HIV InfectionsPhase 1NCT00472719
Safety of and Immune Response to a DNA HIV Vaccine Followed By Boosting With One of Two Serotypes of Adenoviral Vector HIV Vaccine in Healthy Adults
A Phase 1 study testing VRC-HIVADV027-00-VP, VRC-HIVADV038-00-VP and VRC-HIVDNA044-00-VP in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in United States.
Trial summary
The purpose of this study is to determine the safety of and immune response to an experimental DNA HIV vaccine followed by boosting with either an experimental adenoviral vector HIV vaccine of serotype 5 or 35 in HIV uninfected adults. 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?
- VRC-HIVADV027-00-VP, VRC-HIVADV038-00-VP and VRC-HIVDNA044-00-VP
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2007to Jan 2013
- Phase
- Phase 1
- 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
Who may be able to join
- HIV-1 and -2 uninfected
- Have access to a participating HIV Vaccine Trials Unit (HVTU) and willing to be followed for the duration of the study
- Willing to receive HIV test results
- Good general health
- Pre-existing adenovirus 5 (Ad5) neutralizing antibody titer of 1:1000 ratio or greater
- Willing to use acceptable forms of contraception from at least 21 days prior to enrollment through the duration of the study
Who cannot join
- HIV vaccines in prior HIV vaccine trial
- Immunosuppressive medications within 168 days prior to first study vaccine administration
- Blood products within 120 days prior to first study vaccine administration
- Immunoglobulin within 60 days prior to first study vaccine administration
- Live attenuated vaccines within 30 days prior to first study vaccine administration
- Investigational research agents within 30 days prior to first study vaccine administration
Show all 27Show fewer
- Subunit or killed vaccines within 14 days prior to first study vaccine administration
- Current anti-tuberculosis prophylaxis or therapy
- Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health. More information about this criterion can be found in the protocol.
- Any medical, psychiatric, or social condition that would interfere with the study.
- Serious adverse reaction to vaccines. Participants who have had an adverse reaction to pertussis vaccine as a child are not excluded.
- Autoimmune disease or immunodeficiency
- Active syphilis infection. Participants with fully treated syphilis at least 6 months prior to study entry are not excluded.
- Unstable asthma. More information about this criterion can be found in the protocol.
- Diabetes mellitus type 1 or 2. Participants with a history of isolated gestational diabetes are not excluded.
- Absence of thyroid or thyroid disease requiring treatment
- Serious angioedema within the past 3 years or requiring medication within 2 years of study entry
- Body mass index (BMI) of 40 or less OR BMI of 35 or less if certain other criteria apply. More information about these criteria can be found in the protocol.
- Uncontrolled hypertension
- Bleeding disorder
- Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded.
- Seizure disorder
- Absence of spleen
- Certain abnormal laboratory values
- Mental illness that would interfere with compliance with the protocol
- Other conditions that, in the judgment of the investigator, would interfere with the study
- Pregnant or breastfeeding
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Alabama Vaccine CRS
Birmingham, Alabama, 35294
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, 37232-2582
Columbia P&S CRS
New York, New York, 10032-3732
New York Blood Center CRS
New York, New York, 10065
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, 14642
Bridge HIV CRS
San Francisco, California, 94143
Seattle Vaccine and Prevention CRS
Seattle, Washington, 98109-1024
About this study
Official title: A Phase 1B Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Adenoviral Serotype 35 (rAd35) and Serotype 5 (rAd5) HIV-1 Vaccines When Given in Heterologous Prime-Boost Regimens or as a Boost to a Recombinant DNA Vaccine in Healthy, HIV-1-Uninfected Adult Participants With Pre-Existing Immunity to Adenovirus Serotype 5 Infection
The purpose of this study is to determine the safety of and immune response to an experimental DNA HIV vaccine followed by boosting with either an experimental adenoviral vector HIV vaccine of serotype 5 or 35 in HIV uninfected adults. This study will also determine the safety of and immune response to an adenoviral vector HIV vaccine of serotype 5 followed by a booster of an adenoviral vector of serotype 35, or vice versa, in HIV uninfected adults.
