Early Immune Responses to Vaccination - A Substudy to HVTN 205

HIV Infections Clinical Trial

Official title:

Characterization of the Innate Immune Response to Candidate HIV Vaccines, an Ancillary Study to HVTN 205

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908323
• Other study ID #: HVTN 908
• Secondary ID: 10806
• Status: Completed
• Start date: July 2009
• Est. completion date: July 2012

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• JS7 DNA vaccine

• MVA/HIV62 vaccine

Locations

Country	Name	City	State
United States	Alabama Vaccine CRS	Birmingham	Alabama
United States	Bridge HIV CRS	San Francisco	California
United States	Seattle Vaccine and Prevention CRS	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Baker BM, Block BL, Rothchild AC, Walker BD. Elite control of HIV infection: implications for vaccine design. Expert Opin Biol Ther. 2009 Jan;9(1):55-69. doi: 10.1517/14712590802571928 . Review. — View Citation

Browne EP, Littman DR. Myd88 is required for an antibody response to retroviral infection. PLoS Pathog. 2009 Feb;5(2):e1000298. doi: 10.1371/journal.ppat.1000298. Epub 2009 Feb 13. — View Citation

Zwolinska K. [Host genetic factors associated with susceptibility to HIV infection and progression of infection]. Postepy Hig Med Dosw (Online). 2009 Feb 24;63:73-91. Review. Polish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood concentrations of lymphocyte populations, dendritic cells, monocytes, and granulocytes		Throughout study
Primary	Serum concentrations of cytokines and chemokines		Throughout study
Primary	Changes in PBMC gene expression relative to prevaccine levels of key genes expected to change, such as IP-10 and MCP-1		Throughout study

External Links

•   Click here for more information about preventive HIV vaccines