HIV InfectionsPhase 1NCT00124007
Safety of and Immune Response to an Adenoviral HIV Vaccine (VRC-HIVADV014-00-VP) With or Without a Plasmid HIV Vaccine (VRC-HIVDNA016-00-VP) in HIV Uninfected Adults
A Phase 1 study testing VRC-HIVADV014-00-VP and VRC-HIVDNA016-00-VP in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVADV014-00-VP, with or without a second investigational HIV vaccine, VRC-HIVDNA016-00-VP, 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-HIVADV014-00-VP and VRC-HIVDNA016-00-VP
- How many people
- 114 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2005to Apr 2007
- 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
- Willing to follow all the requirements of the study and available for follow-up for the duration of the study
- Have understanding of the study and provide written informed consent
- Willing to undergo HIV testing and counseling and willing to receive HIV test results
- Willing to use acceptable forms of contraception
Who cannot join
- HIV infected
- Hepatitis B virus infected
- Hepatitis C virus infected
- Active or untreated syphilis
- Participated in high-risk behavior for HIV infection within 6 months prior to study entry. More information on this criterion can be found in the protocol.
- Any clinically significant abnormality in history or upon examination (e.g., immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the investigator) within 6 months prior to study entry
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- Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would make the volunteer unsuitable for the study
- Live attenuated vaccines within 30 days prior to study entry OR plan to receive a live attenuated vaccine within 60 days after vaccination in this study
- Subunit or killed vaccines within 14 days prior to study entry OR plan to receive a subunit or killed vaccine within 14 days after vaccination in this study
- Blood transfusion or blood products within 120 days prior to study entry
- Immunoglobulin within 60 days prior to study entry
- Participation in another investigational product clinical trial in the 3 months prior to study entry OR expected to participate in another investigational trial during this study
- Any other investigational HIV vaccine at any time
- History of severe local or systemic reactogenicity to vaccines or history of severe allergic reactions
- Major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or suicide attempt or suicidal thoughts within the 3 years prior to study entry
- Uncontrolled hypertension
- Pregnant, breastfeeding, or plan to become pregnant
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Kenya2 sites
KEMRI, Ctr. for Geographic Medicine Research Coast at Kilifi
Kilifi
KAVI, KNH at Kangemi
Nairobi
About this study
Official title: A Phase I, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by Recombinant, Multiclade HIV-1 Adenoviral Vector Vaccine or the Multiclade HIV-1 Adenoviral Vector Vaccine Alone in Healthy Adult Volunteers Not Infected With HIV
The purpose of this study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVADV014-00-VP, with or without a second investigational HIV vaccine, VRC-HIVDNA016-00-VP, in HIV uninfected adults.
Read the detailed description
The worldwide HIV/AIDS epidemic may only be controlled through development of a safe and effective vaccine that will prevent HIV infection. This study will evaluate the safety and immunogenicity of an experimental adenovirus-vectored multiclade HIV vaccine, VRC-HIVADV014-00-VP, followed with either a similarly structured DNA plasmid HIV vaccine, VRC-HIVDNA016-00-VP, or a placebo. The DNA plasmids in both vaccines code for proteins from HIV subtypes A, B, and C, which together represent 90% of new HIV infections in the world. HIV uninfected volunteers will be recruited in Kenya and Rwanda.
Volunteers will participate in this study for 1 year. Participants will be randomly assigned to one of four groups:
- Group A participants will receive a low dose of the adenovirus-vectored vaccine or placebo at study entry.
- Group B participants will receive a higher dose of the adenovirus-vectored vaccine or placebo at study entry.
- Group C participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2. They will receive either a low dose of the adenovirus-vectored vaccine or placebo at Month 6.
- Group D participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2. They will receive either a higher dose of the adenovirus-vectored vaccine or placebo at Month 6.
All participants will undergo vital signs measurements before and after receiving each vaccination.
Participants in Groups A and B will have 9 study visits over 12 months. A physical exam, adverse events reporting, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits.
Participants in Groups C and D will have 17 study visits over 12 months. A physical exam, adverse events reporting, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits.
- Conditions
- HIV Infections
- Being tested
- VRC-HIVADV014-00-VP, VRC-HIVDNA016-00-VP
- 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.
