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Trial record 1 of 51 for:    ALVAC-HIV vCP1521
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Safety of and Immune Response to an HIV-1 Vaccine (ALVAC-HIV vCP1521) in Infants Born to HIV Infected Mothers

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ClinicalTrials.gov Identifier: NCT00098163
Recruitment Status : Completed
First Posted : December 6, 2004
Last Update Posted : May 4, 2012
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE December 3, 2004
First Posted Date  ICMJE December 6, 2004
Last Update Posted Date May 4, 2012
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2008)
  • Grade 3 or higher adverse events attributable to the vaccine. Mild and moderate adverse event rates will also be tabulated [ Time Frame: At Day 0 and throughout study ]
  • Cell-mediated immunologic response as measured by HIV-specific cytotoxic T-lymphocyte activity against viral antigens [ Time Frame: At Day 0 and throughout study ]
  • Humoral immunologic response as measured by detection of binding antibody to vaccine antigens and by neutralizing antibody assay [ Time Frame: At Day 0 and throughout study ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Grade 3 or higher adverse events attributable to the vaccine. Mild and moderate adverse event rates will also be tabulated
  • Cell-mediated immunologic response as measured by HIV-specific cytotoxic T-lymphocyte activity against viral antigens
  • Humoral immunologic response as measured by detection of binding antibody to vaccine antigens and by neutralizing antibody assay
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2008)
  • Immune status as measured by CD4 cell counts in all immunized infants [ Time Frame: Over the 24-month follow-up period ]
  • Development of immunity to routine vaccination as measured by antibody levels and Bacillus Calmette-Guéerin (BCG) scar formation [ Time Frame: At the end of study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Immune status as measured by CD4 cell counts over the 24-month follow-up period in all immunized infants
  • Development of immunity to routine vaccination as measured by antibody levels and Bacillus Calmette-Guérin (BCG) scar formation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of and Immune Response to an HIV-1 Vaccine (ALVAC-HIV vCP1521) in Infants Born to HIV Infected Mothers
Official Title  ICMJE A Phase I Study to Evaluate the Safety and Immunogenicity of ALVAC-HIV vCP1521 in Infants Born to HIV-1 Infected Women in Uganda
Brief Summary The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, ALVAC-HIV vCP1521, given to infants born to HIV-1 infected mothers in Uganda.
Detailed Description

Mother-to-child transmission (MTCT) of HIV can be caused either by perinatal transmission of HIV or by breastfeeding, a common practice in poorer regions of the world. HIV preventive vaccines are currently under investigation as potential solutions to worldwide MTCT of HIV. This study will evaluate the safety and immunogenicity of an HIV-1 vaccine, ALVAC-HIV vCP1521, in infants born to HIV-1 infected mothers in Uganda. The vaccine is a preparation of a live attenuated recombinant canarypox virus, encoding HIV clades B and E envelope proteins. This study will be conducted at Mulago Hospital in Uganda.

Mothers will enroll in this study during their third trimesters of pregnancy. During screening, mothers will undergo medical history assessment, a physical exam, and blood collection. After delivery and prior to infant enrollment, mothers will have another physical exam; mothers and their infants will be accompanied home by a home visitor who will document contact information.

Infants will be followed for 24 months after birth. Infants will be randomly assigned to receive 4 injections of vaccine or placebo. Study injections will be given at the start of the study and at Weeks 4, 8, and 12. Infants will be observed for 1 hour after each vaccine administration to check for body temperature and local and systemic reactions. They will also be evaluated in the clinic the day after each immunization for any local or systemic reactions. Infants will be visited at home 2 days after vaccine administration by a trained study nurse who will assess reactogenicity. Blood will be collected at 9 selected times: study entry, Weeks 2, 6, 10, and 14, and Months 6, 12, 18, and 24. Sixteen study visits occurring over 2 years will include medical history assessment and physical exams. Childhood immunizations will be given to infants at study entry and at Weeks 6, 10, and 14 and Months 6 and 12.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Biological: ALVAC-HIV vCP1521
    One 1-ml dose of HIV-1 vaccine administered after birth on or before Day 3 and at weeks 4, 8, and 12.
  • Biological: ALVAC HIV-1 vCP1521
    One 1-ml dose of HIV-1 vaccine placebo administered after birth on or before Day 3 and at Weeks 4, 8, and 12.
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Biological: ALVAC-HIV vCP1521
  • Placebo Comparator: 2
    Intervention: Biological: ALVAC HIV-1 vCP1521
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2012)
60
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
50
Actual Study Completion Date  ICMJE May 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria for HIV Infected Women:

  • HIV infected
  • In third trimester of pregnancy
  • CD4 count of more than 500 cells/mm3 at screening
  • Intends to give birth at Mulago Hospital, Uganda
  • Willing to be taken home by a home visitor after delivery to document locator information and willing to be visited at home later

Inclusion Criteria for Infants Born to HIV Infected Women:

  • 3 or fewer days of age
  • Born to an HIV infected woman eligible for the study
  • Weight at birth at least 2000 g (4.4 lbs)

Exclusion Criteria for HIV Infected Women:

  • Prior participation in an HIV-1 vaccine trial
  • Investigational agents, blood products, immunoglobulin, or immunotherapy any time during this pregnancy
  • Documented or suspected serious medical illness or life-threatening condition that may interfere with the study
  • Multiple birth predicted in current pregnancy

Exclusion Criteria for Infants Born to HIV Infected Women:

  • Mother left study prior to infant enrollment and randomization
  • Mother or infant received any active or passive HIV immunotherapy or investigational product other than the study vaccine. Mothers and infants who have taken nevirapine prior to study entry are not excluded.
  • Blood products, immunoglobulin, or immunosuppressive therapy during labor and delivery or prior to study enrollment
  • Abnormal vital signs prior to vaccination or clinical symptoms that may interfere with vaccine reaction assessment
  • Part of a multiple birth
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00098163
Other Study ID Numbers  ICMJE HPTN 027
10141 ( Registry Identifier: DAIDS ES )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
Study Chair: Laura Guay, MD Department of Pathology, Johns Hopkins University
Study Chair: Francis Mmiro, MBChB, FRCOG Department of Obstetrics and Gynecology, Makerere University
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP