Early Immune Responses to Vaccination - A Substudy to HVTN 205

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00908323
First received: May 21, 2009
Last updated: September 22, 2014
Last verified: September 2014

May 21, 2009
September 22, 2014
July 2009
July 2012   (final data collection date for primary outcome measure)
  • Blood concentrations of lymphocyte populations, dendritic cells, monocytes, and granulocytes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Serum concentrations of cytokines and chemokines [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Changes in PBMC gene expression relative to prevaccine levels of key genes expected to change, such as IP-10 and MCP-1 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00908323 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Early Immune Responses to Vaccination - A Substudy to HVTN 205
Characterization of the Innate Immune Response to Candidate HIV Vaccines, an Ancillary Study to HVTN 205

HVTN 908 is a sub study of the HIV vaccine trial, HVTN 205. The purpose of this sub study is to better understand how a person's immune system responds to vaccines, particularly HIV vaccines. More specifically, researchers will determine whether early responses in the immune system help predict strong and long-lasting immunity.

Some of the first HIV vaccines were designed to trigger neutralizing antibody responses as a way to prevent HIV infection. Unfortunately, the first versions of these vaccines were not able to achieve their desired response. An alternative strategy to the antibody approach is the stimulation of HIV-specific CD8 T-lymphocyte (CTL) responses. CTL responses were previously demonstrated to play an important role in the control of simian immunodeficiency virus (SIV), the HIV equivalent studied in rhesus macaque monkeys. Additionally, other studies suggest CTLs play an important role in viral control during chronic infection. Based on this information, several groups have shifted their focus to the development of CTL-based vaccines, some of which have entered advanced clinical trials.

A DNA/rMVA vaccine strategy is structured to bring about both T cell and antibody responses. The primary vaccination is DNA based and will express only HIV proteins as a way to produce an HIV-focused immune response. A secondary, rMVA boost vaccination, which expresses both HIV and MVA proteins will ideally amplify the focused response of the initial vaccination. The DNA and rMVA are physically two different vaccinations given at separate times but together they make up one preventive regimen. Both vaccine components express non-infectious virus-like particles.

The main study, HVTN 205 will evaluate the safety of and immune response to a two vaccine regimen in healthy, HIV-uninfected adults who never received an HIV preventive vaccine before. HVTN 205 will include two parts, Part A, in which the two vaccine regimen is compared to a placebo, and Part B, in which the two vaccine regimen will be compared to both a placebo and a single vaccine regimen with the rMVA vaccine.

HVTN 908 is a sub study of HVTN 205, and will explore the innate immune response to candidate HIV vaccines. In particular, researchers will study whether early immune response following vaccination can predict strong and long-lasting immunity. They will also study whether varying types of vaccines promote different immune responses soon after vaccination.

Only participants enrolled in HVTN 205 are eligible for HVTN 908. Approximately 50 participants will be recruited for the duration of 12 months per participant. The study will last for a total of 2 years, including enrollment, follow-up, and analysis. Potential participants of the sub study will undergo a screening visit before eligibility can be determined. Screening may involve a physical exam, health history, and blood tests.

There will be some additional visits for participants of HVTN 908 that are not included in the main study. Some main study visits may also take extra time for participants enrolled in the sub study. Blood samples will be taken at study visits. These samples are taken in addition to those for the main study.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples 30 - 90 mL per visit

Non-Probability Sample

Participants enrolled in HVTN 205

HIV Infections
  • Biological: JS7 DNA vaccine
  • Biological: MVA/HIV62 vaccine
  • A
    Participants receiving the JS7 DNA and MVA/HIV62 vaccinations in HVTN 205
    Interventions:
    • Biological: JS7 DNA vaccine
    • Biological: MVA/HIV62 vaccine
  • B
    Participants receiving the placebos of the JS7 DNA and MVA/HIV62 vaccines in HVTN 205
    Interventions:
    • Biological: JS7 DNA vaccine
    • Biological: MVA/HIV62 vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Scheduled receipt of a vaccine or placebo in HVTN 205
  • For participants in Part B of HVTN 205, enrollment in HVTN 908 and HVTN 205 at the same time
  • HVTN 908 assessment of understanding: completion of a questionnaire prior to enrollment; demonstration of understanding for all questionnaire items answered incorrectly.
  • Body weight of 50 kg (110 lbs) or more
  • Hemoglobin of 12.0 g/dL or more for female volunteers, and 13.0 g/dL or more for male volunteers
  • Negative HIV-1 and -2 blood test

Exclusion Criteria:

  • Clinically significant medical condition, physical examination finding, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. More information on this criterion can be found in the study protocol.
  • Any medical, psychiatric, or occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, or a participant's ability to give informed consent
  • Pregnancy
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00908323
HVTN 908, 10806
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Erica Andersen-Nissen, PhD Fred Hutchinson Cancer Research Center
National Institute of Allergy and Infectious Diseases (NIAID)
September 2014

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