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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: ALVAC-HIV vCP1521
Biological: ALVAC HIV-1 vCP1521
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase I Study to Evaluate the Safety and Immunogenicity of ALVAC-HIV vCP1521 in Infants Born to HIV-1 Infected Women in Uganda

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Completion Date: May 2009
Arms Assigned Interventions
Experimental: 1 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.
Placebo Comparator: 2 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098163

Locations
Uganda
Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS
Kampala, Uganda
Sponsors and Collaborators
Investigators
Study Chair: Laura Guay, MD Department of Pathology, Johns Hopkins University
Study Chair: Francis Mmiro, MBChB, FRCOG Department of Obstetrics and Gynecology, Makerere University
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00098163     History of Changes
Other Study ID Numbers: HPTN 027, 10141
Study First Received: December 3, 2004
Last Updated: May 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Seronegativity
HIV Preventive Vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 19, 2014