Read the detailed description
The worldwide HIV/AIDS epidemic may only be controlled through development and utilization of a safe and effective vaccine that will prevent HIV infection. Vaccines using a DNA plasmid to prime the response to an adenoviral vector boost are currently being developed. Due to high prevalence of pre-existing immunity to adenovirus serotype Ad5 in the developing world, this study will evaluate boosting with a different serotype, Ad35, as compared to boosting with the Ad5 serotype. This study will also test the effect of the order of administration of recombinant adenoviral vector HIV vaccines when administered without the DNA plasmid vaccine. Two arms of this study will evaluate the safety and immunogenicity of the experimental multiclade, multigene HIV DNA vaccine VRC-HIVDNA044-00-VP, followed by a similarly structured adenovirus vector vaccine boost (either VRC-HIVADV027-00-VP or VRC-HIVADV038-00-VP), in HIV uninfected adults. To determine the effect of pre-existing Ad5 or Ad35 immunity, the other two arms will test the safety and immunogenicity of receiving either VRC-HIVADV027-00-VP followed by VRC-HIVADV038-00-VP, or vice versa.
Each volunteer will participate in the study for at least 6 months. Participants will be randomly assigned to one of four groups and will receive either an experimental vaccine or placebo at each vaccination visit. Group 1 participants will receive an injection of the adenoviral vector vaccine VRC-HIVADV027-00-VP at study entry and an injection of VRC-HIVADV038-00-VP at Month 3. Group 2 participants will receive an injection of the adenoviral vector vaccine VRC-HIVADV038-00-VP at study entry and an injection of VRC-HIVADV027-00-VP at Month 3. Group 3 participants will receive an injection of the VRC-HIVDNA044-00-VP vaccine at study entry and Months 1 and 2, followed by an injection of VRC-HIVADV027-00-VP at Month 6. Group 4 participants will receive an injection of the DNA HIV vaccine at study entry and Months 1 and 2, followed by an injection of VRC-HIVADV038-00-VP at Month 6.
For Groups 1 and 2, there will be 9 study visits. For Groups 3 and 4, there will be 13 study visits. Medication history, assessment of intercurrent illness and adverse effects, and HIV and pregnancy prevention counseling will occur at all visits. A medical history, a physical exam, HIV testing and counseling and blood and urine collection will occur at selected visits. Participants will also be asked to complete social impact and HIV testing and history questionnaires at selected visits.
As of 11/19/07 enrollment and vaccinations have been discontinued. Participants who have already been enrolled have been told which vaccinations they received and will be followed for a total of 5 years.
- Conditions
- HIV Infections
- Being tested
- VRC-HIVADV027-00-VP, VRC-HIVADV038-00-VP, VRC-HIVDNA044-00-VP
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine, Adenovirus
- Medical subject headings
- HIV Infections, Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRC-HIVADV027-00-VPBiological
Adenoviral vector booster vaccine
VRC-HIVADV038-00-VPBiological
Adenovirus vector booster vaccine
VRC-HIVDNA044-00-VPBiological
Experimental, multiclade, multigene HIV DNA vaccine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants in this group will receive an injection of the adenoviral vector vaccine VRC-HIVADV027-00VP at study entry and an injection of VRC-HIVADV038-00-VP at Month 3. There will be 9 study visits for this arm. Receives: Biological: VRC-HIVADV027-00-VP; Biological: VRC-HIVADV038-00-VP |
| 2 | Experimental | Participants in this group will receive an injection of VRC-HIVADV038-00-VP at study entry and an injection of VRC-HIVADV027-00-VP at Month 3. There will be 9 study visits for this group. Receives: Biological: VRC-HIVADV027-00-VP; Biological: VRC-HIVADV038-00-VP |
| 3 | Experimental | Participants in this group will receive an injection of the VRC-HIVDNA044-00-VP vaccine at study entry and Months 1 and 2, followed by an injection of VRC-HIVADV027-00-VPat Month 6. There will be 13 study visits for this group. Receives: Biological: VRC-HIVADV027-00-VP; Biological: VRC-HIVDNA044-00-VP |
| 4 | Experimental | Participants in this group will receive an injection of VRC-HIVDNA044-00-VP at study entry and Months 1 and 2, followed by an injection of VRC-HIVADV038-00-VP at Month 6. There will be 13 study visits for this group. Receives: Biological: VRC-HIVADV038-00-VP; Biological: VRC-HIVDNA044-00-VP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of HIV-1 recombinant Clade A env DNA, rAd5, and rAd35 vaccines in participants with pre-existing immunity to Ad5
Measured: at 9 to 12 months
Magnitude and frequency of immune responses between the adenoviral vaccines following DNA prime, assessed by enzyme-linked immunospot (ELISpot) responses, intracellular cytokine staining (ICS) T-cell responses, and HIV-1 antibody assays
Measured: at 4 weeks following fourth vaccination
Immunogenicity of recombinant HIV-1 Clade A env rAd35 vaccine following a recombinant rAd5 prime, assessed by ELISpot responses, ICS T-cell responses, and HIV-1 antibody assays
Measured: at 4 weeks following the second vaccination
Immunogenicity of recombinant HIV-1 Clade A env rAd5 vaccine following a recombinant rAd35, assessed by ELISpot responses, ICS T-cell responses, and HIV-1 antibody assays
Measured: at 4 weeks following the second vaccination
Secondary outcomes (3)
Rank of HIV-1 rAd5/rAd35, rAd35/rAd5, DNA/rAd5, and DNA/rAd35 regimens based on ELISpot responses, ICS T-cell responses, and HIV-1 antibody assays
Measured: at 4 weeks after second vaccination for Groups 1 and 2, and at 4 weeks after fourth vaccination for Groups 3 and 4
Immunogenicity of HIV-1 rAd35 vaccine given as a prime assessed by ELISpot responses, ICS T-cell responses, and HIV-1 antibody assays
Measured: at 4 weeks following first vaccination
Immunogenicity of HIV-1 rAd5 vaccine given as a prime, assessed by ELISpot responses, ICS T-cell responses, and HIV-1 antibody assays
Measured: at 4 weeks following first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network
- Responsible party
- Sponsor
- Investigators
- Jonathan Fuchs, MD, MPH, Study chair, San Francisco Department of Public Health, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472719
- Sponsor's protocol ID
- HVTN 072
- Other IDs
- 10517
- Status last verified
- Oct 2021
- First submitted
- 11 May 2007
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barouch DH, Nabel GJ. Adenovirus vector-based vaccines for human immunodeficiency virus type 1. Hum Gene Ther. 2005 Feb;16(2):149-56. doi: 10.1089/hum.2005.16.149.
PubMed 15761255Barouch DH, Pau MG, Custers JH, Koudstaal W, Kostense S, Havenga MJ, Truitt DM, Sumida SM, Kishko MG, Arthur JC, Korioth-Schmitz B, Newberg MH, Gorgone DA, Lifton MA, Panicali DL, Nabel GJ, Letvin NL, Goudsmit J. Immunogenicity of recombinant adenovirus serotype 35 vaccine in the presence of pre-existing anti-Ad5 immunity. J Immunol. 2004 May 15;172(10):6290-7. doi: 10.4049/jimmunol.172.10.6290.
PubMed 15128818Cohen P. Immunity's yin and yang. A successful vaccine must first avoid being eliminated by pre-existing immunity before it can promote a protective immune response. IAVI Rep. 2006 Jan-Feb;10(1):1-5. No abstract available.
PubMed 16625717Lemckert AA, Sumida SM, Holterman L, Vogels R, Truitt DM, Lynch DM, Nanda A, Ewald BA, Gorgone DA, Lifton MA, Goudsmit J, Havenga MJ, Barouch DH. Immunogenicity of heterologous prime-boost regimens involving recombinant adenovirus serotype 11 (Ad11) and Ad35 vaccine vectors in the presence of anti-ad5 immunity. J Virol. 2005 Aug;79(15):9694-701. doi: 10.1128/JVI.79.15.9694-9701.2005.
PubMed 16014931Wu L, Kong WP, Nabel GJ. Enhanced breadth of CD4 T-cell immunity by DNA prime and adenovirus boost immunization to human immunodeficiency virus Env and Gag immunogens. J Virol. 2005 Jul;79(13):8024-31. doi: 10.1128/JVI.79.13.8024-8031.2005.
PubMed 15956548
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Adenoviral Serotype 35 (rAd35) and Serotype 5 (rAd5) HIV-1 Vaccines When Given in Heterologous Prime-Boost Regimens or as a Boost to a Recombinant DNA Vaccine in Healthy, HIV-1-Uninfected Adult Participants With Pre-Existing Immunity to Adenovirus Serotype 5 Infection
- ClinicalTrials.gov ID
- NCT00472719
- Acronym / sponsor ID
- HVTN 072
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine, Adenovirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 14 May 2007 (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.
The purpose of this study is to determine the safety of and immune response to an experimental DNA HIV vaccine followed by boosting with either an experimental adenoviral vector HIV vaccine of serotype 5 or 35 in HIV uninfected adults. This study will also determine the safety of and immune response to an adenoviral vector HIV vaccine of serotype 5 followed by a booster of an adenoviral vector of serotype 35, or vice versa, in HIV uninfected adults.
