. doi: 10.1016/s0168-8278(97)80274-7.

    PMID: 9252068BACKGROUND

  • Lemon SM, Thomas DL. Vaccines to prevent viral hepatitis. N Engl J Med. 1997 Jan 16;336(3):196-204. doi: 10.1056/NEJM199701163360307. No abstract available.

    PMID: 8988900BACKGROUND

  • Carne CA, Weller IV, Waite J, Briggs M, Pearce F, Adler MW, Tedder RS. Impaired responsiveness of homosexual men with HIV antibodies to plasma derived hepatitis B vaccine. Br Med J (Clin Res Ed). 1987 Apr 4;294(6576):866-8. doi: 10.1136/bmj.294.6576.866.

    PMID: 3105779BACKGROUND

  • Keet IP, van Doornum G, Safary A, Coutinho RA. Insufficient response to hepatitis B vaccination in HIV-positive homosexual men. AIDS. 1992 May;6(5):509-10. No abstract available.

    PMID: 1535502BACKGROUND

  • Wong EK, Bodsworth NJ, Slade MA, Mulhall BP, Donovan B. Response to hepatitis B vaccination in a primary care setting: influence of HIV infection, CD4+ lymphocyte count and vaccination schedule. Int J STD AIDS. 1996 Nov-Dec;7(7):490-4. doi: 10.1258/0956462961918563.

    PMID: 9116065BACKGROUND

  • Bruguera M, Cremades M, Salinas R, Costa J, Grau M, Sans J. Impaired response to recombinant hepatitis B vaccine in HIV-infected persons. J Clin Gastroenterol. 1992 Jan;14(1):27-30. doi: 10.1097/00004836-199201000-00007.

    PMID: 1532609BACKGROUND

  • Rey D, Krantz V, Partisani M, Schmitt MP, Meyer P, Libbrecht E, Wendling MJ, Vetter D, Nicolle M, Kempf-Durepaire G, Lang JM. Increasing the number of hepatitis B vaccine injections augments anti-HBs response rate in HIV-infected patients. Effects on HIV-1 viral load. Vaccine. 2000 Jan 18;18(13):1161-5. doi: 10.1016/s0264-410x(99)00389-8.

    PMID: 10649616BACKGROUND

  • Sasaki Md, Foccacia R, de Messias-Reason IJ. Efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant for hepatitis B virus in patients with HIV infection. Vaccine. 2003 Nov 7;21(31):4545-9. doi: 10.1016/s0264-410x(03)00500-0.

    PMID: 14575766BACKGROUND

  • Wilson CM, Ellenberg JH, Sawyer MK, Belzer M, Crowley-Nowick PA, Puga A, Futterman DC, Peralta L; Adolescent Medicine HIV/AIDS Research Network. Serologic response to hepatitis B vaccine in HIV infected and high-risk HIV uninfected adolescents in the REACH cohort. Reaching for Excellence in Adolescent Care and Health. J Adolesc Health. 2001 Sep;29(3 Suppl):123-9. doi: 10.1016/s1054-139x(01)00278-6.

    PMID: 11530313BACKGROUND

  • Rutstein RM, Rudy B, Codispoti C, Watson B. Response to hepatitis B immunization by infants exposed to HIV. AIDS. 1994 Sep;8(9):1281-4. doi: 10.1097/00002030-199409000-00010.

    PMID: 7802981BACKGROUND

  • Scolfaro C, Fiammengo P, Balbo L, Madon E, Tovo PA. Hepatitis B vaccination in HIV-1-infected children: double efficacy doubling the paediatric dose. AIDS. 1996 Sep;10(10):1169-70. No abstract available.

    PMID: 8874636BACKGROUND

  • Saltoglu N, Inal AS, Tasova Y, Kandemir O. Comparison of the accelerated and classic vaccination schedules against Hepatitis B: three-week Hepatitis B vaccination schedule provides immediate and protective immunity. Ann Clin Microbiol Antimicrob. 2003 Nov 17;2:10. doi: 10.1186/1476-0711-2-10.

    PMID: 14622443BACKGROUND

  • Marchou B, Picot N, Chavanet P, Auvergnat JC, Armengaud M, Devilliers P, Cerisier JE, Marie FN, Excler JL. Three-week hepatitis B vaccination provides protective immunity. Vaccine. 1993 Nov;11(14):1383-5. doi: 10.1016/0264-410x(93)90165-t.

    PMID: 8310757BACKGROUND

  • Nothdurft HD, Dietrich M, Zuckerman JN, Knobloch J, Kern P, Vollmar J, Sanger R. A new accelerated vaccination schedule for rapid protection against hepatitis A and B. Vaccine. 2002 Jan 15;20(7-8):1157-62. doi: 10.1016/s0264-410x(01)00432-7.

    PMID: 11803077BACKGROUND

  • Wright NM, Campbell TL, Tompkins CN. Comparison of conventional and accelerated hepatitis B immunisation schedules for homeless drug users. Commun Dis Public Health. 2002 Dec;5(4):324-6.

    PMID: 12564251BACKGROUND

MeSH Terms

Conditions

HIV InfectionsHepatitis B

Interventions

Hepatitis B VaccinesVaccines

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesBiological ProductsComplex Mixtures

Study Officials

  • Theodora EM de Vries-Sluijs, MD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 28, 2005

First Posted

September 30, 2005

Study Start

April 1, 2004

Primary Completion

May 1, 2008

Study Completion

February 1, 2010

Last Updated

June 2, 2010

Record last verified: 2010-06

Locations

NL(1)