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

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00098163
First received: December 3, 2004
Last updated: May 3, 2012
Last verified: May 2012

December 3, 2004
May 3, 2012
Not Provided
Not Provided
  • 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 ] [ Designated as safety issue: Yes ]
  • Cell-mediated immunologic response as measured by HIV-specific cytotoxic T-lymphocyte activity against viral antigens [ Time Frame: At Day 0 and throughout study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Grade 3 or higher adverse events attributable to the vaccine
  • cell-mediated immunologic response as measured by HIV-specific T lymphocyte activity against viral proteins
  • humoral immunologic response as measured by detection of binding antibody to vaccine antigens
Complete list of historical versions of study NCT00098163 on ClinicalTrials.gov Archive Site
  • Immune status as measured by CD4 cell counts in all immunized infants [ Time Frame: Over the 24-month follow-up period ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
 
Safety of and Immune Response to an HIV-1 Vaccine (ALVAC-HIV vCP1521) in Infants Born to HIV Infected Mothers
A Phase I Study to Evaluate the Safety and Immunogenicity of ALVAC-HIV vCP1521 in Infants Born to HIV-1 Infected Women in Uganda

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infections
  • 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.
  • Experimental: 1
    Intervention: Biological: ALVAC-HIV vCP1521
  • Placebo Comparator: 2
    Intervention: Biological: ALVAC HIV-1 vCP1521

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2009
Not Provided

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT00098163
HPTN 027, 10141
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
Study Chair: Laura Guay, MD Department of Pathology, Johns Hopkins University
Study Chair: Francis Mmiro, MBChB, FRCOG Department of Obstetrics and Gynecology, Makerere University
National Institute of Allergy and Infectious Diseases (NIAID)
May 2012

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