VRC-HIVADV014-00-VPBiological
VRC-HIVDNA016-00-VPBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Local reactogenicity signs and symptoms
systemic reactogenicity signs and symptoms
laboratory measures of safety
adverse and serious adverse experiences
Secondary outcomes (5)
Proportion of volunteers who have HIV-1 specific T-cell responses quantified by intracellular cytokine staining (ICS; both CD4+ and CD8+) and ELISPOT and magnitude of the responses
proportion of volunteers with HIV-1 specific antibodies and magnitude of the response
proportion of volunteers with increase in antibodies to rAd5
impact of pre-existing immunity to rAd5 on immunogenicity
proportion of volunteers who test "false positive" on standard HIV testing algorithm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2005 (estimated)
- Study startNov 2005
- Study completionApr 2007
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Job Bwayo, MD, PhD, Principal investigator, Kenya AIDS Vaccine Initiative, University of NairobiEtienne Karita, MD, Principal investigator, Project San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124007
- Sponsor's protocol ID
- IAVI V001
- Other IDs
- 10380
- Status last verified
- Oct 2021
- First submitted
- 22 Jul 2005
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Esparza J, Osmanov S. HIV vaccines: a global perspective. Curr Mol Med. 2003 May;3(3):183-93. doi: 10.2174/1566524033479825.
PubMed 12699356Gaschen B, Taylor J, Yusim K, Foley B, Gao F, Lang D, Novitsky V, Haynes B, Hahn BH, Bhattacharya T, Korber B. Diversity considerations in HIV-1 vaccine selection. Science. 2002 Jun 28;296(5577):2354-60. doi: 10.1126/science.1070441.
PubMed 12089434Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. doi: 10.2174/1389450043490686.
PubMed 14738219Omosa-Manyonyi GS, Jaoko W, Anzala O, Ogutu H, Wakasiaka S, Malogo R, Nyange J, Njuguna P, Ndinya-Achola J, Bhatt K, Farah B, Oyaro M, Schmidt C, Priddy F, Fast P. Reasons for ineligibility in phase 1 and 2A HIV vaccine clinical trials at Kenya AIDS vaccine initiative (KAVI), Kenya. PLoS One. 2011 Jan 21;6(1):e14580. doi: 10.1371/journal.pone.0014580.
PubMed 21283743Jaoko W, Karita E, Kayitenkore K, Omosa-Manyonyi G, Allen S, Than S, Adams EM, Graham BS, Koup RA, Bailer RT, Smith C, Dally L, Farah B, Anzala O, Muvunyi CM, Bizimana J, Tarragona-Fiol T, Bergin PJ, Hayes P, Ho M, Loughran K, Komaroff W, Stevens G, Thomson H, Boaz MJ, Cox JH, Schmidt C, Gilmour J, Nabel GJ, Fast P, Bwayo J. Safety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa. PLoS One. 2010 Sep 21;5(9):e12873. doi: 10.1371/journal.pone.0012873.
PubMed 20877623
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by Recombinant, Multiclade HIV-1 Adenoviral Vector Vaccine or the Multiclade HIV-1 Adenoviral Vector Vaccine Alone in Healthy Adult Volunteers Not Infected With HIV
- ClinicalTrials.gov ID
- NCT00124007
- Acronym / sponsor ID
- IAVI V001
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 2005
- Study completion
- Apr 2007 (actual)
- First posted
- 26 Jul 2005 (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 investigational HIV vaccine, VRC-HIVADV014-00-VP, with or without a second investigational HIV vaccine, VRC-HIVDNA016-00-VP, in HIV uninfected adults.
Detailed description
The worldwide HIV/AIDS epidemic may only be controlled through development of a safe and effective vaccine that will prevent HIV infection. This study will evaluate the safety and immunogenicity of an experimental adenovirus-vectored multiclade HIV vaccine, VRC-HIVADV014-00-VP, followed with either a similarly structured DNA plasmid HIV vaccine, VRC-HIVDNA016-00-VP, or a placebo. The DNA plasmids in both vaccines code for proteins from HIV subtypes A, B, and C, which together represent 90% of new HIV infections in the world. HIV uninfected volunteers will be recruited in Kenya and Rwanda.
Volunteers will participate in this study for 1 year. Participants will be randomly assigned to one of four groups:
- Group A participants will receive a low dose of the adenovirus-vectored vaccine or placebo at study entry.
- Group B participants will receive a higher dose of the adenovirus-vectored vaccine or placebo at study entry.
