HIV InfectionsPhase 1NCT00091416
Safety of and Immune Response to an HIV-1 Vaccine Boost (VRC-HIVADV014-00-VP) in HIV Uninfected Adults Who Participated in HVTN 052
A Phase 1 study testing VRC-HIVADV014-00-VP in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
Trial summary
The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, VRC-HIVADV014-00-VP, when given as a vaccine booster to HIV uninfected adults who participated in HVTN 052. 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
- How many people
- 70 participants
- Where
- 8 sitesUnited States
- Study dates
- Start not givento May 2006
- 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
- Previously enrolled in and have completed all 3 study vaccine injections for HVTN 052
- Understanding of vaccination procedure
- Good general health
- HIV uninfected
- Hepatitis B surface antigen negative
- Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive
- Willing to use acceptable forms of contraception
Who cannot join
- Immunosuppressive medications within 168 days prior to study
- Blood products within 120 days prior to study
- Immunoglobulin within 60 days prior to study
- Live attenuated vaccines within 30 days prior to study
- Investigational research agents within 30 days prior to study
- Medically indicated subunit or killed vaccines within 14 days prior to study
Show all 22Show fewer
- Allergy shots within 30 days prior to study
- Current anti-tuberculosis prophylaxis or therapy
- Anaphylaxis or other serious adverse reactions to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
- Autoimmune disease or immunodeficiency
- Active syphilis infection
- Unstable asthma (e.g., daily symptoms; use of oral or orally inhaled corticosteroids or other treatments; emergent care, urgent care, hospitalization, or intubation during the past 2 years)
- Diabetes mellitus. A participant with past gestational diabetes is not excluded.
- Thyroid disease, including removal of thyroid and diagnoses requiring medication. A participant not requiring thyroid medication during the last year is not excluded.
- Serious angioedema. A participant who has had an episode of angioedema over 3 years prior to the study, and has not required medications for at least 2 years, is not excluded.
- Uncontrolled hypertension
- Diagnosis of bleeding disorder
- Malignancy, except those with a surgical excision that has a reasonable assurance of sustained cure and/or is unlikely to recur during the period of the study
- Seizure disorder requiring medication within the last 3 years
- Absence of the spleen
- Mental illness that would interfere with compliance with the protocol
- Pregnancy or breastfeeding
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
Baltimore, Maryland, 21205-1901
Fenway Community Health Clinical Research Site (FCHCRS)
Boston, Massachusetts, 02115
Vanderbilt Vaccine CRS
Nashville, Tennessee, 37232
HIV Prevention & Treatment CRS
New York, New York
Miriam Hospital's HVTU
Providence, Rhode Island, 02906
Univ. of Rochester HVTN CRS
Rochester, New York, 14642-0001
FHCRC/UW Vaccine CRS
Seattle, Washington, 98104
Saint Louis Univ. School of Medicine, HVTU
St Louis, Missouri, 63110-2500
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety of a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Administered to Healthy, HIV-1 Uninfected, Adult Participants Who Received DNA Plasmid Vaccine or Placebo in the HVTN 052 Clinical Trial
The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, VRC-HIVADV014-00-VP, when given as a vaccine booster to HIV uninfected adults who participated in HVTN 052.
Read the detailed description
The worldwide HIV epidemic highlights the importance of developing an affordable, globally successful vaccine for HIV prevention. The VRC-HIVADV014-00-VP adenoviral vector vaccine used in this study was developed to stimulate strong virus-specific CD8 cytotoxic T-lymphocyte (CTL) responses thought to be crucial in an effective preventive HIV vaccine. The purpose of this study is to determine the safety and immunogenicity of a VRC-HIVADV014-00-VP vaccine boost given to healthy, HIV uninfected individuals who participated in HVTN 052, which evaluated the VRC-HIVDNA009-00-VP DNA plasmid vaccine. In that study, participants received either 3 injections of vaccine, 2 injections of vaccine and 1 injection of placebo, or 3 injections of placebo over a 2-month period.
This study will last one year. Participants will be randomly assigned to receive vaccine boost or placebo by intramuscular injection. The injections will be given 6 to 9 months after each participant's first HVTN 052 study injection, preferably as close to 6 months after the first HVTN 052 injection as possible. After a screening visit, study visits will occur at enrollment (when the injection will be given), at Week 2, and at Months 1, 3, 6, and 12. Blood collection, physical exam, and medication assessment will occur at every study visit; urine collection will occur at selected visits.
- Conditions
- HIV Infections
- Being tested
- VRC-HIVADV014-00-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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2004 (estimated)
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Larry Peiperl, MD, Study chair, San Francisco Department of Public Health / University of California - San FranciscoJulie McElrath, MD, PhD, Study chair, Fred Hutchinson Cancer Research Center / University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091416
- Sponsor's protocol ID
- HVTN 057
- Other IDs
- 10123
- Status last verified
- Oct 2021
- First submitted
- 8 Sep 2004
- Last updated
- 14 Oct 2021
- Results posted
- No
Publications
Gomez-Roman VR, Robert-Guroff M. Adenoviruses as vectors for HIV vaccines. AIDS Rev. 2003 Jul-Sep;5(3):178-85.