Detailed description
The worldwide HIV/AIDS epidemic may only be controlled through development and utilization of a safe and effective vaccine that will prevent HIV infection. Vaccines using a DNA plasmid to prime the response to an adenoviral vector boost are currently being developed. Due to high prevalence of pre-existing immunity to adenovirus serotype Ad5 in the developing world, this study will evaluate boosting with a different serotype, Ad35, as compared to boosting with the Ad5 serotype. This study will also test the effect of the order of administration of recombinant adenoviral vector HIV vaccines when administered without the DNA plasmid vaccine. Two arms of this study will evaluate the safety and immunogenicity of the experimental multiclade, multigene HIV DNA vaccine VRC-HIVDNA044-00-VP, followed by a similarly structured adenovirus vector vaccine boost (either VRC-HIVADV027-00-VP or VRC-HIVADV038-00-VP), in HIV uninfected adults. To determine the effect of pre-existing Ad5 or Ad35 immunity, the other two arms will test the safety and immunogenicity of receiving either VRC-HIVADV027-00-VP followed by VRC-HIVADV038-00-VP, or vice versa.
Each volunteer will participate in the study for at least 6 months. Participants will be randomly assigned to one of four groups and will receive either an experimental vaccine or placebo at each vaccination visit. Group 1 participants will receive an injection of the adenoviral vector vaccine VRC-HIVADV027-00-VP at study entry and an injection of VRC-HIVADV038-00-VP at Month 3. Group 2 participants will receive an injection of the adenoviral vector vaccine VRC-HIVADV038-00-VP at study entry and an injection of VRC-HIVADV027-00-VP at Month 3. Group 3 participants will receive an injection of the VRC-HIVDNA044-00-VP vaccine at study entry and Months 1 and 2, followed by an injection of VRC-HIVADV027-00-VP at Month 6. Group 4 participants will receive an injection of the DNA HIV vaccine at study entry and Months 1 and 2, followed by an injection of VRC-HIVADV038-00-VP at Month 6.
For Groups 1 and 2, there will be 9 study visits. For Groups 3 and 4, there will be 13 study visits. Medication history, assessment of intercurrent illness and adverse effects, and HIV and pregnancy prevention counseling will occur at all visits. A medical history, a physical exam, HIV testing and counseling and blood and urine collection will occur at selected visits. Participants will also be asked to complete social impact and HIV testing and history questionnaires at selected visits.
As of 11/19/07 enrollment and vaccinations have been discontinued. Participants who have already been enrolled have been told which vaccinations they received and will be followed for a total of 5 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: VRC-HIVADV027-00-VP, Biological: VRC-HIVADV038-00-VPParticipants in this group will receive an injection of the adenoviral vector vaccine VRC-HIVADV027-00VP at study entry and an injection of VRC-HIVADV038-00-VP at Month 3. There will be 9 study visits for this arm. |
| 2 | Experimental | Biological: VRC-HIVADV027-00-VP, Biological: VRC-HIVADV038-00-VPParticipants in this group will receive an injection of VRC-HIVADV038-00-VP at study entry and an injection of VRC-HIVADV027-00-VP at Month 3. There will be 9 study visits for this group. |
| 3 | Experimental | Biological: VRC-HIVADV027-00-VP, Biological: VRC-HIVDNA044-00-VPParticipants in this group will receive an injection of the VRC-HIVDNA044-00-VP vaccine at study entry and Months 1 and 2, followed by an injection of VRC-HIVADV027-00-VPat Month 6. There will be 13 study visits for this group. |
| 4 | Experimental | Biological: VRC-HIVADV038-00-VP, Biological: VRC-HIVDNA044-00-VPParticipants in this group will receive an injection of VRC-HIVDNA044-00-VP at study entry and Months 1 and 2, followed by an injection of VRC-HIVADV038-00-VP at Month 6. There will be 13 study visits for this group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- HIV-1 and -2 uninfected
- Have access to a participating HIV Vaccine Trials Unit (HVTU) and willing to be followed for the duration of the study
- Willing to receive HIV test results
- Good general health
- Pre-existing adenovirus 5 (Ad5) neutralizing antibody titer of 1:1000 ratio or greater
Key exclusion criteria (27 listed)
- HIV vaccines in prior HIV vaccine trial
- Immunosuppressive medications within 168 days prior to first study vaccine administration
- Blood products within 120 days prior to first study vaccine administration
- Immunoglobulin within 60 days prior to first study vaccine administration
