HIV InfectionsNCT00908323
Early Immune Responses to Vaccination - A Substudy to HVTN 205
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- JS7 DNA vaccine and MVA/HIV62 vaccine
- Type of treatment
- Vaccines
- How many people
- 47 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2009to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants enrolled in HVTN 205
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Alabama Vaccine CRS
Birmingham, Alabama, 35294
Bridge HIV CRS
San Francisco, California, 94143
Seattle Vaccine and Prevention CRS
Seattle, Washington, 98109-1024
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- HIV Infections
- Being tested
- JS7 DNA vaccine, MVA/HIV62 vaccine
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS7 DNA vaccineBiological
MVA/HIV62 vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| A | Participants receiving the JS7 DNA and MVA/HIV62 vaccinations in HVTN 205 Receives: Biological: JS7 DNA vaccine; Biological: MVA/HIV62 vaccine | |
| B | Participants receiving the placebos of the JS7 DNA and MVA/HIV62 vaccines in HVTN 205 Receives: Biological: JS7 DNA vaccine; Biological: MVA/HIV62 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentrations of lymphocyte populations, dendritic cells, monocytes, and granulocytes
Measured: Throughout study
Serum concentrations of cytokines and chemokines
Measured: Throughout study
Changes in PBMC gene expression relative to prevaccine levels of key genes expected to change, such as IP-10 and MCP-1
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Erica Andersen-Nissen, PhD, Study chair, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908323
- Sponsor's protocol ID
- HVTN 908
- Other IDs
- 10806
- Status last verified
- Oct 2021
- First submitted
- 21 May 2009
- Last updated
- 15 Oct 2021
- Results posted
- No
Publications
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.
PubMed 19063693Browne 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.
PubMed 19214214Zwolinska 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. Polish.
PubMed 19252466
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Innate Immune Response to Candidate HIV Vaccines, an Ancillary Study to HVTN 205
- ClinicalTrials.gov ID
- NCT00908323
- Acronym / sponsor ID
- HVTN 908
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jul 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 25 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Biological: JS7 DNA vaccine, Biological: MVA/HIV62 vaccineParticipants receiving the JS7 DNA and MVA/HIV62 vaccinations in HVTN 205 |
| B | – | Biological: JS7 DNA vaccine, Biological: MVA/HIV62 vaccineParticipants receiving the placebos of the JS7 DNA and MVA/HIV62 vaccines in HVTN 205 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants enrolled in HVTN 205
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JS7 DNA vaccine | Biological | A, B |
| MVA/HIV62 vaccine | Biological | A, B |
Primary outcome
Blood concentrations of lymphocyte populations, dendritic cells, monocytes, and granulocytes
Time frame: Throughout study
Serum concentrations of cytokines and chemokines
Time frame: Throughout study
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Background: PubMed 19063693Baker 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.
- Background: PubMed 19214214Browne 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.
- Background: PubMed 19252466Zwolinska 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. Polish.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Andersen-Nissen, PhD study chair
Fred Hutchinson Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood concentrations of lymphocyte populations, dendritic cells, monocytes, and granulocytes (time frame: Throughout study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00908323, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.