- Group C participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2. They will receive either a low dose of the adenovirus-vectored vaccine or placebo at Month 6.
- Group D participants will receive the DNA plasmid vaccine or placebo at study entry and Months 1 and 2. They will receive either a higher dose of the adenovirus-vectored vaccine or placebo at Month 6.
All participants will undergo vital signs measurements before and after receiving each vaccination.
Participants in Groups A and B will have 9 study visits over 12 months. A physical exam, adverse events reporting, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits.
Participants in Groups C and D will have 17 study visits over 12 months. A physical exam, adverse events reporting, and medical and medication history will occur at each visit. HIV testing and counseling and blood and urine collection will occur at selected visits.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Willing to follow all the requirements of the study and available for follow-up for the duration of the study
- Have understanding of the study and provide written informed consent
- Willing to undergo HIV testing and counseling and willing to receive HIV test results
- Willing to use acceptable forms of contraception
Key exclusion criteria (17 listed)
- HIV infected
- Hepatitis B virus infected
- Hepatitis C virus infected
- Active or untreated syphilis
- Participated in high-risk behavior for HIV infection within 6 months prior to study entry. More information on this criterion can be found in the protocol.
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-HIVADV014-00-VP | Biological | – |
| VRC-HIVDNA016-00-VP | Biological | – |
Primary outcome
Local reactogenicity signs and symptoms
systemic reactogenicity signs and symptoms
laboratory measures of safety
adverse and serious adverse experiences
5 secondary outcomes
Proportion of volunteers who have HIV-1 specific T-cell responses quantified by intracellular cytokine staining (ICS; both CD4+ and CD8+) and ELISPOT and magnitude of the responses
proportion of volunteers with HIV-1 specific antibodies and magnitude of the response
proportion of volunteers with increase in antibodies to rAd5
impact of pre-existing immunity to rAd5 on immunogenicity
proportion of volunteers who test "false positive" on standard HIV testing algorithm.
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 1 Nov 2021.
- Background: PubMed 12699356Esparza J, Osmanov S. HIV vaccines: a global perspective. Curr Mol Med. 2003 May;3(3):183-93. doi: 10.2174/1566524033479825.
- Background: PubMed 12089434Gaschen B, Taylor J, Yusim K, Foley B, Gao F, Lang D, Novitsky V, Haynes B, Hahn BH, Bhattacharya T, Korber B. Diversity considerations in HIV-1 vaccine selection. Science. 2002 Jun 28;296(5577):2354-60. doi: 10.1126/science.1070441.
- Background: PubMed 14738219Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. doi: 10.2174/1389450043490686.
- Derived from this study: PubMed 21283743Omosa-Manyonyi GS, Jaoko W, Anzala O, Ogutu H, Wakasiaka S, Malogo R, Nyange J, Njuguna P, Ndinya-Achola J, Bhatt K, Farah B, Oyaro M, Schmidt C, Priddy F, Fast P. Reasons for ineligibility in phase 1 and 2A HIV vaccine clinical trials at Kenya AIDS vaccine initiative (KAVI), Kenya. PLoS One. 2011 Jan 21;6(1):e14580. doi: 10.1371/journal.pone.0014580.
- Derived from this study: PubMed 20877623Jaoko W, Karita E, Kayitenkore K, Omosa-Manyonyi G, Allen S, Than S, Adams EM, Graham BS, Koup RA, Bailer RT, Smith C, Dally L, Farah B, Anzala O, Muvunyi CM, Bizimana J, Tarragona-Fiol T, Bergin PJ, Hayes P, Ho M, Loughran K, Komaroff W, Stevens G, Thomson H, Boaz MJ, Cox JH, Schmidt C, Gilmour J, Nabel GJ, Fast P, Bwayo J. Safety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa. PLoS One. 2010 Sep 21;5(9):e12873. doi: 10.1371/journal.pone.0012873.
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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.
Job Bwayo, MD, PhD principal investigator
Kenya AIDS Vaccine Initiative, University of Nairobi
Etienne Karita, MD principal investigator
Project San Francisco
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VRC-HIVADV014-00-VP and VRC-HIVDNA016-00-VP in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in 2 countries.
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 4 inclusion and 17 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 1 Nov 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 Kenya, Rwanda. 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?
Local reactogenicity signs and symptoms. 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 NCT00124007, 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 1 Nov 2021.