- Live attenuated vaccines within 30 days prior to first study vaccine administration
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 |
|---|---|---|
| VRC-HIVADV027-00-VPAdenoviral vector booster vaccine | Biological | 1, 2, 3 |
| VRC-HIVADV038-00-VPAdenovirus vector booster vaccine | Biological | 1, 2, 4 |
| VRC-HIVDNA044-00-VPExperimental, multiclade, multigene HIV DNA vaccine | Biological | 3, 4 |
Primary outcome
Safety and tolerability of HIV-1 recombinant Clade A env DNA, rAd5, and rAd35 vaccines in participants with pre-existing immunity to Ad5
Time frame: at 9 to 12 months
Magnitude and frequency of immune responses between the adenoviral vaccines following DNA prime, assessed by enzyme-linked immunospot (ELISpot) responses, intracellular cytokine staining (ICS) T-cell responses, and HIV-1 antibody assays
Time frame: at 4 weeks following fourth vaccination
Immunogenicity of recombinant HIV-1 Clade A env rAd35 vaccine following a recombinant rAd5 prime, assessed by ELISpot responses, ICS T-cell responses, and HIV-1 antibody assays
Time frame: at 4 weeks following the second vaccination
Immunogenicity of recombinant HIV-1 Clade A env rAd5 vaccine following a recombinant rAd35, assessed by ELISpot responses, ICS T-cell responses, and HIV-1 antibody assays
Time frame: at 4 weeks following the second vaccination
3 secondary outcomes
Rank of HIV-1 rAd5/rAd35, rAd35/rAd5, DNA/rAd5, and DNA/rAd35 regimens based on ELISpot responses, ICS T-cell responses, and HIV-1 antibody assays
Time frame: at 4 weeks after second vaccination for Groups 1 and 2, and at 4 weeks after fourth vaccination for Groups 3 and 4
Immunogenicity of HIV-1 rAd35 vaccine given as a prime assessed by ELISpot responses, ICS T-cell responses, and HIV-1 antibody assays
Time frame: at 4 weeks following first vaccination
Immunogenicity of HIV-1 rAd5 vaccine given as a prime, assessed by ELISpot responses, ICS T-cell responses, and HIV-1 antibody assays
Time frame: at 4 weeks following first vaccination
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 14 Oct 2021.
- Background: PubMed 15761255Barouch DH, Nabel GJ. Adenovirus vector-based vaccines for human immunodeficiency virus type 1. Hum Gene Ther. 2005 Feb;16(2):149-56. doi: 10.1089/hum.2005.16.149.
- Background: PubMed 15128818Barouch DH, Pau MG, Custers JH, Koudstaal W, Kostense S, Havenga MJ, Truitt DM, Sumida SM, Kishko MG, Arthur JC, Korioth-Schmitz B, Newberg MH, Gorgone DA, Lifton MA, Panicali DL, Nabel GJ, Letvin NL, Goudsmit J. Immunogenicity of recombinant adenovirus serotype 35 vaccine in the presence of pre-existing anti-Ad5 immunity. J Immunol. 2004 May 15;172(10):6290-7. doi: 10.4049/jimmunol.172.10.6290.
- Background: PubMed 16625717Cohen P. Immunity's yin and yang. A successful vaccine must first avoid being eliminated by pre-existing immunity before it can promote a protective immune response. IAVI Rep. 2006 Jan-Feb;10(1):1-5. No abstract available.
- Background: PubMed 16014931Lemckert AA, Sumida SM, Holterman L, Vogels R, Truitt DM, Lynch DM, Nanda A, Ewald BA, Gorgone DA, Lifton MA, Goudsmit J, Havenga MJ, Barouch DH. Immunogenicity of heterologous prime-boost regimens involving recombinant adenovirus serotype 11 (Ad11) and Ad35 vaccine vectors in the presence of anti-ad5 immunity. J Virol. 2005 Aug;79(15):9694-701. doi: 10.1128/JVI.79.15.9694-9701.2005.
- Background: PubMed 15956548Wu L, Kong WP, Nabel GJ. Enhanced breadth of CD4 T-cell immunity by DNA prime and adenovirus boost immunization to human immunodeficiency virus Env and Gag immunogens. J Virol. 2005 Jul;79(13):8024-31. doi: 10.1128/JVI.79.13.8024-8031.2005.
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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.
Jonathan Fuchs, MD, MPH study chair
San Francisco Department of Public Health, University of California, San Francisco
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VRC-HIVADV027-00-VP, VRC-HIVADV038-00-VP and VRC-HIVDNA044-00-VP in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 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 27 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 14 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 7 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety and tolerability of HIV-1 recombinant Clade A env DNA, rAd5, and rAd35 vaccines in participants with pre-existing immunity to Ad5 (time frame: at 9 to 12 months). The study lists 4 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 NCT00472719, which also lists 5 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 14 Oct 2021.