PubMed 14598567McShane H. Prime-boost immunization strategies for infectious diseases. Curr Opin Mol Ther. 2002 Feb;4(1):23-7.
PubMed 11883691Pinto AR, Fitzgerald JC, Giles-Davis W, Gao GP, Wilson JM, Ertl HC. Induction of CD8+ T cells to an HIV-1 antigen through a prime boost regimen with heterologous E1-deleted adenoviral vaccine carriers. J Immunol. 2003 Dec 15;171(12):6774-9. doi: 10.4049/jimmunol.171.12.6774.
PubMed 14662882Shiver JW, Emini EA. Recent advances in the development of HIV-1 vaccines using replication-incompetent adenovirus vectors. Annu Rev Med. 2004;55:355-72. doi: 10.1146/annurev.med.55.091902.104344.
PubMed 14746526
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 I Clinical Trial to Evaluate the Safety of a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Administered to Healthy, HIV-1 Uninfected, Adult Participants Who Received DNA Plasmid Vaccine or Placebo in the HVTN 052 Clinical Trial
- ClinicalTrials.gov ID
- NCT00091416
- Acronym / sponsor ID
- HVTN 057
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- May 2006 (actual)
- First posted
- 9 Sep 2004 (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 test the safety of and immune response to an HIV-1 vaccine, VRC-HIVADV014-00-VP, when given as a vaccine booster to HIV uninfected adults who participated in HVTN 052.
Detailed description
The worldwide HIV epidemic highlights the importance of developing an affordable, globally successful vaccine for HIV prevention. The VRC-HIVADV014-00-VP adenoviral vector vaccine used in this study was developed to stimulate strong virus-specific CD8 cytotoxic T-lymphocyte (CTL) responses thought to be crucial in an effective preventive HIV vaccine. The purpose of this study is to determine the safety and immunogenicity of a VRC-HIVADV014-00-VP vaccine boost given to healthy, HIV uninfected individuals who participated in HVTN 052, which evaluated the VRC-HIVDNA009-00-VP DNA plasmid vaccine. In that study, participants received either 3 injections of vaccine, 2 injections of vaccine and 1 injection of placebo, or 3 injections of placebo over a 2-month period.
This study will last one year. Participants will be randomly assigned to receive vaccine boost or placebo by intramuscular injection. The injections will be given 6 to 9 months after each participant's first HVTN 052 study injection, preferably as close to 6 months after the first HVTN 052 injection as possible. After a screening visit, study visits will occur at enrollment (when the injection will be given), at Week 2, and at Months 1, 3, 6, and 12. Blood collection, physical exam, and medication assessment will occur at every study visit; urine collection will occur at selected visits.
Study design
- Primary purpose
- Prevention
- 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 (7 listed)
- Previously enrolled in and have completed all 3 study vaccine injections for HVTN 052
- Understanding of vaccination procedure
- Good general health
- HIV uninfected
- Hepatitis B surface antigen negative
Key exclusion criteria (22 listed)
- Immunosuppressive medications within 168 days prior to study
- Blood products within 120 days prior to study
- Immunoglobulin within 60 days prior to study
- Live attenuated vaccines within 30 days prior to study
- Investigational research agents within 30 days prior to study
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 | – |
Primary outcome
Not reported in the source record.
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 14598567Gomez-Roman VR, Robert-Guroff M. Adenoviruses as vectors for HIV vaccines. AIDS Rev. 2003 Jul-Sep;5(3):178-85.
- Background: PubMed 11883691McShane H. Prime-boost immunization strategies for infectious diseases. Curr Opin Mol Ther. 2002 Feb;4(1):23-7.
- Background: PubMed 14662882Pinto AR, Fitzgerald JC, Giles-Davis W, Gao GP, Wilson JM, Ertl HC. Induction of CD8+ T cells to an HIV-1 antigen through a prime boost regimen with heterologous E1-deleted adenoviral vaccine carriers. J Immunol. 2003 Dec 15;171(12):6774-9. doi: 10.4049/jimmunol.171.12.6774.
- Background: PubMed 14746526Shiver JW, Emini EA. Recent advances in the development of HIV-1 vaccines using replication-incompetent adenovirus vectors. Annu Rev Med. 2004;55:355-72. doi: 10.1146/annurev.med.55.091902.104344.
- Click here for more information about the HVTN 052 studyLink provided by the sponsor.
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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.
Larry Peiperl, MD study chair
San Francisco Department of Public Health / University of California - San Francisco
Julie McElrath, MD, PhD study chair
Fred Hutchinson Cancer Research Center / University of Washington
8 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-HIVADV014-00-VP in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 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 7 inclusion and 22 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 8 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00091416, which also lists 4 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.